Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
NCT Number: NCT06526988
Acronym: IICAPTAIN-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: BEHAVIORAL: EPIC-HF Patient-facing Tool|BEHAVIORAL: PROMPT-HF Clinician-facing Alert
Sponsor: University of Colorado, Denver
Collaborators: Patient-Centered Outcomes Research Institute|Yale University|Northwestern University|University of Utah|Sutter Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2200
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-03-01
Completion Date: 2028-09-01
Locations: Sutter Health, Walnut Creek, California, 94596, United States|Yale University, New Haven, Connecticut, 06510, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Utah, Salt Lake City, Utah, 84132, United States

Summary:
An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.

Primary Outcome Measures: Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction, The primary outcome for this trial is the proportion of patients with HFrEF who have an increase in the number of prescribed HFrEF therapies (beta blockers, ACE-I/ARB/ARNI, MRA, SGLT2i) and/or dosing intensification from pre-clinic visit to 1 day after., From pre-clinic visit to 1 day after
Secondary Outcome Measures: Individual drug class changes, Change in the number of prescribed HFrEF therapies and/or dosing intensification for the following: beta blockers, ACE-I/ARB/ARNI, MRA, SGLT2i., 0, 1, 30 days|Safety and adverse events, Hospitalizations and emergency room visits with diagnosis of hypotension, bradycardia, acute renal failure, hyperkalemia, allergic reaction to medication, urinary tract infection, worsening heart failure, and other., 1-90 days|Patient activation, In a survey sent to patients, the Patient Assessment of Chronic Illness Care (PACIC) will be collected. This is a patient-level assessment of healthcare that focuses on the receipt of patient-centered care and self-management behaviors. Scores on the PACIC range from 1 to 5, with higher scores indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling. The PACIC sub-domains of 'Patient Activation' and 'Five As' Agree' will be used for this study., Day after visit|Patient Self efficacy, In a survey sent to patients, the Decision Self Efficacy Scale will be collected. It measures self-confidence or belief in one's ability in decision making, including shared decision making. A score of 0 means 'extremely low self efficacy' and a score of 100 means 'extremely high self efficacy'., Day after visit|Clinician attitudes toward patient activation tools and clinical decision support, In a survey sent to clinicians, a six-item attitudes measure adapted for EPIC-HF and PROMPT-HF interventions will be collected., Baseline, at study completion (about 2.5 years)|Clinician acceptability and feasibility of interventions, In a survey sent to clinicians, Acceptability of Intervention Measure and Feasibility of Intervention Measure will be collected., At study completion (about 2.5 years)|Reach of EPIC-HF intervention, Reach of the EPIC-HF intervention will be measured by the proportion and representativeness of eligible patients who receive the intervention. Representativeness will be assessed by comparing participants who opt in versus those who opt out based on demographic/clinical indicators., Throughout study period (about 2.5 years)|Adoption of PROMPT-HF intervention, Adoption of the PROMPT-HF intervention will be measured by the proportion and representativeness of eligible clinicians who enroll versus decline., Throughout study period (about 2.5 years)|Implementation of PROMPT-HF and EPIC-HF interventions, In a survey sent to clinicians and patients, questions on their use and opinions of the PROMPT-HF and EPIC-HF interventions will be collected. In a subset of clinicians and patients, qualitative interviews will be conducted to get a more in-depth understanding of implementation., Throughout study period (about 2.5 years), day after visit for patient, at study completion (about 2.5 years) for clinician|Maintenance of PROMPT-HF and EPIC-HF interventions, Rate of continued use of interventions after study period through interviews with site clinicians and institutional leadership., 6 months after primary data collection completion