NCT04278794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

February 5, 2020

Last Update Submit

March 22, 2023

Conditions

Stroke

Keywords

Older adultsMultimorbidityTransitional careVirtual careStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in health-related quality of life - mental health

    Baseline; 6 months

  • Change in health-related quality of life - physical health

    Baseline; 6 months

  • Change in self-efficacy

    Baseline; 6 months

  • Change in depressive symptoms

    Baseline; 6 months

  • Change in anxiety

    Baseline; 6 months

  • +6 more secondary outcomes

Study Arms (2)

Transitional Care Stroke Intervention (TCSI)

EXPERIMENTAL

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.

Other: Transitional Care Stroke Intervention (TCSI)

Control

NO INTERVENTION

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

Interventions

Transitional Care Stroke Intervention (TCSI)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.

Transitional Care Stroke Intervention (TCSI)

Eligibility Criteria

Age55 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSex and gender-based analysis will be completed. Particular attention will be given to sex/gender differences in experiences with the care team, given reported differences in how women and men collaborate with healthcare providers. Additionally, sex-based sub-group analysis will be completed because of the central role that sex plays in healthcare research.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, L8S 4L8, Canada

Location

Hotel Dieu Shaver

Saint Catherines, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37872479DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maureen Markle-Reid, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Effectiveness-implementation hybrid type I design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 20, 2020

Study Start

November 30, 2020

Primary Completion

April 28, 2022

Study Completion

December 5, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations

CA(2)