Clinical trial NCT00981032: Improving Aspirin Use Among Adults at Risk for Cardiovascular Disease (CVD)
Official title: Improving Implementation of the US Preventive Service Task Force Recommendation for Prophylactic Aspirin Use Among Adults at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Aspirin
Behavior
Cardiovascular Disease
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2009-09-22
Enrollment: 884
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)
timeFrame: Two Weeks
Secondary outcomes:
measure: Patient Knowledge of Risks/Benefits of Aspirin
timeFrame: Two Weeks
Other outcomes:
Locations:
city: Lewistown
country: United States
facility: Geisinger Clinic - Lewistown
state: Pennsylvania
city: Philipsburg
country: United States
facility: Geisinger Clinic - Moshannon Valley
state: Pennsylvania
city: Scranton
country: United States
facility: Geisinger Clinic - Lake Scranton
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Nirav R Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: