Community Assets Supporting Transitions (CAST)

Depressive Symptoms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157999
• Other study ID #: RFHSC 2000003756
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: June 15, 2020

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comorbidity
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Joseph Brant Hospital	Burlington	Ontario
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	School of Nursing, McMaster University	Hamilton	Ontario
Canada	Health Sciences North/Laurentian University	Sudbury	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Labarge Optimal Aging Initiative, Laurentian University, The Ontario Spor Support Unit

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Aging, Community and Health Research Unit McMaster University
•   Canada Research Chair in Aging, Chronic Disease and Health Promotion Interventions
•   Ontario SPOR support unit