An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03882411
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
368
1
2
49.3
7.5

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Electronic shared decision making (eSDM) tool
N/A

Detailed Description

Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.

The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a stepped wedge design across socioeconomically diverse cardiology and primary care clinics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
368 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped Wedge Design with 8 clinics randomized to timing of receipt of intervention. More clinics may be enlisted in the event that a sufficient number of participants from the initial 8 clinics is not achieved.Stepped Wedge Design with 8 clinics randomized to timing of receipt of intervention. More clinics may be enlisted in the event that a sufficient number of participants from the initial 8 clinics is not achieved.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
Actual Study Start Date :
Apr 23, 2019
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electronic shared decision making (eSDM) Tool

When a clinic's randomly allotted intervention period arrives, coronary heart disease patients in a given cluster of clinics will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive a patient preference report generated from the application.

Behavioral: Electronic shared decision making (eSDM) tool
The web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. Providers will receive a patient preference report in real time with options for coordination of care.
Other Names:
  • eSDM intervention
  • No Intervention: Usual Care

    In the year prior to the allocated intervention period, coronary heart disease patients will receive usual care from their providers.

    Outcome Measures

    Primary Outcome Measures

    1. Beck Depression Index (BDI-II) [Baseline, Follow-up visit (approximately 6 months)]

      Change in total BDI (21-item measure of depressive symptoms [0-63]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period

    Secondary Outcome Measures

    1. Proportion of patients who initiate treatment [Baseline, Follow-up visit (approximately 6 months)]

      Proportion of enrolled patients who initiate any depression treatment (medications, cardiac rehab/exercise program, therapy) from baseline to follow up visit in the pre-intervention compared to post-intervention period

    2. Mean change in quality of life years (QALYs) [Baseline, Follow-up visit (approximately 6 months)]

      Change in QALYs from from baseline to follow up visit in the pre-intervention compared to post-intervention period

    3. Mean Patient Activation [Baseline]

      Mean baseline patient activation measure [PAM] (13-items, range 0-100, higher score indicates greater activation] in the pre-intervention compared to post-intervention period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • History of coronary heart disease

    • English or Spanish Speaking

    • Elevated Depressive symptoms (PHQ9 ≥10)

    Exclusion Criteria:
    • Under the care of a psychiatrist (e.g., for schizophrenia)

    • Diagnosis/history of psychosis or schizophrenia

    • Diagnosis/history of bipolar disorder

    • Attempted suicide

    • Non-English or Spanish speaking

    • Dementia or severe cognitive impairment

    • Non-elevated depressive symptoms

    • Alcohol or substance abuse

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Nathalie Moise, MD, MS, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nathalie Moise, Assistant Professor of Medicine, Dept of Medicine, Columbia University
    ClinicalTrials.gov Identifier:
    NCT03882411
    Other Study ID Numbers:
    • AAAR9175 - III
    • 1R01HL141609-01
    First Posted:
    Mar 20, 2019
    Last Update Posted:
    Sep 25, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 Nathalie Moise, Assistant Professor of Medicine, Dept of Medicine, Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 25, 2020