- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278794
Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity
March 22, 2023 updated by: McMaster University
Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity: A Pragmatic Trial of an Outpatient-based Virtual Transitional Care Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- Hamilton Health Sciences
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Saint Catherines, Ontario, Canada
- Hotel Dieu Shaver
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Core components:
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No Intervention: Control
Usual care provided by in-patient and out-patient stroke rehabilitation services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Any hospital readmission for any cause within 6 months
Time Frame: 6-months
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The Health and Social Services Utilization Inventory (HSSUI) will be used to identify patients with any readmission to hospital for any cause within 6 months from study enrolment.
The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective.
The question in the HSSUI pertaining to any hospital readmission for any cause will be: "Have you been readmitted to the hospital in the past 6-months?"
(Yes / No).
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6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health-related quality of life - mental health
Time Frame: Baseline; 6 months
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The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in mental health.
The tool consists of 12 questions that measure functional health and well-being from the participant's perspective.
It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health) by which a psychometrically-based physical component summary and mental component summary score can be calculated.
Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time').
Total scale range 0-100.
Higher scores represent a better mental health - health-related quality of life.
This will be assessed in patients and caregivers.
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Baseline; 6 months
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Change in health-related quality of life - physical health
Time Frame: Baseline; 6 months
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The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in physical health.
The tool consists of 12 questions that measure functional health and well-being from the participant's perspective.
It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health) by which a psychometrically-based physical component summary and mental component summary score can be calculated.
Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time').
Total scale range 0-100.
Higher scores represent a better physical health - health-related quality of life.
This will be assessed in patients and caregivers.
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Baseline; 6 months
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Change in self-efficacy
Time Frame: Baseline; 6 months
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The Stroke Self-Efficacy Questionnaire (SSEQ) will be used to assess change in self-efficacy of the patient.
The SSEQ is a 13-item self-report scale measuring self-efficacy judgements in specific domains of functioning post stroke.
Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident.
A higher score represents a higher self-efficacy.
This will be measured in patients.
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Baseline; 6 months
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Change in depressive symptoms
Time Frame: Baseline; 6 months
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The Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) will be used to assess change in depressive symptoms and symptom severity.
This tool has been used in prior studies of older adults with mood disorders, has a high degree of reliability and validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.
Participants will be asked about the way they have felt or behaved in response to 10 statements such as 'I was happy'.
Response options ask participants to select the frequency they have felt or behaved during the last week, ranging from 'rarely or none of the time (less than 1 day)', 'some or a little of the time (1-2 days)', 'occasionally or moderate (3-4 days)', to 'most or all of the time (5-7 days)'.
Scale range: 0 - 30.
Higher scores represent more depressive symptoms.
This will be measured in patients.
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Baseline; 6 months
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Change in anxiety
Time Frame: Baseline; 6 months
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The Generalized Anxiety Disorder 7-Item (GAD-7) will be used to assess change in anxiety symptoms and severity of symptoms.
The GAD-7 is a 7-item tool that asks about the type and frequency of being bothered by a list of problems.
Response options include 'not at all', 'several days', 'more than half the days', or 'nearly every', over the last two weeks.
Scale range: 0 - 21. Higher scores represent more anxiety.
This will be measured in patients.
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Baseline; 6 months
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Change in stroke physical function
Time Frame: Baseline; 6 months
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The Stroke Impact Scale (SIS-16) will be used to assess change in physical functional capacity following stroke.
The SIS is a self-report questionnaire that evaluates disability and health-related quality of life following stroke.
Scores range from 16 to 80, with a higher score indicating a higher level of functional capacity.
This will be measured in patients.
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Baseline; 6 months
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Change in community integration
Time Frame: Baseline; 6 months
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The Community Integration Questionnaire (CIQ) will be used to assess change in level of integration in community.
The CIQ consists of 15 items relevant to home integration (H), social integration (S), and productive activities (P).
Scores range from 0-29 with a higher score indicating a higher level of community integration.
This will be measured in patients.
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Baseline; 6 months
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Change in use of health and social services
Time Frame: Baseline; 6 months
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The HSSUI will be used to assess change in use of health and social services of patients and caregivers.
The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services, from a societal perspective.
The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists.
Change in the use of health and social services will be assessed for patients and caregivers using the HSSUI.
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Baseline; 6 months
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Change in caregiver strain
Time Frame: Baseline; 6 months
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The Modified Caregiver Strain Index (MCSI) will be used to assess change in caregiver strain.
This tool will ask caregivers a list of 13 activities that they may have found to be difficult such as sleeping, physical strain, financial strain, personal plans, and work and family adjustments as a result of the caregiver role.
Response options include 'yes' according to two levels, either 'yes, on a regular basis' or 'yes, sometimes', or alternatively, 'no'.
Scale range: 0 - 26.
Higher scores represent more strain.
This will be assessed in caregivers.
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Baseline; 6 months
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Relative risk of any hospital readmission for any cause within 6 months
Time Frame: Baseline; 6 months
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The Health and Social Services Utilization Inventory (HSSUI) will be used to assess any readmission to hospital for any cause (patient).
The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective.
The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists.
The relative risk of any hospitalization within six months for any cause will be examined for patients in the intervention group compared to patients in the control group.
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Baseline; 6 months
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Time to any hospital readmission for any cause within 6 months
Time Frame: Baseline; 6 months
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Data from the Institute for Clinical and Evaluative Sciences (IC/ES) will be used to assess the time to any hospital readmission for any cause for patients.
The Hospital Discharge Abstract Database (DAD) within IC/ES will be used to measure readmission.
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Baseline; 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maureen Markle-Reid, PhD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Actual)
April 28, 2022
Study Completion (Actual)
December 5, 2022
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR-419061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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