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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882411
• Other study ID #: AAAR9175 - III
• Secondary ID: 1R01HL141609-01
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Nathalie Moise, MD, MS
• Phone: 2123422889
• Email: nm2562[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• History of coronary heart disease

• English or Spanish Speaking

• Elevated Depressive symptoms (PHQ9 =10)

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Symptoms
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Mean change in quality of life years (QALYs)	Change in QALYs from from baseline to follow up visit in the pre-intervention compared to post-intervention period	Baseline, Follow-up visit (approximately 6 months)
Secondary	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
Secondary	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