- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03157999
Community Assets Supporting Transitions (CAST) (CAST)
A Pragmatic Effectiveness-implementation Trial to Evaluate a Hospital-to-home Transitional Care Intervention Compared to Usual Care for Older Adults With Multiple Chronic Conditions and Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- 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?
- How is a care transition intervention adapted and implemented in diverse settings?
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Burlington, Ontario, Canada
- Joseph Brant Hospital
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Hamilton, Ontario, Canada, L8N 3Z5
- School of Nursing, McMaster University
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Sudbury, Ontario, Canada
- Health Sciences North/Laurentian University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group (CAST)
Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.
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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:
|
|
No Intervention: Control group (usual care)
Participants assigned to the control group will receive usual care at discharge from hospital to home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mental functioning of the older adult study participant
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
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T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
|
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
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Measured by the physical component summary (PCS) score of the Veterans RAND 12 item Health Survey (VR-12).
|
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
Measured by the Veterans RAND 12 item Health Survey (VR-12).
|
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
As measured by the CESD-10 to determine the presence and severity of depressive symptoms.
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T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
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Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
As measured by the GAD-7 (24).
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T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
Time Frame: T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
|
As measured by the Modified Caregiver Strain Index
|
T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
|
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Change in utilization of health and social services by the: 1) older adult study participant, 2) family/friend caregiver of the older adult study participant.
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
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As measured by the Health and Social Services Utilization Inventory
|
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in utilization of health services by the older adult study participant
Time Frame: T2 = 6 months after randomization; T3 = 12 months after randomization
|
As identified through Institute for Clinical Evaluative Sciences (ICES) databases
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T2 = 6 months after randomization; T3 = 12 months after randomization
|
|
Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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As measured through the Unmet Care Needs questionnaire (developed using input from patient/caregiver co-researchers to ensure the inclusion of outcomes that are relevant and meaningful to patients and caregivers).
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T1 = Baseline data collection; T2 = 6 months after randomization
|
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Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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As measured through the Patient-Provider Communication (PCC) questionnaire.
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T1 = Baseline data collection; T2 = 6 months after randomization
|
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Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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As measured through the adapted Client-Centred Care Questionnaired (CCCQ).
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T1 = Baseline data collection; T2 = 6 months after randomization
|
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Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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As measured through the adapted Integrated Care Patient-Reported Experience Measures (IC-PREMs).
|
T1 = Baseline data collection; T2 = 6 months after randomization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carrie McAiney, Ph.D., University of Waterloo
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFHSC 2000003756
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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