Tools to Improve Medication Management for Heart Failure

(IICAPTAIN-HF Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Larry A Allen, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

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

No Placebo Group

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sutter Health Walnut Creek, CA

Northwestern University Chicago, IL

Yale University New Haven, CT

University of Utah Salt Lake City, UT

More Trial Locations

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

Yale University Collaborator

Patient-Centered Outcomes Research Institute Collaborator

Sutter Health Collaborator

Northwestern University Collaborator

University of Utah Collaborator

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] Heart failure (HF) is an increasing global concern. Despite evidence-based pharmacotherapy, morbidity and mortality remain high in HF. Medication non-adherence is a crucial factor in optimising clinical outcomes. A growing number of smartphone applications (apps) assist management. While evidence support their use to promote treatment adherence, apps alone may not be the solution. The objective of this pilot study is to assess the acceptability and feasibility of a tiered intervention added to the NPS MedicineWise dose reminder app (MedicineWise app) in supporting medication adherence in HF.

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] HEART Failure Effectiveness & Leadership Team (HEARTFELT) is a multifaceted intervention designed to improve adherence with the American College of Cardiology/American Heart Association practice guidelines for heart failure (HF). The purpose of this study was to assess differences in clinician adherence with clinical practice guidelines before and after implementation of HEARTFELT. A quasi-experimental, untreated control group design with separate pretest/posttest samples was employed at a community hospital in Connecticut. The untreated historical control group included patients aged 65 years or older with HF and a nonequivalent comparison group of patients with stroke. The posttest samples included patients with the diagnosis of HF and stroke admitted after implementation of the HEARTFELT intervention. The HEARTFELT intervention included automated pathway in electronic medical record (order sets, interdisciplinary plan of care, self-management plan), access to evidence for clinicians and patients, HF self-management education tools, and ongoing discipline-specific feedback regarding adherence. Data were analyzed using parametric and nonparametric methods. The HEARTFELT intervention significantly improved clinician adherence with addressing all self-management categories in the electronic medical record (P = .000) and adherence with self-management education given to the patient in writing at discharge (P = .000). There were no significant differences in adherence with medical interventions (P = .39). While guideline adherence is associated with less practice variation and improved processes, methods of integration into practice in community hospital settings have been largely unexplored. The multifaceted HEARTFELT intervention is promising for its potential to integrate evidence at the point of care, to reduce unwarranted variation in practice, and ultimately to improve the outcomes of individuals with HF.

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] Heart failure with reduced ejection fraction (HFrEF) is one of the most common chronic illnesses in the United States and carries significant risk of morbidity and mortality. Use of guideline-directed medical therapy (GDMT) for patients with HFrEF has been shown to dramatically improve outcomes, but adoption of these treatments remains generally low. Possible explanations for poor GDMT uptake include lack of knowledge about recommended management strategies and provider reluctance due to uncertainties regarding application of said guidelines to real-world practice. One way to overcome these barriers is by harnessing the electronic health record (EHR) to create patient-centered "best practice alerts" (BPAs) that can guide clinicians to prescribe appropriate medical therapies. If found to be effective, these low-cost interventions can be rapidly applied across large integrated healthcare systems. The PRagmatic Trial Of Messaging to Providers about Treatment of Heart Failure (PROMPT-HF) trial is a pragmatic, cluster randomized controlled trial designed to test the hypothesis that tailored and timely alerting of recommended GDMT in heart failure (HF) will result in greater adherence to guidelines when compared with usual care. PROMPT-HF has completed enrollment of 1,310 ambulatory patients with HFrEF cared for by 100 providers who were randomized to receive a BPA vs usual care. The BPA alerted providers to GDMT recommended for their patients and displayed current left ventricular ejection fraction (LVEF) along with the most recent blood pressure, heart rate, serum potassium and creatinine levels, and estimated glomerular filtration rate. It also linked to an order set customized to the patient that suggests medications within each GDMT class not already prescribed. Our goal is to examine whether tailored EHR-based alerting for outpatients with HFrEF will lead to higher rates of GDMT at 30 days post randomization when compared with usual care. Additionally, we are assessing clinical outcomes such as hospital readmissions and death between the alert versus usual care group. Trial Registration: Clinicaltrials.gov NCT04514458.

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

Congestive heart failure adherence redesign trial: a pilot study. [2022] Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study.

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] This study aimed to develop and provide a psychometric and feasibility pilot evaluation of the Heart Failure (HF) Symptom Tracker (HFaST), a new patient-reported tool designed to facilitate communication between patients and health care providers (HCPs) in routine clinical care. The HFaST enables patients to identify worsening HF symptoms, with a long-term goal of preventing hospitalizations or emergency room visits.

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

The impact of perceived adverse effects on medication changes in heart failure patients. [2013] Given the importance of patient safety and well-being, we quantified the likelihood and type of medication changes observed after 5 possible adverse effects (AE) perceived by heart failure (HF) patients.

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] Patients with heart failure (HF) and reduced ejection fraction suffer from a relapsing and remitting disease course, where early treatment changes may improve outcomes. We assessed the clinical integration and safety of the HeartLogic multisensor index and alerts in HF care.

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

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. [2023] Over the last 15-20 years, remarkable developments of heart failure (HF) pharmacotherapies have been achieved. However, HF remains a global healthcare challenge with more than 64 million patients worldwide. Optimization of guideline-directed chronic HF medical therapy is highly recommended with every patient visit to improve outcomes in patients with HF with reduced ejection fraction. However, the majority of patients in real-world settings are treated with doses that are lower than those with proven efficacy in clinical trials, which might be due to concerns of adverse effects and inertia of physicians. Likewise, a significant proportion of patients still do not receive all drug classes that could improve their prognosis. The recent European Society of Cardiology guidelines do not provide detailed recommendations on how these drug classes should be implemented in the treatment of inpatients to allow for both safety and a high likelihood of efficacy. We therefore propose a practical approach algorithm to support physicians to treat HF patients in their daily practice.

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

Optimizing outcomes in heart failure: 2022 and beyond. [2023] Although the development of therapies and tools for the improved management of heart failure (HF) continues apace, day-to-day management in clinical practice is often far from ideal. A Cardiovascular Round Table workshop was convened by the European Society of Cardiology (ESC) to identify barriers to the optimal implementation of therapies and guidelines and to consider mitigation strategies to improve patient outcomes in the future. Key challenges identified included the complexity of HF itself and its treatment, financial constraints and the perception of HF treatments as costly, failure to meet the needs of patients, suboptimal outpatient management, and the fragmented nature of healthcare systems. It was discussed that ongoing initiatives may help to address some of these barriers, such as changes incorporated into the 2021 ESC HF guideline, ESC Heart Failure Association quality indicators, quality improvement registries (e.g. EuroHeart), new ESC guidelines for patients, and the universal definition of HF. Additional priority action points discussed to promote further improvements included revised definitions of HF 'phenotypes' based on trial data, the development of implementation strategies, improved affordability, greater regulator/payer involvement, increased patient education, further development of patient-reported outcomes, better incorporation of guidelines into primary care systems, and targeted education for primary care practitioners. Finally, it was concluded that overarching changes are needed to improve current HF care models, such as the development of a standardized pathway, with a common adaptable digital backbone, decision-making support, and data integration, to ensure that the model 'learns' as the management of HF continues to evolve.

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

Enhancing self-care strategies in heart failure through patient-reported outcome measures. [2019] Heart failure (HF) is a major cause of morbidity and mortality, requiring collaborative patient-centred care. Patient engagement is fundamental to long-term management; patient-reported outcome measures are an increasingly recognised method of assessing medical interventions. A qualitative study of 31 patients with HF found they were twice as likely to use their own management strategies including electronic platforms rather than existing resources. Barriers to self-care included patient education, timely recognition of signs and symptoms of HF with an appropriate escalation plan, non-adherence and polypharmacy.

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] To provide practical information regarding needs, preferences of content and format of an app to assist the self-management in patients with multi-morbidity and heart failure (HF).