Best Practice Advisory Alerts for Heart Failure

(PROMPTHF-Inova Trial)

Overseen By Bhruga Shah, MS, BSN-RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Disqualifiers: Hospice, Prior heart transplant, others

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

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on advising doctors about heart failure medications that are not currently prescribed, so it's best to discuss your specific situation with the trial coordinators.

What data supports the effectiveness of the treatment Best Practice Advisory using Electronic Health Record for heart failure?

Research shows that using electronic health record alerts, like Best Practice Advisory, can help doctors follow heart failure treatment guidelines more closely, leading to better patient outcomes. Studies such as PROMPT-HF and PROMPT-AHF have demonstrated that these alerts can increase the use of recommended therapies, which are known to improve heart failure management. ^{1 2 3 4 5}

Is the Best Practice Advisory for heart failure safe for humans?

The Best Practice Advisory, which uses electronic health records to guide heart failure treatment, has been tested in trials like PROMPT-HF and PROMPT-AHF. These trials focus on improving medication use and care quality, but they do not report any specific safety concerns related to the advisory itself. ^{1 2 3 4 6}

How is the Best Practice Advisory treatment for heart failure unique?

The Best Practice Advisory treatment is unique because it uses electronic health record alerts to guide healthcare providers in prescribing guideline-directed medical therapies for heart failure. This approach aims to improve adherence to recommended treatments by providing timely and tailored alerts, which can be rapidly implemented across healthcare systems. ^{1 4 6 7 8}

Research Team

Mitchell Psotka, MD, PhD

Principal Investigator

Inova Health Care Services

Eligibility Criteria

This trial is for heart failure patients over 18 years old with a left ventricular ejection fraction of 40% or less, seen by a cardiologist at Inova clinics or hospitals. It's not for those who've opted out of EHR research, had a heart transplant, are on full doses of HFrEF meds, or in hospice care.

Inclusion Criteria

My heart's pumping ability is reduced.

Seen by a Cardiologist in an Inova clinic or Inova hospital setting

I am older than 18 years.

Exclusion Criteria

I am not currently receiving hospice care.

You have had a heart transplant before.

I am on the highest doses of all four key heart failure medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are exposed to an electronic health record best practice advisory system to stimulate appropriate medication prescription for heart failure

30 days

Follow-up

Participants are monitored for safety and effectiveness after intervention

1 year

Treatment Details

Interventions

• Best Practice Advisory using Electronic Health Record

Trial Overview The study tests if an electronic alert system helps doctors prescribe the right FDA-approved heart failure meds versus usual care without alerts. Patients will be randomly assigned to receive either the new alert system approach or continue with standard practices.

Participant Groups

Group I: Alert when provider is entering orders Experimental Treatment 1 Intervention

Group II: No alert, usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Heart Failure Collaboratory

Collaborator

Trials

1

Recruited

5,000+

Findings from Research

The PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failure involved 1,012 hospitalized patients with heart failure with reduced ejection fraction (HFrEF) to test an electronic health record system that alerts providers about necessary but unprescribed guideline-directed medical therapy (GDMT).

The study aims to increase the prescription of GDMT at discharge, addressing the common issue of underutilization, which can lead to higher risks of cardiovascular death and hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. Ghazi, L., O'Connor, K., Yamamoto, Y., et al.[2023]

Participation in heart failure (HF) performance improvement registries, such as ADHERE and OPTIMIZE-HF, has led to significant enhancements in the use of guideline-recommended therapies for HF, improving patient care in both hospital and outpatient settings.

These registries have not only improved adherence to quality measures but have also resulted in better clinical outcomes for patients with HF, helping to reduce disparities in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of care and outcomes for heart failure. -Role of registries-. Fonarow, GC.[2022]

A study analyzed the electronic health record (EHR) usage of 548 heart failure patients accessed by 5113 healthcare providers, revealing extensive collaboration among providers during hospital stays.

The findings showed that EHR access involved large groups of providers, with an average of 87.9 providers per collaboration module, highlighting the potential for improved care coordination through better understanding of these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualizing collaborative electronic health record usage for hospitalized patients with heart failure. Soulakis, ND., Carson, MB., Lee, YJ., et al.[2022]

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 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]

A tailored electronic health record (EHR) alert system did not significantly increase the overall prescription rates of guideline-directed medical therapies (GDMT) at discharge for patients hospitalized with acute heart failure, with only 34% of patients receiving GDMT in both alert and no alert groups.

However, the alert did lead to a significant increase in the prescription of mineralocorticoid receptor antagonists (MRAs), suggesting that while the overall impact was limited, targeted alerts can still improve specific aspects of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for management of heart failure with reduced ejection fraction in hospitalized patients: the PROMPT-AHF trial. Ghazi, L., Yamamoto, Y., Fuery, M., et al.[2023]

Multidisciplinary teams using structured medication titration strategies have been shown to be more effective in managing heart failure than traditional methods that rely solely on clinician alerts and educational initiatives.

Remote monitoring technologies, such as invasive pressure monitoring and wearable devices, hold promise for early detection of heart failure worsening, but more real-world data is necessary to validate their effectiveness and establish treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of multidisciplinary teams, electronic health records tools, and technology to optimize heart failure population health. Martyn, T., Montgomery, RA., Estep, JD.[2022]

A study involving 15,381 patients with chronic heart failure across 167 cardiology practices revealed low adherence to guideline-recommended adjunctive therapies, with only 7.3% receiving hydralazine/isosorbide dinitrate and 1.0% receiving pneumococcal vaccination.

Overall adherence to other adjunctive treatments varied but remained inadequate, highlighting significant gaps in the management of heart failure and the need for improved care processes and documentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to guideline-recommended adjunctive heart failure therapies among outpatient cardiology practices (findings from IMPROVE HF). Yancy, CW., Fonarow, GC., Albert, NM., et al.[2022]

References

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

Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

Improving quality of care and outcomes for heart failure. -Role of registries-. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Visualizing collaborative electronic health record usage for hospitalized patients with heart failure. [2022]

4. 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]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for management of heart failure with reduced ejection fraction in hospitalized patients: the PROMPT-AHF trial. [2023]

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

The use of multidisciplinary teams, electronic health records tools, and technology to optimize heart failure population health. [2022]

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

Adherence to guideline-recommended adjunctive heart failure therapies among outpatient cardiology practices (findings from IMPROVE HF). [2022]