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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00981032
First received: September 11, 2009
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Behavioral: Pre-visit Summary
Behavioral: Clinical Decision Sharing Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Implementation of the US Preventive Service Task Force Recommendation for Prophylactic Aspirin Use Among Adults at Risk for Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up) [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Knowledge of Risks/Benefits of Aspirin [ Time Frame: Two Weeks ] [ Designated as safety issue: No ]

Enrollment: 884
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981032

Locations
United States, Pennsylvania
Geisinger Clinic - Lewistown
Lewistown, Pennsylvania, United States, 17044
Geisinger Clinic - Moshannon Valley
Philipsburg, Pennsylvania, United States, 16866
Geisinger Clinic - Lake Scranton
Scranton, Pennsylvania, United States, 18505
Sponsors and Collaborators
Geisinger Clinic
Investigators
Principal Investigator: Nirav R Shah, MD, MPH Geisinger Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Nirav R. Shah, MD, MPH, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT00981032     History of Changes
Other Study ID Numbers: 2008-0264
Study First Received: September 11, 2009
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Geisinger Clinic:
Aspirin
Behavior
Cardiovascular Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014