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Background The prevalence of diabetes mellitus is ubiquitous . Complications and costs of diabetes are rising and are depleting limited re sources . It is imperative for healthcare professionals and patients alike to confront this chronic condition by exploring new interventions . An innovative health care delivery model has emerged in the last 25 years in the form of the group medical visit . Group medical visits can range from of six to twenty patients scheduled together with time allotted for individual care as well as in the group setting . Objectives The review objective was to conduct a systematic review and meta‐ analysis to synthesize the best available evidence related to effectiveness of group medical visits on HbA1c , blood pressure and cholesterol measurements /levels for adult patients with type II diabetes in outpatient setting s. Search strategy A three‐step literature search for studies in English language from 1990 to 2010 was conducted utilising ( a ) a primary search of Medline , CINAHL , PsycINFO and Cochrane Central Register of Controlled Trials , ( b ) a secondary search of non‐indexed data bases , and ( c ) a search of the grey literature . In addition , a manual review of the reference lists of all identified reports and articles was performed to identify additional studies . Inclusion criteria All r and omised and quasi‐experimental studies of adult patients ( > 18 ) with type II diabetes mellitus seen in outpatient health setting s were considered if they met one or more of the following diagnostic outcome measurements : haemoglobin A1c , systolic and diastolic blood pressure , and low density lipoprotein cholesterol . Critical appraisal , data collection and analysis Each of the eligible articles was review ed by two independent review ers . Disagreements between the review ers were resolved through discussion , or with a third review er . Studies that met the inclusion criteria were assessed for method ological quality using the JBI st and ardized critical appraisal tools . Data extraction was undertaken using the st and ardised data extraction tool from JBI‐MAStARI . Main results The search strategy identified 2,040 articles in the published and unpublished literature . Of these , 11 r and omised controlled trials and 4 quasi‐experimental trials met the inclusion criteria and represented 2240 patients included in the final review . There are clear benefits of group medical visits for patients ' HbA1c levels which are consistent in the post‐intervention and change from baseline effect sizes . The most significant effect observed is with the change from baseline results . Some evidence suggests post‐intervention and change from baseline systolic blood pressure improvement at the nine to twelve month interval and change from baseline improvement at the 4 year timeframe . There is no evidence that group visits improve LDL cholesterol values of the group visit participants . Conclusions Group medical visits should be considered by clinicians as an effective non‐pharmacologic intervention that can have a positive impact on biologic markers such as haemoglobin A1c and systolic blood pressure . Implication s for practice The evidence suggests that the most powerful model of Group medical visits ( GMV ) is when a clinician prescriber is present during or immediately after GMV sessions for medication reconciliation or individual patient needs . Implication s for research Future research should include this GMV intervention in r and omised controlled trials across different health systems and socio‐economic and ethnic groups Introduction The prevalence of gestational diabetes mellitus ( GDM ) is rising in the UK . Good glycaemic control improves maternal and neonatal outcomes . Frequent clinical review of patients with GDM by healthcare professionals is required owing to the rapidly changing physiology of pregnancy and its unpredictable course . Novel technologies that allow home blood glucose ( BG ) monitoring with results transmitted in real time to a healthcare professional have the potential to deliver good- quality healthcare to women more conveniently and at a lower cost to the patient and the healthcare provider compared to the conventional face-to-face or telephone-based consultation . We have developed an integrated GDm-health management system and aim to test the impact of using this system on maternal glycaemic control , costs , patient satisfaction and maternal and neonatal outcomes compared to st and ard clinic care in a single large publicly funded ( National Health Service ( NHS ) ) maternity unit . Methods and analysis Women with confirmed gestational diabetes in a current pregnancy are individually r and omised to either the GDm-health system and half the normal clinic visits or normal clinic care . Primary outcome is mean BG in each group from recruitment to delivery calculated , with adjustments made for number of BG measurements , proportion of prepr and ial and postpr and ial readings and length of time in study , and compared between the groups . The secondary objective will be to compare the two groups for compliance to the allocated BG monitoring regime , maternal and neonatal outcomes , glycaemic control using glycated haemoglobin ( HbA1c ) and other BG metrics , and patient attitudes to care assessed using a question naire and re source use . Ethics and dissemination Thresholds for treatment , dietary advice and clinical management are the same in both groups . The results of the study will be published in a peer- review ed journal and disseminated electronically and in print . Trial registration number NCT01916694 ; Pre- results Background Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care . Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications . The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes ( T1D ) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated . Despite the importance of minimizing loss to follow-up there are no r and omized control trials evaluating models of transition from pediatric to adult diabetes care . Methods / Design This is a multicentre r and omized controlled trial . A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated . Eligible subjects will be recruited from three pediatric care centres and r and omly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive st and ard diabetes care . The structured transition program is a multidisciplinary , complex intervention aim ing to provide additional support in the transition period . A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care . The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate . Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year . There will then be a one-year follow-up period for outcome assessment . The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care . Secondary outcome measures include A1C frequency measurement and levels , diabetes related emergency room visits and hospital admissions , frequency of complication screening , and subject perception and satisfaction with care . Discussion This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults . Trial registration Trial Registration Number : Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens . To improve medication management , providers must ensure that their patients underst and potential benefits , harms , and burdens of available options and elicit patients ' preferences and barriers to taking medications . Patients who are actively involved in treatment decision making tend to be more satisfied with their health care , be more adherent to treatment , and have improved clinical outcomes ( 13 ) . Such discussion s , however , can be too time-consuming for clinic visits . For inner-city low-income African American and Latino adults , low health literacy and limited English proficiency are often additional barriers ( 4 ) that reduce the exchange of information and decrease patient participation during primary care visits ( 58 ) . This contributes to less optimal treatment decisions and lower patient satisfaction , leading to poor medication adherence and outcomes ( 3 , 911 ) . There is therefore an urgent need for cost-effective approaches to enable low-re source health systems to help these high-risk population s gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making . Since 2000 , the REACH ( Racial and Ethnic Approaches to Community Health 2010 ) Detroit Partnership , a coalition of community , health system , and academic partners , has used community-based participatory research principles to guide development , implementation , and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit , Michigan . These interventions have built on evidence that community health workers ( CHWs ) are effective in improving diabetes outcomes , particularly among racial and ethnic minority communities ( 12 ) . CHW interventions train community members to work as bridges between their ethnic , cultural , or geographic communities and health care providers ( 13 ) . Two cohorts of participants in our previous CHW-led diabetes self-management support interventions  improved hemoglobin A1c ( HbA1c ) levels and diabetes distress compared with usual care ( 14 , 15 ) . An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence -based information to patients and to help patients make better self-management decisions ( 16 ) . Little is known about the effectiveness of different approaches for nontraditional care providers , such as CHWs , to deliver health information to ethnic minority and low-literacy population s ( 17 ) . By definition , CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support material s with patients as part of their coaching and counseling efforts . Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients ' preferences ( 18 , 19 ) . There is also evidence that tailored health messages are more effective than generic group messages ( 20 , 21 ) , including for patients with diabetes ( 22 , 23 ) . Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest ( 24 ) . Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes ( 25 , 26 ) . To date , however , most e-health applications have been design ed for use by patients with relatively high literacy and the skills to navigate them ( 27 ) . Do more sophisticated , tailored , interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational material s alone ? We addressed this question by developing and evaluating a personally tailored , interactive diabetes medication decision aid ( iDecide [ in English ] or iDecido [ in Spanish ] ) design ed for CHWs to deliver on tablet computers with 3 G wireless access to African American and Latino adults with diabetes and low health literacy . We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence -based information , without tailoring , through print consumer booklets developed by the Agency for Healthcare Research and Quality ( AHRQ ) . Methods Setting This study was developed and implemented by using community-based participatory research principles ( 28 ) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center ( CHASS ) , a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 ( 29 ) . The University of Michigan and CHASS institutional review boards approved the study . Content of AHRQ Consumer Guides The AHRQ guides ( Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes ) ( 30 , 31 ) provide information on diabetes and summarize the effectiveness of currently available medication classes  ( oral and insulin ) on HbA1c . They also provide information on administration methods , costs , medication adverse effects , risks for diabetes complications , suggested questions to discuss with health care providers , and prompts to make notes of any questions for the doctor . The booklets include pictures of patients and tables and graphs summarizing information . Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere ( 32 ) . Briefly , we used community-based participatory research and user-centered design ( 33 , 34 ) principles to iteratively develop and refine the iDecide tool . iDecide is available in English and Spanish , can be delivered via tablet computers , and enables navigation by the CHW and participant to selectively explore issues most important to the participant . The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides . However , its information is presented in a more graphical style suited to patients with low literacy . Table 1 summarizes key differences between the presentation of information in iDecide and the printed material s. The first section illustrates , through animations , how diabetes affects the way glucose is processed in the body and how different medication classes , foods , and physical activity affect blood glucose . The second section includes pictographs showing participants ' own risk for diabetes complications ( tailored according to their baseline HbA1c ) and enabling participants to explore how their risk for different complications changes with their HbA1c levels . In the third section , participants review their current diabetes medications and barriers to taking the medications they had reported on the baseline survey . This section includes an interactive issue card approach to help elicit patient preferences and priorities about different medication characteristics ( for example , cost , adverse effects , effects on weight , and dosing schedules ) ( 22 , 35 ) . The fourth section prompts participants to set goals and develop specific action plans to address identified barriers or other concerns and identify specific questions and concerns to discuss with their doctor about their medications or making lifestyle changes . Personal information from the baseline assessment is interwoven throughout the program ( high-depth tailoring within sentences ) . Motivational interviewingbased , tailored discussion prompts encourage autonomy-supportive CHWpatient interactions at key points with open-ended questions and values exploration to help participants discover their motivation , overcome barriers to change , and develop an action plan ( 36 ) . Table 1 . Comparison of Content and Mode of Delivery Between the iDecide Study Group and the Printed Material s Group Recruitment and R and omization From September 2011 to August 2012 , potentially eligible participants were identified from a computer-generated list of CHASS patients with physician-diagnosed type 2 diabetes . Inclusion criteria required a HbA1c value greater than 7.5 % in the previous 6 months or expressed concerns about current diabetes medications during the screening assessment . Exclusion criteria were age younger than 21 years , terminal health conditions , self-reported alcohol or drug abuse , and conditions ( such as blindness and dementia ) that would impede meaningful participation . Pregnant women and individuals who reported that they could not be contacted by telephone were also excluded . Introductory letters were sent in timed batches . Research staff then telephoned patients and screened them for eligibility . Interested eligible patients met with research staff , who facilitated completion of written informed consent , administered baseline surveys in English or Spanish , and measured HbA1c and blood pressure . Participants received a stipend of $ 20 after each assessment . Within 1 to 14 days , participants were scheduled for a visit with a CHW ( at home , the clinic , or another agreed-upon place ) . At the beginning of the CHW visits , participants were registered into the iDecide program and r and omly assigned by the computer program , through use of a r and om-sequence algorithm , into 1 of 2 study groups . There were no differences between the steps to participate in either study group . Patients , research staff , and CHWs were blinded to r and omization results through completion of all baseline measures up to the start of the intervention . Data assessors remained blinded to group assignment throughout the study . CHW Intervention for Both Study Groups All participants received an initial one-on-one , face-to-face session with a CHW and a copy of the printed material s to take home . The iDecide sessions lasted approximately 2 hours , and the sessions using printed material s lasted The practical , operational issues of access to medical care services are pivotal to all patients . Unlike other marketplaces , where the consumer is the decision maker , employers , payers , and providersrather than patients primarily influence the way the health care system functions . Patients often find themselves on the outside of the system , such as when employers switch health plans and patients must scramble for new providers . Some consumers are leaving the mainstream system to obtain various medical services , for example , using concierge physicians who charge annual fees for upscale service , overseas hospitals for surgery , and walk-in radiology screening services . The fact that patients and providers are leaving the system threatens to make health care access and delivery even more difficult for those who remain ( 1 - 7 ) . Business school students learn that consumers eventually get what they want ; who will give it to them and when are the unknowns . Although health care had been able in the past to function with little attention to consumer preference , the diffusion of consumer forces into health care is giving momentum to this iron law of consumerism . Given the central role of access in health carenothing can happen without itproviders have good reason to consider access from the patient 's perspective . This article presents patient-centered access as a philosophy and integrated concept . We define patient-centered access , identify its primary characteristics , discuss its key principles , and consider its future evolution . Parts of this article will strike a familiar cord . What is different is a comprehensive discussion of access innovation from the patient 's perspective . Related literature usually focuses on a specific access initiative , for example , e-mail communications with patients . All such initiatives are better understood in the broader context of overall system access . Patient-Centered Access Patient-centered access refers to a patient 's ability to secure appropriate and preferred medical assistance when and where it is needed . Characteristics of patient-centered access include availability , appropriateness , preference , and timeliness . Availability involves fundamental access : can a patient obtain a medical service ? Availability is primarily a function of offering a needed service in the patient 's geographic area and within the patient 's financial means . At least 1 of 7 Americans is uninsured , and the adverse effects on personal health and the health care system are well documented ( 8) . Appropriateness involves obtaining the proper level of care . Appropriateness is complicated by the potential discrepancy between what a patient wants and what is medically indicated . Today 's patients have far more access to medical information via the Internet and media . However , patients often lack the knowledge with which to filter and interpret this information . Providers influenced by patient pressure may facilitate inappropriate care , creating additional stress for an already overburdened system . Preference concerns patient access to a preferred provider or specific medical service . Patients may base preferences on experience , the recommendations of others , physical proximity , or marketing messages ( such as direct-to-consumer prescription drug advertising ) . The substantial market shift in recent years from health maintenance organizations to less restrictive preferred-provider organizations illustrates the salience of preference ( 9 , 10 ) . Timeliness concerns receiving care when desired . Most medical services are inseparable from patients ' physical presence . Access for inseparable services is complex because patients and providers must coordinate the time and location of the service . This need for coordination often creates a scenario in which patients are required to wait multiple times : for the primary care appointment , in the medical office , and for specialty care or tests ( 11 ) . Principles of Patient-Centered Access In Crossing the Quality Chasm , the Institute of Medicine proposed 6 aims for improvement in the 21st century : safety , effectiveness , patient-centeredness , timeliness , efficiency , and equitability ( 12 ) . Improving health care access supports each of these aims . A patient 's ability to secure appropriate and preferred medical assistance when and where it is needed should enhance safety , effectiveness , and equity ; will require efficiency ; and reflects patient-centeredness and timeliness . Improving health care access is at the center of improving health care . Enhancing access requires systemic thinking . The goals of patients , providers , and payers must be aligned . Providers that have succeeded in substantially improving access had to rebuild rather than fine-tune their service delivery system ; they focused on changing dysfunctional habits and assumptions as well as on technical medical issues ( 13 ) . As shown in the Figure , implementing patient-centered access requires embracing 3 principles : work at the high end of expertise ; align care with need and preference ; and serve when service is needed . In developing these principles , we conducted a comprehensive literature review from 1985 using the MEDLINE and Academic Health Reference Center data bases and search ing a targeted set of refereed medical journals . Figure . Implementing patient-centered access . Work at the High End of Expertise Many assume that the labor-intensive nature of health care makes productivity gains difficult to realize . Physicians are not assembly-line workers . Regardless of technology , physicians still need to see patients and integrate history , physical examination , test results , judgment born of experience , and specialized medical knowledge to create therapeutic plans . Nonetheless , health care productivity and access gains can be achieved by rethinking the process of who performs specific tasks and how . Health care access can be improved ( and cost of care decreased ) when members of the health care team , including the patient , work up to their training , skills , and experience . When health care professionals consistently work below their level of expertise , scarce re sources are wasted , care is more costly , boredom and frustration increase , and access is impaired . Specialist physicians should do less of what generalist physicians can do , generalist physicians should do less of what nonphysician providers can do , and nonphysician providers should do less of what non clinical staff can do . Each caregiver also should do less of what appropriately instructed patients and families can do for themselves . The application of information technology , team-provided care , and alignment of skills with tasks are necessary to implement this principle . Dr. Charles Burger 's primary care practice in Bangor , Maine , illustrates these approaches . Electronic medical records , examination room terminals  ,  computerized decision support  , and  e-mail patient communications  facilitate nurse practitioners , registered nurses , medical assistants , and patients working at high rather than low levels of their expertise ( 14 ) . For example , when patients call with a medical concern , receptionists use sophisticated triage software to determine whether to schedule an office visit , how soon and by whom the patient should be seen , and how much time the office visit will require ( 15 ) . The Mayo Clinic uses specially trained nonphysician providers for diabetes management after a physician conducts the initial evaluation and creates the care plan . The nonphysician provider monitors the patient and involves the physician if the patient experiences problems . The patient sees the physician at least once every 2 years . Mayo compared the team-care model to the physician-care model in an internal study in 2000 . Among the results was more timely access for patients . Other research supports fuller use of nonphysician provider skills and training ( 16 , 17 ) . In 1 r and omized clinical trial , research ers assigned 1316 patients to a primary care physician or a nurse practitioner . They found only minimal differences in health outcomes and patient satisfaction between the patient groups , although design and sampling issues limit generalizability ( 18 , 19 ) . Align Care with Need and Preference The conventional office visit access model does not fully accommo date patient heterogeneity . The office visit model works best for patients who need to be seen in person and can be well served in the time allotted for the appointment . However , this model often results in system overuse , such as when a patient familiar to the physician makes an office visit only to ask several quickly answered questions , and system underuse , such as when a 20-minute appointment slot prevents the physician from covering all relevant issues with the patient . As family physician Gordon Moore commented : One of the biggest mistakes in primary care is n't what we do to patients but what we omit ( 20 ) . Studies show a relationship between shorter office visits and inappropriate prescribing ( 21 ) , patient reluctance to ask questions ( 22 ) , less attention to psychological concerns ( 23 ) and patient education ( 24 , 25 ) , and lower levels of patient confidence and coping ( 26 ) . As Davidoff has written : The sad truth is that our trillion-dollar medical care system seems to feel that time spent with patients is a luxury it simply ca n't afford ( 27 ) . Diverse patient needs and preferences require a more flexible service delivery model that offers multiple entry paths into the practice . What might this system include in addition to the office visit with a physician ? Each of the following access paths is being used in more practice s. Office Appointments with Nonphysician Providers The use of nonphysician providers as autonomous providers within physician-staffed medical practice s is growing ( 28 ) because of the prevalence of chronic illness and pressure to control health care costs . The Balanced Budget Act of 1997 exp and ed direct Medicare reimbursement for physician The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management  were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group  who were taking insulin  received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise  received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to Background : This study assessed the relation of comorbid depressive syndrome with utilization of emergency department services and preventable inpatient hospitalizations among elderly individuals with chronic medical conditions . Research Design : A cross-sectional study . Setting : Individuals greater than or equal to 65 years of age living in the United States with Medicare part A and B fee-for-service coverage in 1999 . Subjects : A 5 % r and om sample of elderly Medicare recipients ( N = 1,238,895 ) of whom 60,382 ( 4.9 % ) met criteria for a depressive syndrome . Measurements : Medicare beneficiaries were stratified based on the presence of at least 1 of the following medical conditions : coronary artery disease , diabetes mellitus , congestive heart failure , hypertension , prostate cancer , breast cancer , lung cancer , or colon cancer . For each stratum , we compared the odds of emergency department visits , all-cause hospitalization , and hospitalization for ambulatory care sensitive conditions ( ACSC ) , conditions for which timely and effective medical care could decrease risk of hospitalization , for beneficiaries with and without a depressive syndrome . Results : Compared with those without a depressive syndrome , beneficiaries with a depressive syndrome were more likely to be older , white , and female ( P < 0.001 ) . For each of the 8 chronic medical conditions , elderly beneficiaries with a depressive syndrome were at least twice as likely to use emergency department services ( range of adjusted odds ratios , 2.12–3.16 ; P < 0.001 ) ; medical inpatient hospital services ( range of adjusted odds ratios , 2.59–3.71 ; P < 0.001 ) ; and medical inpatient hospital services associated with an ACSC ( range of adjusted odds ratios , 1.72–2.68 ; P < 0.001 ) as compared with those without a depressive syndrome . Conclusions : For elderly individuals with at least 1 chronic medical condition , the presence of a depressive syndrome increased the odds of acute medical service use , suggesting that improvements in clinical management , access to mental health services , and coordination of medical and mental health services could reduce utilization Background Antenatal care ( ANC ) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses , and indirectly through the detection of women at increased risk of delivery complications . The potential benefits of quality antenatal care services are most significant in low-re source countries where morbidity and mortality levels among women of reproductive age and neonates are higher . WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal , perinatal and neonatal outcomes . The aim of this study is to determine the effect of an intervention design ed to increase the use of the package of evidence -based services  included in the WHO ANC model in Mozambique . The primary hypothesis is that the intervention will increase the use of evidence -based practice s during ANC visits in comparison to the st and ard dissemination channels currently used in the country . Methods This is a demonstration project to be developed through a facility-based cluster r and omized controlled trial with a stepped wedge design . The intervention was tailored , based on formative research findings , to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers . The intervention includes four components : the provision of kits with all necessary medicines and laboratory supplies for ANC ( medical and non-medical equipment ) , a storage system , a tracking system , and training sessions for health care providers .  Ten clinics were selected and will start receiving the intervention in a r and om order . Outcomes will be computed at each time point when a new clinic starts the intervention . The primary outcomes are the delivery of selected health care practice s to women attending the first ANC visit , and secondary outcomes are the delivery of selected health care practice s to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practice s. This demonstration project is pragmatic in orientation and will be conducted under routine conditions . Discussion There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-re source countries . This can only be accomplished by the engagement of the country ’s health stakeholders at all levels . This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels : policy , organizational and health care delivery levels . The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘ habits ’ will contribute to obtaining reliable health indicators , not only related to research issues , but also to health care outcomes derived from the new health care model . At policy level , the results of this study may suggest a need for revision of the supply chain management system . Given that supply chain management is a major challenge for many low-re source countries , we envisage that important lessons on how to improve the supply chain in Mozambique and other similar setting s , will be drawn from this study .Trial registration Pan African Clinical Trial Registry data base . Identification number : PACTR201306000550192 Background A new model of complex diabetes care is provided by a multidisciplinary team which incorporates general practitioner ( GP ) Clinical Fellows supported by an Endocrinologist and diabetes educator within a community-based general practice setting . This study evaluates the health and clinical benefits of the new model of care , assesses the acceptability of the model to patients , GPs and other health professionals , and examines the cost-effectiveness of the model . Methods / Design The study is an open , non-inferiority r and omised controlled trial with data collected at baseline , 6 and 12 months . Participants are identified from new patients on hospital-based diabetes outpatient clinic waiting lists and new GP referrals . Eligible consenting patients are r and omised to either a community practice site ( intervention ) or a hospital site ( usual care ) . In the intervention model , medical care is led by a GP Clinical Fellow in partnership with an Endocrinologist . Quantitative measures include clinical indicators with HbA1c as the primary outcome ; patient-reported outcomes include health-related quality of life , mental health and satisfaction with care . Qualitative methods will be used to explore the perspectives and experiences of patients and providers regarding the new model of care . An economic evaluation will also be undertaken . Discussion This model of care seeks to improve the quality and safety of healthcare at the interface between the hospital and primary care sectors for patients with complex diabetes . The study will provide empirical evidence about the impact of the model of care on health outcomes , patient and clinician satisfaction , as well as any economic impacts . Trial registration Clinical Trials Registry Number : AIMS AND OBJECTIVES To examine the effects of a low cost advanced practice nurse telephone intervention for 2 months postbirth in low-income first time mothers with healthy full term infants . BACKGROUND Currently women with non-complicated , healthy full term newborn deliveries receive little to no routine postpartum support . This is problematic if mothers are first time mothers , poor , have problems accessing health care , have language barriers and sparse social support . DESIGN A two group r and omised clinical trial . This study was conducted in an inner city South Florida county hospital . METHODS A control group ( n = 69 ) received routine hospital discharge care . An intervention group ( n = 70 ) received routine hospital discharge care plus APN follow up telephone calls for week 8 postdischarge . Comparison of outcomes included maternal health ( stress , social support , physical health ) , infant health ( routine medical visits , immunisations , weight gain ) , morbidity ( urgent care visits , emergency room visits , re-hospitalisations ) , and health care charges ( urgent care visits , emergency room visits , re-hospitalisations ) . Data were analysed using descriptive statistics and two- sample t-tests . RESULTS Intervention group mothers had significantly lower perceived stress , significantly greater perceived maternal health and social support ; infants had healthier weight gain , fewer emergency room visits ; significantly lower total health care charges ( $ 14,333 vs. $ 70,834 ) compared to controls . CONCLUSION Study results indicate that APN follow up telephone calls to low-income first time mothers with healthy full term infants is an effective , safe , low cost , easy to apply intervention that improved mothers ' and infants ' health outcomes and reduced healthcare charges . RELEVANCE TO CLINICAL PRACTICE APNs are uniquely positioned to conduct follow up interventions aim ed at providing continuity of care including APN telephone follow up . This is imperative for vulnerable population s especially during times of major budget cuts that affect health care services BACKGROUND Physical activity and dietary behavior changes are important to both the primary prevention and secondary management of the majority of our most prevalent chronic conditions ( i.e. , cardiovascular disease , hypertension , type 2 diabetes , breast and colon cancer ) . With over 85 % of Australian adults visiting a general practitioner each year , the general practice setting has enormous potential to facilitate wide scale delivery of health behaviour interventions . However , there are also many barriers to delivery in such setting s , including lack of time , training , re sources and remuneration . Thus there is an important need to evaluate other feasible and effective means of delivering evidence -based physical activity and dietary behaviour programs to patients in primary care , including telephone counseling interventions . METHODS Using a cluster r and omized design with practice as the unit of r and omization , this study evaluated a telephone-delivered intervention for physical activity and dietary change targeting patients with chronic conditions ( type 2 diabetes or hypertension ) recruited from primary care practice s in a socially disadvantaged community in Queensl and , Australia . Ten practice s were r and omly assigned to the telephone intervention or to  usual care  , and 434 patients were recruited . Patients in intervention practice s received a workbook and 18 calls over 12 months . Assessment at baseline , 4- , 12- and 18-months allows for assessment of initial change and maintenance of primary outcomes ( physical activity and dietary behavior change ) and secondary outcomes ( quality of life , cost-effectiveness , support for health behavior change ) . CONCLUSIONS This effectiveness trial adds to the currently limited number of telephone-delivered intervention studies targeting both physical activity and dietary change . It also addresses some of the shortcomings of previous trials by targeting patients from a disadvantaged community , and by including detailed reporting on participant representativeness , intervention implementation and cost-effectiveness , as well as an evaluation of maintenance of health behavior change Abstract Background : Healthcare costs for chronic obstructive pulmonary disease ( COPD ) have continued to increase with the increasing prevalence of the disease . New interventions that can reduce the medical costs of COPD are needed . Tiotropium bromide , a once-daily inhaled anticholinergic , has been evaluated in patients with COPD enrolled in two 1-year r and omised , double-blind , placebo-controlled ( usual care ) trials which showed the drug reduced exacerbations and improved spirometry , dyspnoea , and health status . Objective : To retrospectively assess the direct costs of medical care for COPD in a US healthcare setting for patients treated with tiotropium in addition to usual care compared with usual care alone over a 1-year timeframe . The study was based on re source utilisation in the two previously described trials . Methods : Re source utilisation and clinical data were prospect ively collected for the two 1-year , r and omised , double-blind trials of tiotropium plus usual care versus usual care alone ( placebo ) in 921 patients with COPD . Usual care was defined as any medication for COPD used prior to the trial except anticholinergics and long-acting β-adrenoceptor agonists . Medical care re source utilisation was recorded at every scheduled visit in each trial . Mean total costs were calculated retrospectively by combining the re sources utilised with the appropriate unit costs ( 1999 US dollars ) , excluding study drug ( tiotropium ) costs . Results : Compared with usual care , patients receiving tiotropium in addition to usual care had significantly fewer COPD exacerbations ( 20 % decrease ) , hospitalisations ( 44 % reduction ) and hospital days ( 50 % reduction ) . Utilisation of re sources other than hospitalisation did not differ between study groups . As a consequence , patients receiving tiotropium had significantly lower mean per- patient costs of hospitalisation compared with patients receiving usual care alone ( tiotropium $ US1738 ± $ US259 ; placebo $ US2793 ± $ US453 ) . The mean difference in the cost of hospitalisation ( result ing from all causes , including COPD ) between treatment groups was -$US1056 ( 95 % CI -$US2078 , -$US34 ) , and the difference in total healthcare costs ( excluding study drug acquisition cost ) was -$US1043 ( 95 % CI -$US2136 , $ US48 ) in favour of tiotropium  . The cost of hospital admissions accounted for 48 % of the total direct medical costs in this trial . Conclusions : As hospitalisation is a large contributor to the cost of COPD , the addition of tiotropium to usual care therapy may have the potential to reduce the economic burden of COPD in a US healthcare setting . However , as our study did not consider the acquisition cost of tiotropium , further economic evaluation including this cost is needed to address whether tiotropium is cost saving compared with usual care ( placebo ) Abstract Aims /hypothesis . Metabolic control worsens progressively in Type II ( non-insulin-dependent ) diabetes mellitus despite intensified pharmacological treatment and lifestyle intervention , when these are implemented on a one-to-one basis . We compared traditional individual diabetes care with a model in which routine follow-up is managed by interactive group visits while individual consultations are reserved for emerging medical problems and yearly checks for complications . Methods . A r and omized controlled clinical trial of 56 patients with non-insulin-treated Type II diabetes managed by systemic group education and 56 control patients managed by individual consultations and education .  Results . Observation times were 51.2±2.1 months for group care and 51.2±1.8 for control subjects . Glycated haemoglobin increased in the control group but not in the group of patients ( p<0.001 ) , in whom BMI decreased ( p<0.001 ) and HDL-cholesterol increased ( p<0.001 ) . Quality of life , knowledge of diabetes and health behaviours improved with group care ( p<0.001 , all ) and worsened among the control patients ( p=0.004 to p<0.001 ) . Dosage of hypoglycaemic agents decreased ( p<0.001 ) and retinopathy progressed less ( p<0.009 ) among the group care patients than the control subjects . Diastolic blood pressure ( p<0.001 ) and relative cardiovascular risk ( p<0.05 ) decreased from baseline in group patients and control patients alike . Over the study period , group care required 196 min and 756.54 US $ per patient , compared with 150 min and 665.77 US $ for the control patients , result ing in an additional 2.12 US $ spent per point gained in the quality of life score . Conclusion /interpretation . Group care by systemic education is feasible in an ordinary diabetes clinic and cost-effective in preventing the deterioration of metabolic control and quality of life in Type II diabetes without increasing pharmacological treatment Background Type 2 diabetes ( T2D ) brings significant human and healthcare costs . Its progressive nature means achieving normoglycaemia is increasingly difficult , yet critical to avoiding long term vascular complications . Nearly one-half of people with T2D have glycaemic levels out of target . Insulin is effective in achieving glycaemic targets , yet initiation of insulin is often delayed , particularly in primary care . Given limited access to specialist re sources and the size of the diabetes epidemic , primary care is where insulin initiation must become part of routine practice . This would also support integrated holistic care for people with diabetes . Our Stepping Up Program is based on a general practitioner ( GP ) and practice nurse ( PN ) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses . Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care . Methods This protocol is for a cluster r and omized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D . 224 patients between the ages of 18 and 80 years with T2D , on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5 % in the last six months will be recruited from 74 general practice s. The unit of r and omization is the practice . Primary outcome is change in glycated haemoglobin HbA1c ( measured as a continuous variable ) . We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5 % lower than control group at 12 months follow up . Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of < 7.0 % . We will also collect data on patient psychosocial outcomes and healthcare utilization and costs . Discussion The study is a pragmatic translational study with important potential implication s for people with T2D , healthcare professionals and funders of healthcare though making better use of scarce healthcare re sources , improving timely access to therapy that can improve disease outcomes .Trial registration Australian and New Zeal and Clinical Trials Registry OBJECTIVE Appropriate glycemic control is fundamental to diabetes care , but aggressive glucose targets and intensive therapy may unintentionally increase episodes of hypoglycemia . We quantified the burden of severe hypoglycemia requiring medical intervention in a well-defined population of insured individuals with diabetes receiving care in integrated health care delivery systems across the U.S. RESEARCH DESIGN AND METHODS This observational cohort study included 917,440 adults with diabetes receiving care during 2005 to 2011 at participating SUrveillance , PREvention , and ManagEment of Diabetes Mellitus ( SUPREME-DM ) network sites .  Severe hypoglycemia rates were based on any occurrence of hypoglycemia-related ICD-9 codes from emergency department or inpatient medical encounters and reported overall and by age , sex , comorbidity status , antecedent A1C level , and medication use . RESULTS Annual rates of severe hypoglycemia ranged from 1.4 to 1.6 events per 100 person-years . Rates of severe hypoglycemia were higher among those with older age , chronic kidney disease , congestive heart failure , cardiovascular disease , depression , and higher A1C levels , and in users of insulin , insulin secretagogues , or β-blockers ( P < 0.001 for all ) . Changes in severe hypoglycemia occurrence over time were not clinical ly significant in the cohort as a whole but were observed in subgroups of individuals with chronic kidney disease , congestive heart failure , and cardiovascular disease . CONCLUSIONS Risk of severe hypoglycemia in clinical setting s is considerably higher in identifiable patient subgroups than in r and omized controlled trials . Strategies that reduce the risk of hypoglycemia in high-risk patients are needed BACKGROUND Maternal complications including psychological and mental health problems and neonatal morbidity have been commonly observed in the postpartum period . Home visits by health professionals or lay supporters in the weeks following the birth may prevent health problems from becoming chronic with long-term effects on women , their babies , and their families . OBJECTIVES To assess outcomes for women and babies of different home-visiting schedules during the early postpartum period . The review focuses on the frequency of home visits , the duration ( when visits ended ) and intensity , and on different types of home-visiting interventions . SEARCH METHODS We search ed the Cochrane Pregnancy and Childbirth Group 's Trials Register ( 28 January 2013 ) and reference lists of retrieved articles . SELECTION CRITERIA R and omised controlled trials ( RCTs ) ( including cluster- RCTs ) comparing different types of home-visiting interventions  enrolling participants in the early postpartum period ( up to 42 days after birth ) . We excluded studies in which women were enrolled and received an intervention during the antenatal period ( even if the intervention continued into the postnatal period ) and studies recruiting only women from specific high-risk groups . ( e.g. women with alcohol or drug problems ) . DATA COLLECTION AND ANALYSIS Study eligibility was assessed by at least two review authors . Data extraction and assessment of risk of bias were carried out independently by at least two review authors . Data were entered into Review Manager software . MAIN RESULTS We included data from 12 r and omised trials with data for more than 11,000 women . The trials were carried out in countries across the world , and in both high- and low-re source setting s. In low-re source setting s women receiving usual care may have received no additional postnatal care after early hospital discharge . The interventions and control conditions varied considerably across studies with trials focusing on three broad types of comparisons : schedules involving more versus fewer postnatal home visits ( five studies ) , schedules involving different models of care ( three studies ) , and home versus hospital clinic postnatal check-ups ( four studies ) . In all but two of the included studies , postnatal care at home was delivered by healthcare professionals . The aim of all interventions was broadly to assess the wellbeing of mothers and babies , and to provide education and support , although some interventions had more specific aims such as to encourage breastfeeding , or to provide practical support . For most of our outcomes only one or two studies provided data , and overall results were inconsistent . There was no evidence that home visits were associated with improvements in maternal and neonatal mortality , and no strong evidence that more postnatal visits at home were associated with improvements in maternal health . More intensive schedules of home visits did not appear to improve maternal psychological health and results from two studies suggested that women receiving more visits had higher mean depression scores . The reason for this finding was not clear . There was some evidence that postnatal care at home may reduce infant health service utilisation in the weeks following the birth , and that more home visits may encourage more women to exclusively breastfeed their babies . There was some evidence that home visits are associated with increased maternal satisfaction with postnatal care . AUTHORS ' CONCLUSIONS Overall , findings were inconsistent . Postnatal home visits may promote infant health and maternal satisfaction . However , the frequency , timing , duration and intensity of such postnatal care visits should be based upon local needs . Further well design ed RCTs evaluating this complex intervention will be required to formulate the optimal package The aim of this study was to determine whether home telehealth , when integrated with the health facility 's electronic medical record system , reduces healthcare costs and improves quality -of-life outcomes relative to usual home healthcare services for elderly high re source users with complex co-morbidities . Study patients were identified through the medical center 's data base . Intervention patients received home telehealth units that used st and ard phone lines to communicate with the hospital . FDA -approved peripheral devices monitored vital signs and valid question naires were used to evaluate quality -of-life outcomes . Out-of-range data triggered electronic alerts to nurse case managers . ( No live video or audio was incorporated in either direction . ) Templated progress notes facilitated seamless data entry into the patient 's electronic medical record . Participants ( n = 104 ) with complex heart failure , chronic lung disease , and /or diabetes mellitus were r and omly assigned to an intervention or control group for 6 - 12 months . Parametric and nonparametric analyses were performed to compare outcomes for ( 1 ) subjective and objective quality -of-life measures , ( 2 ) health re source use , and ( 3 ) costs . In contrast to the control group , scores for home telehealth subjects showed a statistically significant decrease at 6 months for bed-days-of-care ( p < 0.0001 ) , urgent clinic/emergency room visits ( p = 0.023 ) , and A1C levels ( p < 0.0001 ) ; at 12 months for cognitive status ( p < 0.028 ) ; and at 3 months for patient satisfaction ( p < 0.001 ) . Functional levels and patient-rated health status did not show a significant difference for either group . Integrating home telehealth with the healthcare institution 's electronic data base significantly reduces re source use and improves cognitive status , treatment compliance , and stability of chronic disease for homebound elderly with common complex co-morbidities ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Background Type 2 diabetes ( T2DM ) affects 113.9 million people in China , the largest number of any country in the world ( JAMA 310:948–59 , 2013 ) . T2DM prevalence has risen dramatically from around 1 % in the 1980s to now over 10 % and is expected to continue rising . Despite the growing disease burden , few people with T2DM are achieving adequate management targets to prevent complications . Health system infrastructure in China is struggling to meet these gaps in care , and innovative , cost-effective and affordable solutions are needed . One promising strategy that may be particularly relevant to the Chinese context is improving support for lay family members to care for their relatives with T2DM . Methods We hypothesise that an interactive mobile health management system can support lay family health promoters ( FHP ) and healthcare staff to improve clinical outcomes for family members with T2DM through medical assessment , regular monitoring , lifestyle advice and the prescribing of guidelines recommended medications . This intervention will be implemented as a cluster r and omised controlled trial involving 80 communities ( 40 communities in Beijing and 40 rural villages in Hebei province ) and 2000 people with T2DM . Outcome analyses will be conducted blinded to intervention allocation . The primary outcome is the proportion of patients achieving ≥2 “ ABC ” goals ( HbA1c < 7.0 % , blood pressure ( BP ) < 140/80 mmHg and LDL cholesterol < 100 mg/dl or 2.6 mmol/L ) at the end of follow-up ( Diabetes Care 36(Supplement 1):S11-S66 , 2013 ) . Secondary outcomes include the proportion of patients achieving individual ABC targets ; mean changes in HbA1c , BP , LDL , renal function ( serum creatinine and urinary albumin ) , body mass index , quality of life ( QOL , EQ-5D ) , and healthcare utilisation from baseline ; and cost-effectiveness/utility of intervention . Trial outcomes will be accompanied by detailed process and economic evaluations . Discussion The Chinese government has prioritised prevention and treatment of diabetes as 1 of 11 National Basic Public Health Services . Despite great promise for mHealth interventions to improve access to effective health care , there remains uncertainty about how this can be successfully achieved . The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China . Trial registration Clinical trials.gov DIABETES MELLITUS EXACTS AN ENORMOUS TOLL IN the United States by decreasing quality of life and causing death and disability , all at a huge economic cost . Yet simple diagnostic criteria and effective treatment choices that prevent or delay the onset of costly diabetes complications are readily available to health care professionals . It is time for health care professionals and patients with diabetes to take action together to reduce premature morbidity and mortality from diabetes-caused disease . The National Diabetes Education Program is the first joint diabetes initiative of the National Institutes of Health and the Centers for Disease Control and Prevention and involves public and private partnerships to promote early diagnosis and improve the treatment and outcomes for patients with type 1 and type 2 diabetes mellitus . It is estimated that in the United States , type 2 diabetes can be present for up to 9 to 12 years before initial clinical diagnosis . Microvasculardiseaseprogressesduringthis time , causing 15 % to 20 % of patients to have retinopathy and 5 % to 10%tohaveproteinuriaat the timeofdiagnosis . Patients with type 2 diabetes have high rates of hypertension , dyslipidemia , and obesity , major reasons for their 2to 4-fold higher rates ofcardiovasculardisease . Type2diabetes isoccurring increasingly in younger people . Although every patient can be expected to benefit from any increment in improved glycemic control , blood glucose control is more effective in preventing the initial development of microvascular complications than inpreventing theprogressionofcomplicationsonce theyhave become established . This finding underscores the need for aggressive treatment as soon as type 2 diabetes is diagnosed . Diabetes accounts for almost $ 100 billion in direct medical costs and indirect expenditures attributable to diabetes each year . Further , while patients with diabetes represented 4.5 % of the US population in 1992 , they accounted for 15 % of total US health care expenditures and 27 % of Medicare expenditures . There is a marked correlation between glycemic control of diabetes as measured by glycosylated hemoglobin ( HbA1c ) testing and the cost of medical care . Medical care charges increase significantly for every 1 % increase in HbA1c level above 7 % . In 1994 , excess expenditures for patients with diabetes in a managed care setting totaled $ 282.7 million or $ 3494 per person—2.4 times the cost for control subjects . Nearly 38 % of the total excess was spent treating the long-term complications of diabetes , predominantly coronary heart disease and end-stage renal disease . Because of its high and increasing prevalence , type 2 diabetes contributes a significant portion of these costs . There is substantial evidence that the human and economic burden of diabetes can be reduced significantly by early , aggressive therapeutic intervention . The Diabetes Control and Complications Trial and the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) demonstrated that intensive blood glucose control for patients with type 1 and type 2 diabetes significantly reduced the risk for retinopathy , nephropathy , and neuropathy . Lowering blood pressure in a subset of UKPDS patients to a mean of 144/82 mm Hg reduced the risk of strokes , diabetes-related deaths , heart failure , microvascular complications , and vision INTRODUCTION Diabetic foot ulcers are a feared complication of diabetes . Care delivered via telemedicine is suggested to be a more integrated care pathway to manage diabetic foot ulcers than traditionally delivered healthcare . Our aim was to explore patients ' experiences with telemedicine follow-up care as compared to traditional care . METHODS Interpretive description was used as an analysis strategy . Data were collected using individual semi-structured interviews in the context of a larger ongoing clustered r and omized controlled trial . Twenty-four patients ( 13 in the intervention group ; 11 in the control group ) , aged 38 - 88 years were purposively recruited from the RCT in order to obtain a diverse sample in terms of group composition ( intervention vs. control ) , age , gender , marital status , setting , and comorbidities present . The control group received traditional care . RESULTS Three themes emerged from the interpretive analysis : competence of healthcare professionals , continuity of care , and easy access . This was independed of types of follow-up that had limited impact on the patients ' follow-up experiences . Competence of healthcare professionals and continuity of care were crucial , because they can either enhance or jeopardize wound care . If these two latter factors were absent , patients would lose confidence in the wound care process . If this happened , patients pointed out that the expert knowledge of a specialist clinic was essential to receive good care . When telemedicine functioned optimally , telemedicine was an advantage in the treatment , because the images quickly captured changes in the wound healing that immediately could be corrected . Easy access is important for patients , but the importance of accessibility appears to be primary when the other two factors were present . CONCLUSION The best wound care pathway for patients with diabetes foot ulcers is depended on a combination of competence and professional skills in wound management , and continuity of care . If telemedicine is functioning as intended , it can be an important additional tool Background The Northwestern University Center for Education and Research on Therapeutics ( CERT ) , funded by the Agency for Healthcare Research and Quality , is one of seven such centers in the USA . The thematic focus of the Northwestern CERT is ‘ Tools for Optimizing Medication Safety . ’ Ensuring drug safety is essential , as many adults struggle to take medications , with estimates indicating that only half of adults take drugs as prescribed . This report describes the methods and rationale for one innovative project within the CERT : the ‘ Primary Care , Electronic Health Record-Based Strategy to Promote Safe and Appropriate Drug Use ’ . Methods / Design The overall objective of this 5-year study is to evaluate a health literacy-informed , electronic health record-based strategy for promoting safe and effective prescription medication use in a primary care setting . A total of 600 English and Spanish-speaking patients with diabetes will be consecutively recruited to participate in the study . Patients will be r and omized to receive either usual care or the intervention ;  those in the intervention arm will receive a set of print material s design ed to support medication use and prompt provider counseling and medication reconciliation . Participants will be interviewed in person after their index clinic visit and again one month later . Process outcomes related to intervention delivery will be recorded . A medical chart review will be performed at 6 months . Patient outcome measures include medication underst and ing , adherence and clinical measures ( hemoglobin A1c , blood pressure , and cholesterol ; exploratory outcomes only ) . Discussion Through this study , we will be able to examine the impact of a health literacy-informed , electronic health record-based strategy on medication underst and ing and adherence among diabetic primary care patients . The measurement of process outcomes will help inform how the strategy might ultimately be refined and disseminated to other sites . Strategies such as these are needed to address the multifaceted challenges related to medication self-management among patients with chronic conditions . Trial registration Clinical trials.gov NCT01669473 Background Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems . Antenatal care has the potential to reduce maternal morbidity and improve newborns ’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining . We evaluated the association between a mobile phone intervention and antenatal care in a re source -limited setting . We aim ed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy . Methods This study was an open label pragmatic cluster-r and omised controlled trial with primary healthcare facilities in Zanzibar as the unit of r and omisation . 2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery . 24 primary health care facilities in six districts were r and omized to either mobile phone intervention or st and ard care . The intervention consisted of a mobile phone text-message and voucher component . Primary outcome measure was four or more antenatal care visits during pregnancy . Secondary outcome measures were tetanus vaccination , preventive treatment for malaria , gestational age at last antenatal care visit , and antepartum referral . Results The mobile phone intervention was associated with an increase in antenatal care attendance . In the intervention group 44 % of the women received four or more antenatal care visits versus 31 % in the control group ( OR , 2.39 ; 95 % CI , 1.03 - 5.55 ) . There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant . Conclusions The  wired mothers ’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services , more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred . Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in re source -limited setting s . Trial registration Clinical Trials.gov , NCT01821222 & NA ; Little is known about the relationship between chronic pain status and overall use of healthcare . We examined whether disabling chronic pain was associated with more frequent use of healthcare in three setting s : primary care , emergency departments , and hospital admissions . We used data from Computer‐Assisted Telephone Interviews ( CATI ) of 17,543 residents in New South Wales , Australia aged 16 and over who were r and omly sample d using a population ‐based two‐stage stratified sample and r and om digit dialling methods . The overall response rate was 70.8 % . Compared to chronic pain respondents with no or limited pain‐related disability , those with most pain‐related disability reported more : primary care visits in the last 2 weeks and last 12 months ( adjusted mean number of visits 0.59 vs 0.40 and 10.72 vs 4.81 , both P<0.005 ) ; hospital admissions ( 0.46 vs 0.18 , P<0.005 ) ; and emergency department visits ( 0.85 vs 0.17 , P>0.005 ) . In modelling , having chronic pain per se , or having chronic pain with any level of activity interference predicted health care use after adjusting for age , gender , self‐rated health , psychological distress , comorbidity and access to care . Higher levels of pain‐related disability predicted health care use more than other pain status variables . There was a strong association between pain‐related disability and greater use of services . Further work is needed to underst and the nature of this association . Given the fluctuating course of chronic pain over time , there is a significant segment of the population that may be at risk of developing higher levels of disability associated with increased use of services Background The costs of gestational diabetes mellitus ( GDM ) screening have been frequently reported , but total GDM-related health care costs compared to the health care costs of women without GDM have not been reported . The aim of this study was to analyse GDM-related health care costs among women with an elevated risk of GDM . Methods The study was based on a cluster-r and omised GDM prevention trial ( N = 848 ) carried out at maternity clinics , combined with data from the Finnish Medical Birth Register and Care Registers for Social Welfare and Health Care . Costs of outpatient visits to primary and secondary care , cost of inpatient hospital care before and after delivery , the use of insulin , delivery costs and babies ’ stay in the neonatal intensive care unit were analysed . Women who developed GDM were compared to those who were not diagnosed with GDM . Results Total mean health care costs adjusted for age , body mass index and education were 25.1 % higher among women diagnosed with GDM ( € 6,432 vs. € 5,143 , p < 0.001 ) than among women without GDM . The cost of inpatient visits was 44 % higher and neonatal intensive care unit use was 49 % higher in the GDM group than among women without GDM . The delivery costs were the largest single component in both groups . Conclusions A confirmed GDM diagnosis was associated with a significant increase in total health care costs . Effective lifestyle counselling by primary health care providers may offer a means of reducing the high costs of secondary care Substantial healthcare expenses can impoverish households or push them further into poverty . In this paper , we examine the cost of obstetric care  and the social and economic consequences associated with exposure to economic shocks up to a year following the end of pregnancy in Burkina Faso . Burkina Faso is a low-income country with poor health outcomes and a poorly functioning health system . We present an inter-disciplinary analysis of an ethnographic study of 82 women nested in a prospect i ve cohort study of 1013 women . We compare the experiences of women who survived life-threatening obstetric complications ( ' near-miss ' events ) with women who delivered without complications in hospitals . The cost of emergency obstetric care  was significantly higher than the cost of care for uncomplicated delivery . Compared with women who had uncomplicated deliveries , women who survived near-miss events experienced substantial difficulties meeting the costs of care , reflecting the high cost of emergency obstetric care and the low socioeconomic status of their households . They reported more frequent sale of assets , borrowing and slower repayment of debt in the year following the expenditure . Healthcare costs consumed a large part of households ' re sources and women who survived near-miss events continued to spend significantly more on healthcare in the year following the event , while at the same time experiencing continued cost barriers to accessing healthcare . In-depth interviews confirm that the economic burden of emergency obstetric care  contributed to severe and long-lasting consequences for women and their households . The necessity of meeting unexpectedly high costs challenged social expectations and patterns of reciprocity between husb and s , wives and wider social networks , placed enormous strain on everyday survival and shaped physical , social and economic well-being in the year that followed the event . In conclusion , we consider the implication s of our findings for financing mechanisms for maternity care in low-income setting BACKGROUND Postpartum hospital stays seem likely to remain limited even under new laws which m and ate that insurers cover 48-hour hospitalization after uncomplicated delivery . Clinicians , who are increasingly practicing in capitated arrangements , need better information to maximize clinical benefit to mothers and newborns using finite re sources . OBJECTIVE AND INTERVENTIONS : This study 's aim was to evaluate the clinical outcomes , patient perceptions , and costs of a revised model of perinatal care services . In this model , a new postpartum care center was established for routine follow-up of newborns within 48 hours after hospital discharge , educational efforts were shifted from the postpartum hospitalization to the prenatal period , and lactation consultant hours were increased . DESIGN AND PARTICIPANTS Controlled , nonr and omized ( double cohort ) study that compared mothers and newborns with hospital stays of 48 hours or less during the Baseline Care ( preintervention ) study period ( N = 344 ) with those under the Revised Care ( postintervention ) study period ( N = 456 ) . SETTING The Hayward , California , medical center of Kaiser Permanente , a nonprofit health maintenance organization .  DATA COLLECTION Telephone interviews were attempted with all mothers 3 weeks after delivery . Data on rehospitalizations , emergency department ( ED ) and clinic visits , and costs during the first 14 postpartum days were collected from computerized data bases and chart review . OUTCOME MEASURES The combined clinical outcome was defined as any undesirable health event , including rehospitalization , an ED visit , or an urgent clinic visit by either the mother or newborn within the first 14 days postpartum , or breastfeeding discontinuation within the first 21 days postpartum . Maternal satisfaction and costs were also studied . RESULTS Of 876 attempted interviews , 800 were completed ( 91 % ) . Analyses were adjusted for age , race , education , parity , breastfeeding experience , and other relevant variables . Among the interviewed mother-newborn pairs , 45 % in the Revised Care group experienced the combined clinical outcome , compared with 52 % in the Baseline Care group . Newborns in the Revised Care group ( 29 % ) were significantly less likely to make urgent clinic visits during the first 14 days of life than those in the Baseline Care group ( 36 % ) . There were no differences between groups in newborn ED visits or rehospitalizations , maternal clinical outcomes , or breastfeeding continuation . Mothers in the Revised Care group expressed higher satisfaction with the newborn 's care , the amount of information they received about newborn care and breastfeeding , and the amount of help they received with breastfeeding . Planned hospital care , planned follow-up visits , and unplanned care costs decreased by $ 149 per delivery , while the new prenatal class and increased lactation consultant services cost $ 58 per delivery , for an estimated overall reduction in cost . CONCLUSIONS We conclude that the revised model of perinatal care in this health maintenance organization medical center improved clinical outcomes and maternal satisfaction for low-risk mothers and newborns without increasing costs The objective of the study was to determine the effectiveness and cost-effectiveness of primary care and community-oriented interventions in managing HbA1c , blood pressure , and lipids , and reducing hospitalizations and emergency room visits over 2 years . We describe an ongoing , r and omized controlled trial of 542 urban African-Americans with type 2 diabetes ages 25 years and older who are members of a university-affiliated managed-care organization in Baltimore , MD . The participants are 74 % female , have a mean age of 58 years , and 35 % have yearly incomes greater than 7500 US dollars . Participants were r and omized to one of two intervention groups for a period of 2 years : ( 1 ) usual medical care plus minimal telephone intervention implemented by a trained lay health educator ( control group ) or ( 2 ) usual medical care plus intensive intervention implemented by a nurse case manager (NCM)/community health worker ( CHW ) team . The intensive NCM/CHW team executes individual plans of care using evidence -based algorithms that focus on traditional diabetes self-management , screening and management of diabetes-related complications , and social issues surrounding diabetes care . Face-to-face NCM visits are conducted in the clinic once per year and CHW visits are conducted in the participant 's home one to three times per year , both with additional follow-up contacts as needed . Written and verbal feedback ( when necessary ) is provided to the participant 's primary care physician . All participants are expected to attend a 24-month follow-up visit where data are collected by interviewers blinded to intervention assignment . As of May 1 , 2003 , recruitment is complete , interventions are being fully implemented , and 24-month follow-up visits are beginning . Baseline sociodemographic characteristics , health-care utilization , health behaviors , and clinical characteristics of the study population are reported . This study is design ed to test the hypothesis that a primary -care-based NCM plus CHW team approach is an effective , practical , and economically feasible strategy for translating current knowledge about type 2 diabetes into high- quality health care for urban African-Americans Context Dissatisfaction with traditional care for patients with chronic conditions is leading to new models of care . Contribution The investigators found that protocol -based care by medical assistants for patients with diabetes mellitus , chronic obstructive pulmonary disease , or chronic heart failure did not prevent rehospitalization but did improve quality of life at a reasonable cost . Caution Relatively few practice s were included in the study . Implication Medical assistants can participate in new models of care for patients with chronic conditions . Primary care faces the challenge of caring for an increasing number of patients with multiple chronic conditions with a diminishing workforce ( 1 , 2 ) . These patients are at high risk for potentially avoidable hospitalizations , which result in substantial system-level health care spending ( 3 ) and affect patient quality of life ( 4 ) . Although most hospitalizations are deemed unavoidable ( 5 , 6 ) , primary care physicians report that self-management support and intensified monitoring could prevent 40 % of hospitalizations in patients with multiple chronic conditions ( 7 ) . Studies of nurse-led care management interventions that focus on patients at high risk for future health care use , such as Guided Care ( 8) or Geriatric Re sources for Assessment and Care of Elders ( 9 ) , have recently evaluated self-management support and intensified monitoring . Despite substantial improvements in quality of care ( 8) and reductions in health care use ( 10 ) , these interventions did not reduce overall health care spending ( 8 , 10 ) , partly because savings from reduced health care use were offset by the costs of these interventions . In small primary care setting s ( solo practice s or 2-person partnerships ) , re sources are often limited and extensive collaborative models , such as multiprofessional care management , may be difficult to implement . The medical assistant workforce is one of the fastest growing workforces in primary care practice s in the United States ( 11 ) , and all primary care practice s in Germany employ medical assistants . Medical assistants in the United States are trained in a 3-year part-time curriculum in practice ( 3920 hours ) and vocational school ( 840 hours ) . Despite recent attempts to involve medical assistants in chronic care , their work focuses primarily on clerical duties ( including reception ) and routine tasks , such as blood sampling or electrocardiogram recording , and their median annual salary is $ 28860 ( 11 ) . Certified medical assistants in the United States and Germany are comparable with regard to education , tasks , and remuneration ( 11 ) . Involving medical assistants in chronic care management may improve access to health services ( 12 ) . Early programs that exp and ed the medical assistant 's role to include chronic care services ( under the supervision of primary care physicians ) , such as self-management support ( 13 ) or telephone monitoring in patients with osteoarthritis ( 14 ) , major depression ( 15 ) , or chronic heart failure ( 16 ) , showed significant results in terms of specialist consultation rates ( 13 , 14 ) , medication management ( 14 ) , depressive symptoms ( 15 ) , and self-care behavior ( 16 ) . All of these programs were " scripted , " meaning that medical assistants followed evidence -based protocol s and algorithms with defined interview questions . We aim ed to determine whether a medical assistantbased scripted care management intervention ( primary carebased care management [ PraCMan ] ) would reduce hospitalizations in primary care patients with type 2 diabetes , chronic obstructive pulmonary disease ( COPD ) , or chronic heart failure who had a high predicted risk for future hospitalization . Methods Design We performed a cluster r and omized clinical trial using primary care practice s as units of r and omization to minimize contamination bias . We have published details of the study design ( 17 ) . Setting and Participants We conducted the study between July 2010 and June 2013 and enrolled patients from October to December 2010 . Practice s were eligible for the study if they employed at least 1 primary care physician ( such as a general practitioner or general internist ) and at least 1 medical assistant and if both were willing to participate in the study . Primary care physicians had to be enrolled in the primary carecentered care contract of a large health plan in Germany ( AOK Baden-Wrttemberg ) ( 18 ) . Because " medical assistant " is a defined health profession in Germany ( 19 ) , we did not need additional inclusion criteria for them . Practice s were recruited from July to September 2010 . We informed all 1177 primary care physicians within the health plan of AOK Baden-Wrttemberg about the study and invited all interested physicians to participate in the study . Eligible patients were aged 18 years or older and were receiving medical treatment for at least 1 of the following index conditions : type 2 diabetes mellitus , COPD , or chronic heart failure . Furthermore , patients had to have a high risk for future hospitalization ( that is , a predicted likelihood of hospitalization within the upper quartile of the total population of health plan patients , as determined by analysis of data from the preceding 18 months [ 20 ] ) . We calculated the likelihood of hospitalization by assessing the deidentified insurance cl aims data of all health plan beneficiaries from the participating practice s using the vali date d prediction software Case Smart Suite Germany 0.7 ( Verisk Health ) ( 21 ) . We excluded patients who met the following criteria : active cancer ( cancer diagnosis and current receipt of radiotherapy or chemotherapy ) , moderate to severe dementia , permanent residency in a nursing home , participation in a concurrent clinical trial ( including telemonitoring studies ) , severe physical and mental disorders ( such as dementia , psychotic disorder , or palliative care needs ) , or other problems that hindered active participation in the intervention ( such as language barriers ) , as assessed by the primary care physician . Previous studies have vali date d this process of inclusion and exclusion ( 20 ) . After providing written informed consent , participating patients provided baseline data . We concealed the allocation to intervention or control groups until each practice completed patient enrollment and baseline assessment . R and omization and Interventions Primary care practice s were r and omly allocated to care management or usual care in a 1:1 ratio by block r and omization with variable block lengths . Because population density has a substantial effect on hospitalizations ( 22 ) , we stratified r and omization according to the population density of the participating practice sites ( urban vs. rural ) , based on a map provided by the Federal Agency of Regional Development Planning . We used computer-generated r and omization lists ( SAS , version 9.2 [ SAS Institute ] ) . A research assistant who was not otherwise involved in the project performed the central r and omization . We informed physicians about their allocation via an official letter and asked them to inform participating patients . Because of the nature of the intervention , blinding primary care physicians , medical assistants , and patients was not possible . However , we blinded the assessment of the primary and secondary end points as well as the responsible statistician to study group allocation . Training of Practice Teams We trained 71 medical assistants in a 2-day course on behavioral counseling strategies , symptom monitoring , medication assessment , and  interprofessional communication  by using a training manual ( Appendix Table 1 ) . Training was complemented by 20 hours of self- study . Appendix Table 1 . Training Manual Intervention Using early evidence on a collaborative care concept for patients with multiple chronic conditions in an established nonprofit U.S. HMO ( 23 ) , we trained medical assistants by using a paper-based assessment checklist to reveal patients ' needs and re sources ( 17 ) . Primary care physicians and patients negotiated patient-specific goals , with a special emphasis on self-management tasks ( 24 ) . Medical assistants developed specific action plans to achieve these goals together with patients and caregivers . A folder that included health information and an optional emergency plan was offered to all patients . Medical assistants monitored goal achievement and symptom deterioration either face-to-face with patients in the clinic or by telephone using paper-based checklists ( 25 , 26 ) . Monitoring intervals were tailored to the patient 's health status but were scheduled at least once every 6 weeks . Primary care physicians met with medical assistants weekly to review patient progress . We fixed the maximum caseload for medical assistants at 20 patients ( in addition to their daily duties , such as reception and phlebotomy ) . We financially incentivized intervention practice teams by providing $ 135 per enrolled patient per year to cover staff costs . Usual Care Patients in the control group received the best primary care according to evidence -based practice guidelines ( 18 ) . Outcomes and Follow-up The primary outcome was the number of all-cause hospitalizations at 12 months at the patient level . We set the date of r and omization as the starting date of the intervention . We did not include hospitalizations that occurred before the start of the intervention ( that is , before 3 November 2010 ) , but we did include hospitalizations that persisted after the end of the intervention ( that is , after 3 November 2012 ) . Secondary measures included the number of days in the hospital ; hospitalizations related to index conditions ; patient-reported quality of life , which was assessed with the 12-Item Short Form Health Survey ( SF-12 ) ( mental and physical health scales ranging from 0 [ poor ] to 100 [ good ] ) ( 27 ) ; general health , which was assessed with the EuroQol instrument ( EQ-5D ) ( scores ranging from 0 [ poor health ] to 1 [ perfect health ] ) ( 28 ) ; and all-cause mortality . We estimated intervention costs using st and ard wages UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT Objectives : To conduct an economic evaluation comparing a traditional antenatal visiting schedule ( traditional care ) with a reduced schedule of visits ( new style care ) for women at low risk of complications . Methods : Economic evaluation using the results of a r and omised controlled trial , the Antenatal Care Project . This took place between 1993 and 1994 in antenatal clinics in South East London and involved 2794 women at low risk of complications . Results : The estimated baseline costs to the UK National Health Service ( NHS ) for the traditional schedule were £ 544 per woman , of which £ 251 occurred antenatally , with a range of £ 327–1203 per woman . The estimated baseline costs to the NHS for the reduced visit schedule was £ 563 per woman , of which £ 225 occurred antenatally , with a range of £ 274–1741 per woman . Savings from new style care that arose antenatally were offset by the greater numbers of babies in this group who required special or intensive care . Sensitivity analyses based on possible variations in unit costs and re source use and modelled postnatal stay showed considerable variation and substantial overlap in costs . Conclusions : Patterns of antenatal care involving fewer routine visits for women at low risk of complications are unlikely to result in savings to the Health Service . In addition , women who had the reduced schedule of care reported greater dissatisfaction with their care and poorer psychosocial outcomes which argues against reducing numbers of antenatal visits Background Care management interventions in the German health-care system have been evaluated with promising results , but further research is necessary to explore their full potential in the context of multi-morbidity . Our aim in this trial is to assess the efficacy of a primary care practice network – based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions . Methods / Design The study is design ed as a prospect i ve , 18-month , multicentre , investigator-blinded , two-arm , open-label , individual-level , r and omized parallel-group superiority trial . We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient . Data will be collected at baseline ( T0 ) , at the primary endpoint after 9 months ( T1 ) and at follow-up after 18 months ( T2 ) . The primary outcome will be the differences between the  intervention and control groups  in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities ( SDSCA-G ) . The secondary outcomes will be the differences between the intervention and control groups in : changes in scores on the SDSCA-G subscales , glycosylated haemoglobin A level , health-related quality of life , self-efficacy , differences in ( severe ) symptomatic hypoglycaemia , cost-effectiveness and financial family burden . The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements : ( 1 ) three home visits , including structured assessment of medical and social needs ; ( 2 ) 24 structured telephone monitoring contacts ; and ( 3 ) self-monitoring of blood glucose levels after T1 in 3-month intervals . The control group will receive usual care . The confirmatory primary analysis will be performed following the intention-to-treat ( ITT ) principle . The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle . In health economic evaluations , we will estimate the incremental cost-effectiveness ratios . Discussion We hope that the results of this study will provide insights into the efficacy of practice network – based care management among patients with complex health-care needs . Trial registration Current Controlled Trials IS RCT N83908315 ( IS RCT N assigned 25 February 2014 ) Context A previous Markov modelbased analysis estimated that use of the Diabetes Prevention Program diet and exercise intervention to forestall diabetes in high-risk people would be cost-effective from a societal perspective . Contribution Using a vali date d model design ed to be more complete and realistic than previous models , the authors estimated that the intervention would cost society about $ 62600 per quality -adjusted life-year saved . It would be cost-saving if the annual cost of the intervention decreased from $ 672 to $ 100 . Implication s This model suggests that the Diabetes Prevention Program intervention costs more per quality -adjusted life-year saved than previously estimated , and health plans and insurers may consider it too expensive to cover . The Editors Recent r and omized , controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs ( 1 , 2 ) or glucose-lowering drugs ( 2 - 4 ) . For example , in the Diabetes Prevention Program ( DPP ) , the relative reductions in the 2.8-year incidence of diabetes were 58 % in the lifestyle modification group and 31 % in the metformin group ( 2 ) . This raises hopes of substantially reducing the morbidity , mortality , and cost of this important disease . However , the trial was too short to observe the effects on microvascular or macrovascular outcomes , and the programs cost several hundred dollars a year ( 5 ) . These findings generate obvious questions : What are the long-term effects of trying to prevent diabetes in high-risk people ? Does lifestyle modification truly prevent or just postpone diabetes ? Is such a prevention program cost-effective ? What is the best strategy ? A previous analysis has suggested that lifestyle modification would be cost-effective over 75 years from a societal perspective ( 6 ) . We used a more thorough , clinical ly realistic , and independently vali date d model to estimate the short- and intermediate-term health and economic effects of different prevention programs for high-risk individuals and health plans , as well as for society . Methods We conducted the analysis by using the Archimedes model , which has been described elsewhere ( 7 - 9 ) . Briefly , it is a simulation model written at a relatively high level of anatomic , physiologic , clinical , and administrative detail . It uses object-oriented programming to create in the model objects that correspond to objects in reality , one-to-one . Among the hundreds of objects are  people , pancreases , cells , plasma glucose levels , coronary arteries , plaque , chest pain , emergency departments , electrocardiograms , aspirin , and angioplasties  . Helpful analogies might be a flight simulator ( in which the objects include the plane and its wings , airports , runways , buildings , and the wind ) , or the SimCity computer game . In the Archimedes model , each individual is simulated down to the level of hepatic glucose production , insulin resistance , -cell fatigue , and similar biological variables . The core of the model is a set of differential equations that represent the anatomy and physiology pertinent to diseases and their complications . Currently , the model includes diabetes , congestive heart failure , coronary artery disease , stroke , hypertension , and asthma in a single integrated model . The structure and equations of the model pertinent to diabetes and its complications are described elsewhere ( 8 , 9 ) . The Appendix and a technical report available through our Web site ( 10 ) describe additional aspects of the model and its validations that are pertinent to this analysis . Calculations are performed by using a distributed computing network . Clinical Events The model includes the biological variables and outcomes relevant to diabetes and its complications . Examples are basal hepatic glucose production ; insulin amount ; insulin resistance ; fasting plasma glucose ; hemoglobin A1c ( HbA1c ) ; 2-hour oral glucose tolerance ; high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , and total cholesterol ; triglycerides ; systolic and diastolic blood pressures and their determinants ( for example , cardiac output , arterial compliance , peripheral resistance ) ; weight and body mass index ( BMI ) ; stenosis of coronary arteries ; retinopathy ( assessed by the Early Treatment of Diabetic Retinopathy scale ) ; urine protein ; creatinine ; peripheral neuropathy ; foot ulcers of varying degrees of severity ; and amputations . The use of differential equations preserves the continuous nature of biological variables as well as the interactions between them . Clinical outcomes are defined in terms of the underlying variables , as occurs in reality . For example , a person is said to have diabetes if his or her fasting plasma glucose level exceeds 6.9375 mmol/L ( 125 mg/dL ) or results on a 2-hour oral glucose tolerance test exceed 11.0445 mmol/L ( 199 mg/dL ) . This enables the model to incorporate different definitions and changes in definitions . The model is continuous : Biological variables are changing and interacting continuously , the natural histories and severity of conditions progress smoothly , any clinical event can occur at any time , and the timing of events is as condensed or drawn out as occurs in reality . The model also includes a detailed representation of the processes and logistics of clinical care and their related costs . Interventions , both to prevent diabetes and to manage it when it occurs , are modeled at the level of the underlying biology . Pertinent to this analysis is that in the model , diet and exercise reduce weight ( 2 ) ; reduce blood pressure ( 11 ) ; improve LDL cholesterol , HDL cholesterol , and total cholesterol levels ( 12 ) ; and decrease fasting plasma glucose levels ( 2 ) . The effects of metformin in the model are to reduce fasting plasma glucose and 2-hour oral glucose tolerance test results ( 2 ) ( by reducing basal hepatic glucose production ) , decrease LDL cholesterol and triglyceride levels ( 13 ) , and retard weight gain . Data used to build the model were derived from basic physiologic studies , surveys , epidemiologic studies , and clinical trials using methods described in the technical report ( 10 ) . Every variable in the model is estimated from at least 1 empirical source ; no variables are simply assumed . We identified specific sources by search ing MEDLINE from 1970 to 28 February 2005 and by consulting textbooks and clinical experts . Because the model includes scores of continuously valued , interacting variables , it does not have simplified states , transitions , or events at discrete time intervals that can be tabulated , as is commonly done for a Markov-type model . The equations themselves are in the technical report ( 10 ) . For nonmathematical readers , we have calculated annualized rates of change of representative biological variables and annualized rates of occurrence of representative clinical events , and compared them with rates for comparable events observed in epidemiologic studies and clinical trials . The Appendix reports those results . Costs The DPP measured the direct medical costs of delivering the lifestyle and metformin interventions  ( for example , personnel , health education material s , medications , and laboratory tests ) . Compared with the placebo group 's costs , costs in the lifestyle group were $ 1356 more per person in the first year , with approximately $ 672 in annual costs thereafter ; for the metformin group , costs were $ 977 in the first year and averaged $ 742 per year thereafter ( 5 ) . Following the completion of the DPP , metformin became generic . When this is considered , the cost of the metformin program is reduced to about $ 780 for 3 years , or about $ 260 a year . In the DPP study , costs apply to the year 2000 . To calculate the routine costs of providing health care to high-risk people before they develop diabetes , as well as to people with diabetes and its complications , the model includes a detailed mathematical representation of a health care system , including such elements as facilities , personnel , tests and treatments , protocol s , and provider behaviors . For the base-case analysis , we obtained itemized costs from Kaiser Permanente , a nonprofit , group- practice , integrated managed care organization that provides comprehensive care ( with no deductibles or copayments ) . The facilities , personnel , protocol s , and costs in the model are based on that organization 's records , at the level of detail at which actual accounts are kept ( for example , 37 different kinds of office visits ) . The model calculates costs by keeping track of the occurrence of every event that has cost implication s and adding them up . The costs assigned to any event or item were calculated by Kaiser Permanente 's cost-accounting department using micro-costing methods ( 14 ) , and they represent the real costs to the organization , not charges , reimbursements , or diagnosis-related groups . Because costs vary from setting to setting , the implication s of different cost structures are examined in the sensitivity analysis . Calculation of costs applies to the year 2000 . Indirect costs , such as lost time from work and decreased productivity , are included in the cost-effectiveness analysis through the Quality of Well-Being Index ( 14 ) . We calculated the effects of lifestyle and metformin interventions  on quality of life . For people who do not yet have diabetes , we used utility weights reported for the participants of the DPP study ( 15 ) . For people who have diabetes and its complications , we used the results of a published survey by Coffey and colleagues ( 16 ) . Both surveys used the Quality of Well-Being Index . The decrements in quality of life were assumed to be additive for people who have 2 or more complications , with a limit that quality of life could not be less than 0 . Use of an additive rule biases the calculation of cost/ quality -adjusted life-year ( QALY ) in favor of a prevention program , making the program appear more cost-effective than would occur if a multiplicative model were used . We discuss the
The most significant effect observed is with the change from baseline results .
Some evidence suggests post-intervention and change from baseline systolic blood pressure improvement at the nine to twelve month interval and change from baseline improvement at the 4 year timeframe .
There is no evidence that group visits improve LDL cholesterol values of the group visit participants .
IMPLICATION S FOR PRACTICE The evidence suggests that the most powerful model of Group medical visits ( GMV ) is when a clinician prescriber is present during or immediately after GMV sessions for medication reconciliation or individual patient needs .
BACKGROUND The prevalence of diabetes mellitus is ubiquitous .
Complications and costs of diabetes are rising and are depleting limited re sources .
It is imperative for healthcare professionals and patients alike to confront this chronic condition by exploring new interventions .
An innovative health care delivery model has emerged in the last 25 years in the form of the group medical visit .
Group medical visits can range from of six to twenty patients scheduled together with time allotted for individual care as well as in the group setting .