Tools to Improve Medication Management for Heart Failure

(IICAPTAIN-HF Trial)

Recruiting at 4 trial locations

Overseen By Daniel D Matlock, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Left ventricular assist device, Transplant, GFR < 15, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the management of treatments for heart failure with reduced ejection fraction (HFrEF). It tests two tools: the EPIC-HF Patient-facing Tool, which helps patients understand and engage in their treatment decisions, and the PROMPT-HF Clinician-facing Alert, which guides doctors in adjusting medications during visits. Individuals with HFrEF who are not on all recommended heart medications at ideal doses and have seen a heart doctor in the past year might be suitable candidates for this trial. As an unphased trial, it offers patients the opportunity to actively contribute to advancements in heart failure care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It focuses on improving and intensifying heart failure medications, so you may need to adjust your current treatment with your doctor's guidance.

What prior data suggests that these tools are safe for improving medication management in heart failure?

Research has shown that the EPIC-HF and PROMPT-HF tools are safe to use. In studies, these tools helped doctors improve heart failure treatments without causing harm to patients.

The EPIC-HF tool is sent to patients before their doctor visits, encouraging discussions about heart failure treatments. This tool has helped doctors prescribe the right medications more effectively, with no reports of harm or side effects.

The PROMPT-HF tool sends alerts to doctors during patient visits, reminding them to consider important heart failure medications. Studies found that these alerts increased the proper use of medications without causing safety issues.

While these tools are not medications, they play a crucial role in improving heart failure management. Research supports their safety in facilitating effective collaboration between doctors and patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tools because they aim to enhance the management of heart failure by using technology in innovative ways. The EPIC-HF Patient-facing Tool empowers patients with educational videos and a checklist, helping them better understand and manage their condition before appointments. Meanwhile, the PROMPT-HF Clinician-facing Alert provides doctors with tailored electronic health record alerts, recommending guideline-directed medical therapy, which can lead to more personalized and timely care. These tools differ from traditional treatments that often rely solely on medications, as they incorporate digital engagement and real-time clinical decision support to potentially improve outcomes for patients with heart failure.

What evidence suggests that this trial's tools could be effective for improving medication management in heart failure?

Research has shown that the EPIC-HF patient tool, which includes a video and checklist sent to patients before their clinic visits, helps doctors enhance heart failure treatments. As a result, patients might receive better care, leading to improved heart health and quality of life. In this trial, some participants will receive the EPIC-HF patient tool. Others will experience the PROMPT-HF clinician tool, which sends alerts to doctors during visits. Studies have found that it significantly increased the use of recommended heart failure treatments within 30 days. Additionally, some participants will receive both tools together, which can lead to more consistent use of heart medications, potentially improving patient outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Larry A Allen, MD, MHS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for patients with chronic heart failure who have a reduced ability of the heart to pump blood (HFrEF). It's designed to help these individuals improve their cardiac function and quality of life by optimizing their medication regimen. Participants should be willing to use new tools aimed at enhancing treatment.

Inclusion Criteria

I am a heart specialist with patients who have severe heart failure.

Patient must have had a routine cardiology outpatient clinic appointment in the previous 12 months

I am over 18 years old.

Exclusion Criteria

I do not speak English or Spanish.

I am being considered for or have had a transplant.

My kidney function is severely reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Phase

Adaptation and implementation of EPIC-HF and PROMPT-HF interventions at 5 health systems using the PRISM framework

6 months

Multiple visits for adaptation and testing

Testing Phase

Testing the effectiveness and interaction of EPIC-HF and PROMPT-HF interventions to improve GDMT prescribing

2.5 years

Routine clinic visits for intervention delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• EPIC-HF Patient-facing Tool
• PROMPT-HF Clinician-facing Alert

Trial Overview The study tests two digital tools: EPIC-HF, which is a video and checklist for patients before clinic visits, and PROMPT-HF, an alert system for clinicians during visits. The goal is to see if these tools can help increase the use of recommended heart failure medications across five health systems.

How Is the Trial Designed?

Group I: PROMPT-HF Clinician-facing Alert Experimental Treatment 1 Intervention

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

Group II: EPIC-HF Patient-facing Tool Experimental Treatment 1 Intervention

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.

Group III: Both (EPIC-HF and PROMPT-HF Interventions) Experimental Treatment 2 Interventions

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.

Group IV: Usual Care Active Control 1 Intervention

Patients will receive care as usual.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Sutter Health

Collaborator

Trials

26

Recruited

68,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The HEARTFELT intervention significantly improved clinician adherence to self-management categories in heart failure care, as evidenced by a P-value of .000, indicating a strong effect after implementation.

While the intervention enhanced education and self-management support for patients, it did not show significant improvements in adherence to medical interventions, suggesting that further strategies may be needed to address this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guideline adherence before and after implementation of the HEARTFELT (HEART Failure Effectiveness & Leadership Team) intervention. Dykes, PC., Acevedo, K., Boldrighini, J., et al.[2019]

The Heart Failure Symptom Tracker (HFaST) is a new 6-item tool developed to help patients identify worsening heart failure symptoms, which can improve communication with healthcare providers and potentially reduce hospitalizations.

In a pilot study with 100 heart failure patients, the HFaST demonstrated good reliability and validity, with healthcare providers rating it as a good or excellent method for tracking symptoms, indicating its feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST). Lewis, EF., Coles, TM., Lewis, S., et al.[2020]

This pilot study will evaluate the acceptability and feasibility of a tiered intervention combined with the NPS MedicineWise dose reminder app to improve medication adherence in 55 Australian patients with heart failure.

The study aims to measure the effectiveness of this approach using the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) over 6 months, alongside secondary outcomes like self-reported adherence and health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of the NPS MedicineWise mobile phone application in supporting medication adherence in patients with chronic heart failure: Protocol for a pilot study. Chapman-Goetz, J., Packham, N., Gabb, G., et al.[2022]

A qualitative study involving 31 heart failure patients revealed that they preferred using their own management strategies, including electronic platforms, over existing resources for managing their condition.

Key barriers to effective self-care identified included a lack of patient education, difficulties in recognizing symptoms of heart failure, non-adherence to treatment plans, and issues related to taking multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing self-care strategies in heart failure through patient-reported outcome measures. Segan, L., Nanayakkara, S., Mak, V., et al.[2019]

A study in Spain identified key features for an app designed to help patients with heart failure manage their condition, emphasizing the need for components that enhance understanding of heart failure, promote self-care, and involve family support.

Patients expressed a strong preference for features that improve emergency contact with health services, provide nutritional information, suggest exercises for physical improvement, and offer insights on food and drug interactions, highlighting the importance of motivation in their self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needs of patients with multi-morbidity and heart failure for the development of a mHealth to improve their self-management: A qualitative analysis. Bas-Sarmiento, P., Fernández-Gutiérrez, M., Poza-Méndez, M., et al.[2023]

In a study of 754 heart failure patients, 50% reported experiencing dizziness and 44% reported a dry cough, with these adverse effects leading to a 38% increased likelihood of medication changes.

Among the reported adverse effects, a dry cough was associated with the highest risk of medication change (1.83 times more likely), while patients reporting gout had a fourfold increase in the likelihood of starting or intensifying alleviating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of perceived adverse effects on medication changes in heart failure patients. De Smedt, RH., Jaarsma, T., Haaijer-Ruskamp, FM., et al.[2013]

A workshop by the European Society of Cardiology identified key barriers to effective heart failure management, including treatment complexity, financial constraints, and fragmented healthcare systems, which hinder optimal patient outcomes.

To improve heart failure care, the workshop emphasized the need for standardized pathways, better integration of guidelines into primary care, and enhanced patient education, alongside ongoing initiatives like updated ESC guidelines and quality improvement registries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing outcomes in heart failure: 2022 and beyond. Jankowska, EA., Andersson, T., Kaiser-Albers, C., et al.[2023]

Despite advancements in heart failure (HF) treatments over the past 15-20 years, many patients are still not receiving optimal doses of medications, which can hinder their recovery and overall health outcomes.

The proposed practical approach algorithm aims to help physicians better implement guideline-directed therapies for HF patients, ensuring both safety and efficacy in treatment, as current guidelines lack detailed recommendations for inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. Abdin, A., Bauersachs, J., Soltani, S., et al.[2023]

The PROMPT-HF trial is testing whether electronic health record (EHR) alerts can improve adherence to guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) among 1,310 patients, aiming to enhance treatment outcomes.

By providing tailored alerts that include patient-specific data, the trial seeks to determine if this approach can lead to higher rates of GDMT prescriptions and better clinical outcomes, such as reduced hospital readmissions and mortality, compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Ghazi, L., Desai, NR., Simonov, M., et al.[2022]

The CHART-P pilot study demonstrated that providing individualized self-management support to low-income heart failure patients and feedback to their physicians is feasible, with 87% of patients receiving over 80% of the interventions.

Patients showed a significant reduction in median sodium intake from 3.5 g to 2.0 g (p<0.01), indicating improved dietary adherence, although medication adherence did not show statistically significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congestive heart failure adherence redesign trial: a pilot study. Mangla, A., Doukky, R., Powell, LH., et al.[2022]

The HeartLogic multisensor index was safely integrated into the care of 200 heart failure patients, leading to medication adjustments in 74% of alert cases, which helped improve patient outcomes.

Patients showed a significant reduction in NT-proBNP levels from a median of 1316 pg/mL to 743 pg/mL over 12 months, indicating improved heart function after alert-prompted treatment changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. Hernandez, AF., Albert, NM., Allen, LA., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.051863

The EPIC-HF Trial A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33201741/

The EPIC-HF Trial - PubMed - NIH A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916424005694

133 Rationale And Design Of The Implementation ... The I-I-CAPTAIN-HF study—Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal medicines for Heart Failure with ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/10.1001/jamacardio.2023.4565?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamacardio.2023.4553

STRONG-HF Evidence for Proactive, Patient-Centered ... A study comparing registry patients against clinical trial patients with similar patient characteristics found a large discrepancy in GDMT use, ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2022.03.338

Electronic Alerts to Improve Heart Failure Therapy in ... A real-time, targeted, and tailored EHR-based alerting system for outpatients with HFrEF led to significantly higher rates of GDMT at 30 days when compared ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/579976

Implementation and Interaction of Clinician And Patient ... 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 ...