Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients ≥ 18 years old

Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, and Diabetology

Medical history entry, visit diagnosis, or problem list entry of PAD

Not prescribed LDL-C-lowering therapy

Disqualifiers

Patients taking a statin, ezetimibe, bempedoic acid, a PCSK9 inhibitor, inclisiran or a combination will be excluded

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computer Alert

    Behavioral

    On-screen alert-based decision support raising awareness of need for lipid-lowering therapy in patients with peripheral artery disease

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: AlertExperimental treatment 1 intervention
Group B: No AlertNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Frequency of prescription of oral LDL-C-lowering therapy

The frequency of prescription of oral LDL-C-lowering therapy will be assessed using a report from the medical record

Time frame
90 days

Secondary outcomes

1

Change in LDL-C level

Change in LDL-C level will be assessed via the medical record

Time frame
6 months

Other outcomes

1

Frequency of all-cause mortality

The frequency will be assessed using a report from the medical record

Time frame
6 months
2

Frequency of major adverse cardiovascular events

The frequency of major adverse cardiovascular events (including myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) will be assessed using a report from the medical record

Time frame
6 months
3

Frequency of major adverse limb events

The frequency of major adverse limb events (including amputation and peripheral artery revascularization) will be assessed using a report from the medical record

Time frame
6 months
4

Frequency of all-cause hospitalization

The frequency of all-cause hospitalization will be assessed using a report from the medical record

Time frame
6 months

Sponsors and contacts

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Brigham and Women's Hospital

Lead sponsor

Esperion Therapeutics, Inc.

Collaborator