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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278794
• Other study ID #: CIHR-419061
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 5, 2022

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 5, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Transitional Care Stroke Intervention (TCSI)
Core components: 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. 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. 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. 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Hotel Dieu Shaver	Saint Catherines	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Canadian Frailty Network, Hamilton Health Sciences Corporation, Health Quality Ontario, Heart and Stroke Foundation of Canada, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any hospital readmission for any cause within 6 months	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).	6-months
Secondary	Change in health-related quality of life - mental health	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.	Baseline; 6 months
Secondary	Change in health-related quality of life - physical health	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.	Baseline; 6 months
Secondary	Change in self-efficacy	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.	Baseline; 6 months
Secondary	Change in depressive symptoms	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.	Baseline; 6 months
Secondary	Change in anxiety	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.	Baseline; 6 months
Secondary	Change in stroke physical function	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.	Baseline; 6 months
Secondary	Change in community integration	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.	Baseline; 6 months
Secondary	Change in use of health and social services	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.	Baseline; 6 months
Secondary	Change in caregiver strain	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.	Baseline; 6 months
Secondary	Relative risk of any hospital readmission for any cause within 6 months	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.	Baseline; 6 months
Secondary	Time to any hospital readmission for any cause within 6 months	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.	Baseline; 6 months