Coronary Heart Disease, Depressive Symptoms
Conditions
Keywords
Implementation science
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.
Interventions
BEHAVIORALElectronic 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
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed