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Completed

NCT Number: NCT00981032

Improving Aspirin Use Among Adults at Risk for Cardiovascular Disease (CVD)

The investigators' aim is to implement an intervention to increase aspirin prophylaxis use among patients that is patient initiated, optimizes use of physician and staff time, appropriately compensates staff, provides clinicians with tools necessary for managing aspiring prophylaxis, and ensures continuous management.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Clinic - Lewistown, Lewistown, Pennsylvania, United States

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About this study

This intervention addresses a fundamental question of how clinicians need to be directly involved in motivating behavior change (i.e., aspirin prophylaxis). While complex behavior change likely demands high levels of involvement, a single simple action (aspirin prophylaxis) may not require such complex interactions.

We propose to compare the effectiveness of three models of care in a rigorous randomized controlled trial that will consist of a 3-arm, within-clinic design in which patients will be randomized to either the physician-initiated, the patient-initiated model, or to a control group in which usual care is delivered. In a patient-initiated model, patients are active participants in their own care and receive a pre-visit summary that contains an individualized risk assessment and patient education. In the physician-initiated model, patients receive the pre-visit summary and the physician uses a clinical decision support tool through the electronic health record that details the patient risk of CVD.

The specific aims of the proposed work are to compare the reliability and overall effectiveness of two different methods for motivating patients to take aspirin to prevent stroke and heart attacks as well as to develop a plan for translating the intervention into a process that is suitable for a paper-based clinic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with an appointment in the Geisinger clinic who:

  • are between the ages of 45-70 (male) or 50-70 (female), and
  • have one of the following risk factors:
  • Smoke
  • Direct LDL > 160 mg/dl
  • HDL < 45 mg/dl (males) HDL < 35 mg/dl (females)
  • Diabetes diagnosis
  • Hypertension diagnosis
  • CAD diagnosis

Exclusion criteria

  • > 70 years
  • Stomach Ulcer History
  • Aspirin Allergy
  • Anti-coagulation Therapy History
  • Clotting Disorder Diagnosis
  • Hypersensitivity to non-steroidal anti-inflammatory agents such as Ibuprofen, Aleve, or Motrin
  • Hemorrhagic Stroke History
  • Current Aspirin use
  • 1st Outpatient Visit

Treatment and study plan

Pre-visit Summary

Behavioral

The intervention is a pre-visit summary given to the patient prior to their appointment. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use.

Clinical Decision Sharing Tool

Behavioral

This intervention includes a pre-visit summary and a clinical decision sharing tool. Patients will receive a pre-visit summary prior to their appointment. They will also view a clinical decision sharing tool in conjunction with the physician in the office. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use. The clinical decision sharing tool informs the physician of the patient's heart attack or stroke risk and determines if the patient would benefit from aspirin use.

Primary outcomes

  1. Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)

    Time frame: Two Weeks

Secondary outcomes

  1. Patient Knowledge of Risks/Benefits of Aspirin

    Time frame: Two Weeks

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Improving Implementation of the US Preventive Service Task Force Recommendation for Prophylactic Aspirin Use Among Adults at Risk for Cardiovascular Disease

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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