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Behavioral Intervention
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,877,416 Total Patients Enrolled
1 Trials studying Dyslipidemia
10,544 Patients Enrolled for Dyslipidemia
Esperion Therapeutics, Inc.Industry Sponsor
25 Previous Clinical Trials
21,518 Total Patients Enrolled
1 Trials studying Dyslipidemia
177 Patients Enrolled for Dyslipidemia
Gregory PiazzaPrincipal InvestigatorBWH