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

An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Electronic shared decision making (eSDM) tool

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 pre-post design across socioeconomically diverse cardiology and primary care clinics.

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of coronary heart disease
• English or Spanish Speaking
• Elevated Depressive symptoms (PHQ9 ≥10)
• Appointment at participating cardiology or primary care clinics

Exclusion Criteria:

• Under the care of a psychiatrist [**On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period**]
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electronic shared decision making (eSDM) Tool; In the pre-intervention period, patients in clinic clusters will receive usual care. When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application. During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up.

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. In addition to education, providers will receive a patient preference report in real time with options for coordination of care; Other Names: eSDM intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Index (BDI-II)	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	Baseline, Follow-up visit (approximately 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who initiate treatment	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	Baseline, Follow-up visit (approximately 6 months)
Mean Patient Activation	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	Baseline
Mean Decisional Conflict Scale	Mean decisional conflict (measures personal perceptions of uncertainty around choosing among treatment option, 10 items, range 0-100, higher score indicates greater conflict) of patients.	Baseline
Mean change in quality of life (QoL)	Change in QoL from from baseline to follow up visit in the pre-intervention compared to post-intervention period	Baseline, Follow-up visit (approximately 6 months)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nathalie Moise, MD, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Implementation science
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Depression; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AAAR9175 - III; 1R01HL141609-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No