Abdominal Aortic AneurysmPROVE-AAANCT03115346
Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
A study testing Decision aid in people with Abdominal Aortic Aneurysm, run by VA Office of Research and Development at 22 sites in United States.
Trial summary
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 22 sitesUnited States
- Study dates
- 15 Apr 2017to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veteran with a > or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery
Who cannot join
- Veterans who are not candidates for both open and endovascular repair, and are less than < 5.0 cm AAA in size
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, 02301
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Jackson C. Montgomery VA Medical Center, Muskogee, OK
Muskogee, Oklahoma, 74401
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1873
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
Official title: Alignment of Treatment Preferences and Repair Type for Veterans With AAA
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. There are 22-24 VA Medical Centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. Twelve Veterans will be enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a decision aid with information about the two types of surgery for AAA repair, open and endovascular, and complete a survey about their preferences. Veterans at control sites will complete the same survey, but will not receive the decision aid. After their surgery, Veterans will take another survey asking about their satisfaction. The LSI will compare the results of the survey between Veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.
Read the detailed description
This is a cluster randomized trial comparing two ways to better align Veterans' preferences and treatments for AAA: (1) a validated decision aid describing AAA repair types with a survey measuring Veterans' preference for repair type -- versus (2) the survey alone. Enrolled Veterans will be candidates for either endovascular or open repair, and be followed at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, the investigators will determine Veterans' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, the investigators will compare agreement between Veterans' preferences and repair type between the decision aid+survey and survey-alone groups. In Aim 3, the investigators will investigate the facilitators and barriers of implementing a decision aid in a VA surgical clinic. The investigators will identify factors associated with agreement. The investigators' findings will be reported to the National Surgery Office Vascular Surgery Advisory Board to help ensure Veterans' preferences remain at the center of AAA treatment decisions. The investigators have recruited 20 VA Medical Centers and their vascular surgery teams to participate in this trial.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Decision aid
- 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.
Decision aidOther
Decision aid for repair type for aortic abdominal aneurysms
| Study group | Role | What they receive |
|---|---|---|
| decision aid | Experimental | the experimental group will receive the decision aid Receives: Other: Decision aid |
| control | No intervention | the control group will only receive the survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veteran Preference for Repair Type
The investigators' survey will measure the effect of the decision aid on Veterans preference for repair type for abdominal aortic aneurysms and domains associated with preference for each repair type (endovascular or open)
Measured: 30 days
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type
The investigators' survey instruments will assess the effect of the decision aid on the agreement between Veteran's preference for repair type and actual repair type they receive
Measured: 30 days
Secondary outcomes (1)
Decision Regret Scale
The investigators will use the patient satisfaction questionnaire short form 18 to assess patient satisfaction. Patient satisfaction will be reported based on the average Decision Process Score for both decision and control groups, with a score of 5 representing the highest level of satisfaction and a score of 0 representing the lowest level of satisfaction.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Apr 2017
- Primary completion10 Dec 2020
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a cluster randomized study. Sites will be randomly assigned to the intervention group - (decision aid +survey), or control group (survey only). The randomization scheme is 9:1, for complex and intermediate VA sites.
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Philip Goodney, MD, Principal investigator, White River Junction VA Medical Center, White River Junction, VT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115346
- Sponsor's protocol ID
- IIR 15-085
- Acronym
- PROVE-AAA
- Status last verified
- Sep 2024
- First submitted
- 11 Apr 2017
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghaffarian AA, Griffin CL, Kraiss LW, Sarfati MR, Brooke BS. Comparative effectiveness of one-stage versus two-stage basilic vein transposition arteriovenous fistulas. J Vasc Surg. 2018 Feb;67(2):529-535.e1. doi: 10.1016/j.jvs.2017.07.115. Epub 2017 Sep 21.
PubMed 28943003Mirabelli LG, Cosker RM, Kraiss LW, Griffin CL, Smith BK, Sarfati MR, Al-Dulaimi R, Brooke BS. Rapid Methods for Routine Frailty Assessment during Vascular Surgery Clinic Visits. Ann Vasc Surg. 2018 Jan;46:134-141. doi: 10.1016/j.avsg.2017.08.010. Epub 2017 Sep 6.
PubMed 28887242Perri JL, Nolan BW, Goodney PP, DeMartino RR, Brooke BS, Arya S, Conrad MF, Cronenwett JL. Factors affecting operative time and outcome of carotid endarterectomy in the Vascular Quality Initiative. J Vasc Surg. 2017 Oct;66(4):1100-1108. doi: 10.1016/j.jvs.2017.03.426. Epub 2017 Jul 14.
PubMed 28712813DeMartino RR, Brooke BS, Neal D, Beck AW, Conrad MF, Arya S, Desai S, Aziz F, Ryan P, Cronenwett JL, Kraiss LW; Vascular Quality Initiative. Development of a validated model to predict 30-day stroke and 1-year survival after carotid endarterectomy for asymptomatic stenosis using the Vascular Quality Initiative. J Vasc Surg. 2017 Aug;66(2):433-444.e2. doi: 10.1016/j.jvs.2017.03.427. Epub 2017 Jun 2.
PubMed 28583737David RA, Brooke BS, Hanson KT, Goodney PP, Genovese EA, Baril DT, Gloviczki P, DeMartino RR. Early extubation is associated with reduced length of stay and improved outcomes after elective aortic surgery in the Vascular Quality Initiative. J Vasc Surg. 2017 Jul;66(1):79-94.e14. doi: 10.1016/j.jvs.2016.12.122. Epub 2017 Mar 31.
PubMed 28366307Brooke BS, Sarfati MR, Zhang Y, Zhang Y, Presson AP, Greene TH, Kraiss LW. Cardiac Stress Testing during Workup for Abdominal Aortic Aneurysm Repair Is Not Associated with Improved Patient Outcomes. Ann Vasc Surg. 2017 Jul;42:222-230. doi: 10.1016/j.avsg.2016.10.057. Epub 2017 Mar 10.
PubMed 28288889Williams CR, Brooke BS. Effectiveness of open versus endovascular abdominal aortic aneurysm repair in population settings: A systematic review of statewide databases. Surgery. 2017 Oct;162(4):707-720. doi: 10.1016/j.surg.2017.01.014. Epub 2017 Feb 24.
PubMed 28242088Jones DW, Schermerhorn ML, Brooke BS, Conrad MF, Goodney PP, Wyers MC, Stone DH; Vascular Quality Initiative. Perioperative clopidogrel is associated with increased bleeding and blood transfusion at the time of lower extremity bypass. J Vasc Surg. 2017 Jun;65(6):1719-1728.e1. doi: 10.1016/j.jvs.2016.12.102. Epub 2017 Feb 20.
PubMed 28222991Hoel AW, Faerber AE, Moore KO, Ramkumar N, Brooke BS, Scali ST, Sedrakyan A, Goodney PP. A pilot study for long-term outcome assessment after aortic aneurysm repair using Vascular Quality Initiative data matched to Medicare claims. J Vasc Surg. 2017 Sep;66(3):751-759.e1. doi: 10.1016/j.jvs.2016.12.100. Epub 2017 Feb 17.
PubMed 28222989Goodney PP, Spangler EL, Newhall K, Brooke BS, Schanzer A, Tan TW, Beck AW, Hallett JH, MacKenzie TA, Edelen MO, Hoel AW, Rigotti NA, Farber A. Feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons in the Vascular Physician Offer and Report (VAPOR) Trial. J Vasc Surg. 2017 Apr;65(4):1152-1160.e2. doi: 10.1016/j.jvs.2016.10.121. Epub 2017 Feb 9.
PubMed 28190719Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized Venous Thromboembolism Risk Stratification Using the 2005 Caprini Score to Identify the Benefits and Harms of Chemoprophylaxis in Surgical Patients: A Meta-analysis. Ann Surg. 2017 Jun;265(6):1094-1103. doi: 10.1097/SLA.0000000000002126.
PubMed 28106607Martin LA, Finlayson SRG, Brooke BS. Patient Preparation for Transitions of Surgical Care: Is Failing to Prepare Surgical Patients Preparing Them to Fail? World J Surg. 2017 Jun;41(6):1447-1453. doi: 10.1007/s00268-017-3884-z.
PubMed 28101609Bartline PB, Suckow BD, Brooke BS, Kraiss LW, Mueller MT. Outcomes in Critical Limb Ischemia Compared by Distance from Referral Center. Ann Vasc Surg. 2017 Jan;38:122-129. doi: 10.1016/j.avsg.2016.07.063. Epub 2016 Aug 13.
PubMed 27531079Newhall K, Suckow B, Spangler E, Brooke BS, Schanzer A, Tan TW, Burnette M, Edelen MO, Farber A, Goodney P; VAPOR investigators. Impact and Duration of Brief Surgeon-Delivered Smoking Cessation Advice on Attitudes Regarding Nicotine Dependence and Tobacco Harms for Patients with Peripheral Arterial Disease. Ann Vasc Surg. 2017 Jan;38:113-121. doi: 10.1016/j.avsg.2016.06.005. Epub 2016 Aug 10.
PubMed 27521828Chin JA, Skrip L, Sumpio BE, Cardella JA, Indes JE, Sarac TP, Dardik A, Ochoa Chaar CI. Percutaneous endovascular aneurysm repair in morbidly obese patients. J Vasc Surg. 2017 Mar;65(3):643-650.e1. doi: 10.1016/j.jvs.2016.06.115. Epub 2016 Dec 27.
PubMed 28034584
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alignment of Treatment Preferences and Repair Type for Veterans With AAA
- ClinicalTrials.gov ID
- NCT03115346
- Acronym / sponsor ID
- PROVE-AAA / IIR 15-085
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. There are 22-24 VA Medical Centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. Twelve Veterans will be enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a decision aid with information about the two types of surgery for AAA repair, open and endovascular, and complete a survey about their preferences. Veterans at control sites will complete the same survey, but will not receive the decision aid. After their surgery, Veterans will take another survey asking about their satisfaction. The LSI will compare the results of the survey between Veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.
Detailed description
This is a cluster randomized trial comparing two ways to better align Veterans' preferences and treatments for AAA: (1) a validated decision aid describing AAA repair types with a survey measuring Veterans' preference for repair type -- versus (2) the survey alone. Enrolled Veterans will be candidates for either endovascular or open repair, and be followed at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, the investigators will determine Veterans' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, the investigators will compare agreement between Veterans' preferences and repair type between the decision aid+survey and survey-alone groups. In Aim 3, the investigators will investigate the facilitators and barriers of implementing a decision aid in a VA surgical clinic. The investigators will identify factors associated with agreement. The investigators' findings will be reported to the National Surgery Office Vascular Surgery Advisory Board to help ensure Veterans' preferences remain at the center of AAA treatment decisions. The investigators have recruited 20 VA Medical Centers and their vascular surgery teams to participate in this trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized study. Sites will be randomly assigned to the intervention group - (decision aid +survey), or control group (survey only). The randomization scheme is 9:1, for complex and intermediate VA sites.
| Arm | Type | Receives |
|---|---|---|
| decision aid | Experimental | Other: Decision aidthe experimental group will receive the decision aid |
| control | No intervention | –the control group will only receive the survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Veteran with a > or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery
Key exclusion criteria (1 listed)
- Veterans who are not candidates for both open and endovascular repair, and are less than < 5.0 cm AAA in size
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidDecision aid for repair type for aortic abdominal aneurysms | Other | decision aid |
Primary outcome
Veteran Preference for Repair Type
Time frame: 30 days
The investigators' survey will measure the effect of the decision aid on Veterans preference for repair type for abdominal aortic aneurysms and domains associated with preference for each repair type (endovascular or open)
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type
Time frame: 30 days
The investigators' survey instruments will assess the effect of the decision aid on the agreement between Veteran's preference for repair type and actual repair type they receive
1 secondary outcome
Decision Regret Scale
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28943003Ghaffarian AA, Griffin CL, Kraiss LW, Sarfati MR, Brooke BS. Comparative effectiveness of one-stage versus two-stage basilic vein transposition arteriovenous fistulas. J Vasc Surg. 2018 Feb;67(2):529-535.e1. doi: 10.1016/j.jvs.2017.07.115. Epub 2017 Sep 21.
- Background: PubMed 28887242Mirabelli LG, Cosker RM, Kraiss LW, Griffin CL, Smith BK, Sarfati MR, Al-Dulaimi R, Brooke BS. Rapid Methods for Routine Frailty Assessment during Vascular Surgery Clinic Visits. Ann Vasc Surg. 2018 Jan;46:134-141. doi: 10.1016/j.avsg.2017.08.010. Epub 2017 Sep 6.
- Background: PubMed 28712813Perri JL, Nolan BW, Goodney PP, DeMartino RR, Brooke BS, Arya S, Conrad MF, Cronenwett JL. Factors affecting operative time and outcome of carotid endarterectomy in the Vascular Quality Initiative. J Vasc Surg. 2017 Oct;66(4):1100-1108. doi: 10.1016/j.jvs.2017.03.426. Epub 2017 Jul 14.
- Background: PubMed 28583737DeMartino RR, Brooke BS, Neal D, Beck AW, Conrad MF, Arya S, Desai S, Aziz F, Ryan P, Cronenwett JL, Kraiss LW; Vascular Quality Initiative. Development of a validated model to predict 30-day stroke and 1-year survival after carotid endarterectomy for asymptomatic stenosis using the Vascular Quality Initiative. J Vasc Surg. 2017 Aug;66(2):433-444.e2. doi: 10.1016/j.jvs.2017.03.427. Epub 2017 Jun 2.
- Background: PubMed 28366307David RA, Brooke BS, Hanson KT, Goodney PP, Genovese EA, Baril DT, Gloviczki P, DeMartino RR. Early extubation is associated with reduced length of stay and improved outcomes after elective aortic surgery in the Vascular Quality Initiative. J Vasc Surg. 2017 Jul;66(1):79-94.e14. doi: 10.1016/j.jvs.2016.12.122. Epub 2017 Mar 31.
- Background: PubMed 28288889Brooke BS, Sarfati MR, Zhang Y, Zhang Y, Presson AP, Greene TH, Kraiss LW. Cardiac Stress Testing during Workup for Abdominal Aortic Aneurysm Repair Is Not Associated with Improved Patient Outcomes. Ann Vasc Surg. 2017 Jul;42:222-230. doi: 10.1016/j.avsg.2016.10.057. Epub 2017 Mar 10.
- Background: PubMed 28242088Williams CR, Brooke BS. Effectiveness of open versus endovascular abdominal aortic aneurysm repair in population settings: A systematic review of statewide databases. Surgery. 2017 Oct;162(4):707-720. doi: 10.1016/j.surg.2017.01.014. Epub 2017 Feb 24.
- Background: PubMed 28222991Jones DW, Schermerhorn ML, Brooke BS, Conrad MF, Goodney PP, Wyers MC, Stone DH; Vascular Quality Initiative. Perioperative clopidogrel is associated with increased bleeding and blood transfusion at the time of lower extremity bypass. J Vasc Surg. 2017 Jun;65(6):1719-1728.e1. doi: 10.1016/j.jvs.2016.12.102. Epub 2017 Feb 20.
- Background: PubMed 28222989Hoel AW, Faerber AE, Moore KO, Ramkumar N, Brooke BS, Scali ST, Sedrakyan A, Goodney PP. A pilot study for long-term outcome assessment after aortic aneurysm repair using Vascular Quality Initiative data matched to Medicare claims. J Vasc Surg. 2017 Sep;66(3):751-759.e1. doi: 10.1016/j.jvs.2016.12.100. Epub 2017 Feb 17.
- Background: PubMed 28190719Goodney PP, Spangler EL, Newhall K, Brooke BS, Schanzer A, Tan TW, Beck AW, Hallett JH, MacKenzie TA, Edelen MO, Hoel AW, Rigotti NA, Farber A. Feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons in the Vascular Physician Offer and Report (VAPOR) Trial. J Vasc Surg. 2017 Apr;65(4):1152-1160.e2. doi: 10.1016/j.jvs.2016.10.121. Epub 2017 Feb 9.
- Background: PubMed 28106607Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized Venous Thromboembolism Risk Stratification Using the 2005 Caprini Score to Identify the Benefits and Harms of Chemoprophylaxis in Surgical Patients: A Meta-analysis. Ann Surg. 2017 Jun;265(6):1094-1103. doi: 10.1097/SLA.0000000000002126.
- Background: PubMed 28101609Martin LA, Finlayson SRG, Brooke BS. Patient Preparation for Transitions of Surgical Care: Is Failing to Prepare Surgical Patients Preparing Them to Fail? World J Surg. 2017 Jun;41(6):1447-1453. doi: 10.1007/s00268-017-3884-z.
- Individual participant dataSharing planned: No
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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.
Philip Goodney, MD principal investigator
White River Junction VA Medical Center, White River Junction, VT
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Abdominal Aortic Aneurysm, run by VA Office of Research and Development at 22 sites 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 1 inclusion and 1 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Veteran Preference for Repair Type (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115346, which also lists 33 linked publications.
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 26 Sep 2024.