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Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON): study protocol of a cluster controlled trial.

ABSTRACT: 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.

SUBMITTER: Anrys P

PROVIDER: S-EPMC4788941 | biostudies-other | 2016 Mar

REPOSITORIES: biostudies-other

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Project description:BackgroundAcquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework.MethodsNursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents' data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms.ResultsSeven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention (n = 64) or control group (n = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents' disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups.ConclusionOur data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention.Trial registrationGerman clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016.

Project description:BackgroundClose to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.Methods/designThis study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or "clusters" were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.DiscussionThis project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.

Project description:IntroductionThis protocol describes a study of a quality improvement collaborative (QIC) to support implementation and delivery of comprehensive geriatric assessment (CGA) in UK care homes. The QIC will be formed of health and social care professionals working in and with care homes and will be supported by clinical, quality improvement and research specialists. QIC participants will receive quality improvement training using the Model for Improvement. An appreciative approach to working with care homes will be encouraged through facilitated shared learning events, quality improvement coaching and assistance with project evaluation.Methods and analysisThe QIC will be delivered across a range of partnering organisations which plan, deliver and evaluate health services for care home residents in four local areas of one geographical region. A realist evaluation framework will be used to develop a programme theory informing how QICs are thought to work, for whom and in what ways when used to implement and deliver CGA in care homes. Data collection will involve participant observations of the QIC over 18 months, and interviews/focus groups with QIC participants to iteratively define, refine, test or refute the programme theory. Two researchers will analyse field notes, and interview/focus group transcripts, coding data using inductive and deductive analysis. The key findings and linked programme theory will be summarised as context-mechanism-outcome configurations describing what needs to be in place to use QICs to implement service improvements in care homes.Ethics and disseminationThe study protocol was reviewed by the National Health Service Health Research Authority (London Bromley research ethics committee reference: 205840) and the University of Nottingham (reference: LT07092016) ethics committees. Both determined that the Proactive HEAlthcare of Older People in Care Homes study was a service and quality improvement initiative. Findings will be shared nationally and internationally through conference presentations, publication in peer-reviewed journals, a graphical illustration and a dissemination video.

Project description:Importance:Strategies to reduce the inappropriate prescription of antipsychotics have been the focus of recent attention but have shown considerable variation in their effectiveness. Objective:To evaluate the effectiveness of academic detailing in nursing homes targeting appropriate prescribing of antipsychotics. Design, Setting, and Participants:We conducted a pragmatic, cluster randomized clinical trial comparing the effect of academic detailing vs usual care on prescribing antipsychotics in 40 nursing homes with 5363 residents in Ontario, Canada. Data were collected from October 2015 to March 2016 and analyzed from April to August 2018. Primary analyses were conducted using intention to treat. Intervention:Academic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits). Academic detailers had direct and ongoing contact with the nursing homes from the time of launch. Main Outcomes and Measures:The primary outcome, defined at the level of the resident, was whether continuous antipsychotics were dispensed in the past week. Secondary outcomes included prescribing of other psychotropic medications and clinical outcomes and scores. Prescribing outcomes were assessed at baseline and at 3, 6, and 12 months, and clinical outcomes and scores were assessed at baseline and 3 and 6 months. Results:A total of 40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents). Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men). At 12 months, there was no statistically significant difference in the frequency of daily antipsychotic use (intervention: 569 patients [25.2%]; control: 769 [25.6%]; odds ratio, 1.06; 95% CI, 0.93-1.20; P = .49). There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months. Conclusions and Relevance:The intervention did not further reduce antipsychotic prescribing in nursing homes beyond system-level secular trends occurring alongside usual care. Our findings highlight the need for a more targeted approach to quality improvement strategies, including academic detailing, that account for the timing and topic of interventions. Trial Registration:ClinicalTrials.gov Identifier: NCT02604056.

Project description:BackgroundQuality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures.Methods/designSixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention. Analysis will use a three-level mixed model.DiscussionBy focusing on improving local interactions, CONNECT is expected to maximize staff's ability to implement content learned in a falls QI program and integrate it into knowledge and action. Our previous pilot work shows that CONNECT is feasible, acceptable and appropriate.Trial registrationClinicalTrials.gov: NCT00636675.

Project description:IntroductionMany people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.Methods and analysisA feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.Ethics and disseminationThis protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.Trial registration numberISRCTN14948133; Pre-results.

Project description:BACKGROUND: Inappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people. Inappropriate drug use may increase the risk of the occurrence of 'geriatric giants' such as immobility, instability, incontinence and cognitive impairment. There are indications that clinical medication reviews (CMR) can reduce inappropriate drug use. However, CMRs have not yet been implemented at a large scale in primary care. An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs. The aim of this study is to assess whether this CMR program is (cost-) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms. METHODS: A cluster randomised controlled trial will be performed in 20 Dutch general practices including 500 patients. Patients of 65 years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug. GP practices will be stratified by practice size and randomly allocated to control (n?=?10) or intervention group (n?=?10). The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist. Primary outcome measures are patient's quality of life and the presence of self-reported geriatric symptoms during a follow-up period of 6 months. Secondary outcomes are costs of healthcare utilisation, feasibility, number of drug related problems, medication adherence and satisfaction with medication. DISCUSSION: This study is expected to add evidence on the (cost-) effectiveness of an optimally facilitated, prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP. The strength of this study is that it will be conducted in daily clinical practice. This improves the possibilities to implement the CMRs in the primary care setting on a large scale. TRIAL REGISTRATION: Netherlands Trial register: NTR4264.

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Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON): study protocol of a cluster controlled trial.

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