Skip to content

A Patient Activation Approach to Implementing Depression Treatment in Cardiac Patients

A Theory-Informed, Brief Patient Activation and Motivational Interviewing Approach to Implementing Depression Treatment in Cardiac Patients: A Quality Improvement Initiative

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07390331
Acronym
iHeart_2
Enrollment
200
Registered
2026-02-05
Start date
2026-03-03
Completion date
2029-01-31
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and CVD

Keywords

patient activation, depression treatment uptake, depression treatment optimization

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALiHeart Depcare tool

The 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.

Sponsors

Columbia University
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of eligible patients who initiate or intensify depression treatmentUp to 6 monthsThis is designed to measure depression treatment reach, which is defined as the percentage of eligible patients who initiate or intensify depression treatment within 6 months of the index visit, as indicated by ≥1 pharmacy fill data of a new or changed antidepressant and/or a new visit with a mental health provider (e.g., psychologist, psychiatrist, behavioral health provider like social workers) and/or primary care provider with a visit diagnosis of depression and/or an exercise program (e.g., cardiac rehabilitation), which will be assessed through chart extraction and tallied.

Secondary

MeasureTime frameDescription
Percentage of patients in whom their clinician referred to mental health treatmentBaselineThis is designed to measure treatment adoption, which is defined as the percentage of patients in whom their clinician referred to mental health treatment (e.g., collaborative care, psychotherapy, psychiatry, cardiac rehab) and/or prescribed/changed antidepressants and/or psychological/supportive counseling at the index visit, which will be assessed through chart extraction and tallied.
Mean adherence to cardiac medicationsApproximately between 3 to 9 months from baselineMean adherence will be assessed as the mean proportion of days covered (PDC) for key cardiovascular disease medications (i.e., statin, antihypertensives) based on fill dates in the 3-9 months after the index visit.

Countries

United States

Contacts

CONTACTNathalie Moise, MD, MS, FAHA
nm2562@cumc.columbia.edu212-342-2889
PRINCIPAL_INVESTIGATORNathalie Moise, MD, MS, FAHA

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026