EHR Alerts for Heart Failure

(BETTER CARE-HF Trial)

Recruiting at 3 trial locations

Overseen By Amrita Mukhopadhyay, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Ventricular assist device, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, there are specific exclusions related to certain medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment EHR-Embedded Alert for heart failure?

The PROMPT-HF trial suggests that using EHR-based alerts to remind doctors about recommended heart failure treatments can improve adherence to guidelines, potentially leading to better patient outcomes. This approach is low-cost and can be quickly implemented across healthcare systems, making it a promising tool for improving heart failure care. ^{1 2 3 4 5}

Is the EHR alert system for heart failure safe for humans?

The use of electronic health record (EHR) alerts has been studied for improving medication safety and monitoring, such as in warfarin management, and has shown potential in reducing adverse drug events. However, specific safety data for EHR alerts in heart failure is not directly available from the provided research. ^{6 7 8 9 10}

How does the EHR-Embedded Alert treatment for heart failure differ from other treatments?

The EHR-Embedded Alert treatment is unique because it uses electronic health record (EHR) alerts to guide clinicians in prescribing guideline-directed medical therapies (GDMT) for heart failure, aiming to improve adherence to treatment guidelines. This approach leverages technology to provide timely, patient-specific recommendations, which can be rapidly implemented across healthcare systems, unlike traditional methods that rely solely on clinician judgment. ^{1 3 11 12 13}

Research Team

Amrita Mukhopadhyay

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for patients with heart failure and reduced ejection fraction (HFrEF). It's designed to test if an electronic alert can help doctors follow heart failure treatment guidelines better. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 18 and 90 years old.

Patient with an encounter visit at participating cardiology practice during the study period

Patient with EF of less than or equal to 40% on most recent echocardiogram at the time of visit

Exclusion Criteria

Pregnancy

Ventricular assist device

I am not enrolled in hospice care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the automated EHR-embedded alert to improve prescribing of guideline-directed medical therapy

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

36 months

Treatment Details

Interventions

• EHR-Embedded Alert

Trial Overview The study is testing an automated alert embedded in the electronic health record system. The goal is to see if it improves the prescription of recommended treatments for HFrEF across multiple health systems.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants who are randomized to receive the intervention (i.e., displaying the automated EHR-embedded alert).

Group II: Standard of Care Active Control 1 Intervention

Participants who are randomized to the control group (i.e., not displaying the automated EHR-embedded alert).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

OhioHealth

Collaborator

Trials

31

Recruited

5,500+

Findings from Research

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]

Electronic health records (EHR) can significantly enhance the management of congestive heart failure (CHF) by standardizing care, promoting adherence to evidence-based guidelines, and improving workflow efficiency, as discussed in a review of various EHR tools.

The review highlights that EHR technologies, such as clinical decision support and telehealth, not only improve patient engagement and performance metrics but also contribute to quality improvement and clinical research in CHF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Management Innovation Enabled by Electronic Health Records. Kao, DP., Trinkley, KE., Lin, CT.[2021]

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]

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 FDA's ASTER pilot study demonstrated that electronic health record (EHR)-triggered adverse event reports can provide valuable postmarketing safety information, particularly for known adverse drug events (ADEs).

However, the quality of the reports varied, with many lacking critical details such as informative descriptions and relevant laboratory data, highlighting the need for improved data quality to enhance the utility of EHR-triggered ADE reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Brajovic, S., Piazza-Hepp, T., Swartz, L., et al.[2012]

The implementation of 'stealth' alerts in electronic health records led to a significant increase in anticoagulation monitoring, with 39% of patients completing monitoring within 5 days after co-prescribing a medication that interacts with warfarin, compared to 34% before the alerts were introduced.

This innovative approach directs alerts to a specialized anticoagulation management service rather than the prescribing clinicians, reducing alert fatigue and improving patient safety through better monitoring of potential drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Stealth" alerts to improve warfarin monitoring when initiating interacting medications. Koplan, KE., Brush, AD., Packer, MS., et al.[2021]

Patients with stage 3 and 4 chronic kidney disease (CKD) are at high risk for adverse drug events (ADEs) due to the kidneys' role in medication clearance, highlighting the need for effective monitoring systems.

Interviews with clinics revealed significant differences in electronic decision support practices and organizational culture, which are crucial factors to consider when implementing electronic drug-disease alerts to reduce ADEs in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. Lin, CP., Guirguis-Blake, J., Keppel, GA., et al.[2018]

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]

References

1. 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]

2. Ireland pubmed.ncbi.nlm.nih.gov

Electronic physiologic and subjective data acquisition in home-dwelling heart failure patients: An assessment of patient use and perception of usability. [2018]

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

Heart Failure Management Innovation Enabled by Electronic Health Records. [2021]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. [2012]

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

"Stealth" alerts to improve warfarin monitoring when initiating interacting medications. [2021]

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

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. [2018]

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

Real-time clinical note monitoring to detect conditions for rapid follow-up: A case study of clinical trial enrollment in drug-induced torsades de pointes and Stevens-Johnson syndrome. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Use of CIED Generated Heart Failure Risk Score (HFRS) Alerts in an Integrated, Multi-Disciplinary Approach to HF Management-A Prospective Cohort Study. [2023]

12. 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]

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

Comparison of partners-heart failure algorithm vs care alert in remote heart failure management. [2020]