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NCT03115346: PROVE-AAA

Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

Completed NA Results posted Last updated 26 September 2024
What this trial tests

NA trial testing Decision aid in Abdominal Aortic Aneurysm in 241 participants. Completed in 30 May 2022.

Timeline
15 April 2017
Primary endpoint
10 December 2020
30 May 2022

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment241
Start date15 April 2017
Primary completion10 December 2020
Estimated completion30 May 2022
Sites22 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Abdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Veteran Preference for Repair Type Primary · 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)

Veteran Preference for Open
GroupValue95% CI
Decision Aid25
Control25
Veteran Preference for EVAR
GroupValue95% CI
Decision Aid95
Control80
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type Primary · 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

GroupValue95% CI
Decision Aid88
Control75
Decision Aid6
Control15
Decision Regret Scale Secondary · 30 days

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.

GroupValue95% CI
Decision Aid4.93.2 – 5.4
Control4.952.9 – 5.6

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Decision aids for people facing health treatment or screening decisions.
    Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
  2. Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.
    Eid MA, Barry MJ, Tang GL, Henke PK, et al · · 2022 · cited 18× · PMID 35947375 · DOI 10.1001/jamasurg.2022.2935

Verify or expand the search:

Other trials of Decision aid

Trials testing the same drug.

Other recruiting trials for Abdominal Aortic Aneurysm

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03115346.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing