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

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: \textquotedblgood\textquotedbl; 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

Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial

BACKGROUND Acquired 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. METHODS Nursing 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. RESULTS Seven 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. CONCLUSION Our 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 REGISTRATION German clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016

Development of a complex intervention to improve participation of nursing home residents with joint contractures: a mixed-method study

Joint contractures in nursing home residents limit the capacity to perform daily activities and restrict social participation. The purpose of this study was to develop a complex intervention to improve participation in nursing home residents with joint contractures

Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial DRKS-ID:DRKS00015185

BACKGROUND Nursing 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/DESIGN This 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. DISCUSSION We 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 REGISTRATION DRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018

Additional file 1: Figure S1. of Is employment-focused case management effective for patients with substance use disorders? Results from a controlled multi-site trial in Germany covering a 2-years-period after inpatient rehabilitation

Linkage with follow-up services immediately after discharge. (JPG 2784 kb

Developing and piloting a multifactorial intervention to address participation and quality of life in nursing home residents with joint contractures (JointConImprove): study protocol

Background: Joint contractures are common problems in frail older people in nursing homes. Irrespective of the exact extent of older individuals in geriatric care settings living with joint contractures, they appear to be a relevant problem. Also, the new emphasis on the syndrome of joint contractures, e. g. by the German statutory long term care insurance, led to an increase in assessment and documentation efforts and preventive interventions in clinical care. However, more attention should be paid to the actual situation of older individuals in nursing homes with prevalent joint contractures, particularly their experience of related activity limitations and participation restrictions. Thus, the aim of this study is 1) to develop a tailored intervention to improve functioning, and especially participation and quality of life in older residents with joint contractures in nursing homes and 2) to test the feasibility of the intervention accompanied by a rigorous process evaluation.Methods: The complex intervention, which will be developed in this project follows the UK Medical Research Council (MRC) framework and integrates the perspectives of all potentially relevant user groups, from the affected individuals to clinicians and researchers. The development process will comprise a systematic literature review, reanalysis of existing data and the integration of the knowledge of the affected individuals and experts. The developed intervention including a comprehensive process evaluation will be pilot tested with residents with joint contractures in three nursing homes. Discussion: The projected study will provide a tailored intervention to improve functioning, participation and quality of life in older residents with joint contractures in nursing homes. With this focus, the intervention will support patient relevant outcomes. The pilot study including process evaluation will offer a first opportunity to indicate the size of the intervention’s effect and prepare further studies

Predictive accuracy of the Post-Stroke Depression Prediction Scale : A prospective binational observational study✰

BACKGROUND: Depression after a stroke is a common complication that negatively influences stroke rehabilitation. Early identification, followed by adequate treatment of depression, improves recovery from stroke. To support early identification, the Post-stroke Depression Prediction Scale (DePreS) was developed to predict in the first week after stroke, the risk of depression in the second month. In this study we investigate the predictive accuracy of the DePreS in stroke patients. METHODS: In this prospective multicenter observational study, hospitalized stroke patients were included from three stroke units in the Netherlands and Germany using consecutive sampling. In the first week after stroke, the predicted risk for depression was estimated with the DePreS. Two months after stroke, major depressive disorder was determined with the Composite International Diagnostic Interview. RESULTS: Of the 93 included patients, 17 (18.3%) showed symptoms of major depressive disorder. With a cut-off value of ≥ 0, DePreS performed optimally with a sensitivity of 0.65 (95% CI 0.42-0.87), specificity of 0.74 (95% CI 0.64-0.84), positive predictive value of 0.35 (95% CI 0.19-0.52), and negative predictive value of 0.90 (95% CI 0.80-1.00). The AUC was 0.71 (95% CI 0.56-0.86). LIMITATIONS: The generalizability of the study findings is limited to patients able to communicate adequately. CONCLUSIONS: This study demonstrates that the DePreS is an adequate instrument for early and reliable identification of stroke patients who are not at risk of MDD in the second months after stroke. This limits the need for structural diagnostic follow-up to patients with a high risk

Predictive accuracy of the Post-Stroke Depression Prediction Scale : A prospective binational observational study✰

BACKGROUND: Depression after a stroke is a common complication that negatively influences stroke rehabilitation. Early identification, followed by adequate treatment of depression, improves recovery from stroke. To support early identification, the Post-stroke Depression Prediction Scale (DePreS) was developed to predict in the first week after stroke, the risk of depression in the second month. In this study we investigate the predictive accuracy of the DePreS in stroke patients. METHODS: In this prospective multicenter observational study, hospitalized stroke patients were included from three stroke units in the Netherlands and Germany using consecutive sampling. In the first week after stroke, the predicted risk for depression was estimated with the DePreS. Two months after stroke, major depressive disorder was determined with the Composite International Diagnostic Interview. RESULTS: Of the 93 included patients, 17 (18.3%) showed symptoms of major depressive disorder. With a cut-off value of ≥ 0, DePreS performed optimally with a sensitivity of 0.65 (95% CI 0.42-0.87), specificity of 0.74 (95% CI 0.64-0.84), positive predictive value of 0.35 (95% CI 0.19-0.52), and negative predictive value of 0.90 (95% CI 0.80-1.00). The AUC was 0.71 (95% CI 0.56-0.86). LIMITATIONS: The generalizability of the study findings is limited to patients able to communicate adequately. CONCLUSIONS: This study demonstrates that the DePreS is an adequate instrument for early and reliable identification of stroke patients who are not at risk of MDD in the second months after stroke. This limits the need for structural diagnostic follow-up to patients with a high risk