Clinical trial NCT04278794: Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity
Official title: Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity: A Pragmatic Trial of an Outpatient-based Virtual Transitional Care Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Older adults
Multimorbidity
Transitional care
Virtual care
Stroke
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Hamilton Health Sciences Corporation
name: Health Quality Ontario
name: Canadian Frailty Network
name: Ontario Ministry of Health and Long Term Care
First posted: 2020-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effectiveness-implementation hybrid type I design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Stroke is the leading cause of death and adult disability in Canada. Sixty percent of these older adults (\> 65 years) will return to their homes after a stroke and will require ongoing rehabilitation. About 92% of older adults have two or more chronic conditions. These patients often require services from a number of providers in a number of settings and are therefore, susceptible to fragmented health care when transitioning from hospital to home. New interventions are needed to improve the quality of care as patients move from hospital to home after a stroke. The proposed research project will examine the impact of a new intervention on patient/caregiver health, patient/caregiver and provider experience and costs, compared to usual health care services. The new intervention will be coordinated by a system navigator and consists of four core components: 1) development of a comprehensive discharge plan, 2) up to 6 home visits (supported by phone calls) by an interprofessional outpatient team, 3) monthly case conferences including the interprofessional care team who will discuss and focus on the patient's goals and care needs, and 4) linkages to other healthcare and community services. This multidisciplinary project will build on our previous study, which provided the groundwork for further study of this new intervention.

Detailed description: The overall purpose of this pragmatic randomized controlled trial (RCT) is to adapt, implement and evaluate a novel person- and family-centred Transitional Care Stroke Intervention (TCSI) for older adults (\> 55 years) with stroke and multimorbidity (\>2 chronic conditions) and their caregivers. The TCSI is a theory- and evidence-based 6-month intervention designed to improve the health, experience, and quality of transitioning from hospital-to-home for this vulnerable population. An effectiveness-implementation hybrid type I design will be used, which will focus primarily on examining the effectiveness of the TCSI on quadruple aim outcomes: (i) patient and caregiver health outcomes, (ii) patient and caregiver experience, (iii) provider/manager experience, and (iv) patient healthcare service use costs, and will also evaluate implementation outcomes (e.g., barriers, facilitators, fidelity). Our earlier pre-post study provided evidence to support the feasibility, acceptability and preliminary effectiveness of the TCSI on reducing hospital readmissions and emergency department visits (for any cause). These improvements were achieved at no additional cost. The key components of the TCSI in this earlier study included home visits supported by telephone calls by an interprofessional team (IP), patient-centered care planning, and care coordination/recruitment. The following enhancements to the TCSI will be included in the trial: 1) integrating the navigator role across the care continuum, 2) testing the TCSI with a larger sample and more rigorous (RCT) design, 3) enhancing patient self-management, and 4) evaluating the impact of the intervention on caregiver health outcomes and experience. These improvements alongside the inclusion of additional evaluation measures will enable rigorous evaluation of the TCSI and position it for future scale-up and spread

Eligibility criteria: Inclusion Criteria:

* age 55 years or greater
* hospitalized for stroke and receiving in-patient rehabilitation
* diagnosed with at least 2 or more chronic conditions
* will be discharged to the community from in-patient rehabilitation (not hospital or long-term care)
* not planning to move out of the study catchment area in the next 6 months
* referred to outpatient stroke rehabilitation services
* capable of providing informed consent, or have a substitute decision-maker who is capable and able to provide informed consent on his/her behalf
* competent in English, or has an interpreter who is competent in English

Exclusion Criteria:

* less than 55 years of age
* fewer than two chronic conditions
* planned discharge to hospital or long-term care facility
* cognitively impaired with no substitute decision maker who is capable to provide consent
* not competent in English with no interpreter

Primary outcomes:
measure: Any hospital readmission for any cause within 6 months
timeFrame: 6-months
Secondary outcomes:
measure: Change in health-related quality of life - mental health
timeFrame: Baseline; 6 months
measure: Change in health-related quality of life - physical health
timeFrame: Baseline; 6 months
measure: Change in self-efficacy
timeFrame: Baseline; 6 months
measure: Change in depressive symptoms
timeFrame: Baseline; 6 months
measure: Change in anxiety
timeFrame: Baseline; 6 months
measure: Change in stroke physical function
timeFrame: Baseline; 6 months
measure: Change in community integration
timeFrame: Baseline; 6 months
measure: Change in use of health and social services
timeFrame: Baseline; 6 months
measure: Change in caregiver strain
timeFrame: Baseline; 6 months
measure: Relative risk of any hospital readmission for any cause within 6 months
timeFrame: Baseline; 6 months
measure: Time to any hospital readmission for any cause within 6 months
timeFrame: Baseline; 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Saint Catherines
country: Canada
facility: Hotel Dieu Shaver
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Markle-Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References: