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

NCT06300450 | Recruiting

• 1 other identifier: 2022P002171
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Diseases; Dyslipidemias

Keywords

Dyslipidemia; Peripheral Artery Disease; Peripheral Vascular Disease; Computerized Decision Support

Outcome Measures

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

  90 days

Secondary Outcomes (1)

• Change in LDL-C level

  6 months

Other Outcomes (4)

• Frequency of all-cause mortality

  6 months

• Frequency of major adverse cardiovascular events

  6 months

• Frequency of major adverse limb events

  6 months

Study Arms (2)

Alert

EXPERIMENTAL

Alert-based CDS will consist of an on-screen electronic alert that will notify the clinician that the patient has an indication for LDL-C-lowering therapy but is not prescribed any. The clinician will have the opportunity to proceed to an order template through which appropriate lipid-lowering can be prescribed. The clinician could also elect to learn more about current evidence-based recommendations for LDL-C lowering in the PAD population. Finally, the clinician could elect to proceed without ordering oral LDL-C-lowering therapy or reading evidence-based recommendations for LDL-C lowering but would have to provide a rationale for not doing so.

Behavioral: Computer Alert

No Alert

NO INTERVENTION

No on-screen notification will be issued to the clinician

Interventions

Computer Alert BEHAVIORAL

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

Also known as: EPIC Best Practice Advisory

Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Esperion Therapeutics, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Dyslipidemias

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gregory Piazza

  BWH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Piazza

CONTACT

6177326984; gpiazza@bwh.harvard.edu

Candrika D Kharaini

CONTACT

6177326984; cdkhairani@@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators and outcomes assessors will be blinded to the assignment of the clinician to the computer alert or control (non-alert) group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Model Details: 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this patient- and provider-facing alert-based CDS (EPIC BPA)

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)