Computer Alerts for Peripheral Arterial Disease (PAD-ALERT Trial)

N/A

Recruiting

Led By Gregory Piazza

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted at one hospital with 400 patients. It will test a computerized tool called EPIC Best Practice Advisory to see if it can help doctors and patients follow guidelines for using stat

Who is the study for?

This trial is for patients with Peripheral Artery Disease (PAD) who are not currently taking medication to lower LDL cholesterol. It's designed to see if a computer alert can help improve the use of recommended treatments.

What is being tested?

The study tests an electronic alert system that reminds healthcare providers and patients about the benefits of statins or alternative therapies for lowering cholesterol in PAD patients not on treatment.

What are the potential side effects?

Since this trial focuses on a decision support tool rather than a drug, there aren't direct side effects from the intervention itself. However, any prescribed lipid-lowering therapy will have its own potential side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of prescription of oral LDL-C-lowering therapy

Secondary study objectives

Change in LDL-C level

Other study objectives

Frequency of all-cause hospitalization

Frequency of all-cause mortality

Frequency of major adverse cardiovascular events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AlertExperimental Treatment1 Intervention

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.

Group II: No AlertActive Control1 Intervention

No on-screen notification will be issued to the clinician

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