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Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

ABSTRACT: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.ClinicalTrials.gov: NCT02295462.

SUBMITTER: Richter C

PROVIDER: S-EPMC4464611 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

Richter Christin C Berg Almuth A Fleischer Steffen S Köpke Sascha S Balzer Katrin K Fick Eva-Maria EM Sönnichsen Andreas A Löscher Susanne S Vollmar Horst Christian HC Haastert Burkhard B Icks Andrea A Dintsios Charalabos-Markos CM Mann Eva E Wolf Ursula U Meyer Gabriele G

Implementation science : IS 20150604

<h4>Background</h4>The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for t ...[more]

PMID: 26037324

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Project description:BackgroundAgitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL). There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost.Methods and findingsThis was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU) in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review), followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy). Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI]), neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH]), antipsychotic use, global deterioration (Clinical Dementia Rating), mood (Cornell Scale for Depression in Dementia), unmet needs (Camberwell Assessment of Need for the Elderly), mortality, quality of interactions (Quality of Interactions Scale [QUIS]), pain (Abbey Pain Scale), and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0.24). There were also statistically significant benefits in agitation (CMAI Z score 2.68, p = 0.0076; mean difference 4.27, SEM 1.59; 95% CI -7.39, -1.15; Cohen's D 0.23) and overall neuropsychiatric symptoms (NPI-NH Z score 3.52, p < 0.001; mean difference 4.55, SEM 1.28; 95% CI -7.07,-2.02; Cohen's D 0.30). Benefits were greatest in people with moderately severe dementia. There was a statistically significant benefit in positive care interactions as measured by QUIS (19.7% increase, SEM 8.94; 95% CI 2.12, 37.16, p = 0.03; Cohen's D 0.55). There were no statistically significant differences between WHELD and TAU for the other outcomes. A sensitivity analysis using a pre-specified imputation model confirmed statistically significant benefits in DEMQOL-Proxy, CMAI, and NPI-NH outcomes with the WHELD intervention. Antipsychotic drug use was at a low stable level in both treatment groups, and the intervention did not reduce use. The WHELD intervention reduced cost compared to TAU, and the benefits achieved were therefore associated with a cost saving. The main limitation was that antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. An additional limitation was the inherent challenge of assessing QoL in this patient group.ConclusionsThese findings suggest that the WHELD intervention confers benefits in terms of QoL, agitation, and neuropsychiatric symptoms, albeit with relatively small effect sizes, as well as cost saving in a model that can readily be implemented in nursing homes. Future work should consider how to facilitate sustainability of the intervention in this setting.Trial registrationISRCTN Registry ISRCTN62237498.

Project description:IntroductionHealthcare is changing due to the ageing of the general population, complex care demands and growing attention to person-centred care. To deal with these changes and provide the best possible person-centred care, the different professionals in nursing homes should all collaborate intensively. However, most professionals work within the field of their own expertise and share very little knowledge, experiences and insights. A lack of an interprofessional learning and working culture also prevents professionals with different expertise from working and learning intensively together to achieve high-quality person-centred care. There is a gap of knowledge about how to develop such a culture. Our aim is to provide insights into what actions, in what context and to what extent can contribute to an impactful development of an interprofessional learning and working culture.Methods and analysisThe realist action research design will be applied. It consists of three iterative steps: plan, act and observe, and reflect. First, we will formulate the theory about interprofessional learning and working culture and measure this culture by means of interviews, focus groups and questionnaires. Second, we will apply the nine principles of Practice Development to coach professionals from six Dutch nursing homes to improve their interprofessional learning and working culture. Finally, we will evaluate the impact of the changed attitudes and skills on healthcare practice.Ethics and disseminationApproval for the project was given by the Hogeschool van Arnhem en Nijmegen (HAN) Research Ethics Committee, the Netherlands, registration number EACO 164.12/19. All organisations, professionals and residents/family members will be informed verbally and by letter about the study and asked for informed consent. The results will be presented in peer-reviewed scientific journals, professional journals and at symposia and conferences. The findings will be transferred to an online toolbox and e-learning modules for graduated professionals and students.

Project description:Objective: Determine the accuracy of nursing home self-reported antipsychotic prescribing before and after implementation of a Medicare campaign to reduce use.Methods: Quasi-experimental study comparing trends in self-reported antipsychotic prescribing relative to claims-based prescribing. Setting is a nationwide sample of 11,912 facilities, 2011-2013. Participants are long-stay nursing home residents (n = 586,281) with prescribing data in Medicare Minimum Data Set 3.0 and Medicare Part D claims database. Verified with a pharmacy dispensing database. Main outcomes are the discrepancies in quarterly prevalence of antipsychotic prescribing between nursing home self-reports and claims data and the characteristics of facilities and residents where discrepancies were identified.Results: Nursing homes underreport their antipsychotic prescribing levels, on average, by 1 percentage point per quarter relative to Medicare Part D claims (0.013, 95% confidence interval (CI), 0.012-0.015; p<.001). After the Medicare campaign, the underreporting gap increased by another half a percentage point (0.004, 95% CI .003-.005; p = .012). Nursing home residents with dementia, Alzheimer's disease or bipolar disorders were at the highest risk for underreported antipsychotic prescribing before the campaign (Adjusted Odds ratio (AOR) 1.385, 95% CI: 1.330-1.444; AOR 1.234, 95% CI: 1.172-1.300; AOR 1.574, 95% CI: 1.444-1.716, respectively) and afterwards. After the launch of the Medicare campaign, underreported antipsychotic prescribing occurred most in for-profit nursing homes (AOR 1.088, 95% CI: 1.005-1.178) and facilities in the US South (AOR 1.262, 95% CI: 1.145-1.391). Agreement was high between claims and dispensing data (99.7%).Conclusion: Nursing homes did not identify up to 6,000 residents per calendar quarter as having received antipsychotics despite these prescriptions being paid by Medicare and dispensed by a pharmacy. Nursing home rates of antipsychotic prescribing from self-reported data may be biased.

Project description:BackgroundPerson-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions.MethodsFive individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes.ResultsFacilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians.ConclusionsThe findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes.Trial registrationClinicalTrials.gov identifier: NCT02295462 ; November 20, 2014.

Project description:BACKGROUND:The literature suggests that person-centred care can contribute to quality of life and wellbeing of nursing home residents, relatives and staff. However, there is sparse research evidence on how person-centred care can be operationalised and implemented in practice, and the extent to which it may promote wellbeing and satisfaction. Therefore, the U-Age nursing home study was initiated to deepen the understanding of how to integrate person-centred care into daily practice and to explore the effects and meanings of this. METHODS:The study aims to evaluate effects and meanings of a person-centred and thriving-promoting intervention in nursing homes through a multi-centre, non-equivalent controlled group before-after trial design. Three nursing homes across three international sites have been allocated to a person-centred and thriving-promoting intervention group, and three nursing homes have been allocated to an inert control group. Staff at intervention sites will participate in a 12-month interactive educational programme that operationalises thriving-promoting and person-centred care three dimensions: 1) Doing a little extra, 2) Developing a caring environment, and 3) Assessing and meeting highly prioritised psychosocial needs. A pedagogical framework will guide the intervention. The primary study endpoints are; residents' thriving, relatives' satisfaction with care and staff job satisfaction. Secondary endpoints are; resident, relative and staff experiences of the caring environment, relatives' experience of visiting their relative and the nursing home, as well as staff stress of conscience and perceived person-centredness of care. Data on study endpoints will be collected pre-intervention, post-intervention, and at a six-month follow up. Interviews will be conducted with relatives and staff to explore experiences and meanings of the intervention. DISCUSSION:The study is expected to provide evidence that can inform further research, policy and practice development on if and how person-centred care may improve wellbeing, thriving and satisfaction for people who reside in, visit or work in nursing homes. The combination of quantitative and qualitative data will illuminate the operationalisation, effects and meaning of person-centred and thriving-promoting care. TRIAL REGISTRATION:The trial was registered at ClinicalTrials.gov March 19, 2016, identifier NCT02714452 .

Project description:IntroductionAntipsychotics are used for managing behavioral and psychological symptoms of dementia (BPSD) but have risks. Anticholinergics can worsen outcomes in dementia. The Improving Antipsychotic Appropriateness in Dementia Patients educational program (IA-ADAPT) and Centers for Medicare and Medicaid Services Partnership to Improve Dementia Care (CMS Partnership) promote improved care for BPSD. The purpose of this study was to evaluate the impact of these programs on medication use and BPSD among nursing home residents.MethodsThis quasi-experimental longitudinal study used Medicare and assessment data for Iowa nursing home residents from April 2011 to December 2012. Residents were required to be eligible for six continuous months for inclusion. Antipsychotic use and anticholinergic use were evaluated on a monthly basis, and changes in BPSD were tracked using assessment data. Results are presented as odds ratios (ORs) per month after exposure to the IA-ADAPT or the start of the CMS Partnership.ResultsOf 426 eligible Iowa nursing homes, 114 were exposed to the IA-ADAPT in 2012. Nursing home exposure to the IA-ADAPT was associated with reduced antipsychotic use (OR [95% CI] = 0.92 [0.89-0.95]) and anticholinergic use (OR [95% CI] = 0.95 [0.92-0.98]), reduced use of excessive antipsychotic doses per CMS guidance (OR [95% CI] = 0.80 [0.75-0.86]), increased odds of a potentially appropriate indication among antipsychotic users (OR [95% CI] = 1.04 [1.00-1.09]), and decreased documentation of verbal aggression (OR [95% CI] = 0.96 [0.94-0.99]). Facilities with two or more IA-ADAPT exposures had greater reductions in antipsychotic and anticholinergic use than those with only one. The CMS Partnership was associated with reduced antipsychotic use (OR [95% CI] = 0.96 [0.94-0.98]) and decreased documentation of any measured BPSD (OR [95% CI] = 0.98 [0.97-0.99]) as well as delirium specifically (OR [95% CI] = 0.98 [0.96-0.99]).DiscussionThis study suggests that the IA-ADAPT and the CMS Partnership improved medication use with no adverse impact on BPSD.

Project description:Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Current Controlled Trials ISRCTN66138978.

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Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

Publications

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

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