Abdominal Aortic AneurysmNCT01301534
Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting.
An observational study of Abdominal Aortic Aneurysm, run by Mike O'Callaghan Military Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- Male patients (DoD beneficiaries) between the ages of 65-75 years old.
Who cannot join
- Female patients.
- Non-English speaking.
- Patients who have already had abdominal CT scan, abdominal MRI, aortography or aortic ultrasound.
- Patients already diagnosed with AAA
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael O'Callaghan Federal Hospital/Nellis Air Force Base
Nellis Air Force Base, Nevada, 89191
About this study
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.
Read the detailed 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:
- Nurse initiated Telephone Consult (T-Con) (see attached)
- Mail-0ut Letter to the patient (see attached)
- Provider, Nurse and Technician Education with point-of-care patient referrals , Exam Room Flyer
- 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.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ethan Zimmerman, M.D., Principal investigator, Michael O'Callaghan Federal Hospital/Nellis Air Force Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301534
- Sponsor's protocol ID
- FWH20110041H
- Status last verified
- Nov 2013
- First submitted
- 18 Feb 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting.
- ClinicalTrials.gov ID
- NCT01301534
- Acronym / sponsor ID
- FWH20110041H
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Nurse initiated Telephone Consult (T-Con) (see attached)
- Mail-0ut Letter to the patient (see attached)
- Provider, Nurse and Technician Education with point-of-care patient referrals , Exam Room Flyer
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- Male patients (DoD beneficiaries) between the ages of 65-75 years old.
Key exclusion criteria (4 listed)
- Female patients.
- Non-English speaking.
- Patients who have already had abdominal CT scan, abdominal MRI, aortography or aortic ultrasound.
- Patients already diagnosed with AAA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
improving screening rates for AAA
Time frame: 1 year
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Zimmerman, M.D. principal investigator
Michael O'Callaghan Federal Hospital/Nellis Air Force Base
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improving screening rates for AAA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.