Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00262977
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 37.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Electronic prompt plus patient-directed intervention; Behavioral: Electronic prompt to clinician to prescribe aspirin	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: Sep 1, 2004
• Study Completion Date: May 1, 2005

Outcome Measures

Primary Outcome Measures

1. Patient reported aspirin use daily or every other day. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University, Division of General Internal Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Stephen D Persell, MD, MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00262977
• Other Study ID Numbers: 1402-001
• First Posted: Dec 7, 2005
• Last Update Posted: Jul 22, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: diabetes mellitus; cardiovascular diseases; aspirin; quality of healthcare
• Additional relevant MeSH terms: Diabetes Mellitus; Aspirin

Study Results

No Results Posted as of Jul 22, 2010