Community Assets Supporting Transitions (CAST)

Study Overview
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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: 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.

Official Title
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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

Conditions
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Comorbidity, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Intervention group (CAST)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (CAST)<br>Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care. | Behavioral: Intervention group (CAST)<br>* 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.<br>|
| No Intervention: Control group (usual care)<br>Participants assigned to the control group will receive usual care at discharge from hospital to home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | As measured by the CESD-10 to determine the presence and severity of depressive symptoms. | T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization | 
| 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). | 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) | As measured by the Modified Caregiver Strain Index | T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization | 
| 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 | 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 | As identified through Institute for Clinical Evaluative Sciences (ICES) databases | 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). | 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). | T1 = Baseline data collection; T2 = 6 months after randomization | 
| 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. | T1 = Baseline data collection; T2 = 6 months after randomization | 
| 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). | T1 = Baseline data collection; T2 = 6 months after randomization | 
| 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). | T1 = Baseline data collection; T2 = 6 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults, Transitional Care, Caregiver, Intervention