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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EPIC-HF Patient-facing Tool, PROMPT-HF Clinician-facing Alert for heart failure?

The PROMPT-HF trial suggests that using electronic health record alerts to guide clinicians in prescribing recommended heart failure treatments can improve adherence to guidelines, potentially leading to better patient outcomes. Additionally, the HEARTFELT intervention showed that integrating evidence-based practices into electronic medical records can enhance clinician adherence to heart failure management guidelines, which is associated with improved patient care. ^{1 2 3 4 5}

Is the EPIC-HF or PROMPT-HF tool safe for humans?

The available research does not provide specific safety data for the EPIC-HF or PROMPT-HF tools, but they are designed to improve medication management by alerting healthcare providers to recommended treatments, which suggests they are generally safe as they do not involve direct patient intervention. ^{1 3 6 7 8}

How is the EPIC-HF and PROMPT-HF treatment different from other heart failure treatments?

The EPIC-HF and PROMPT-HF treatment is unique because it uses electronic health record (EHR) alerts to guide clinicians in prescribing guideline-directed medical therapy (GDMT) for heart failure, aiming to improve adherence to treatment guidelines and patient outcomes. This approach is novel as it leverages technology to provide timely, tailored recommendations to healthcare providers, potentially increasing the use of effective therapies in real-world settings. ^{1 3 9 10 11}

Research Team

Larry A Allen, MD, MHS

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical practice guideline adherence before and after implementation of the HEARTFELT (HEART Failure Effectiveness & Leadership Team) intervention. [2019]

3. United States 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). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Congestive heart failure adherence redesign trial: a pilot study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST). [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of perceived adverse effects on medication changes in heart failure patients. [2013]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Optimizing outcomes in heart failure: 2022 and beyond. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Enhancing self-care strategies in heart failure through patient-reported outcome measures. [2019]

11. United States 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. [2023]