Yale New Haven Hospital
New Haven, Connecticut, 06512, United States
NCT Number: NCT04686604
A randomized single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06512, United States
Heart failure (HF) is the major cause of healthcare expenditure, morbidity, and mortality in the United States. HF is the primary diagnosis for hospital discharge in ~1 million and a secondary diagnosis in ~2 million hospitalizations annually in the US. In fact, inpatient admissions account for more than half of HF healthcare expenditure. However, data from several registries over the last three decades has failed to see use of these evidence- based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field. It remains unclear as to why many patients with HF reduced ejection fraction (HFrEF) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. Whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.
The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Time frame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Assessed as an increase in the number of prescribed targeted evidence-based medical therapies for HFrEF. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.
Time frame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Increase in proportion of patients on beta blockers
Time frame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Increase in proportion of patients on ACEi/ARB/ARNI
Time frame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Increase in proportion of patients on MRAs
Time frame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Increase in proportion of patients on SGLT2i
Time frame: Assessed from the date of discharge to the date of hospital readmission, up to 30 days post-discharge
Time frame: Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge
Time frame: Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization
Time frame: Assessed from the date of discharge and up to 30 days post-discharge.
Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.
Yale University
Other
Acronym: PROMPT-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03446651
Cardiovascular Diseases, Heart Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT05806606
Behavior, Cardiovascular Diseases
Hong Kong
View Trial DetailsNCT06847438
Cardiovascular Diseases, Heart Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT07721909
Cardiovascular Diseases, Heart Diseases
Muscat, Oman
View Trial Details