A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients (iHeart_2)

Columbia University

Status: Enrolling

Conditions: Depression and CVD

Treatments: Behavioral: iHeart Depcare tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07390331

P30AG064198 (U.S. NIH Grant/Contract)

AAAV9954

Details and patient eligibility

About

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.

Full description

Depression is common in patients with coronary heart disease (CHD) and associated with increased cardiac morbidity and mortality. Evidence-based mental health treatment improves depressive symptoms and quality of life, yet few CHD patients engage in treatment. The investigator previously tested the efficacy of an implementation strategy centered around a patient activation and psychoeducation tool (iHeart DepCare) for improving depressive symptoms and uptake of depression treatment in CHD patients. The research now expands to test the real-world effectiveness of the iHeart DepCare tool in cardiology and primary care settings.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age
• PHQ9 or PHQ8 score >=8
• History of coronary heart disease per EHR search for ICD-9 codes of 410-414 and ICD-10 codes: I20, I21, I22, I23, I24, I25.
• Appointment with a primary care provider (PCP) or cardiologist in an integrated care setting in NYP/Columbia (e.g., does not include procedure or lab-only visits)
• Has a PCP at NYP/Columbia active on the NYP/Columbia EHR

Exclusion criteria

• Not English or Spanish speaking
• History of severe mental illness (bipolar disorder, schizophrenia, chronic/recurrent depression, history of suicide attempt or self-inflicted injuries)
• Dementia
• Had an integrated mental health visit in the last 3 months as indicated in the EHR
• Enrollment in the post-implementation period of IRB# AAAR9175

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Screening alone

No Intervention group

Description:

As 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.

Screening plus iHeart DepCare tool and Motivational Interviewing

Active Comparator group

Description:

As 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.

Treatment:

Behavioral: iHeart Depcare tool