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

NCT06526988 | Recruiting

• 2 other identifiers: 24-1449BPS-2023C1-31460
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart failure; Patient-centered care; Clinical decision support; Guideline-directed medical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Individual drug class changes

  0, 1, 30 days

• Safety and adverse events

  1-90 days

• Patient activation

  Day after visit

• Patient Self efficacy

  Day after visit

• Clinician attitudes toward patient activation tools and clinical decision support

  Baseline, at study completion (about 2.5 years)

Study Arms (4)

Usual Care

NO INTERVENTION

Patients will receive care as usual.

EPIC-HF Patient-facing Tool

EXPERIMENTAL

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.

Behavioral: EPIC-HF Patient-facing Tool

PROMPT-HF Clinician-facing Alert

EXPERIMENTAL

Clinicians will receive tailored electronic health record (EHR) alerts recommending guideline-directed medical therapy (GDMT) in eligible patients with HFrEF during outpatient visits.

Behavioral: PROMPT-HF Clinician-facing Alert

Both (EPIC-HF and PROMPT-HF Interventions)

EXPERIMENTAL

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.

Behavioral: EPIC-HF Patient-facing Tool; Behavioral: PROMPT-HF Clinician-facing Alert

Interventions

EPIC-HF Patient-facing Tool BEHAVIORAL

A brief, animated video designed to engage and activate patients around their HFrEF medication prescribing sent prior to routine cardiology clinic visit, accompanied by a one-page HeartMeds Guide checklist.

Both (EPIC-HF and PROMPT-HF Interventions); EPIC-HF Patient-facing Tool

PROMPT-HF Clinician-facing Alert BEHAVIORAL

A best practice alert will appear for each eligible patient upon opening of the order entry screen in the patient's medical record. This alerts the provider of the presence of HFrEF, notes the patient's current LVEF and current evidence-based medications, and gives access to an order set with recommended evidence-based, guideline-recommended, and FDA- approved therapies for patients with HFrEF. Providers will also have access to a link to best available guideline recommended information regarding treatment of heart failure to allow further education if desired by the provider. The alerts will also clearly state the expected monitoring and follow-up required for prescriptions of these medications.

Both (EPIC-HF and PROMPT-HF Interventions); PROMPT-HF Clinician-facing Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Yale University: collaborator
• Northwestern University: collaborator
• University of Utah: collaborator
• Sutter Health: collaborator

Study Sites (5)

Sutter Health

Walnut Creek, California, 94596, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (11)

• Allen LA, Venechuk G, McIlvennan CK, Page RL 2nd, Knoepke CE, Helmkamp LJ, Khazanie P, Peterson PN, Pierce K, Harger G, Thompson JS, Dow TJ, Richards L, Huang J, Strader JR, Trinkley KE, Kao DP, Magid DJ, Buttrick PM, Matlock DD. An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial. Circulation. 2021 Feb 2;143(5):427-437. doi: 10.1161/CIRCULATIONAHA.120.051863. Epub 2020 Nov 17.

  PMID: 33201741 BACKGROUND

• Venechuk GE, Khazanie P, Page RL 2nd, Knoepke CE, Helmkamp LJ, Peterson PN, Pierce K, Thompson JS, Huang J, Strader JR, Dow TJ, Richards L, Trinkley KE, Kao DP, McIlvennan CK, Magid DJ, Buttrick PM, Matlock DD, Allen LA. An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial. Am Heart J. 2020 Nov;229:144-155. doi: 10.1016/j.ahj.2020.08.013. Epub 2020 Aug 28.

  PMID: 32866454 BACKGROUND

• Swat SA, Helmkamp LJ, Tietbohl C, Thompson JS, Fitzgerald M, McIlvennan CK, Harger G, Ho PM, Ahmad FS, Ahmad T, Buttrick P, Allen LA. Clinical Inertia Among Outpatients With Heart Failure: Application of Treatment Nonintensification Taxonomy to EPIC-HF Trial. JACC Heart Fail. 2023 Nov;11(11):1579-1591. doi: 10.1016/j.jchf.2023.06.022. Epub 2023 Aug 16.

  PMID: 37589610 BACKGROUND

• Venechuk G, Allen LA, Thompson JS, Morris MA, Matlock DD, McIlvennan CK, Dickert NW, Tietbohl C. Trust and activation in defining patient-clinician interactions for chronic disease management. Patient Educ Couns. 2023 Jan;106:113-119. doi: 10.1016/j.pec.2022.09.012. Epub 2022 Sep 22.

  PMID: 36167759 BACKGROUND

• Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.

  PMID: 35385798 BACKGROUND

• Desai AS, Maclean T, Blood AJ, Bosque-Hamilton J, Dunning J, Fischer C, Fera L, Smith KV, Wagholikar K, Zelle D, Gaziano T, Plutzky J, Scirica B, MacRae CA. Remote Optimization of Guideline-Directed Medical Therapy in Patients With Heart Failure With Reduced Ejection Fraction. JAMA Cardiol. 2020 Dec 1;5(12):1430-1434. doi: 10.1001/jamacardio.2020.3757.

  PMID: 32936209 BACKGROUND

• Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.

  PMID: 36356631 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Dunlay SM, Killian JM, Roger VL, Schulte PJ, Blecker SB, Savitz ST, Redfield MM. Guideline-Directed Medical Therapy in Newly Diagnosed Heart Failure With Reduced Ejection Fraction in the Community. J Card Fail. 2022 Oct;28(10):1500-1508. doi: 10.1016/j.cardfail.2022.07.047. Epub 2022 Jul 25.

  PMID: 35902033 BACKGROUND

• Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070.

  PMID: 30025570 BACKGROUND

• Kilsdonk E, Peute LW, Jaspers MW. Factors influencing implementation success of guideline-based clinical decision support systems: A systematic review and gaps analysis. Int J Med Inform. 2017 Feb;98:56-64. doi: 10.1016/j.ijmedinf.2016.12.001. Epub 2016 Dec 5.

  PMID: 28034413 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Larry A Allen, MD, MHS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry A Allen, MD, MHS

CONTACT

303-724-4713; larry.allen@cuanschutz.edu

Daniel D Matlock, MD, MPH

CONTACT

303-724-9941; daniel.matlock@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)