Trial Outcomes & Findings for Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT (NCT NCT02437188)
NCT ID: NCT02437188
Last Updated: 2019-08-01
Results Overview
The percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.
COMPLETED
NA
88 participants
Enrollment to 3 months post surgery
2019-08-01
Participant Flow
Veterans indicated for orthopedic surgery and identified to be at-risk for poor outcomes were recruited following their indication clinic visit at the VAMC orthopedic clinic.
Eligible participants were randomized at their enrollment visit following phone screening. They were excluded if imminent risk of suicide. Active treatment groups received both ACT and TAU.
Participant milestones
| Measure |
ACT + TAU
Acceptance and Commitment Therapy plus Treatment as Usual
|
Treatment as Usual (TAU)
Treatment as Usual
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
40
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
ACT + TAU
Acceptance and Commitment Therapy plus Treatment as Usual
|
Treatment as Usual (TAU)
Treatment as Usual
|
|---|---|---|
|
Overall Study
Randomized but did not receive surgery
|
4
|
8
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
Baseline characteristics by cohort
| Measure |
ACT + TAU
n=40 Participants
Acceptance and Commitment Therapy plus Treatment as Usual
|
Treatment as Usual
n=34 Participants
Treatment as usual - preoperative education and perioperative analgesia
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
63 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
62.6 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
35 participants
n=107 Participants
|
75 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 3 months post surgeryThe percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.
Outcome measures
| Measure |
ACT + TAU
n=32 Participants
Acceptance and Commitment Therapy plus treatment as usual
|
Treatment as Usual (TAU)
n=35 Participants
Treatment as Usual
|
|---|---|---|
|
Percent of Veterans Willing and Able to Receive the ACT Intervention.
|
80 percent
|
100 percent
|
PRIMARY outcome
Timeframe: 3 months post surgeryPopulation: Intent-to-treat - with randomized participants who received surgery
Participants will be asked to rate the intensity of their maximum pain on a vertical, 0-10 numeric rating scale (0-10 NRS) with 0.5 increments at 3 months after surgery. Participants will be asked to provide a number that represents their highest pain intensity during the day if 0 is no pain and 10 is the most intense pain imaginable.
Outcome measures
| Measure |
ACT + TAU
n=40 Participants
Acceptance and Commitment Therapy plus treatment as usual
|
Treatment as Usual (TAU)
n=35 Participants
Treatment as Usual
|
|---|---|---|
|
Amount of Pain Intensity on 0-10 Numeric Rating Scale
|
7.5 score on a scale
Interval 5.5 to 8.0
|
8 score on a scale
Interval 6.0 to 9.0
|
PRIMARY outcome
Timeframe: 3 months post surgeryPopulation: Intent-to-treat - for participants who received surgery
Participants will be asked total daily dose of opioid medications at 3 months after surgery. All opioid doses converted to oral morphine equivalents.
Outcome measures
| Measure |
ACT + TAU
n=40 Participants
Acceptance and Commitment Therapy plus treatment as usual
|
Treatment as Usual (TAU)
n=35 Participants
Treatment as Usual
|
|---|---|---|
|
Amount of Opioid Use
|
0 mg oral morphine
Interval 0.0 to 168.0
|
0 mg oral morphine
Interval 0.0 to 200.0
|
PRIMARY outcome
Timeframe: 6 months post surgeryPopulation: Intent-to-treat - with participants who received surgery
Participants will record their pain daily after surgery via an electronic (REDCap) or hardcopy log. When pain \< 3 has been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of pain.
Outcome measures
| Measure |
ACT + TAU
n=40 Participants
Acceptance and Commitment Therapy plus treatment as usual
|
Treatment as Usual (TAU)
n=35 Participants
Treatment as Usual
|
|---|---|---|
|
Length of Pain (Days)
|
66 days
Interval 28.0 to 128.0
|
74 days
Interval 32.0 to 184.0
|
PRIMARY outcome
Timeframe: 6 months post surgeryPopulation: Intent-to-treat - with participants who received surgery
Participants will record all pain medications (i.e. opioids and non-opioids) taken on a computerized pain medication form (or hardcopy log if participant does not have computer access available) until 3 months after surgery. The computerized pain medication form will list the drug name, route, dose, number taken, and date/time of each dose. When 0 doses of opioids have been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of opioid use.
Outcome measures
| Measure |
ACT + TAU
n=40 Participants
Acceptance and Commitment Therapy plus treatment as usual
|
Treatment as Usual (TAU)
n=35 Participants
Treatment as Usual
|
|---|---|---|
|
Length of Opioid Use (Days)
|
42.5 days
Interval 30.0 to 96.0
|
51 days
Interval 34.0 to 94.0
|
Adverse Events
ACT + TAU
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACT + TAU
n=40 participants at risk
|
Treatment as Usual
n=34 participants at risk
|
|---|---|---|
|
Psychiatric disorders
Distress-based symptom increase
|
2.5%
1/40 • Number of events 1
|
14.7%
5/34 • Number of events 5
|
|
Nervous system disorders
Pain increase
|
2.5%
1/40 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
Additional Information
Dr. Lilian Dindo, Assistant Professor
Baylor College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place