Community Assets Supporting Transitions (CAST) (CAST)

March 21, 2023 updated by: Maureen Markle-Reid, McMaster University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Maureen F Markle-Reid, Ph.D.
  • Phone Number: 22306 (905)-525-9140
  • Email: mreid@mcmaster.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada
        • Joseph Brant Hospital
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8N 3Z5
        • School of Nursing, McMaster University
      • Sudbury, Ontario, Canada
        • Health Sciences North/Laurentian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (CAST)
Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
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).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
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)
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
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
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
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
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).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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).
Time Frame: T1 = Baseline data collection; T2 = 6 months after randomization
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences
Laurentian University
The Ontario Spor Support Unit
Labarge Optimal Aging Initiative

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carrie McAiney, Ph.D., University of Waterloo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RFHSC 2000003756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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