Community Assets Supporting Transitions (CAST) (CAST)
Primary Purpose
Comorbidity, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention group (CAST)
Sponsored by

About this trial
This is an interventional other trial for Comorbidity focused on measuring Older Adults, Transitional Care, Caregiver, Intervention
Eligibility Criteria
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.
Sites / Locations
- Joseph Brant Hospital
- Hamilton General Hospital
- School of Nursing, McMaster University
- Health Sciences North/Laurentian University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group (CAST)
Control group (usual care)
Arm Description
Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.
Participants assigned to the control group will receive usual care at discharge from hospital to home.
Outcomes
Primary Outcome Measures
Change in mental functioning of the older adult study participant
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Secondary Outcome Measures
Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Measured by the physical component summary (PCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Measured by the Veterans RAND 12 item Health Survey (VR-12).
Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured by the CESD-10 to determine the presence and severity of depressive symptoms.
Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured by the GAD-7 (24).
Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
As measured by the Modified Caregiver Strain Index
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.
As measured by the Health and Social Services Utilization Inventory
Change in utilization of health services by the older adult study participant
As identified through Institute for Clinical Evaluative Sciences (ICES) databases
Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
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).
Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the Patient-Provider Communication (PCC) questionnaire.
Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the adapted Client-Centred Care Questionnaired (CCCQ).
Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
As measured through the adapted Integrated Care Patient-Reported Experience Measures (IC-PREMs).
Full Information
NCT ID
NCT03157999
First Posted
April 12, 2017
Last Updated
March 21, 2023
Sponsor
McMaster University
Collaborators
The Ontario Spor Support Unit, Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Laurentian University, Labarge Optimal Aging Initiative
1. Study Identification
Unique Protocol Identification Number
NCT03157999
Brief Title
Community Assets Supporting Transitions (CAST)
Acronym
CAST
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
The Ontario Spor Support Unit, Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Laurentian University, Labarge Optimal Aging Initiative
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comorbidity, Depressive Symptoms
Keywords
Older Adults, Transitional Care, Caregiver, Intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (CAST)
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.
Arm Title
Control group (usual care)
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will receive usual care at discharge from hospital to home.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group (CAST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mental functioning of the older adult study participant
Description
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Outcome Measure Information:
Title
Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
Description
Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
Measured by the physical component summary (PCS) score of the Veterans RAND 12 item Health Survey (VR-12).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
Measured by the Veterans RAND 12 item Health Survey (VR-12).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
As measured by the CESD-10 to determine the presence and severity of depressive symptoms.
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
As measured by the GAD-7 (24).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
Description
As measured by the Modified Caregiver Strain Index
Time Frame
T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
Title
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.
Description
As measured by the Health and Social Services Utilization Inventory
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in utilization of health services by the older adult study participant
Description
As identified through Institute for Clinical Evaluative Sciences (ICES) databases
Time Frame
T2 = 6 months after randomization; T3 = 12 months after randomization
Title
Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
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).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization
Title
Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
As measured through the Patient-Provider Communication (PCC) questionnaire.
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization
Title
Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
As measured through the adapted Client-Centred Care Questionnaired (CCCQ).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization
Title
Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
Description
As measured through the adapted Integrated Care Patient-Reported Experience Measures (IC-PREMs).
Time Frame
T1 = Baseline data collection; T2 = 6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen F Markle-Reid, Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carrie McAiney, Ph.D.
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph Brant Hospital
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
School of Nursing, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Health Sciences North/Laurentian University
City
Sudbury
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24886344
Citation
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.
Results Reference
background
PubMed Identifier
21867539
Citation
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.
Results Reference
background
PubMed Identifier
34310640
Citation
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.
Results Reference
derived
PubMed Identifier
32650732
Citation
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.
Results Reference
derived
Links:
URL
http://ossu.ca/
Description
Ontario SPOR support unit
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Community Assets Supporting Transitions (CAST)
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