Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Behavioral: EPIC-HF Patient-facing Tool; Behavioral: PROMPT-HF Clinician-facing Alert

• Registration Number: NCT06526988
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

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.

Aim 2. Test the effectiveness, as well as the interaction, of the EPIC-HF and PROMPT-HF interventions to improve GDMT prescribing from before to after the clinic visit among 2000 patients at 5 health systems using a 2x2 factorial design randomized at the clinician-level.

* Hypothesis 2A - Effectiveness: Both EPIC-HF and PROMPT-HF will improve GDMT intensification.

* Hypothesis 2B - Interaction: Patient- and clinician-facing tools may work better when used in combination.

Cluster-randomization will occur at the clinician level, where the clinician is randomized to 1 of 4 study arms (usual care, EPIC-HF only, PROMPT-HF only, both). Randomization will be stratified at the site level. Patient assignment follows clinician randomization.

Following processes developed in Aim 1, each site will deliver the assigned intervention(s) to patients and clinicians as per randomization. Those clinicians randomized to intervention(s) will have the intervention delivered to the clinician themselves (PROMPT-HF) and/or their patient (EPIC-HF) prior to the patient's scheduled routine clinic appointment. The interventions will be implemented as standard of care across those in the intervention arms and occur for all eligible patients.

Patient-level data will be collected through the patients' EHRs.

Aim 3. Evaluate ongoing implementation of EPIC-HF and PROMPT-HF using Practical, Robust Implementation and Sustainability Model (PRISM) to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors.

• Hypothesis 3: Understanding key mandatory elements and tailored adaptations to the interventions and their delivery will maximize equitable impact across implementation outcomes (reach), increase uptake by the clinics and their clinicians (adoption), ease appropriate deployment (implementation and adaptations), and lead to sustained use after the clinical trial (maintenance).

Implementation of EPIC-HF and PROMPT-HF will be explored using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes from the PRISM framework to understand the most effective means of sustainable delivery.

Reach: Investigators will attempt to characterize 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.

Effectiveness: Assessed in Aim 2, above.

Adoption: The absolute number, proportion, and representativeness of settings and intervention agents (clinicians) who are willing to initiate a program will be assessed. Effectively, adoption should be 100% at the site level since all programs who were approached have agreed to participate. Data will be collected on adoption at the clinician level, where each clinician can enroll or decline at study start, and then adopt or ignore PROMPT-HF CDS during study conduct. Clinicians' attitudes towards the new approach will be explored using clinician surveys measured before and after the trial.

Implementation: The investigators will assess the extent to which the intervention is implemented as intended (fidelity) and adaptations made. With a mixed methods evaluation, the experiences of EPIC-HF and PROMPT-HF and their combination will be explored.

Maintenance: The study team will systematically collect data on local decisions regarding maintenance and will also assess staff recommendations for sustainment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Study Start: 2025-03-01
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

Clinician:

• Clinician (MD, PA, NP) who practices in cardiology outpatient clinics
• Regularly sees patients with left ventricular ejection fraction (EF) </=40%, where their panel of patients over the last year included at least 25 patients with heart failure with reduced ejection fraction (HFrEF)

Patient:

• Age > 18 years
• LVEF </=40% on most recent cardiology imaging study
• Has had a routine cardiology outpatient clinic appointment in the previous 12 months
• Not on all 4 pillars of GDMT at optimal doses: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor/angiotensin converting enzyme inhibitor/angio-tensin receptor blocker, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter

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Exclusion Criteria

Patient:

• Has a left ventricular assist device
• Under evaluation for or listed for transplant (or s/p transplant)
• Glomerular filtration rate (GFR) less than 15
• On IV inotropes
• On hospice care
• Non-English or Non-Spanish speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
EPIC-HF Patient-facing Tool	EPIC-HF Patient-facing Tool	Patients will receive the patient engagement video and HeartMeds Guide checklist electronically about 2-7 days and 0-1 days prior to their next clinic appointment after enrollment.
PROMPT-HF Clinician-facing Alert	PROMPT-HF Clinician-facing Alert	Clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.
Both (EPIC-HF and PROMPT-HF Interventions)	EPIC-HF Patient-facing Tool	Patients will receive the patient engagement video and HeartMeds Guide checklist electronically about 2-7 days and 0-1 days prior to their next clinic appointment after enrollment, and clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.
Both (EPIC-HF and PROMPT-HF Interventions)	PROMPT-HF Clinician-facing Alert	Patients will receive the patient engagement video and HeartMeds Guide checklist electronically about 2-7 days and 0-1 days prior to their next clinic appointment after enrollment, and clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.

Primary Outcome Measures

Name	Time	Method
Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction	From pre-clinic visit to 1 day after	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.

Secondary Outcome Measures

Name	Time	Method
Individual drug class changes	0, 1, 30 days	Change in the number of prescribed HFrEF therapies and/or dosing intensification for the following: beta blockers, ACE-I/ARB/ARNI, MRA, SGLT2i.
Clinician acceptability and feasibility of interventions	At study completion (about 2.5 years)	In a survey sent to clinicians, Acceptability of Intervention Measure and Feasibility of Intervention Measure will be collected.
Adoption of PROMPT-HF intervention	Throughout study period (about 2.5 years)	Adoption of the PROMPT-HF intervention will be measured by the proportion and representativeness of eligible clinicians who enroll versus decline.
Implementation of PROMPT-HF and EPIC-HF interventions	Throughout study period (about 2.5 years), day after visit for patient, at study completion (about 2.5 years) for clinician	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.
Safety and adverse events	1-90 days	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.
Patient activation	Day after visit	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.
Reach of EPIC-HF intervention	Throughout study period (about 2.5 years)	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.
Patient Self efficacy	Day after visit	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'.
Clinician attitudes toward patient activation tools and clinical decision support	Baseline, at study completion (about 2.5 years)	In a survey sent to clinicians, a six-item attitudes measure adapted for EPIC-HF and PROMPT-HF interventions will be collected.
Maintenance of PROMPT-HF and EPIC-HF interventions	6 months after primary data collection completion	Rate of continued use of interventions after study period through interviews with site clinicians and institutional leadership.

Trial Locations

Locations (4)

Sutter Health; 🇺🇸 Walnut Creek, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States