Best Practice Advisory Alerts for Heart Failure
(PROMPTHF-Inova Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMitchell Psotka, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inova Health Care Services
Disqualifiers: Hospice, Prior heart transplant, others
No Placebo Group
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.
12345Is 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.
12346How 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.
14678Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Alert when provider is entering ordersExperimental Treatment1 Intervention
Group II: No alert, usual careActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Inova Health SystemFalls Church, VA
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Who Is Running the Clinical Trial?
Inova Health Care ServicesLead Sponsor
Heart Failure CollaboratoryCollaborator
References
Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. [2023]Acute Heart failure (AHF) is among the most frequent causes of hospitalization in the United States, contributing to substantial health care costs, morbidity, and mortality. Inpatient initiation of guideline-directed medical therapy (GDMT) is recommended for patients with heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death or HF hospitalization. However, underutilization of GDMT prior to discharge is pervasive, representing a valuable missed opportunity to optimize evidence-based care. The PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failure tests the effectiveness of an electronic health record embedded clinical decision support system that informs providers during hospital management about indicated but not yet prescribed GDMT for eligible AHF patients with HFrEF. PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failureis an open-label, multicenter, pragmatic randomized controlled trial of 1,012 patients hospitalized with HFrEF. Eligible patients randomized to the intervention group are exposed to a tailored best practice advisory embedded within the electronic health record that alerts providers to prescribe omitted GDMT. The primary outcome is an increase in the proportion of additional GDMT medication classes prescribed at the time of discharge compared to those in the usual care arm.
Improving quality of care and outcomes for heart failure. -Role of registries-. [2022]Heart failure (HF) results in substantial morbidity, mortality, and costs, yet quality of care varies widely and is frequently inadequate. Performance improvement registries have been developed to improve the quality of care and outcomes for patients with HF in both the inpatient and outpatient settings. HF registries in the United States include ADHERE, OPTIMIZE-HF, GWTG-HF, and IMPROVE HF. These registries collect data on clinical characteristics, admission, hospital, discharge, and/or outpatient care, as well as outcomes. Web-based tools that provide real-time feedback of performance and other quality measures benchmarked to other sites and national data are frequently utilized. Process-of-care improvement tools, including evidence-based clinical decision support, customizable order sets, and patient education are also used. Participation in performance improvement registries has been associated with substantial improvements in the use of guideline-recommended therapies for HF in both the inpatient and outpatient settings. Conformity with HF quality measures has also been shown to improve and disparities in care have also been reduced or eliminated. There have also been improvements in clinical outcomes. This paper reviews the evidence that participation in HF performance improvement registries is associated with improved use of guideline-recommended HF therapies, better conformity with quality measures, and improved outcomes in patients with HF.
Visualizing collaborative electronic health record usage for hospitalized patients with heart failure. [2022]To visualize and describe collaborative electronic health record (EHR) usage for hospitalized patients with heart failure.
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.
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.
Electronic health record alerts for management of heart failure with reduced ejection fraction in hospitalized patients: the PROMPT-AHF trial. [2023]Patients hospitalized for acute heart failure (AHF) continue to be discharged on an inadequate number of guideline-directed medical therapies (GDMT) despite evidence that inpatient initiation is beneficial. This study aimed to examine whether a tailored electronic health record (EHR) alert increased rates of GDMT prescription at discharge in eligible patients hospitalized for AHF.
The use of multidisciplinary teams, electronic health records tools, and technology to optimize heart failure population health. [2022]Given the limited population level, adoption of optimal therapy that has been shown in recent clinical trials and heart failure registries, efforts to rapidly and safely improve adoption of guideline-directed medical therapy for heart failure should be prioritized. Opportunities to leverage remote monitoring technology, the electronic health record (EHR), and multidisciplinary teams to improve heart failure care merit review.
Adherence to guideline-recommended adjunctive heart failure therapies among outpatient cardiology practices (findings from IMPROVE HF). [2022]Although previous studies have documented adherence with certain established heart failure (HF) quality metrics in outpatient cardiology practices, the extent to which there is conformity with other evidence-based, guideline-driven quality metrics in outpatients with HF is unknown. IMPROVE HF is a prospective cohort study designed to characterize the current management of patients with chronic HF and left ventricular ejection fraction