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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Pre-visit Summary; Behavioral: Clinical Decision Sharing Tool

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 Type: Interventional
• Enrollment (Actual): 884
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lewistown, Pennsylvania, United States, 17044
      • Geisinger Clinic - Lewistown
    • Philipsburg, Pennsylvania, United States, 16866
      • Geisinger Clinic - Moshannon Valley
    • Scranton, Pennsylvania, United States, 18505
      • Geisinger Clinic - Lake Scranton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)	Two Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Knowledge of Risks/Benefits of Aspirin	Two Weeks

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Nirav R Shah, MD, MPH, Geisinger Clinic

Publications and helpful links

Helpful Links

• (Click here for more information about Geisinger Health System)

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Estimate): February 17, 2011
• Last Update Submitted That Met QC Criteria: February 16, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Aspirin; Cardiovascular Disease; Behavior
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2008-0264