NCT01301534

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.5 years

First QC Date

February 18, 2011

Last Update Submit

November 21, 2013

Conditions

Keywords

abdominal aortic aneurysm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

T-Con

1\. Nurse initiated Telephone Consult (T-Con)

Mail-Out

2\. Mail-0ut Letter to the patient

Education

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

Control group

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

Eligibility Criteria

Age65 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit approximately 1700 males (DoD beneficiaries) between the ages of 65-75 from their existing medical diagnostic records. There will be no special populations included. Some respondents may be patients of the PI however; the data sets received by the PI will be anonymous and will not be linked directly to the subjects.

You may qualify if:

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • Male patients (DoD beneficiaries) between the ages of 65-75 years old.

You may not qualify if:

  • Female patients.
  • Non-English speaking.
  • Patients who have already had abdominal CT scan, abdominal MRI, aortography or aortic ultrasound.
  • Patients already diagnosed with AAA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael O'Callaghan Federal Hospital/Nellis Air Force Base

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Ethan Zimmerman, M.D.

    Michael O'Callaghan Federal Hospital/Nellis Air Force Base

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations