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Community Assets Supporting Transitions (CAST) (CAST)

This study is currently recruiting participants.
Verified July 2017 by Maureen Markle-Reid, McMaster University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03157999
First Posted: May 17, 2017
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Ontario SPOR SUPPORT UNIT
Labarge Optimal Aging Initiative
Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences
Laurentian University
Information provided by (Responsible Party):
Maureen Markle-Reid, McMaster University
  Purpose
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.

Condition Intervention
Comorbidity Depressive Symptoms Behavioral: Intervention group (CAST)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Maureen Markle-Reid, McMaster University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).

  • 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).

  • 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).

  • 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.

  • 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).

  • 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

  • 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

  • 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

  • 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).

  • 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.

  • 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).

  • 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).


Estimated Enrollment: 216
Actual Study Start Date: July 25, 2017
Estimated Study Completion Date: December 13, 2019
Estimated Primary Completion Date: December 4, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157999


Contacts
Contact: Maureen F Markle-Reid, Ph.D. (905)-525-9140 ext 22306 mreid@mcmaster.ca
Contact: Agata Drozd, MA (905)-525-9140 ext 20307 drozda@mcmaster.ca

Locations
Canada, Ontario
Joseph Brant Hospital Not yet recruiting
Burlington, Ontario, Canada
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
School of Nursing, McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Health Sciences North/Laurentian University Not yet recruiting
Sudbury, Ontario, Canada
Sponsors and Collaborators
McMaster University
Ontario SPOR SUPPORT UNIT
Labarge Optimal Aging Initiative
Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences
Laurentian University
Investigators
Principal Investigator: Maureen F Markle-Reid, Ph.D. McMaster University
Principal Investigator: Carrie McAiney, Ph.D. McMaster University
  More Information

Additional Information:
Publications:
Responsible Party: Maureen Markle-Reid, Associate Professor; Canada Research Chair in Aging, Chronic Disease and Health Promotion Interventions, McMaster University
ClinicalTrials.gov Identifier: NCT03157999     History of Changes
Other Study ID Numbers: RFHSC 2000003756
First Submitted: April 12, 2017
First Posted: May 17, 2017
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maureen Markle-Reid, McMaster University:
Older Adults
Transitional Care
Caregiver
Intervention

Additional relevant MeSH terms:
Depression
Behavioral Symptoms


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