The Impact of a Multidisciplinary Information Technology–Supported Program on Blood Pressure Control in Primary Care Improving Adherence to Medication in Stroke Survivors: A Pilot Randomised Controlled Trial Pilot Study to Test the Effectiveness of Different Financial Incentives to Improve Medication Adherence Compliance With Secondary Prevention of Ischemic Stroke: A Prospective Evaluation A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial Effectiveness of a pharmacist-led drug counseling on enhancing antihypertensive adherence and blood pressure control: a randomized controlled trial. The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial.
Background —Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects . Effective programs to address this problem are lacking . We hypothesized that an information technology – supported management program could help improve blood pressure ( BP ) control . Methods and Results —This r and omized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP > 130/80 and daytime BP > 135/85 mm Hg measured with ambulatory monitoring ( ABPM ) . Intervention subjects received a BP monitor and access to an information technology – supported adherence and BP monitoring system providing nurses , pharmacists , and physicians with monthly reports . Control subjects received usual care . The mean ( ±SD ) follow-up was 348 ( ±78 ) and 349 ( ±84 ) days in the intervention and control group , respectively . The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic ( −11.9 versus −7.1 mm Hg ; P<0.001 ) and diastolic BP ( −6.6 versus −4.5 mm Hg ; P=0.007 ) . The proportion of subjects that achieved Canadian Guideline target BP ( 46.0 % versus 28.6 % ) was also greater in the intervention group ( P=0.006 ) . We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control . The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents ( P=0.03 ) , more antihypertensive classes at study end ( P=0.007 ) , and a trend toward improved adherence measured by prescription refills ( P=0.07 ) . Conclusions —This multidisciplinary information technology – supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting Background Adherence to preventive medication is often poor , and current interventions have had limited success . Purpose This study was conducted to pilot a r and omised controlled trial aim ed at increasing adherence to preventive medication  in stroke survivors using a brief , personalised intervention . Methods Sixty-two stroke survivors were r and omly allocated to either a two-session intervention aim ed at increasing adherence via ( a ) introducing a plan linked to environmental cues ( implementation intentions ) to help establish a better medication-taking routine ( habit ) and ( b ) eliciting and modifying any mistaken patient beliefs regarding medication/stroke or a control group . Primary outcome was adherence to antihypertensive medication  measured objective ly over 3 months using an electronic pill bottle . Results Fifty-eight people used the pill bottle and were analysed as allocated ; 54 completed treatment . The intervention result ed in 10 % more doses taken on schedule ( intervention , 97 % ; control , 87 % ; 95 % CI for difference ( 0.2 , 16.2 ) ; p = 0.048 ) . Conclusions A simple , brief intervention increased medication adherence in stroke survivors , over and above any effect of increased patient contact or mere measurement . ( http://controlled-trials.com , number IS RCT N38274953 . Background : Medication nonadherence affects health care costs , morbidity , and mortality . Concepts from behavioral economics can guide the development of interventions to improve medication adherence . Objective : To measure the relative effectiveness of 2 behavioral economic-based incentive structures to improve medication adherence . Methods : This r and omized controlled trial compared adherence among participants taking antihypertensive or antihyperlipidemic medications r and omized to usual care ( UC ) , guaranteed pay-out ( GPO ) incentives , or lottery incentives .  Daily adherence was measured over a 90-day period using electronic caps ( Medication Event Monitoring System [ MEMS ] ) . The GPO group received $ 30 up-front in a virtual account , with $ 0.50 deducted for each missed dose .  Lottery group participants were eligible for a weekly $ 50 drawing , but only if they had taken their medication as prescribed all week . An electronic survey assessed self-reported adherence . Statistical analysis included descriptive statistics , paired t tests , ANOVA , and Pearson ’s correlations . Results : In all , 36 participants were r and omized ( UC , n = 11 ; GPO , n = 14 ; lottery , n = 11 ) .  Mean percentage ( ±SD ) of days adherent during the incentive period was highest in the lottery group ( 96 % ± 5 % ) , followed by the GPO group ( 94 % ± 9 % ) and the UC group ( 94 % ± 9 % ) . There were no statistically significant differences among groups ( P > 0.05 ) . MEMS-measured adherence was not significantly correlated with a patient ’s self-reported adherence ( P > 0.05 ) at baseline but was correlated at 90-day follow-up ( P < 0.001 ) . Conclusions : Although no statistically significant differences in adherence were demonstrated in this small sample of highly adherent participants , larger studies in a more diverse population or with other medications might show otherwise Background and Purpose — Compliance with pharmacological therapy is essential for the efficiency of secondary prevention of ischemic stroke . Few data exist regarding patient compliance with antithrombotic and risk factor treatment outside of controlled clinical trials . The aim of the present study was to assess the rate of and predictors for compliance with secondary stroke prevention 1 year after cerebral ischemia and to identify reasons for noncompliance . Methods — Patients with a diagnosis of ischemic stroke or TIA and antithrombotic discharge medication were prospect ively recruited . At 1 year , the proportion of patients compliant with antithrombotic treatment and with medication for risk factors ( eg , hypertension , diabetes , hyperlipidemia ) was evaluated through structured telephone interviews . In addition , the reasons for nontreatment with antithrombotic and risk factor medication were determined . Independent predictors for compliance were analyzed by logistic regression analyses . Results — Of 588 consecutive patients admitted to our stroke unit , 470 had a discharge diagnosis of cerebral ischemia ( TIA 26.2 % , cerebral infa rct 73.8 % ) and recommendations for  antithrombotic therapy . At 1 year , 63 patients ( 13.4 % ) had died and 21 ( 4.5 % ) were lost to follow-up , thus , 386 could finally be evaluated . Of the patients , 87.6 % were still on antithrombotic medication , and 70.2 % were treated with the same agent prescribed on discharge . Of the patients with hypertension , diabetes , and hyperlipidemia , 90.8 % , 84.9 % , and 70.2 % were still treated for their respective risk factors . Logistic regression analyses revealed age ( OR 1.03 , 95 % CI 1.00 to 1.06 ) , stroke severity on admission ( OR 1.09 , 95 % CI 1.00 to 1.20 ) , and cardioembolic cause ( OR 4.13 , 95 % CI 1.23 to 13.83 ) as independent predictors of compliance . Conclusions — Compliance with secondary prevention in patients with ischemic stroke is rather good in the setting of our study . Higher age , a more severe neurological deficit on admission , and cardioembolic stroke cause are associated with better long-term compliance . Knowledge of these determinants may help to further improve the quality of stroke prevention Theory-based intervention programmes to support health-related behaviour change aim to increase health impact and improve underst and ing of mechanisms of behaviour change . However , the science of intervention development remains at an early stage . We present a causal modelling approach to developing complex interventions for evaluation in r and omized trials . In this approach a generic model links behavioural determinants , causally through behaviour , to physiological and biochemical variables , and health outcomes . It is tailored to context , target population , behaviours and health outcomes . The development of a specific causal model based on theory and evidence is illustrated by the ProActive programme , supporting increased physical activity  among individuals at risk of Type 2 diabetes . The model provides a rational guide to appropriate measures , intervention points and intervention techniques , and can be tested quantitatively . Causal modelling is critically compared to other approaches to intervention development and evaluation , and research directions are indicated Objective To test whether offering financial incentives to patients with psychotic disorders is effective in improving adherence to maintenance treatment with antipsychotics . Design Cluster r and omised controlled trial . Setting Community mental health teams in secondary psychiatric care in the United Kingdom . Participants Patients with a diagnosis of schizophrenia , schizoaffective disorder , or bipolar disorder , who were prescribed long acting antipsychotic ( depot ) injections but had received 75 % or less of the prescribed injections . We r and omly allocated 73 teams with a total of 141 patients . Primary outcome data were available for 35 intervention teams with 75 patients ( 96 % of r and omised ) and for 31 control teams with 56 patients ( 89 % of r and omised ) . Interventions Participants in the  intervention group were offered £ 15 ( € 17 ; $ 22 ) for each depot injection over a 12 month period . Participants in the control condition received treatment as usual . Main outcome measure The primary outcome was the percentage of prescribed depot injections given during the 12 month intervention period . Results 73 teams with 141 consenting patients were r and omised , and outcomes were assessed for 131 patients ( 93 % ) .  Average baseline adherence was 69 % in the intervention group and 67 % in the control group . During the 12 month trial period adherence was 85 % in the intervention group and 71 % in the control group . The adjusted effect estimate was 11.5 % ( 95 % confidence interval 3.9 % to 19.0 % , P=0.003 ) . A secondary outcome was an adherence of ≥95 % , which was achieved in 28 % of the intervention group and 5 % of the control group ( adjusted odds ratio 8.21 , 95 % confidence interval 2.00 to 33.67 , P=0.003 ) . Although differences in clinician rated clinical improvement between the groups failed to reach statistical significance , patients in the intervention group had more favourable subjective quality of life ratings ( β=0.71 , 95 % confidence interval 0.26 to 1.15 , P=0.002 ) . The number of admissions to hospital and adverse events were low in both groups and did not show substantial differences . Conclusion Offering modest financial incentives to patients with psychotic disorders is an effective method for improving adherence to maintenance treatment with antipsychotics . Trial registration Current Controlled Trials IS RCT N77769281 Adherence to antihypertensive medications represents a crucial success factor for optimal blood pressure ( BP ) control in clinical practice . This study evaluated whether an additional pharmacist-led medication counseling could achieve better optimal BP control and enhance compliance .  In a design ated family clinic in a region with similar resident characteristics to Hong Kong , patients taking ≥ one antihypertensive agent with suboptimal compliance were r and omly allocated to a brief 3-minute drug advice ( control ; n = 161 ) or pharmacist counseling ( intervention ; n = 113 ) . The two groups were compared by repeated measure ANOVA at 3-months and 6-months with BP control and medication compliance as outcome variables , respectively . The proportions of patients having optimal compliance increased from 0 % to 41.1 % at 3 months and 61.9 % at 6 months ( P < 0.001 ) . The proportion of patients having optimal BP control improved from 64.1 % at baseline to 74.0 % at 3 months and 74.5 % at 6 months ( P = 0.023 ) . There were no significant differences between the two groups in the changes of BP control and compliance levels . This study implied that even a brief 3-minute drug advice might lead to improved BP levels  among patients on antihypertensive medications in general practice , but did not demonstrate additional effects by pharmacist counseling BACKGROUND This report details the development of the Men 's Safer Sex website and the results of a feasibility r and omised controlled trial ( RCT ) , health economic assessment and qualitative evaluation . OBJECTIVES ( 1 ) Develop the Men 's Safer Sex website to address barriers to condom use ; ( 2 ) determine the best design for an online RCT ; ( 3 ) inform the methods for collecting and analysing health economic data ; ( 4 ) assess the Sexual Quality of Life ( SQoL ) question naire and European Quality of Life-5 Dimensions , three-level version ( EQ-5D-3L ) to calculate quality -adjusted life-years ( QALYs ) ; and ( 5 ) explore clinic staff and men 's views of online research methodology . METHODS ( 1 ) Website development : we combined evidence from research literature and the views of experts ( n = 18 ) and male clinic users ( n = 43 ) ; ( 2 ) feasibility RCT : 159 heterosexually active men were recruited from three sexual health clinics and were r and omised by computer to the Men 's Safer Sex website plus usual care ( n = 84 ) or usual clinic care only ( n = 75 ) . Men were invited to complete online question naires at 3 , 6 , 9 and 12 months , and sexually transmitted infection ( STI ) diagnoses were recorded from clinic notes at 12 months ; ( 3 ) health economic evaluation : we investigated the impact of using different question naires to calculate utilities and QALYs ( the EQ-5D-3L and SQoL question naire ) , and compared different methods to collect re source use ; and ( 4 ) qualitative evaluation : thematic analysis of interviews with 11 male trial participants and nine clinic staff , as well as free-text comments from online outcome question naires . RESULTS ( 1 ) Software errors and clinic Wi-Fi access presented significant challenges . Response rates for online question naires were poor but improved with larger vouchers ( from 36 % with £ 10 to 50 % with £ 30 ) . Clinical records were located for 94 % of participants for STI diagnoses . There were no group differences in condomless sex with female partners [ incidence rate ratio ( IRR ) 1.01 , 95 % confidence interval ( CI ) 0.52 to 1.96 ] . New STI diagnoses were recorded for 8.8 % ( 7/80 ) of the intervention group and 13.0 % ( 9/69 ) of the control group ( IRR 0.75 , 95 % CI 0.29 to 1.89 ) . ( 2 ) Health-care re source data were more complete using patient files than question naires . The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included . ( 3 ) The pilot RCT fitted well around clinical activities but 37 % of the intervention group did not see the Men 's Safer Sex website and technical problems were frustrating . Men 's views of the Men 's Safer Sex website and research procedures were largely positive . CONCLUSIONS It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome ; however , technical errors and a poor response rate limited the collection of online self-reported outcomes . The next steps are ( 1 ) to optimise software for online trials , ( 2 ) to find the best ways to integrate digital health promotion with clinical services , ( 3 ) to develop more precise methods for collecting re source use data and ( 4 ) to work out how to overcome barriers to digital intervention testing and implementation in the NHS . TRIAL REGISTRATION Current Controlled Trials IS RCT N18649610 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 91 . See the NIHR Journals Library website for further project information BACKGROUND Poor adherence to long-term antipsychotic injectable ( LAI ) medication in patients with psychotic disorders is associated with a range of negative outcomes . No psychosocial intervention has been found to be consistently effective in improving adherence . OBJECTIVES To test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives . DESIGN A cluster r and omised controlled trial with economic and nested qualitative evaluation . The intervention period lasted for 12 months with 24 months ' follow-up . The unit of r and omisation was mental health teams in the community . SETTING Community teams in secondary mental health care . PARTICIPANTS Patients with a diagnosis of schizophrenia , schizoaffective psychosis or bipolar illness , receiving ≤ 75 % of their prescribed LAI medication . In total , 73 teams with 141 patients ( intervention n = 78 and control n = 63 ) were included . INTERVENTIONS Participants in the intervention group received £ 15 for each LAI medication . Patients in the control group  received treatment as usual . MAIN OUTCOME MEASURES PRIMARY OUTCOME adherence to LAI medication  ( the percentage of received out of those prescribed ) . SECONDARY OUTCOMES percentage of patients with at least 95 % adherence ; clinical global improvement ; subjective quality of life ; satisfaction with medication ; hospitalisation ; adverse events ; and costs . Qualitative evaluation : semistructured interviews with patients in the intervention group and their clinicians . RESULTS PRIMARY OUTCOME outcome data were available for 131 patients .  Baseline adherence was 69 % in the intervention group and 67 % in the control group . During the intervention period , adherence was significantly higher in the intervention group than in the control group ( 85 % vs. 71 % ) [ adjusted mean difference 11.5 % , 95 % confidence interval ( CI ) 3.9 % to 19.0 % ; p = 0.003 ] . Secondary outcome : patients in the intervention group showed statistically significant improvement in adherence of at least 95 % ( adjusted odds ratio 8.21 , 95 % CI 2.00 to 33.67 ; p = 0.003 ) and subjective quality of life ( difference in means 0.71 , 95 % CI 0.26 to 1.15 ; p = 0.002 ) . Follow-ups : after incentives stopped , adherence did not differ significantly between groups , neither during the first 6 months ( adjusted difference in means -7.4 % , 95 % CI -17.0 % to 2.1 % ; p = 0.175 ) nor during the period from month 7 to month 24 ( difference in means -5.7 % , 95 % CI -13.1 % to 1.7 % ; p = 0.130 ) . Cost-effectiveness : the average costs of the financial incentives was £ 303 . Overall costs per patient were somewhat higher in the intervention group , but the difference was not significant . Semistructured interviews : the majority of patients and clinicians reported positive experiences with the incentives beyond their monetary value . These included improvement in the therapeutic relationship . The majority of both patients and clinicians perceived no negative impact after the intervention was stopped after 1 year . CONCLUSIONS Financial incentives are effective in improving adherence to LAI medication . Health-care costs ( including costs of the financial incentive ) are unlikely to be increased substantially by this intervention . Once the incentives stop , the advantage is not maintained . The experiences of both patients and clinicians are largely , but not exclusively , positive . Whether or not financial incentives are effective for patients with more favourable background , those on oral mediation or for shorter or longer time periods remains unknown . TRIAL REGISTRATION Current Controlled Trials IS RCT N77769281 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 70 . See the NIHR Journals Library website for further project information
Background Medications targeting stroke risk factors have shown good efficacy , yet adherence is suboptimal .
A lack of underlying theory may contribute to the ineffectiveness of eliciting or sustaining behaviour change in many existing interventions targeting medication adherence in stroke .
Intervention effectiveness and implementation could be enhanced by consideration of evidence base and theory to drive development .
The purpose of this study is to identify appropriate components for a theory-driven and evidence -based medication adherence intervention for stroke survivors .
Methods The Behaviour Change Wheel ( BCW ) , a guide to intervention development , informed our systematic process of intervention development .