Clinical trial NCT03157999: Community Assets Supporting Transitions (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
Overall status: COMPLETED
Phase: NA
Conditions: Comorbidity
Depressive Symptoms
Keywords: Older Adults
Transitional Care
Caregiver
Intervention
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Ontario Spor Support Unit
name: Canadian Institutes of Health Research (CIHR)
name: Institute for Clinical Evaluative Sciences
name: Laurentian University
name: The Labarge Optimal Aging Initiative
First posted: 2017-05-17
Enrollment: 127
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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:

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.

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.

Primary outcomes:
measure: Change in mental functioning of the older adult study participant
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary outcomes:
measure: Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable)
timeFrame: T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
measure: 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.
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in utilization of health services by the older adult study participant
timeFrame: T2 = 6 months after randomization; T3 = 12 months after randomization
measure: Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization
measure: Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization
measure: Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization
measure: Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).
timeFrame: T1 = Baseline data collection; T2 = 6 months after randomization
Other outcomes:
Locations:
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: School of Nursing, McMaster University
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North/Laurentian University
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen F Markle-Reid, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Carrie McAiney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.