Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-04-18 @ 3:25 AM
Study NCT ID:
NCT01301534
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improving screening rates for AAA', 'timeFrame': '1 year', 'description': '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?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abdominal aortic aneurysm'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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:\n\n1. Nurse initiated Telephone Consult (T-Con) (see attached)\n2. Mail-0ut Letter to the patient (see attached)\n3. Provider, Nurse and Technician Education with point-of-care patient referrals , Exam Room Flyer\n4. Control group (i.e. usual care)\n\nThe 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.\n\nInformation 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.\n\nThe data will then be analyzed by Dr. Anneke Bush (WHMC statistician) and the results will be provided to the Principal Investigator for analysis."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB\n* Male patients (DoD beneficiaries) between the ages of 65-75 years old.\n\nExclusion:\n\n* Female patients.\n* Non-English speaking.\n* Patients who have already had abdominal CT scan, abdominal MRI, aortography or aortic ultrasound.\n* Patients already diagnosed with AAA'}, 'identificationModule': {'nctId': 'NCT01301534', 'briefTitle': 'Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting.', 'organization': {'class': 'FED', 'fullName': "Mike O'Callaghan Military Hospital"}, 'officialTitle': 'Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting.', 'orgStudyIdInfo': {'id': 'FWH20110041H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T-Con', 'description': '1\\. Nurse initiated Telephone Consult (T-Con)'}, {'label': 'Mail-Out', 'description': '2\\. Mail-0ut Letter to the patient'}, {'label': 'Education', 'description': '3\\. Provider, Nurse and Technician Education with point-of-care patient referrals , Exam Room Flyer'}, {'label': 'Control group', 'description': '4\\. Control group (i.e. usual care)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '89191', 'city': 'Nellis Air Force Base', 'state': 'Nevada', 'country': 'United States', 'facility': "Michael O'Callaghan Federal Hospital/Nellis Air Force Base", 'geoPoint': {'lat': 36.24607, 'lon': -115.05721}}], 'overallOfficials': [{'name': 'Ethan Zimmerman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Michael O'Callaghan Federal Hospital/Nellis Air Force Base"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Mike O'Callaghan Military Hospital", 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}