Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity

NCT ID: NCT04278794

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-12-05

Brief Summary

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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

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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

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Effectiveness-implementation hybrid type I design.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Study patients will be blinded to their group allocation. Those aware that they are receiving or not receiving the intervention are more likely to provide biased assessments of the effectiveness of the intervention than blinded participants. Participants who are aware that they are not receiving the intervention may be less likely to comply with the trial protocol, and more likely to drop out of the trial. To minimize assessment bias, Research Assistants will be blinded to group allocation. The statistical analyst will be blinded to the group allocation of the participants when analyzing the data.

Study Groups

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Transitional Care Stroke Intervention (TCSI)

Participants randomly assigned to the intervention group will be offered the intervention in addition to usual care provided by in-patient and outpatient stroke rehabilitation services. The TCSI is a 6-month stroke transitional care intervention, provided in addition to usual stroke care, that includes four core components: comprehensive hospital discharge plan, structured home visits and telephone support, monthly intraprofessional case conferences, and linkages to primary care and other healthcare and community services. The TCSI will be delivered by an interprofessional team of care providers at the study site, including an occupational therapist, registered nurse, speech language pathologist, physical therapist, and social worker from a hospital-based outpatient stroke rehabilitation setting.

Group Type EXPERIMENTAL

Transitional Care Stroke Intervention (TCSI)

Intervention Type OTHER

Core components:

1. Comprehensive Hospital Discharge Plan. The Care Coordinator will meet with staff in the in-patient unit along with patients and their caregivers to develop and implement a comprehensive discharge plan.
2. Structured home visits and telephone support. As part of the structured home visits and telephone support, a member of the IP team will provide up to 6 home visits over 6 months. The team will provide: screening and assessment; medication review and reconciliation; self-management support; education; and caregiver assessment.
3. Monthly IP case conferences. 6 monthly IP team case conferences will be held to discuss goals identified by the patient, collectively develop a plan of care, and identify needs.
4. Linkages to services. Facilitate timely follow-up with the primary care provider and build relationships with local health and social service providers. These referrals and links will provide the foundation for continued use post-intervention.

Control

Usual care provided by in-patient and out-patient stroke rehabilitation services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transitional Care Stroke Intervention (TCSI)

Core components:

1. Comprehensive Hospital Discharge Plan. The Care Coordinator will meet with staff in the in-patient unit along with patients and their caregivers to develop and implement a comprehensive discharge plan.
2. Structured home visits and telephone support. As part of the structured home visits and telephone support, a member of the IP team will provide up to 6 home visits over 6 months. The team will provide: screening and assessment; medication review and reconciliation; self-management support; education; and caregiver assessment.
3. Monthly IP case conferences. 6 monthly IP team case conferences will be held to discuss goals identified by the patient, collectively develop a plan of care, and identify needs.
4. Linkages to services. Facilitate timely follow-up with the primary care provider and build relationships with local health and social service providers. These referrals and links will provide the foundation for continued use post-intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Health Quality Ontario

OTHER

Sponsor Role collaborator

Canadian Frailty Network

OTHER

Sponsor Role collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maureen Markle-Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Hotel Dieu Shaver

Saint Catherines, Ontario, Canada

Site Status

Countries

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Canada

References

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Markle-Reid M, Fisher K, Walker KM, Beauchamp M, Cameron JI, Dayler D, Fleck R, Gafni A, Ganann R, Hajas K, Koetsier B, Mahony R, Pollard C, Prescott J, Rooke T, Whitmore C. The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial. BMC Geriatr. 2023 Oct 24;23(1):687. doi: 10.1186/s12877-023-04403-1.

Reference Type DERIVED
PMID: 37872479 (View on PubMed)

Other Identifiers

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CIHR-419061

Identifier Type: -

Identifier Source: org_study_id

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