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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981032
• Other study ID #: 2008-0264
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: February 16, 2011
• Start date: October 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 884
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Pre-visit Summary
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
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.

Locations

Country	Name	City	State
United States	Geisinger Clinic - Lewistown	Lewistown	Pennsylvania
United States	Geisinger Clinic - Moshannon Valley	Philipsburg	Pennsylvania
United States	Geisinger Clinic - Lake Scranton	Scranton	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)		Two Weeks	No
Secondary	Patient Knowledge of Risks/Benefits of Aspirin		Two Weeks	No

External Links

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