Heart Failure With Reduced Ejection FractionIICAPTAIN-HFNCT06526988
Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
A study testing EPIC-HF Patient-facing Tool and PROMPT-HF Clinician-facing Alert in people with Heart Failure With Reduced Ejection Fraction, run by University of Colorado, Denver at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- EPIC-HF Patient-facing Tool and PROMPT-HF Clinician-facing Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Mar 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 10 patients with heart failure with reduced ejection fraction (HFrEF)
- Patient:
- Age > 18 years
- LVEF </=40% on most recent cardiology imaging study
- Has a new or return clinic visit with an enrolled clinician within the next 7 days
- Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter
Who cannot join
- Patient:
- Has a left ventricular assist device
- Under evaluation for or listed for transplant (or s/p transplant)
- Glomerular filtration rate (GFR) less than 20 or on dialysis
- On hospice care
- Preferred language neither English or Spanish
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Larry Allen, MD, MHS, 303-724-4713, larry.allen@cuanschutz.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Faraz Ahmad, MD, MS
- Recruiting
Yale University
New Haven, Connecticut, 06510
Francis P Wilson, MD, MSCE
Nihar Desai, MD, MPH
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Josef Stehlik, MD, MPH
- Recruiting
Sutter Health
Walnut Creek, California, 94596
Xiaowei (Sherry) Yan, PhD, MS
About this study
Official title: 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
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.
Read the 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.
- Being tested
- EPIC-HF Patient-facing Tool, PROMPT-HF Clinician-facing Alert
- Keywords
- Heart failure, Patient-centered care, Clinical decision support, Guideline-directed medical therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIC-HF Patient-facing ToolBehavioural
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.
PROMPT-HF Clinician-facing AlertBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: EPIC-HF Patient-facing Tool; Behavioral: PROMPT-HF Clinician-facing Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-clinic visit to 1 day after
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after primary data collection completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start6 Mar 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Yale University, Northwestern University, University of Utah, Sutter Health
- Responsible party
- Sponsor
- Investigators
- Larry A Allen, MD, MHS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526988
- Sponsor's protocol ID
- 24-1449
- Other IDs
- BPS-2023C1-31460
- Acronym
- IICAPTAIN-HF
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate participant data will be reported. A de-identified study dataset will be available on a data repository website after study collection and analysis is completed.
Publications
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.
PubMed 33201741Venechuk 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.
PubMed 32866454Swat 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.
PubMed 37589610Venechuk 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.
PubMed 36167759Ghazi 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.
PubMed 35385798Desai 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.
PubMed 32936209Mebazaa 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.
PubMed 36356631Heidenreich 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.
PubMed 35363499Dunlay 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.
PubMed 35902033Greene 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.
PubMed 30025570Kilsdonk 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.
PubMed 28034413
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06526988
- Acronym / sponsor ID
- IICAPTAIN-HF / 24-1449
- Keywords
- Heart failure, Patient-centered care, Clinical decision support, Guideline-directed medical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Yale University, Northwestern University, University of Utah, Sutter Health
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive care as usual. |
| EPIC-HF Patient-facing Tool | Experimental | Behavioral: EPIC-HF Patient-facing ToolPatients 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 | Experimental | Behavioral: PROMPT-HF Clinician-facing AlertClinicians 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) | Experimental | Behavioral: EPIC-HF Patient-facing Tool, Behavioral: PROMPT-HF Clinician-facing AlertPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 10 patients with heart failure with reduced ejection fraction (HFrEF)
- Age > 18 years
- LVEF </=40% on most recent cardiology imaging study
- Has a new or return clinic visit with an enrolled clinician within the next 7 days
Key exclusion criteria (6 listed)
- Has a left ventricular assist device
- Under evaluation for or listed for transplant (or s/p transplant)
- Glomerular filtration rate (GFR) less than 20 or on dialysis
- On hospice care
- Preferred language neither English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPIC-HF Patient-facing ToolA 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. | Behavioural | Both (EPIC-HF and PROMPT-HF Interventions), EPIC-HF Patient-facing Tool |
| PROMPT-HF Clinician-facing AlertA 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. | Behavioural | Both (EPIC-HF and PROMPT-HF Interventions), PROMPT-HF Clinician-facing Alert |
Primary outcome
Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction
Time frame: 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.
10 secondary outcomes
Individual drug class changes
Time frame: 0, 1, 30 days
Safety and adverse events
Time frame: 1-90 days
Patient activation
Time frame: Day after visit
Patient Self efficacy
Time frame: Day after visit
Clinician attitudes toward patient activation tools and clinical decision support
Time frame: Baseline, at study completion (about 2.5 years)
Clinician acceptability and feasibility of interventions
Time frame: At study completion (about 2.5 years)
Reach of EPIC-HF intervention
Time frame: Throughout study period (about 2.5 years)
Adoption of PROMPT-HF intervention
Time frame: Throughout study period (about 2.5 years)
Implementation of PROMPT-HF and EPIC-HF interventions
Time frame: 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
Time frame: 6 months after primary data collection completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 33201741Allen 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.
- Background: PubMed 32866454Venechuk 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.
- Background: PubMed 37589610Swat 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.
- Background: PubMed 36167759Venechuk 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.
- Background: PubMed 35385798Ghazi 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.
- Background: PubMed 32936209Desai 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.
- Background: PubMed 36356631Mebazaa 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.
- Background: PubMed 35363499Heidenreich 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.
- Background: PubMed 35902033Dunlay 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.
- Background: PubMed 30025570Greene 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.
- Background: PubMed 28034413Kilsdonk 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.
- Individual participant dataSharing planned: No. Only aggregate participant data will be reported. A de-identified study dataset will be available on a data repository website after study collection and analysis is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Larry A Allen, MD, MHS principal investigator
University of Colorado, Denver
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIC-HF Patient-facing Tool and PROMPT-HF Clinician-facing Alert in people with Heart Failure With Reduced Ejection Fraction, run by University of Colorado, Denver at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larry A Allen, MD, MHS (303-724-4713, larry.allen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensification of GDMT in patients with Heart Failure with Reduced Ejection Fraction (time frame: From pre-clinic visit to 1 day after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526988, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.