Abdominal Aortic Aneurysm
Conditions
Brief 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. 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.
Interventions
OTHERDecision aid
Decision aid for repair type for aortic abdominal aneurysms
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Veteran with a \> or = 5.0 cm AAA who are candidates for both open and endovascular surgical repair, with no previous AAA repair surgery
Exclusion criteria
* Veterans who are not candidates for both open and endovascular repair, and are less than \< 5.0 cm AAA in size
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Veteran Preference for Repair Type | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision Regret Scale | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid the experimental group will receive the decision aid
Decision aid: Decision aid for repair type for aortic abdominal aneurysms | 126 |
| Control the control group will only receive the survey | 109 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Did not have AAA surgery | 28 | 15 |
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Control | Total | Decision Aid |
|---|---|---|---|
| Age, Continuous | 74 years | 74 years | 73 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 97 Participants | 208 Participants | 111 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 108 Participants | 234 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 126 | 5 / 109 |
| other Total, other adverse events | 0 / 126 | 0 / 109 |
| serious Total, serious adverse events | 0 / 126 | 0 / 109 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid | Agreement Between Veterans Preferences for Repair Type and Actual Repair Type | Veterans that had agreement between preference and repair received | 88 Participants |
| Decision Aid | Agreement Between Veterans Preferences for Repair Type and Actual Repair Type | Veterans that did not have agreement between preference and repair received | 6 Participants |
| Control | Agreement Between Veterans Preferences for Repair Type and Actual Repair Type | Veterans that had agreement between preference and repair received | 75 Participants |
| Control | Agreement Between Veterans Preferences for Repair Type and Actual Repair Type | Veterans that did not have agreement between preference and repair received | 15 Participants |
Primary
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)
Time frame: 30 days
Population: These numbers differ from the participant flow module due to omitted survey answers by participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid | Veteran Preference for Repair Type | Veteran Preference for Open | 25 Participants |
| Decision Aid | Veteran Preference for Repair Type | Veteran Preference for EVAR | 95 Participants |
| Control | Veteran Preference for Repair Type | Veteran Preference for Open | 25 Participants |
| Control | Veteran Preference for Repair Type | Veteran Preference for EVAR | 80 Participants |
Secondary
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.
Time frame: 30 days
Population: These numbers differ from the participant flow module due to omitted survey answers by participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Decision Regret Scale | 4.9 score on a scale |
| Control | Decision Regret Scale | 4.95 score on a scale |