Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Electronic prompt plus patient-directed intervention; Behavioral: Electronic prompt to clinician to prescribe aspirin

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 Type: Interventional
• Enrollment: 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Division of General Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient reported aspirin use daily or every other day.

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: December 5, 2005
• First Submitted That Met QC Criteria: December 5, 2005
• First Posted (Estimate): December 7, 2005

Study Record Updates

• Last Update Posted (Estimate): July 22, 2010
• Last Update Submitted That Met QC Criteria: July 21, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: cardiovascular diseases; aspirin; diabetes mellitus; quality of healthcare
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 1402-001