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

NCT ID: NCT00981032

Last Updated: 2011-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-07-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pre-visit Summary

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Clinical Decision Sharing Tool

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Geisinger Clinic

Principal Investigators

Nirav R Shah, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Clinic - Lewistown

Lewistown, Pennsylvania, United States

Geisinger Clinic - Moshannon Valley

Philipsburg, Pennsylvania, United States

Geisinger Clinic - Lake Scranton

Scranton, Pennsylvania, United States

Countries

United States

Related Links

http://www.geisinger.org

(Click here for more information about Geisinger Health System)

Other Identifiers

2008-0264

Identifier Type: -

Identifier Source: org_study_id