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Improving Aspirin Use in Diabetes: A Cluster Randomized Trial
This study has been completed.
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00262977
  Purpose

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 Intervention
Diabetes Mellitus
Behavioral: Electronic prompt plus patient-directed intervention
Behavioral: Electronic prompt to clinician to prescribe aspirin

MedlinePlus related topics: Diabetes
Drug Information available for: Acetylsalicylic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Northwestern University:

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

Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: May 2005
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 beteween patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262977

Locations
United States, Illinois
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
  More Information

Study ID Numbers: 1402-001
Study First Received: December 5, 2005
Last Updated: December 5, 2005
ClinicalTrials.gov Identifier: NCT00262977  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Metabolic Diseases
Aspirin
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009