Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction: I-I-CAPTAIN-HF

I-I-CAPTAIN-HF is a multi-site, type-2 hybrid implementation-effectiveness trial conducted at 5 sites: the University of Colorado (central site), Yale University, Northwestern University, University of Utah, and Sutter Health.

Aim 1. Implement the EPIC-HF and PROMPT-HF interventions at 5 health systems through participatory work with a multi-level team using the PRISM framework to guide the delivery of a host of implementation strategies that respect mandatory aspects of the interventions (function) and explore adaptations (form) to maximize equitable reach, broad adoption, fidelity of implementation, and long-term maintenance.

• Hypothesis 1A: Standard EHR logic (in Epic) can be created for HFrEF identification and automated delivery of both interventions, followed by tailoring to individual system EHR infrastructure.
• Hypothesis 1B: Challenges around automated intervention delivery can be identified, solutions developed, and processes shared for optimal integration into the local clinic environment.
• Hypothesis 1C: Issues of equity-digital access, language, out-of-pocket cost, social determinants of health-can be addressed by intervention and delivery adaptations, respecting uniqueness of recipients.

The initial phase of I-I-CAPTAIN-HF explores a host of implementation strategies that will take the existing EPIC-HF and PROMPT-HF interventions and optimize their ability to be implemented widely while retaining tool fidelity. Current versions of EPIC-HF and PROMPT-HF were tested in single sites under research conditions that have led to barriers to wider uptake. In Aim 1, the investigators and study team will 1) form an External Advisory Committee, 2) apply PRISM domains to define mandatory functions of the interventions, 3) engage site partners to define form adaptations using the iPRISM web tool to assess context, 4) vet adaptable forms to consider fidelity to function, 5) decide final forms for each site, and 6) pilot local versions of each interventions using EHR technical testing to ensure feasibility, usability, and acceptability. The tools will be implemented and automated within each EHR and used as standard of care for all eligible patients.

Prior to conclusion of Aim 1, all sites will pilot test their site-based implementation approach to assess feasibility, usability, and user acceptability before widespread implementation in Aim 2. This process will conclude with interviews with team members to assess the fidelity to the intervention, as well as gather data on adaptations to the intervention by each site. These interviews will be conducted by the central site (University of Colorado) study team and occur with those involved at each site with implementing the interventions and could include site-principal investigators and/or co-investigators, IT leadership or analysts.