A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT07390331
- Status
- Recruiting
Conditions
- Depression and CVD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- iHeart Depcare tool — BEHAVIORALThe iHeart DepCare tool is an electronic patient activation and psychoeducation tool (available in English and Spanish) designed to bridge depression screening with treatment. The tool includes: 1) a description of depressive symptoms; 2) a checklist of behavioral risk factors; 3) an animation of a CVD patient going through the process of symptom recognition, help seeking, and treatment completion following a CVD event; 4) psychoeducation videos; 5) depression treatment selection support (adapted to include behavioral risk factor preferences); and 6) additional cardiac resources the patient can reference. Patients may receive brief motivational interviewing as well as technical/navigational support per patient preference to reinforce learning. Patient treatment preferences are sent via EPIC to the mental health and treating providers.
Study Details
This study, which is being conducted as part of a Quality Improvement (QI) Initiative at Columbia University Irving Medical Center, will test whether delivering the iHeart DepCare tool increases real world reach and adoption of depression treatment among CHD patients. As part of the QI Initiative, Clinic Navigators will administer and record (in EPIC) depression screening in advance of primary care and cardiology appointments. Eligible patients with elevated depressive symptoms will be randomized to receive usual care vs. the iHeart DepCare tool in conjunction with brief motivational, technical and navigation support per patient preference. Aim 1: To test the effect of iHeart DepCare on depression treatment optimization (primary outcome) among coronary heart disease patients with elevated depressive symptoms. Aim 2: To explore the effect of iHeart DepCare on implementation outcomes, including provider referrals, among coronary heart disease patients with elevated depressive symptoms.
Key Dates
- Start date
- Mar 3, 2026
- Status verified
- Mar 2026
- Primary completion
- May 30, 2028
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: Screening aloneAs part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion. Patients will receive the clinic's mental health informational resource.
- Active Comparator: Screening plus iHeart DepCare tool and Motivational InterviewingAs part of a Quality Improvement Initiative, navigators and clinical staff call patients to screen patients for depression using the Patient Health Questionnaire (PHQ)-2 followed by the PHQ-9 in advance of scheduled office visits with cardiologists or primary care clinicians and enter results into Epic for providers to view during their visits and refer and manage depression at their discretion. Eligible patients who screen positive for depression (PHQ-9 ≥8) are administered the Heart DepCare tool along with motivational, technical and navigational support per patient preference. Clinical and mental health providers are sent the patient's treatment preferences via EPIC.
Primary Outcome Measure
Percentage of eligible patients who initiate or intensify depression treatment [ Time Frame: Up to 6 months ]
Central Contacts
- Nathalie Moise, MD, MS, FAHA212-342-2889
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | Nathalie Moise, MD, MS, FAHA 212-342-2889 Nathalie Moise, MD, MS, FAHA (PRINCIPAL_INVESTIGATOR) |