Clinical trial NCT04686604: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Official title: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-12-29
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years admitted to a hospital within the Yale New Haven Hospital system (either Yale New Haven Hospital, St. Raphael's Campus, Greenwich Hospital, or Bridgeport Hospital).
* Have HFrEF defined as:

  1. NT-pro-BNP \>500 pg/ml within 24 hours of admission
  2. On IV loop diuretic within 24 hours of admission
  3. Left ventricular ejection fraction ≤40% (most recent)

Exclusion Criteria:

* Patients within 48 hours of admission
* Patients in the intensive care unit
* Patients on hospice service
* Patients receiving intravenous milrinone
* Patient on NPO (nothing by mouth) order
* Patients on all evidence based medical therapy for HFrEF (on all 4 classes of evidence based medical therapy: beta-blockers, ACEi/ARB/ARNI, MRA, SGLT2i)
* Opted out of medical record research

Primary outcomes:
measure: Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy
timeFrame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary outcomes:
measure: The percentage increase of beta blockers for HFrEF
timeFrame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
measure: The percentage increase of ACEi/ARB/ARNI for HFrEF
timeFrame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
measure: The percentage increase of MRAs for HFrEF
timeFrame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
measure: The percentage increase of SGLT2i for HFrEF
timeFrame: Assessed from the date of randomization to discharge date, assessed up to 12 months.
measure: 30-day hospital readmission rates
timeFrame: Assessed from the date of discharge to the date of hospital readmission, up to 30 days post-discharge
measure: 30-day emergency department visits
timeFrame: Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge
measure: 6 months all-cause mortality
timeFrame: Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization
measure: Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge
timeFrame: Assessed from the date of discharge and up to 30 days post-discharge.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Tariq Ahmad, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: