Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

Diabetes Mellitus Clinical Trial

Official title:

Improving Appropriate Aspirin Use Among Adults With Diabetes in a Primary Care Setting: Using an Electronic Medical Record to Target a Physician-supervised Nurse Practitioner Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262977
• Other study ID #: 1402-001
• Status: Completed
• Phase: N/A
• First received: December 5, 2005
• Last updated: July 21, 2010
• Start date: September 2004
• Est. completion date: May 2005

Study information

• Verified date: July 2010
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Our aim is to determine if a patient-directed intervention is more effective than computerized clinician reminders alone for improving aspirin use in adults with diabetes.

Description:

Many patients with diabetes do not use aspirin to prevent cardiovascular events. Quality improvement initiatives involving both patients and physicians may be more effective than physician-directed approaches alone.

In a large urban primary care internal medicine practice, this study seeks to test if a patient-directed intervention is more effective than computerized clinician reminders alone for improving the appropriate use of aspirin in adults with diabetes.

The study design is a cluster-randomized trial by physician. The frequency of self-reported regular aspirin use will be compared between patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Diabetes mellitus

• Age at least 40 years old

• At least 2 clinic visits in the 18 months prior to the intervention

Exclusion Criteria:

• Primary care physician declined enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Electronic prompt plus patient-directed intervention

• Electronic prompt to clinician to prescribe aspirin

Locations

Country	Name	City	State
United States	Northwestern University, Division of General Internal Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported aspirin use daily or every other day.