The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial.

BACKGROUND: This study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care on health outcomes, self-management, patient experience, and health and social service use costs in older adults (≥ 55 years) with stroke and multimorbidity (≥ 2 chronic conditions). METHODS: This pragmatic randomized controlled trial (RCT) included older adults discharged from hospital to community with stroke and multimorbidity using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional (IP) team, and included care coordination/system navigation support, phone/video visits, monthly IP team conferences, and an online resource to support system navigation. The primary outcome was risk of hospital readmission (all cause) after six-months. Secondary outcomes included physical and mental functioning, stroke self-management, patient experience, and health and social service use costs. The intention-to-treat principle was used to conduct the primary and secondary analyses. RESULTS: Ninety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). No significant between-group differences were seen for baseline to six-month risk of hospital readmission. Differences favouring the intervention group were seen in the following secondary outcomes: physical functioning (SF-12 PCS mean difference: 5.10; 95% CI: 1.58-8.62, p = 0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51-11.50, p = 0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p = 0.005). No between-group differences were found in total healthcare costs or other secondary outcomes. CONCLUSIONS: Although participation in the TCSI did not impact hospital readmissions, there were improvements in physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs. Challenges associated with the COVID-19 pandemic, including the shift from in-person to virtual delivery, and re-deployment of interventionists could have influenced the results. A larger pragmatic RCT is needed to determine intervention effectiveness in diverse geographic settings and ethno-cultural populations and examine intervention scalability. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04278794 . Registered May 2, 2020.

An integrated hospital-to-home transitional care intervention for older adults with stroke and multimorbidity: A feasibility study.

BACKGROUND: Stroke is the leading cause of death and adult disability in Canada. Eighty percent of older adults (≥65 years) who have suffered a stroke will return to their homes, and 60% will require ongoing rehabilitation. The transition between hospital and home is often fragmented, leading to adverse health outcomes, hospital readmissions, and increased health-care costs. This study examined the feasibility of a 6-month integrated transitional care stroke intervention (TCSI), and explored its effects on health outcomes, patient and provider experience, and cost in 30 community-living older adults (≥55 years) with stroke and multimorbidity (≥2 chronic conditions) using outpatient stroke rehabilitation services. METHODS: The TCSI is a 6-month intervention delivered by an interprofessional (IP) team (occupational therapist, physiotherapist, speech language pathologist, registered nurse, social worker). It involved care coordination, home visiting, and IP case conferences, supported by a web-based application. A qualitative descriptive approach was used to explore the feasibility of implementing the intervention. A prospective one-group pretest/posttest was used to evaluate the effects of the intervention on health outcomes and use and costs of health services, from baseline to 6 months. RESULTS: Participants had an average of eight comorbid conditions. The intervention was feasible and acceptable to both older adults and providers. From baseline to 6 months, there was no statistically significant difference in health outcomes. However, there was a significant reduction in the total per person use and costs of health services. CONCLUSIONS: This study established the feasibility of conducting a larger randomized controlled trial of this intervention.

Feasibility and preliminary effects of an integrated hospital-to-home transitional care intervention for older adults with stroke and multimorbidity: A study protocol.

BACKGROUND: Stroke is a major life-altering event and the leading cause of death and disability in Canada. Most older adults who have suffered a stroke will return home and require ongoing rehabilitation in the community. Transitioning from hospital to home is reportedly very stressful and challenging, particularly if stroke survivors have multiple chronic conditions. New interventions are needed to improve the quality of transitions from hospital to home for this vulnerable population. OBJECTIVES: The primary objective of this study is to examine the feasibility of implementing a new 6-month transitional care intervention supported by a web-based app. The secondary objective is to explore its preliminary effects. DESIGN: A single arm, pre/post, pragmatic feasibility study of 20-40 participants in Ontario, Canada. Participants will be community-dwelling older adults (≥55 years) with a confirmed stroke diagnosis, ≥2 co-morbid conditions, and referred to a hospital-based outpatient stroke rehabilitation centre. The 6-month transitional care intervention will be delivered by an interprofessional (IP) team and involve care coordination/system navigation, self-management education and support, home visits, telephone contacts, IP team meetings and a web-based app. Primary evaluation of the intervention will be based on feasibility outcomes (e.g. acceptability, fidelity). Preliminary intervention effects will be based on 6-month changes in health outcomes, patient experience, provider experience and cost. CONCLUSIONS: Information on the feasibility and preliminary effects of this newly-developed intervention will be used to optimize the design and methods for a future pragmatic trial to test the effectiveness and implementation of the intervention in other contexts and settings.

FIT for FUNCTION: study protocol for a randomized controlled trial.

BACKGROUND: The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. METHODS/DESIGN: This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated as non-parametric and analyzed using a Mann-Whitney U test. DISCUSSION: This is a RCT with broad study eligibility criteria intended to recruit a wide spectrum of individuals living in the community with stroke. If positive benefits are demonstrated, results will provide strong research evidence to support the implementation of structured, community-based exercise and education/self-management programs for a broad range of people living in the community with stroke. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02703805 . Registered on 14 October 2014.

Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity-study protocol for a stepped-wedge randomised trial.

INTRODUCTION: Physical exercise after stroke is essential for improving recovery and general health, and reducing future stroke risk. However, people with stroke are not sufficiently active on return to the community after rehabilitation. We developed the Promoting Optimal Physical Exercise for Life (PROPEL) programme, which combines exercise with self-management strategies within rehabilitation to promote ongoing physical activity in the community after rehabilitation. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. We hypothesise that individuals who complete PROPEL will be more likely to meet recommended frequency, duration and intensity of exercise compared with individuals who do not complete the programme up to 6 months post discharge from stroke rehabilitation. METHODS AND ANALYSIS: Individuals undergoing outpatient stroke rehabilitation at one of six hospitals will be recruited (target n=192 total). A stepped-wedge design will be employed; that is, the PROPEL intervention (group exercise plus self-management) will be 'rolled out' to each site at a random time within the study period. Prior to roll-out of the PROPEL intervention, sites will complete the control intervention (group aerobic exercise only). Participation in physical activity for 6 months post discharge will be measured via activity and heart rate monitors, and standardised physical activity questionnaire. Adherence to exercise guidelines will be evaluated by (1) number of 'active minutes' per week (from the activity monitor), (2) amount of time per week when heart rate is within a target range (ie, 55%-80% of age-predicted maximum) and (3) amount of time per week completing 'moderate' or 'strenuous' physical activities (from the questionnaire). We will compare the proportion of active and inactive individuals at 6 months post intervention using mixed-model logistic regression, with fixed effects of time and phase and random effect of cluster (site). ETHICS AND DISSEMINATION: To date, research ethics approval has been received from five of the six sites, with conditional approval granted by the sixth site. Results will be disseminated directly to study participants at the end of the trial, and to other stake holders via publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02951338; Pre-results.