Community Assets Supporting Transitions (CAST)

NCT ID: NCT03157999

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

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2020-06-15

Brief Summary

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The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input from community members. The program will be delivered by a Registered Nurse, who will provide support to patients via home visits and telephone calls. The nurse's role will involve linking patients and their caregivers with needed services and supports, reviewing medications that the patients are taking, assessing patients' health, building the skills of patients in problem-solving and managing their care, and providing education to patients and their caregivers.

Detailed Description

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Implementing transitional care interventions for older adults with depressive symptoms and multiple chronic conditions (MCC) is a pressing concern since older adults with depression face persistent health disparities. The Community Assets Supporting Transitions (CAST) research team seeks to address these health inequities, and improve health outcomes in this vulnerable and under-served population by developing and implementing an intervention that will improve patients' self-management ability, support their families and caregivers, and build capacity for primary care and other health and non-health providers to collaborate in delivering home and community services. The proposed study builds on our pilot study that evaluated a nurse-led intervention for older adult home care clients with MCC and depressive symptoms and demonstrated that the intervention was feasible and effective in reducing depressive symptoms.

The overall aim of the study is to improve care transitions in older adults with MCC and depressive symptoms. The project will address three research questions:

1. What is the effect of a new, nurse-led hospital-to-home transitional care intervention compared to usual care on health outcomes and costs for older adults with MCC and depressive symptoms?
2. How is a care transition intervention adapted and implemented in diverse settings?
3. What is required to sustain and scale up the intervention? We hypothesize that the intervention will improve health outcomes and reduce use of expensive health services compared to usual care at no additional cost, from a societal perspective.

Conditions

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Comorbidity Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The proposed study design is a pragmatic randomized controlled trial (RCT). A pragmatic design applies RCT methodology in actual care settings to better inform decisions on the likely benefits, harms, and costs of real world implementation. The design is further classified as a Type II hybrid effectiveness-implementation study, which assigns equal weight to assessing program effectiveness and implementation.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The Research Assistant who will be collecting the outcome measures will be blinded to group allocation (intervention vs. control) for the duration of data collection.

Study Groups

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Intervention group (CAST)

Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.

Group Type EXPERIMENTAL

Intervention group (CAST)

Intervention Type BEHAVIORAL

Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes:

* care coordination and system navigation (including facilitating timely primary care follow-up);
* medication management;
* assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms);
* evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions;
* patient and caregiver education; and goal setting and problem-solving therapy.

Control group (usual care)

Participants assigned to the control group will receive usual care at discharge from hospital to home.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention group (CAST)

Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes:

* care coordination and system navigation (including facilitating timely primary care follow-up);
* medication management;
* assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms);
* evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions;
* patient and caregiver education; and goal setting and problem-solving therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Is an adult, age 65 or older;
* Is planned for discharge from hospital to the community (this includes retirement homes and transitional care beds);
* Self-reports having a diagnosis of at least two chronic conditions;
* Is experiencing depressive symptoms, assessed using the 2-item version of the Patient Health Questionnaire (PHQ-2);
* Lives within one of the study regions (Sudbury, Burlington, or Hamilton), and is not planning to move out of the region during the trial (defined as a one-year period);
* Is capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf; and
* Is competent in English, or has an interpreter who is competent in English.

Exclusion Criteria

* Is being discharged from the hospital to a long-term care home or tertiary care.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ontario Spor Support Unit

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role collaborator

Laurentian University

OTHER

Sponsor Role collaborator

The Labarge Optimal Aging Initiative

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Maureen Markle-Reid

Professor and Canada Research Chair in Aging, Chronic Disease and Health Promotion Interventions

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maureen F Markle-Reid, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Carrie McAiney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

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Joseph Brant Hospital

Burlington, Ontario, Canada

Site Status

Health Sciences North/Laurentian University

Greater Sudbury, Ontario, Canada

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

School of Nursing, McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Markle-Reid M, McAiney C, Forbes D, Thabane L, Gibson M, Browne G, Hoch JS, Peirce T, Busing B. An interprofessional nurse-led mental health promotion intervention for older home care clients with depressive symptoms. BMC Geriatr. 2014 May 10;14:62. doi: 10.1186/1471-2318-14-62.

Reference Type BACKGROUND
PMID: 24886344 (View on PubMed)

Markle-Reid MF, McAiney C, Forbes D, Thabane L, Gibson M, Hoch JS, Browne G, Peirce T, Busing B. Reducing depression in older home care clients: design of a prospective study of a nurse-led interprofessional mental health promotion intervention. BMC Geriatr. 2011 Aug 25;11:50. doi: 10.1186/1471-2318-11-50.

Reference Type BACKGROUND
PMID: 21867539 (View on PubMed)

Markle-Reid M, McAiney C, Fisher K, Ganann R, Gauthier AP, Heald-Taylor G, McElhaney JE, McMillan F, Petrie P, Ploeg J, Urajnik DJ, Whitmore C. Effectiveness of a nurse-led hospital-to-home transitional care intervention for older adults with multimorbidity and depressive symptoms: A pragmatic randomized controlled trial. PLoS One. 2021 Jul 26;16(7):e0254573. doi: 10.1371/journal.pone.0254573. eCollection 2021.

Reference Type DERIVED
PMID: 34310640 (View on PubMed)

Markle-Reid M, McAiney C, Ganann R, Fisher K, Gafni A, Gauthier AP, Heald-Taylor G, McElhaney J, Ploeg J, Urajnik DJ, Valaitis R, Whitmore C. Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial. BMC Geriatr. 2020 Jul 10;20(1):240. doi: 10.1186/s12877-020-01638-0.

Reference Type DERIVED
PMID: 32650732 (View on PubMed)

Related Links

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http://ossu.ca/

Ontario SPOR support unit

Other Identifiers

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RFHSC 2000003756

Identifier Type: -

Identifier Source: org_study_id

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