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Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.

ABSTRACT: BACKGROUND:Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation. METHODS:The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis. RESULTS:Seven nursing homes (n =?4 intervention groups, n =?3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: "good"; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers. CONCLUSION:The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial. TRIAL REGISTRATION:German clinical trials register, DRKS00010037 . Registered 12 February 2016.

SUBMITTER: Klingshirn H

PROVIDER: S-EPMC7405353 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.

Klingshirn Hanna H Müller Martin M Beutner Katrin K Hirt Julian J Strobl Ralf R Grill Eva E Meyer Gabriele G Saal Susanne S

BMC geriatrics 20200805 1

<h4>Background</h4>Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation.<h4>Methods</h4>The implementatio ...[more]

PMID: 32758147

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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:BackgroundNursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study.Methods/designThis multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators' workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents' participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents' quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost-utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation.DiscussionWe expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals.Trial registrationDRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018.

Project description:IntroductionPain is a common symptom in people with dementia; untreated, it reduces quality of life and causes suffering. People with dementia living in nursing homes most often have dementia in moderate to severe stages. The cognitive impairment, including language and communication difficulties, challenges pain assessment. Since pain is a subjective experience, self-reporting is the gold standard of assessment methods. Healthcare professionals are advised to help people with dementia communicate about their pain. The proposed scoping review is the first step in the development of a systematic pain assessment model for people with dementia living in nursing homes. The scoping review aims to identify, categorise and summarise knowledge on how pain assessment processes in this population are described in the literature, with a special focus on self-reporting.Methods and analysisThe scoping review will be conducted following the six-stage framework developed by Arksey and O'Malley, in addition to recent methodological developments. Systematic searches in CINAHL, Embase, Medline and PsycInfo will be conducted. The protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklists, and the scoping review will adhere to the PRISMA-ScR checklist. The review will include research that concerns assessment of pain in people with dementia living in nursing homes. Studies will be evaluated for quality and ethical standards. The analysis process will follow Bradbury-Jones et al's PAGER framework. Patterns will be formed using thematic analysis. An overview of advances, gaps, evidence for practice and research recommendations associated with each pattern will be prepared. The research questions and results will be presented to and discussed in a reference group comprising nursing home residents, relatives, healthcare professionals and nursing home managers.Ethics and disseminationThe scoping review aims to collect and summarise data from available publications and does not require ethical approval. The final manuscript will be submitted to a peer-reviewed, open-access journal. REGISTRATION IN OPEN SCIENCE FRAMEWORK: https://osf.io/8kaf5/.

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: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:BackgroundMedication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC.MethodsThis study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes.DiscussionThis study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults.Trial registrationNCT04762303 , Registered February 21, 2021.

Project description:Background and objectivesThe proportion of racial/ethnic minority older adults in nursing homes (NHs) has increased dramatically and will surpass the proportion of white adults by 2030.Yet, little is known about minority groups' experiences related to the quality of life (QOL). QOL is a person-centered measure, capturing multiple aspects of well-being. NH quality has been commonly measured using clinical care indicators, but there is growing recognition for the need to include QOL. This study examines the role of individual race/ethnicity, facility racial/ethnic composition, and the interaction of both for NH resident QOL.Research design and methodsWe used a unique state-level data set that includes self-reported QOL surveys with a random sample of long-stay Minnesota NH residents, using a multidimensional measure of QOL. These surveys were linked to resident clinical data from the Minimum Dataset 3.0 and facility-level characteristics. Minnesota is one of the two states in the nation that collects validated QOL measures, linked to data on resident and detailed facility characteristics. We used mixed-effects models, with random intercepts to model summary QOL score and individual domains.ResultsWe identified significant racial disparities in NH resident QOL. Minority residents report significantly lower QOL scores than white residents, and NHs with higher proportion minority residents have significantly lower QOL scores. Minority residents have significantly lower adjusted QOL than white residents, whether they are in low- or high-minority facilities, indicating a remaining gap in individual care needs.Discussion and implicationsThe findings highlight system-level racial disparities in NH residents QOL, with residents who live in high-proportion minority NHs facing the greatest threats to their QOL. Efforts need to focus on reducing racial/ethnic disparities in QOL, including potential public reporting (similar to quality of care) and resources and attention to provision of culturally sensitive care in NHs to address residents' unique needs.

Project description:Antipsychotic medications are routinely prescribed in nursing homes to address the behavioral and psychological symptoms of dementia. Unfortunately, inappropriate prescribing of antipsychotic medications is common and associated with increased morbidity, adverse drug events, and hospitalizations. Multifaceted interventions can achieve a 12-20 % reduction in antipsychotic prescribing levels in nursing homes. Effective interventions have featured educational outreach and ongoing performance feedback.This pragmatic, cluster-randomized control trial and embedded process evaluation seeks to determine the effect of adding academic detailing to audit and feedback on prescribing of antipsychotic medications in nursing homes, compared with audit and feedback alone. Nursing homes within pre-determined regions of Ontario, Canada, are eligible if they express an interest in the intervention. The academic detailing intervention will be delivered by registered health professionals following an intensive training program including relevant clinical issues and techniques to support health professional behavior change. Physicians in both groups will have the opportunity to access confidential reports summarizing their prescribing patterns for antipsychotics in comparison to the local and provincial average. Participating homes will be allocated to one of the two arms of the study (active/full intervention versus standard audit and feedback) in two waves, with a 2:1 allocation ratio. Homes will be randomized after stratifying for geography, baseline antipsychotic prescription rates, and size, to ensure a balance of characteristics. The primary outcome is antipsychotic dispensing in nursing homes, measured 6 months after allocation; secondary outcomes include clinical outcomes and healthcare utilization.Policy-makers and the public have taken note that antipsychotics are used in nursing homes in Ontario far more than other jurisdictions. Academic detailing can be an effective technique to address challenges in appropriate prescribing in nursing homes, but effect sizes vary widely. This opportunistic, policy-driven evaluation, embedded within a government-initiated demonstration project, was designed to ensure policy-makers receive the best evidence possible regarding whether and how to scale up the intervention.ClinicalTrials.gov NLM Identifier: NCT02604056 .

Dataset Information

Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.

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Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.

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