Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262977
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : July 22, 2010
Information provided by:
Northwestern University

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 Not Applicable

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  (Clinical Trial)
Enrollment : 300 participants
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 : September 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Primary Outcome Measures :
  1. Patient reported aspirin use daily or every other day.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262977

United States, Illinois
Northwestern University, Division of General Internal Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Stephen D Persell, MD, MPH Northwestern University Identifier: NCT00262977     History of Changes
Other Study ID Numbers: 1402-001
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by Northwestern University:
diabetes mellitus
cardiovascular diseases
quality of healthcare

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors