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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Pre-visit Summary; Behavioral: Clinical Decision Sharing Tool

• Registration Number: NCT00981032
• Lead Sponsor: Geisinger Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Study Start: 2009-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 884

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:

  1. Smoke
  2. Direct LDL > 160 mg/dl
  3. HDL < 45 mg/dl (males) HDL < 35 mg/dl (females)
  4. Diabetes diagnosis
  5. Hypertension diagnosis
  6. CAD diagnosis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-visit Summary	Pre-visit Summary	Patients in this arm will receive a pre-visit summary 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	Clinical Decision Sharing Tool	Patients in this arm 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 Outcome Measures

Name	Time	Method
Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)	Two Weeks

Secondary Outcome Measures

Name	Time	Method
Patient Knowledge of Risks/Benefits of Aspirin	Two Weeks

Trial Locations

Locations (3)

Geisinger Clinic - Lewistown; 🇺🇸 Lewistown, Pennsylvania, United States

Geisinger Clinic - Lake Scranton; 🇺🇸 Scranton, Pennsylvania, United States

Geisinger Clinic - Moshannon Valley; 🇺🇸 Philipsburg, Pennsylvania, United States