Stopping antipsychotic drug therapy in demented nursing home patients: a randomized, placebo-controlled study--the Bergen District Nursing Home Study (BEDNURS). An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475] A randomized trial of dementia care in nursing homes. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial Variations in the treatment culture of nursing homes and responses to regulations to reduce drug use. Alzheimer Special Care Units Compared With Traditional Nursing Home for Dementia Care: Are There Differences at Admission and in Clinical Outcomes? Antipsychotic Drug Use and Mortality in Older Adults with Dementia A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Consort 2010 statement: extension to cluster randomised trials No Long-Term Effect of Behavioral Treatment on Psychotropic Drug Use for Agitation in Alzheimer's Disease Patients A randomized trial of a program to reduce the use of psychoactive drugs in nursing homes. Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial Predictors of antipsychotic withdrawal or dose reduction in a randomized controlled trial of provider education. Reducing antipsychotic drug use in nursing homes. A controlled trial of provider education. Effects of a pharmacist's medication review in nursing homes. Randomised controlled trial. A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia. Effects of a restraint reduction intervention and OBRA '87 regulations on psychoactive drug use in nursing homes. The impact of regular multidisciplinary team interventions on psychotropic prescribing in Swedish nursing homes. Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing". Management of problematic behavioral symptoms associated with dementia: A cognitive developmental approach Framework for design and evaluation of complex interventions to improve health
BACKGROUND Despite modest efficacy , unpredictable individual utility , and a high rate of adverse effects , behavioural and psychological symptoms of dementia ( BPSD ) are common determinants for antipsychotic drug therapy in nursing home patients . AIMS To explore the impact on BPSD of stopping long-term antipsychotic treatment in nursing home patients with dementia . METHODS Fifty-five patients ( 43 women ; mean age 84.1 ) taking haloperidol , risperidone , or olanzapine for BPSD were r and omly assigned to cessation ( intervention group , n=27 ) or continued treatment with antipsychotic drugs ( reference group , n=28 ) for 4 consecutive weeks . The Neuropsychiatric Inventory ( NPI ) Question naire was used to examine changes in behavioural and psychological symptoms . RESULTS By study completion , 23 of the 27 intervention group patients were still off antipsychotics . Symptom scores ( NPI ) remained stable or even improved in 42 patients ( intervention group , 18 out of 27 ; reference group , 24 out of 28 ; p=0.18 ) . As compared to patients with stable or improved symptom scores , patients with behavioural deterioration after antipsychotic cessation used higher daily drug doses at baseline ( p=0.42 ) . CONCLUSION A large share of elderly nursing home patients on long-term treatment with antipsychotics for BPSD , do well without this treatment . St and ardized symptom evaluations and drug cessation attempts should therefore be undertaken at regular intervals Background The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting . Methods Twenty facilities took part in a r and omized controlled trial with a seven month follow-up period . Two outreach visits were delivered by a pharmacist . At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates , psychotropic drug prescribing and stroke risk reduction practice s ( BP monitoring , aspirin and warfarin use ) for the facility relevant to the physician . The effect of the interventions was determined via pre- and post-intervention case note audit . Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications . Chi-square tests , independent sample s t-test , and logistic regression were used in the analysis . Results Data were available from case notes at baseline ( n = 897 ) and seven months follow-up ( n = 902 ) , 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits . Pre- and post-intervention data were available for 715 participants . There were no differences between the intervention and control groups for the three month fall rate . We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention . The exception was significantly greater use of " as required " antipsychotics in the intervention group compared with the control group after the pharmacy intervention ( RR = 4.95 ; 95%CI 1.69–14.50 ) . There was no statistically significant difference between groups for the numbers of patients " at risk of stroke " on aspirin at follow-up . Conclusions While the strategy was well received by the physicians involved , there was no change in prescribing patterns . Patient care in residential setting s is complex and involves contributions from the patient 's physician , family and residential care staff . The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained OBJECTIVE To evaluate the efficacy of a dementia care program to reduce behavior disorders in nursing home patients with dementia . DESIGN R and omized controlled clinical trial with 6-month follow-up . SETTING A 250-bed community nursing home . PATIENTS The nursing home was screened to identify patients with dementia and behavior disorders . A total of 118 patients were eligible for r and omization . Of these , 89 ( 75.4 % ) were r and omized , and 81 of these ( 91.0 % ) completed the trial . INTERVENTION The A.G.E. dementia care program consisted of Activities , Guidelines for psychotropic medications , and Educational rounds . The control treatment was usual nursing home care . MEASUREMENTS Behavior disorders , antipsychotic drug and physical restraint use , patient activity levels , and cognitive and functional status . RESULTS After 6 months , 12 of 42 ( 28.6 % ) intervention patients exhibited behavior disorders compared with 20 of 39 ( 51.3 % ) controls ( OR = 0.38 ; 95 % CI [ 0.15 , 0.95 ] ; P = .037 ) . Controls were more than twice as likely to receive antipsychotics ( OR = 2.55 , 95 % CI [ 0.96 , 6.76 ] ; P < .056 ) , to be restrained during activity times ( OR = 2.98 , 95 % CI [ 1.10 , 8.04 ] ; P < .028 ) , and to be restrained on nursing units ( OR = 2.14 , 95 % CI [ 0.9 , 5.3 ] ; P < .10 ) . Intervention patients were much more likely to participate in activities ( OR = 13.71 ; 95 % CI [ 4.51 , 41.73 ] ; P = .001 ) . CONCLUSIONS The A.G.E. program reduces the prevalence of behavior disorders and the use of antipsychotic drugs and restraints . It is practical , feasible , and appears to improve the lives of patients with dementia in nursing homes Abstract Objective To evaluate the effectiveness of a training and support intervention for nursing home staff in reducing the proportion of residents with dementia who are prescribed neuroleptics . Design Cluster r and omised controlled trial with blinded assessment of outcome . Setting 12 specialist nursing homes for people with dementia in London , Newcastle , and Oxford . Participants Residents of the 12 nursing homes ; numbers varied during the study period . Intervention Training and support intervention delivered to nursing home staff over 10 months , focusing on alternatives to drugs for the management of agitated behaviour in dementia . Main outcome measures Proportion of residents in each home who were prescribed neuroleptics and mean levels of agitated and disruptive behaviour ( Cohen-Mansfield agitation inventory ) in each home at 12 months . Results At 12 months the proportion of residents taking neuroleptics in the intervention homes ( 23.0 % ) was significantly lower than that in the control homes ( 42.1 % ) : average reduction in neuroleptic use 19.1 % ( 95 % confidence interval 0.5 % to 37.7 % ) . No significant differences were found in the levels of agitated or disruptive behaviour between intervention and control homes . Conclusions Promotion of person centred care and good practice in the management of patients with dementia with behavioural symptoms provides an effective alternative to neuroleptics OBJECTIVE The study examined the relationship between treatment cultures of nursing homes and their responses to regulations to reduce use of psychotropic drugs m and ated by the 1987 Omnibus Budget Reconciliation ACT : The authors hypothesized that reduction in use of antipsychotic drugs was more likely to occur in homes with a resident-centered culture emphasizing psychosocial care , avoidance of psychotropic drugs , pharmacist feedback , and involvement of mental health workers . The authors also predicted greater reductions in drug use in facilities with a less severe case mix and better capacity for change . METHODS Data were collected in a stratified r and om sample of 16 skilled nursing facilities in Wisconsin . Participants included 1,181 residents in the baseline study and 1,650 residents in the follow-up study . Treatment culture was measured with a question naire for assessing nurses ' beliefs and philosophies of care and their interactions with pharmacists and mental health workers . RESULTS No significant change was observed in the use of benzodiazepines , antidepressants , or polymedicine  ( two or more psychotropic medications ) . However , use of antipsychotic drugs  decreased significantly , from 24 percent to 16 percent . The change in use varied dramatically across facilities , from an 85 percent reduction to a 19 percent increase . Findings also revealed significant variability in treatment cultures . Greater reductions in use of antipsychotic drugs  were found in facilities with a resident-centered culture , a less severe case mix , and a higher nurse-to-resident staffing ratio . CONCLUSIONS Future policy and quality improvement efforts must address treatment cultures , staffing , and other organizational barriers to nursing home reform Background Studies comparing Alzheimer Special Care Units ( ASCUs ) with traditional nursing homes ( NHs ) have reported conflicting results . Objectives To compare the characteristics and the effects on mortality , hospitalization , use of physical restraints , falls , and antipsychotics  among patients admitted to ASCUs or to NHs . Methods A sequential cohort of patients with dementia was recruited and followed for 18 months in a sample of r and omly selected ASCUs and NHs . Data on socio-demographic , cognitive , functional , behavioral , and clinical characteristics , and drug exposure were collected at baseline and at 6-month intervals up to 18 months . Results A total of 349 patients were enrolled in 35 ASCUs and 81 in 9 NHs . Patients admitted to ASCUs were younger , cognitively and functionally less impaired , but had more behavioral disturbances than those in NH . During follow-up , ASCU patients had a lower risk of hospitalization ( odds ratio : 0.67 ; 95 % confidence interval : 0.46 - 0.99 ; P=0.04 ) , and use of physical restraints ( odds ratio : 0.66 ; 95 % confidence interval : 0.51 - 0.86 ; P=0.003 ) , and showed a higher rate of withdrawal of antipsychotics  ( P=0.003 ) . No difference was found in mortality and falls . Propensity score analysis gives similar results . Conclusions This study found that patients with dementia in ASCUs had different baseline clinical and functional characteristics from those in NHs . They had a lower rate of hospitalization and use of physical restraints at 6-month follow-up , and a higher probability of having  antipsychotic agents  withdrawn Context Recent reports suggest that antipsychotics are associated with increased risk for death in patients with dementia . Contribution This large , population -based study from Canada assessed the risk for death after dispensation of antipsychotics in older adults with dementia . New use of antipsychotics compared with nonuse was associated with increased risk for death at 30 days . Conventional agents were associated with higher risks than were atypical agents . Caution Sensitivity analyses showed that unmeasured confounders might diminish or erase observed associations . Implication Both conventional and atypical antipsychotics may be associated with an increased risk for death in elderly persons with dementia . The Editors Various challenging behavioral and psychological symptoms commonly develop in older adults with dementia and predispose them and their caregivers to poor outcomes ( 1 ) . Nonpharmacologic strategies are recommended as first-line management for these symptoms ( 2 ) , but they may be difficult to implement in clinical practice ( 3 ) . For many reasons , antipsychotic medications are routinely prescribed in this setting ( 4 , 5 ) . Conventional antipsychotics , such as haloperidol , have been available since the 1950s . Meta-analyses of clinical trials evaluating conventional antipsychotics to treat agitation in dementia show that these agents have modest efficacy and important adverse effects compared with placebo ( 6 , 7 ) . In the past decade , use of newer atypical antipsychotics has been rapidly increasing in clinical practice because these agents were thought to produce fewer adverse effects than conventional agents ( 2 ) . A Canadian study found that the prevalence of antipsychotic use in older adults increased from 2.2 % in 1993 to 3.0 % at the end of 2002 . In that study , atypical antipsychotics , which were unavailable in 1993 , accounted for 82.5 % of all antipsychotics dispensed in 2002 ( 8) . Short-term r and omized , controlled trials ( RCTs ) have studied the role of atypical antipsychotics in the management of behavioral and psychological symptoms of dementia ( 2 , 9 ) . An RCT involving 421 out patients with Alzheimer disease and psychosis , aggression , or agitation concluded that the adverse effects of these newer drugs offset their advantages ( 10 ) . As a result , improvements in behavioral symptoms with antipsychotic drug treatment do not necessarily lead to improvements in overall quality of life for patients or their caregivers ( 11 ) . In April 2005 , the U.S. Food and Drug Administration ( FDA ) issued a public health advisory that the use of atypical antipsychotics to treat elderly patients with dementia was associated with an increased risk for death compared with placebo ( 12 ) . In June 2005 , Health Canada issued a similar warning and additional data ( 13 ) . These warnings stem from review s of RCTs that involve the atypical agents risperidone , olanzapine , quetiapine , and aripiprazole . The mortality rate was approximately 1.6 to 1.7 times higher than with placebo and was greater with antipsychotics than with placebo in 15 of the 17 trials review ed by the U.S. FDA ( 12 ) . The warnings extend to all currently available atypical antipsychotics . Other publications have provided support for these warnings and have raised further safety concerns about older conventional antipsychotics ( 1416 ) . Important questions remain unanswered . Although RCTs provide the best evidence of treatment efficacy and harm , the individual RCTs in this case had low event rates . Reliable estimates of the mortality risk were generated only when data were combined by meta- analysis ( 14 ) . Furthermore , these RCTs were generally short in duration and could not provide information about the long-term effect of antipsychotics on mortality ( 14 , 17 ) . Finally , these trials provide estimates of harm primarily for atypical antipsychotics . Relatively few data are available on harms associated with older conventional antipsychotics . Studies suggest that important differences may exist in the safety profiles of conventional and atypical agents ( 15 , 16 , 18 , 19 ) . Using population -based data , we sought to determine the risk for all-cause mortality in older adults with dementia who received atypical antipsychotics , conventional antipsychotics , or no antipsychotic .  Because important baseline differences exist among these groups , we used propensity score matching to improve their comparability . We also evaluated the effect of duration of treatment with antipsychotics on the risk for death . Methods Data Sources Ontario is Canada 's most populous province . During our study , Ontario had a population of approximately 12 million people , of whom 1.4 million were 65 years of age or older . A universally funded health program covers nearly all physician services , medications , and hospital services for patients 65 years of age or older in Ontario . Information from 4 administrative health care data bases was linked to develop the study cohort : pharmacy records from the Ontario Drug Benefit program , hospitalization records from the Canadian Institute for Health Information Discharge Abstract Data base , physician billing information for inpatient and outpatient services from the Ontario Health Insurance Plan , and basic demographic information and vital statistics from the Registered Persons Data base . We used encrypted unique identifiers that are common among data bases to link anonymous information on demographic characteristics and health services utilization for patients in our study . Little basic information on patients is missing in these data bases . For example , the coding accuracy of drug cl aims in the Ontario Drug Benefit program data base is excellent , with an error rate of only 0.7 % ( 20 ) . The study was approved by the ethics review board of Sunnybrook and Women 's College Health Sciences Centre , Toronto , Ontario , Canada . Dementia Cohort We identified a cohort of all Ontario residents 66 years of age or older with a diagnosis of dementia ( in the Ontario Health Insurance Plan or Discharge Abstract Data base ) between 1 April 1997 and 31 March 2002 . To focus on antipsychotic drug treatment for behavioral and psychological symptoms of dementia , we excluded patients who had evidence of other psychotic disorders ( such as schizophrenia ) or were receiving palliative care services . To reduce the potential for selection bias , we studied only new users of antipsychotics and excluded those who had received antipsychotics in the year before cohort entry ( 21 ) . Exposure to Antipsychotics We identified new use of antipsychotics if any agent available through the Ontario Drug Benefit program was dispensed after cohort entry . Cohort entry ( that is , the index date ) was defined as the date of the first dispensed antipsychotic drug . Available atypical drugs included olanzapine , quetiapine , and risperidone , and available conventional drugs included chlorpromazine , flupenthixol , fluphenazine , haloperidol , loxapine , pericyazine , perphenazine , pimozide , thioridazine , and trifluoperazine . Clozapine was rarely used in Ontario during the study period , and we therefore excluded patients who were receiving this medication . Other atypical antipsychotics ( such as aripiprazole and ziprasidone ) are not licensed for use in Canada . We decided that exposure to an antipsychotic was discontinued ( and we censored follow-up ) if the patient did not refill his or her antipsychotic prescription within an interval composed of the days of drug supply plus a grace period of 20 % . For example , we censored follow-up for a patient who did not refill his or her 60-day antipsychotic prescription within 72 days . We also censored follow-up for patients who switched from atypical to conventional antipsychotics ( or vice versa ) . However , we continued follow-up for patients who switched from 1 atypical antipsychotic to another , because data suggest no statistically significant difference in the risk for death associated with individual drugs in this class ( 13 , 14 , 16 ) . We applied the same rules to conventional antipsychotics .  All-Cause Mortality The primary outcome was all-cause mortality , as recorded in the Registered Persons Data base ( for patients who were not hospitalized at the time of death ) or the Discharge Abstract Data base ( for patients who died while hospitalized ) . To assess the influence of the duration of antipsychotic exposure on the outcome , we evaluated the risk for death at 30 , 60 , 120 , and 180 days after the initial dispensing of antipsychotic medication . Cohort Matching We stratified the dementia cohort to support separate analyses among persons living in the community and those residing in long-term care at cohort entry . Studies have demonstrated that rates of antipsychotic prescribing are substantial among older adults newly admitted to long-term care facilities ( 4 ) . Furthermore , long-term care residents typically carry a greater burden of comorbid disease and are more vulnerable to adverse drug events than are their counterparts in the community ( 22 , 23 ) . Our first objective was to determine the risk for death among older adults with dementia who received atypical antipsychotics compared with those who were not exposed to any antipsychotic .  Because antipsychotic use was not r and omly assigned in the study cohorts , we addressed potential confounding and selection biases by developing a propensity score for antipsychotic use . We then applied this score to match users of atypical antipsychotics with nonusers in the dementia cohort . The rationale and methods underlying the use of a propensity score for a proposed causal exposure variable are described elsewhere ( 24 ) . Recent studies provide guidance on the selection of variables to include in the propensity score ( 25 , 26 ) . We developed a logistic regression model by using 42 covariates describing patient characteristics . Tables 1 and 2 list many of the characteristics included in the propensity score . After a structured and iterative assessment of the balance of measured covariates Background There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia , but there are very few long-term trials to inform clinical practice . The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease . Methods and Findings Design : R and omised , blinded , placebo-controlled parallel two-group treatment discontinuation trial . Setting : Oxfordshire , Newcastle and Gateshead , London and Edinburgh , United Kingdom . Participants : Patients currently prescribed the neuroleptics thioridazine , chlorpromazine , haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo . Interventions : Continue neuroleptic treatment for 12 mo or switch to an identical placebo . Outcome measures : Primary outcome was total Severe Impairment Battery ( SIB ) score . Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory ( NPI ) . Results : 165 patients were r and omised ( 83 to continue treatment and 82 to placebo , i.e. , discontinue treatment ) , of whom 128 ( 78 % ) commenced treatment ( 64 continue/64 placebo ) . Of those , 26 were lost to follow-up ( 13 per arm ) , result ing in 51 patients per arm analysed for the primary outcome . There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo ; estimated mean difference in deterioration ( favouring placebo ) −0.4 ( 95 % confidence interval [ CI ] −6.4 to 5.5 ) , adjusted for baseline value ( p = 0.9 ) . For neuropsychiatric symptoms , there was no significant difference between the continue treatment and placebo groups ( n = 56 and 53 , respectively ) in the estimated mean change in NPI scores between baseline and 6 mo ; estimated mean difference in deterioration ( favouring continue treatment ) −2.4 ( 95 % CI −8.2 to 3.5 ) , adjusted for baseline value ( p = 0.4 ) . Both results became more pronounced at 12 mo . There was some evidence to suggest that those patients with initial NPI ≥ 15 benefited on neuropsychiatric symptoms from continuing treatment . Conclusions For most patients with AD , withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status .  Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms , but this benefit must be weighed against the side effects of therapy . Trial registration : Cochrane Central Registry of Controlled Trials/National Research Register ( # IS RCT N33368770 ) Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. To determine if teaching caregivers behavior management techniques ( BMTs ) reduces long-term psychotropic use in Alzheimer 's disease ( AD ) patients , we examined 12-month follow-up data from a 4-month r and omized study com paring placebo , BMTs , trazodone , and haloperidol for the treatment of  agitated behaviors in persons with AD . After 4 months , treatment was allowed with any agent . Between 42.8 % and 51 % of AD patients received additional psy chotropics between 4 and 12 months . The relative risk of being prescribed any psychotropic drug after the 4-month trial was at or about 1.0 for subjects in each drug arm or placebo arm versus BMTs . We concluded that teaching  caregivers BMTs did not diminish long-term prescription of psychotropic drugs . ( J Geriatr Psychiatry Neurol 2002 ; 15:95 - 98 ) BACKGROUND Although psychoactive medications have substantial side effects in the elderly , these drugs are used frequently in nursing homes . Few interventions have succeeded in changing this situation , and little is known about the clinical effects of such interventions . METHODS We studied six matched pairs of nursing homes ; at one r and omly selected nursing home in each pair , physicians , nurses , and aides participated in an educational program in geriatric psychopharmacology .  At base line we determined the type and quantity of drugs received by all residents ( n = 823 ) , and a blinded observer performed st and ardized clinical assessment s of the residents who were taking psychoactive medications .  After the five-month program , drug use and patient status were reassessed . RESULTS Scores on an index of psychoactive-drug use , measuring both the magnitude and the probable inappropriateness of medication use , declined significantly more in the nursing homes in which the program was carried out ( experimental nursing homes ) than in the control nursing homes ( decrease , 27 percent vs. 8 percent ; P = 0.02 ) . The use of  antipsychotic drugs  was discontinued in more residents in the experimental nursing homes than in the control nursing homes ( 32 percent vs. 14 percent ) ; the comparable figures for the discontinuation of long-acting benzodiazepines were 20 percent vs. 9 percent , and for antihistamine hypnotics , 45 percent vs. 21 percent . In the experimental nursing homes residents who were initially taking antipsychotic drugs showed less deterioration on several measures of cognitive function than similar residents in the control facilities , but they were more likely to report depression . Those who were initially taking benzodiazepines or antihistamine hypnotic agents reported less anxiety than controls but had more loss of memory . Most other measures of clinical status remained unchanged in both groups . CONCLUSIONS An educational program targeted to physicians , nurses , and aides can reduce the use of psychoactive drugs in nursing homes without adversely affecting the overall behavior and level of functioning of the residents AIMS To evaluate whether a year long clinical pharmacy program involving development of professional relationships , nurse education on medication issues , and individualized medication review s could change drug use , mortality and morbidity in nursing home residents . METHODS A cluster r and omised controlled trial , where an intervention home was matched to three control homes , was used to examine the effect of the clinical pharmacy intervention on resident outcomes . The study involved 905 residents in 13 intervention nursing homes and 2325 residents in 39 control nursing homes in south-east Queensl and and north-east New South Wales , Australia . The outcome measures were : continuous drug use data from government prescription subsidy cl aims , cross-sectional drug use data on prescribed and administered medications , deaths and morbidity indices ( hospitalization rates , adverse events and disability indices ) . RESULTS This intervention result ed in a reduction in drug use with no change in morbidity indices or survival . Differences in nursing home characteristics , as defined by cluster analysis with SUDAAN , negated intervention-related apparent significant improvements in survival . The use of benzodiazepines , nonsteroidal anti-inflammatory drugs , laxatives , histamine H2-receptor antagonists and antacids  was significantly reduced in the intervention group , whereas the use of digoxin and diuretics remained similar to controls . Overall , drug use in the intervention group was reduced by 14.8 % relative to the controls , equivalent to an annual prescription saving of A64 dollars per resident ( approximately 25 pound sterling ) . CONCLUSIONS This intervention improved nursing home resident outcomes related to changes in drug use and drug-related expenditure . The continuing divergence in both drug use and survival at the end of the study suggests that the difference would have been more significant in a larger and longer study , and even more so using additional instruments specific for measuring outcomes related to changes in drug use BACKGROUND Data from 12-week placebo-controlled trials have led to mounting concerns about increased mortality in patients with Alzheimer 's disease ( AD ) who are prescribed antipsychotics ;  however , there are no mortality data from long-term placebo-controlled trials . We aim ed to assess whether continued treatment with antipsychotics in people with AD is associated with an increased risk of mortality . METHODS Between October , 2001 , and December , 2004 , patients with AD who resided in care facilities in the UK were enrolled into a r and omised , placebo-controlled , parallel , two-group treatment discontinuation trial . Participants were r and omly assigned to continue with their antipsychotic treatment ( thioridazine , chlorpromazine , haloperidol , trifluoperazine , or risperidone ) for 12 months or to switch their medication to an oral placebo . The primary outcome was mortality at 12 months . An additional follow-up telephone assessment was done to establish whether each participant was still alive 24 months after the enrollment of the last participant ( range 24 - 54 months ) . Causes of death were obtained from death certificates . Analysis was by intention to treat ( ITT ) and modified intention to treat ( mITT ) . This trial is registered with the Cochrane Central Registry of Controlled Trials/National Research Register , number IS RCT N33368770 . FINDINGS 165 patients were r and omised ( 83 to continue antipsychotic treatment and 82 to placebo ) , of whom 128 ( 78 % ) started treatment ( 64 continued with their treatment and 64 received placebo ) . There was a reduction in survival in the patients who continued to receive antipsychotics compared with those who received placebo . Cumulative probability of survival during the 12 months was 70 % ( 95 % CI 58 - 80 % ) in the continue treatment group versus 77 % ( 64 - 85 % ) in the placebo group for the mITT population . Kaplan-Meier estimates of mortality for the whole study period showed a significantly increased risk of mortality for patients who were allocated to continue antipsychotic treatment compared with those allocated to placebo ( mITT log rank p=0.03 ; ITT p=0.02 ) . The hazard ratio for the mITT group was 0.58 ( 95 % CI 0.35 to 0.95 ) and 0.58 ( 0.36 to 0.92 ) for the ITT population . The more pronounced differences between groups during periods of follow up longer than 12 months were evident at specific timepoints ( 24-month survival 46%vs 71 % ; 36-month survival 30%vs 59 % ) . INTERPRETATION There is an increased long-term risk of mortality in patients with AD who are prescribed antipsychotic medication ; these results further highlight the need to seek less harmful alternatives for the long-term treatment of neuropsychiatric symptoms in these patients . FUNDING UK Alzheimer 's Research Trust OBJECTIVES To evaluate the effects of an educational program to reduce antipsychotic use in nursing homes that had high use rates post-OBRA-87 and to identify factors that predicted antipsychotic withdrawal or 50 % or greater dose reduction . DESIGN / SETTING A r and omized controlled trial ( RCT ) of the educational program ( nursing home the unit of r and omization and analysis ) was conducted in 12 Tennessee nursing homes ( 6 education/6 control ) . Cohort analysis in baseline antipsychotic users identified factors predicting withdrawal or dose reduction . SUBJECTS The RCT analysis included 1152 patients in the homes at baseline and 6 months . The cohort analysis included 133 baseline antipsychotic users in the five education homes able to implement the recommendations of the educational program . OUTCOME MEASURES Change in days of antipsychotic use per 100 days of nursing home residence , withdrawal from antipsychotics , reduction in antipsychotic dose by 50 % or more . RESULTS Following the educational intervention , use of antipsychotics in the six education homes decreased from 25.3 days per 100 at baseline to 19.7 days per 100 by month 6 , a 23 % reduction relative to control homes ( P = .014 ) . In the withdrawal analysis , 44 ( 33 % ) of 133 baseline antipsychotic users were withdrawn . Factors at baseline predicting successful withdrawal were low antipsychotic dose , no use of benzodiazepines or antidepressants , and behavioral symptoms score below the median . However , although an additional 22 patients had dose reductions > or = 50 % , none of the predictors of withdrawal were associated with dose reductions . CONCLUSIONS Focused provider education programs may facilitate antipsychotic reduction above and beyond that attributable to regulatory changes . Patients who are poor c and i date s for total antipsychotic withdrawal may tolerate substantial dose reductions , which should reduce their risk of adverse antipsychotic effects OBJECTIVE In the United States , 20 % or more of nursing home residents receive antipsychotic drugs , primarily for the behavioral manifestations of dementia . This high level of use of drugs with substantial toxicity has engendered a strong and persistent controversy and recently has led to explicit regulatory measures to curtail use ( Omnibus Budget Reconciliation Act of 1987 ) . We developed and tested a comprehensive program to reduce antipsychotic use through education of physicians , nurses , and other nursing home staff . The primary elements of the program were instruction in use of behavioral techniques to manage behavior problems and encouragement of a trial of gradual antipsychotic withdrawal . DESIGN In a nonr and omized controlled trial , the program was implemented ( beginning in August 1990 ) in two rural Tennessee community nursing homes with elevated antipsychotic use ; two other comparable homes were selected as concurrent controls . PATIENTS Throughout the study 194 residents were in the education homes and 184 were in the control homes . Residents in both groups of homes had comparable demographic characteristics and functional status , and each group had a baseline rate of 29 days of antipsychotic use per 100 days of nursing home residence . MAIN OUTCOME MEASURES The primary end points were postintervention changes in administration of antipsychotics and other psychotropic drugs , use of physical restraints , and frequency of behavior problems . RESULTS Days of antipsychotic use decreased by 72 % in the education homes vs 13 % in the control homes ( P < .001 ) . No significant changes were noted in the use of other psychotropic drugs in either group . Days of physical restraint use decreased 36 % in the education homes vs 5 % in the control homes ( P < .001 ) . Behavior problem frequency did not increase in either group , even among the 48 % of baseline antipsychotic users in the education homes who had antipsychotic drug regimens discontinued for 3 or more months . CONCLUSIONS The educational program led to a substantial reduction in antipsychotic use with no increase in the frequency of behavior problems . This suggests that for many antipsychotic drug users benefits may be marginal and that programs to reduce such drug use among the 250,000 US nursing home residents receiving these drugs should have high priority BACKGROUND Older people in nursing and residential homes often have complex disabilities and behavioural disturbances . Recent publicity has highlighted the dangers of medication in this group , and controls over prescribing have been suggested . AIMS To investigate the effect of a review of medication by a pharmacist . METHOD An 8-month prospect i ve trial of an active medication review by a pharmacist was carried out on 330 residents in nursing homes in Manchester . RESULTS The intervention group experienced greater deterioration in cognitive function and behavioural disturbance than the control group , but the changes in depression and quality of life were similar for both groups . The number of drugs prescribed fell in the intervention group , but not in the control group , with a corresponding saving in drug costs . The number of deaths was significantly smaller in the intervention homes during the intervention period ( 4 v. 14 ) but not overall during the study period as a whole ( 26 v. 28 ) . CONCLUSION This clinical intervention reduced the number of medicines prescribed to elderly people in nursing homes , with minimal impact on their morbidity and mortality BACKGROUND To date , no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia . Research ers have emphasized that there is an urgent need for more systematic research in the area . OBJECTIVE AND METHOD A single-blinded , parallel-groups ( one intervention , one comparison , and one no-intervention group ) r and omized controlled trial ( RCT ) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia . The intervention adopted a life-story approach , while the comparison group provided friendly discussion s to control for any changes in outcome as a result of social contacts and attention . The Social Engagement Scale ( SES ) and Well-being/Ill-being Scale ( WIB ) were the outcome measures used . The outcomes of the groups were examined with reference to the baseline ( T0 ) , immediately ( T1 ) , and six weeks ( T2 ) after intervention . The final sample had 101 subjects ( control group : n=30 ; comparison group : n=35 ; intervention group : n = 36 ) . Using multivariate analysis with repeated measures , no significant differences in outcome were found between groups at either T1 or T2 . Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0 , T2 and T1 , and T2 and T0 . Significant differences were observed in the intervention group when comparing T1 and T0 WIB ( p = .014 ) , but not for the other groups . CONCLUSION Although the intervention did not lead to significant differences between the three groups over time , there was a significant improvement in psychosocial well-being for the intervention group OBJECTIVES To describe the changes in psychoactive drug use in nursing homes after implementation of physical restraint reduction interventions and m and ates of the Omnibus Budget Reconciliation Act of 1987 ( OBRA ' 87 ) . METHODS A secondary analysis was conducted using data from a controlled clinical trial that took place in three nursing homes : a control home , one that received an educational intervention , and one that received an educational/consultation intervention . All three homes were influenced by the OBRA m and ates . Complete pre- and 6 months ' post-intervention data on use of psychoactive drugs and physical restraints were available for 446 resident subjects . Changes were first analyzed with the resident subjects as the unit of analysis and then using the nursing home ward ( n = 16 ) as the unit of analysis . RESULTS While physical restraint use declined in the home that received the educational/consultation intervention , neither neuroleptic nor benzodiazepine use increased in any of the homes after the interventions . The percentage of residents taking neuroleptics declined in the control home ( 18.6 % to 11.3 % , P = .014 ) . Benzodiazepine use , which was more prevalent than described previously in the literature , declined in all three homes ( P < .001 ) . Of those residents whose physical restraints were discontinued , only 2 % were started on neuroleptics . When the effect of OBRA m and ates on appropriateness of neuroleptic use was examined , the percentage of residents on neuroleptics who lacked an OBRA-approved indication declined from 21.3 % to 14.6 % in the total sample , and from 39.9 % to 8 % in the control home . CONCLUSIONS Interventions to reduce physical restraint did not lead to an increase in psychoactive drug use ; further , reduction in both can occur simultaneously . OBRA m and ates regarding psychoactive drug use were not uniformly effective , but appear , at minimum , to have increased awareness of the indications for neuroleptics OBJECTIVE To evaluate the impact of regular multidisciplinary team interventions on the quantity and quality of psychotropic drug prescribing in Swedish nursing homes . DESIGN A r and omized controlled trial . SETTING A sample of 33 nursing homes : 15 experimental homes and 18 control homes representing 5 % of all Swedish nursing homes . PARTICIPANTS The sample consisted of 1854 long-term care residents with an average age of 83 years . Seventy percent of the residents were women , and 42 % had a documented diagnosis of dementia . An additional 5 % had a psychotic disorder , and 7 % had a diagnosis of depression . INTERVENTION Experimental homes participated in an outreach program that was design ed to influence drug use through improved teamwork among physicians , pharmacists , nurses , and nurses ' assistants . Multidisciplinary team meetings were held on a regular basis throughout the 12-month study period . MEASUREMENTS Lists of each resident 's prescriptions were collected 1 month before and 1 month after the 12-month intervention . Measures included the proportion of residents with any psychotropic drug , polymedicine , and therapeutic duplication and proportion of residents with nonrecommended and acceptable drugs in each psychotropic drug class , as defined by current Swedish guidelines . RESULTS Baseline results show extensive psychotropic drug prescribing , with the most commonly prescribed drugs being hypnotics ( 40 % ) , anxiolytics ( 40 % ) , and antipsychotics ( 38 % ) . After 12 months of team meetings in the experimental homes , there was a significant decrease in the prescribing of psychotics ( -19 % ) , benzodiazepine hypnotics ( -37 % ) , and antidepressants ( -59 % ) . Orders for more acceptable antidepressants also increased in the experimental homes . In the control homes there was increased use of acceptable antidepressants , but there were no significant reductions in other drug classes . CONCLUSIONS There is excessive prescription of psychotropic drugs in Swedish nursing homes . Improved teamwork among caregivers can improve prescribing as defined by clinical guidelines Improving precision and economy in the prescribing of drugs is a goal whose importance has increased with the proliferation of new and potent agents and with growing economic pressures to contain health-care costs . We implemented an office-based physician education program to reduce the excessive use of three drug groups : cerebral and peripheral vasodilators , an oral cephalosporin , and propoxyphene .  A four-state sample of 435 prescribers of these drugs was identified through Medicaid records and r and omly assigned to one of three groups . Physicians who were offered personal educational visits by clinical pharmacists along with a series of mailed " unadvertisements " reduced their prescribing of the target drugs by 14 per cent as compared with controls ( P = 0.0001 ) . A comparable reduction in the number of dollars reimbursed for these drugs was also seen between the two groups , result ing in substantial cost savings . No such change was seen in physicians who received mailed print material s only . The effect persisted for at least nine months after the start of the intervention , and no significant increase in the use of expensive substitute drugs was found . Academically based " detailing " may represent a useful and cost-effective way to improve the quality of drug-therapy decisions and reduce unnecessary expenditures The purpose of this 3-year study was to test the efficacy of using a theoretical model based on Piaget ’s cognitive developmental stages for consistent behavioral and environmental interventions for persons at all stages of Alzheimer ’s disease and related disorders ( ADRD ) in nursing home and special care units . The specific aims were to reduce problematic behavioral symptoms and the number , amount and frequency of use of psychotropic medications . After 18 months , problem behaviors and some types of psychotropic medications significantly decreased in the treatment group but not in the control group . Results of the study indicate that using behavioral and environmental interventions based on Piaget levels of cognitive development may be an effective method of managing problematic behavioral symptoms and decreasing the use of psychotropic medications in institutionalized ADRD patients R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community
BACKGROUND Antipsychotic medication is regularly prescribed in care homes to control ' behavioural and psychological symptoms of dementia ' despite moderate efficacy , significant adverse effects , and available non-pharmacological alternatives .
OBJECTIVES To evaluate the effectiveness of psychosocial interventions to reduce antipsychotic medication in care home residents .