An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)
- Conditions
- Depressive SymptomsCoronary Heart Disease
- Registration Number
- NCT03882411
- Lead Sponsor
- Columbia University
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 361
- History of coronary heart disease
- English or Spanish Speaking
- Elevated Depressive symptoms (PHQ9 ≥10)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Trial Locations
- Locations (1)
Columbia University Irving Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital🇺🇸New York, New York, United States