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

Not Applicable

Recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Electronic shared decision making (eSDM) Tool	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.

Primary Outcome Measures

Name	Time	Method
Beck Depression Index (BDI-II)	Baseline, Follow-up visit (approximately 6 months)	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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who initiate treatment	Baseline, Follow-up visit (approximately 6 months)	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
Mean Patient Activation	Baseline	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
Mean Decisional Conflict Scale	Baseline	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.
Mean change in quality of life (QoL)	Baseline, Follow-up visit (approximately 6 months)	Change in QoL from from baseline to follow up visit in the pre-intervention compared to post-intervention period

Locations (1): Columbia University Irving Medical Center/New York Presbyterian Hospital
🇺🇸
New York, New York, United States