EHR Alerts for Heart Failure

(BETTER CARE-HF Trial)

Recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help doctors prescribe the best medications for people with heart failure and reduced ejection fraction (HFrEF), a condition where the heart doesn’t pump blood effectively. The focus is on an electronic alert system (EHR-Embedded Alert) that appears in a doctor's digital records to remind them to follow treatment guidelines. One group of participants will receive these alerts, while the other group will not. Individuals treated for heart issues with a recent heart test showing an ejection fraction of 40% or less might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in heart failure management.

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 prior data suggests that this EHR-embedded alert is safe for patients with heart failure?

Research has shown that electronic health record (EHR) alerts can safely assist doctors in following heart failure treatment guidelines. Studies indicate these alerts improve adherence to treatment plans, potentially enhancing patient care without added risks.

No direct evidence of safety issues with EHR alerts exists. Designed as helpful reminders, they have been used without reports of harm. These alerts serve as a tool to guide treatment decisions, not as a drug or device.

Overall, EHR alerts appear to be a safe method for improving heart failure care, with no evidence suggesting harm in healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EHR-Embedded Alert for heart failure because it introduces a new method for early intervention by integrating automated alerts directly within electronic health records (EHRs). Unlike traditional heart failure treatments that rely on medication and patient-reported symptoms, this approach aims to enhance early detection and timely management by alerting healthcare providers to potential issues as they arise. This proactive system could lead to more personalized care and potentially improve patient outcomes by facilitating quicker responses to changes in a patient's condition.

What evidence suggests that this EHR-embedded alert is effective for heart failure?

Research has shown that electronic health record (EHR) tools can significantly enhance heart failure care by helping doctors adhere to treatment guidelines. In this trial, participants in the intervention arm will receive an automated EHR-embedded alert. One study found that a real-time, customized EHR alert system led to much higher use of recommended treatments for patients with heart failure and reduced heart function within 30 days. Another review found that using EHR tools was linked to lower chances of hospitalization at both 30 and 90 days. These findings suggest that EHR alerts can improve patient care by ensuring timely and effective treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Amrita Mukhopadhyay

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9167063/

Electronic Health Records and Heart Failure - PMC There is evidence that specific EHR-based tools can improve adherence to evidence-based guidelines of HF care, patient self-management, and clinical outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735109722044898

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 ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836552

Electronic Health Record Interventions to Reduce Risk of ... This systematic review and meta-analysis investigates whether electronic health record (EHR)–based interventions are associated with reduced ...

4. jacc.org jacc.org/doi/10.1016/j.jchf.2023.11.020

Electronic Health Record Alerts for Heart Failure Cluster-randomized trial comparing ambulatory decision support tools to improve heart failure care.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272288/

Electronic Health Record Interventions to Reduce Risk of ... In this systematic review and meta-analysis of RCTs, the use of EHR-based interventions was associated with a reduction in 30-day and 90-day ...

6. medicine.yale.edu medicine.yale.edu/news-article/electronic-health-record-strategies-can-improve-care-of-patients-with-heart-failure/

Electronic Health Record Strategies Can Improve Care of ... A recent review published in Current Heart Failure Reports analyzes clinical trials to highlight EHR strategies that have been applied to the ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2023.02.040

The EHR Has Exposed an Urgent Moral Imperative to ... Best practice alerts (BPAs) for heart failure that curtail deficiencies in knowledge and inertia can be built into the EHR with relative ease. These are low- ...