Improving Aspirin Use in Diabetes: A Cluster Randomized Trial

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00262977
First received: December 5, 2005
Last updated: July 21, 2010
Last verified: July 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 between 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00262977     History of Changes
Other Study ID Numbers: 1402-001
Study First Received: December 5, 2005
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014