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Trial Outcomes & Findings for Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm (NCT NCT03115346)

NCT ID: NCT03115346

Last Updated: 2024-09-26

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

241 participants

Primary outcome timeframe

30 days

Results posted on

2024-09-26

Participant Flow

In this study we had 241 total enrollments, including three dual enrollments. Three participants were enrolled at one Prove-AAA site and were then subsequently enrolled at another Prove-AAA site. All three of these participants were fully withdrawn via a protocol deviation filed with the central institutional review board to only be enrolled at one site. Out of the 238 enrolled participants three were fully withdrawn via protocol deviation.

Unit of analysis: Study Sites

Participant milestones

Participant milestones
Measure
Veteran's Hospital Vascular Surgery Clinics Using Decision Aid
Participants in this arm of the study were given a information packet describing endovascular repair and Open AAA surgery prior to seeing their vascular surgeon.
Veterans Hospital Vascular Surgery Clinics Providing Usual Care
Participants in this arm of the study did not receive an informational packet prior to visiting with their vascular surgeon
Overall Study
STARTED
126 11
109 11
Overall Study
COMPLETED
95 11
87 11
Overall Study
NOT COMPLETED
31 0
22 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Veteran's Hospital Vascular Surgery Clinics Using Decision Aid
Participants in this arm of the study were given a information packet describing endovascular repair and Open AAA surgery prior to seeing their vascular surgeon.
Veterans Hospital Vascular Surgery Clinics Providing Usual Care
Participants in this arm of the study did not receive an informational packet prior to visiting with their vascular surgeon
Overall Study
Did not have AAA surgery
28
15
Overall Study
Death
3
1
Overall Study
Withdrawal by Subject
0
3
Overall Study
Lost to Follow-up
0
3

Baseline Characteristics

Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Decision Aid
n=126 Participants
the experimental group will receive the decision aid Decision aid: Decision aid for repair type for aortic abdominal aneurysms
Control
n=109 Participants
the control group will only receive the survey
Total
n=235 Participants
Total of all reporting groups
Age, Continuous
73 years
n=5 Participants
74 years
n=7 Participants
74 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
126 Participants
n=5 Participants
108 Participants
n=7 Participants
234 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
7 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
White
111 Participants
n=5 Participants
97 Participants
n=7 Participants
208 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=5 Participants
3 Participants
n=7 Participants
10 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: These numbers differ from the participant flow module due to omitted survey answers by participants.

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)

Outcome measures

Outcome measures
Measure
Decision Aid
n=120 Participants
the experimental group will receive the decision aid Decision aid: Decision aid for repair type for aortic abdominal aneurysms
Control
n=105 Participants
the control group will only receive the survey
Veteran Preference for Repair Type
Veteran Preference for Open
25 Participants
25 Participants
Veteran Preference for Repair Type
Veteran Preference for EVAR
95 Participants
80 Participants

PRIMARY outcome

Timeframe: 30 days

Population: These numbers differ from the participant flow module because only 98 participants received AAA repair in the intervention group and 94 in the control group received AAA repair. From these participants who had AAA repair, analysis was limited to 94 in the decision aid group and 90 in the control group due to participants being lost to follow-up or omitted survey answers.

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

Outcome measures

Outcome measures
Measure
Decision Aid
n=94 Participants
the experimental group will receive the decision aid Decision aid: Decision aid for repair type for aortic abdominal aneurysms
Control
n=90 Participants
the control group will only receive the survey
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type
Veterans that had agreement between preference and repair received
88 Participants
75 Participants
Agreement Between Veterans Preferences for Repair Type and Actual Repair Type
Veterans that did not have agreement between preference and repair received
6 Participants
15 Participants

SECONDARY outcome

Timeframe: 30 days

Population: These numbers differ from the participant flow module due to omitted survey answers by participants.

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.

Outcome measures

Outcome measures
Measure
Decision Aid
n=125 Participants
the experimental group will receive the decision aid Decision aid: Decision aid for repair type for aortic abdominal aneurysms
Control
n=107 Participants
the control group will only receive the survey
Decision Regret Scale
4.9 score on a scale
Interval 3.2 to 5.4
4.95 score on a scale
Interval 2.9 to 5.6

Adverse Events

Decision Aid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Eid

VA Hospital

Phone: 502-295-8961

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place