NCT00981032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
884

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

September 11, 2009

Last Update Submit

February 16, 2011

Conditions

Cardiovascular Disease

Keywords

AspirinBehaviorCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)

    Two Weeks

Secondary Outcomes (1)

  • Patient Knowledge of Risks/Benefits of Aspirin

    Two Weeks

Study Arms (2)

Pre-visit Summary

EXPERIMENTAL

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

Clinical Decision Sharing Tool

EXPERIMENTAL

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

Interventions

Pre-visit SummaryBEHAVIORAL

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.

Pre-visit Summary
Clinical Decision Sharing ToolBEHAVIORAL

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.

Clinical Decision Sharing Tool

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Smoke
  • Direct LDL \> 160 mg/dl
  • HDL \< 45 mg/dl (males) HDL \< 35 mg/dl (females)
  • Diabetes diagnosis
  • Hypertension diagnosis
  • CAD diagnosis

You may not qualify if:

  • \> 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
  • st Outpatient Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geisinger Clinic - Lewistown

Lewistown, Pennsylvania, 17044, United States

Location

Geisinger Clinic - Moshannon Valley

Philipsburg, Pennsylvania, 16866, United States

Location

Geisinger Clinic - Lake Scranton

Scranton, Pennsylvania, 18505, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesBehavior

Study Officials

  • Nirav R Shah, MD, MPH

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 22, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

US(3)