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

Condition(s) targeted: Cardiovascular Disease

Intervention: Pre-visit Summary (Behavioral); Clinical Decision Sharing Tool (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Geisinger Clinic

Official(s) and/or principal investigator(s):
Nirav R Shah, MD, MPH, Principal Investigator, Affiliation: Geisinger Clinic

Overall contact:
Nirav R Shah, MD, MPH, Phone: 570-214-9525, Email: nrshah@geisinger.edu

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.

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

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

Primary outcome: Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)

Secondary outcome: Patient Knowledge of Risks/Benefits of Aspirin

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.

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Both.

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

Nirav R Shah, MD, MPH, Phone: 570-214-9525, Email: nrshah@geisinger.edu

Geisinger Clinic - Lewistown, Lewistown, Pennsylvania 17044, United States; Not yet recruiting

Geisinger Clinic - Moshannon Valley, Philipsburg, Pennsylvania 16866, United States; Recruiting

Geisinger Clinic - Lake Scranton, Scranton, Pennsylvania 18505, United States; Recruiting

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Starting date: October 2009
Last updated: July 9, 2010