Clinical trial NCT03882411: An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)
Official title: An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Coronary Heart Disease
Keywords: Implementation science
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-03-20
Enrollment: 361
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post single group design with 8 clinic clusters randomized to timing of receipt of intervention with patients nested within providers nested within clinic clusters.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Index (BDI-II)
timeFrame: Baseline, Follow-up visit (approximately 6 months)
Secondary outcomes:
measure: Proportion of patients who initiate treatment
timeFrame: Baseline, Follow-up visit (approximately 6 months)
measure: Mean Patient Activation
timeFrame: Baseline
measure: Mean Decisional Conflict Scale
timeFrame: Baseline
measure: Mean change in quality of life (QoL)
timeFrame: Baseline, Follow-up visit (approximately 6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Nathalie Moise, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: