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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01301534
Other study ID # FWH20110041H
Secondary ID
Status Completed
Phase N/A
First received February 18, 2011
Last updated November 21, 2013
Start date December 2010
Est. completion date June 2012

Study information

Verified date November 2013
Source Mike O'Callaghan Federal Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Standard of care dictates that eligible patients should receive an abdominal aortic aneurysm (AAA) screening ultrasound. At present, different military primary care physicians utilize different methods at their discretion to ensure their patients get screened—telephone contact; mail-out reminders; referring patients for ultrasound directly from an office visit; as well as other methods—which we will refer to as "usual care". The purpose of this study is to improve screening rates for AAA and determine what notification methods are best at improving screening rates.


Description:

Approximately 1700 male patients (DoD beneficiaries) between the ages of 65-75 will be selected from their medical records. The information on the attached abstracted data sheet will be collected. As part of standard patient care operations, the Family Medicine and Internal Medicine Departments will inform patients on the need to receive a AAA screening ultrasound, based on their primary care manager's (PCM) preference for clinical notification:

1. Nurse initiated Telephone Consult (T-Con) (see attached)

2. Mail-0ut Letter to the patient (see attached)

3. Provider, Nurse and Technician Education with point-of-care patient referrals , Exam Room Flyer

4. Control group (i.e. usual care)

The Provider, Nurse and Technician Education will consist of a presentation given by the Principal Investigator (see attached PowerPoint) to the Family Medicine and Internal Medicine clinic staff and the posting of Exam Room Flyers in each Family Medicine and Internal Medicine exam room to prompt and encourage patient referrals for a AAA screening ultrasound.

Information requested on the attached abstracted data sheet will be used for initial identification of patients that should have a AAA screening ultrasound and again 3-4 months later to see if these same individuals received the procedure. All informational data sets will be totally de-identified by the Research Coordinator, Nellis Air Force Base, prior to releasing to the Principle Investigator.

The data will then be analyzed by Dr. Anneke Bush (WHMC statistician) and the results will be provided to the Principal Investigator for analysis.


Recruitment information / eligibility

Status Completed
Enrollment 1700
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Male
Age group 65 Years to 75 Years
Eligibility Inclusion:

- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB

- Male patients (DoD beneficiaries) between the ages of 65-75 years old.

Exclusion:

- Female patients.

- Non-English speaking.

- Patients who have already had abdominal CT scan, abdominal MRI, aortography or aortic ultrasound.

- Patients already diagnosed with AAA

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States Michael O'Callaghan Federal Hospital/Nellis Air Force Base Nellis AFB Nevada

Sponsors (1)

Lead Sponsor Collaborator
Mike O'Callaghan Federal Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary improving screening rates for AAA Will the concerted use of (1) a nurse-initiated telephone consult (T-Con), (2) mail out reminder or (3) provider, nurse and technician education with point-of-care reminders be more successful than usual care at improving screening rates for AAA? 1 year No
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