Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

Study Overview
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Brief Summary
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A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.

Detailed Description
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Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. 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 HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. 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. This study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.

Official Title
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Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Age 18 or over Seen in eligible internal medicine or cardiology clinic Left ventricular ejection fraction less than or equal to 40% Registered in the Yale Heart Failure Registry Patient Exclusion Criteria: Opted out of EHR-based research Under hospice care Already receiving each targeted class of evidence-based HFrEF medical therapy Selection of Providers: Practicing at an eligible internal medicine or cardiology clinic High frequency of visits by eligible patients based on retrospective chart review

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EHR-based alert<br>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 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. | Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)<br>* 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 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.<br>|
| No Intervention: Usual Care<br>Providers will not receive an alert and will proceed with usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HFrEF with an increase in prescribed HFrEF therapy | Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is. | Assessed from the date of randomization to 30 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient on beta blockers | Assessed as the number of patients with prescribed beta blockers | Assessed from the date of randomization to 30 days post-randomization | 
| Percentage of patient on ACE inhibitors | Assessed as the number of patients with a prescribed ACEi | Assessed from the date of randomization to 30 days post-randomization | 
| Percentage of patient on ARBs | Assessed as the number of patients with a prescribed ARB | Assessed from the date of randomization to 30 days post-randomization | 
| Percentage of patient on ARNIs | Assessed as the number of patients with a prescribed ARNI | Assessed from the date of randomization to 30 days post-randomization | 
| Percentage of patient on MRAs | Assessed as the number of patients with a prescribed MRA | Assessed from the date of randomization to 30 days post-randomization | 
| Percentage of patient on SGLT2 inhibitors | Assessed as the number of patients with a prescribed SGLT2i | Assessed from the date of randomization to 30 days post-randomization | 
| Rate of one-year all-cause mortality |  | Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization | 
| Rate of 30-day hospital admission |  | Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization | 
| Rate of 30-day all-cause emergency department visits |  | Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization | 
| Total six-month healthcare costs |  | Assessed from the date of randomization to 6 months post-randomization | 
| Percentage of filled prescriptions | Proportion of prescriptions filled as assessed by SureScripts | Assessed 6 months post-randomization | 
| Medication dose of any prescribed beta blocker |  | Assessed at 6 months post-randomization | 
| Medication dose of any prescribed ACEi |  | Assessed at 6 months post-randomization | 
| Medication dose of any prescribed ARB |  | Assessed at 6 months post-randomization | 
| Medication dose of any prescribed ARNI |  | Assessed at 6 months post-randomization | 
| Medication dose of any prescribed MRA |  | Assessed at 6 months post-randomization | 
| Medication dose of any prescribed SGLT2 inhibitor |  | Assessed at 6 months post-randomization |