Recruiting

Computerized Decision Support

Sponsor:

Brigham and Women's Hospital

Code:

NCT06300450

Conditions

Peripheral Artery Disease

Peripheral Vascular Diseases

Dyslipidemias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computer Alert

Study Details

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

Study ID

NCT06300450

Start date

Mar 1, 2023

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alert

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.

no intervention: No Alert

No on-screen notification will be issued to the clinician

Interventions

Computer Alert

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

Primary outcome measure

  • Frequency of prescription of oral LDL-C-lowering therapy [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Gregory Piazza

6177326984gpiazza@bwh.harvard.edu

Candrika D Kharaini

6177326984cdkhairani@@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gregory Piazza, MD, MS

617-732-6984gpiazza@bwh.harvard.edu

gpiazza@bwh.harvard.edu

Principal Investigator:

Gregory Piazza, MD, MS

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-17.