Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation IHEART DEPCARE trial
Study context
- Population
- English- and Spanish-speaking coronary heart disease (CHD) patients ≥21 years of age with screen-detected elevated depressive symptoms (Patient Health Questionnaire-9 score ≥10) and a scheduled visit during the relevant time period; all primary care and cardiology clinicians at participating clinics4 sites · 8 clusters
- Planned comparison
- Post-implementation period compared to pre-implementation period
Methodological detailspre-post single group, open label design, 4 sites (8 clusters in total) introduced to the multilevel strategy in random order, patients nested within clinicians, nested within clusters, protocol and analysis plan
- Pre-post single group, open label design
- 4 sites (8 clusters in total) introduced to the multilevel strategy in random order
- Patients nested within clinicians, nested within clusters
- Protocol and analysis plan
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Trial conduct
- Launched in April 2019; estimated to conclude by July 2025
- Changes from pre-COVID-19 protocol: stepped wedge design replaced by single pre-post design randomized to strategy timing; reduced exclusion criteria; direct BHP referrals; multiplicity addressed in statistical analysis plan
Original publication
Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation IHEART DEPCARE trial. Am Heart J. Published 18 February 2025. doi:10.
Summarised from the published abstract; every number is checked against it