Trial Outcomes & Findings for Video-based, Patient-Focused Opioid Education in the Perioperative Period (NCT NCT03986866)
NCT ID: NCT03986866
Last Updated: 2022-04-26
Results Overview
Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
7 days
Results posted on
2022-04-26
Participant Flow
Participant milestones
| Measure |
No Video
Patients are not shown the informational video on the safe usage of opioids.
|
Video
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
No Video
Patients are not shown the informational video on the safe usage of opioids.
|
Video
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
patient required admission so no longer fit study exclusion criteria of ambulatory surgery
|
2
|
2
|
Baseline Characteristics
Video-based, Patient-Focused Opioid Education in the Perioperative Period
Baseline characteristics by cohort
| Measure |
No Video
n=53 Participants
Patients are not shown the informational video on the safe usage of opioids.
|
Video
n=50 Participants
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 7 daysKnowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.
Outcome measures
| Measure |
No Video
n=36 Participants
Patients are not shown the informational video on the safe usage of opioids.
|
Video
n=33 Participants
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Knowledge of Post Operative Opioids
|
8.32 units on a scale
Standard Deviation 2.5
|
9.36 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Up to 3 monthsPost-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark.
Outcome measures
| Measure |
No Video
n=53 Participants
Patients are not shown the informational video on the safe usage of opioids.
|
Video
n=50 Participants
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Number of Patients Who Discontinued Opioids by 3 Months
|
47 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 90-150 daysFeasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively.
Outcome measures
| Measure |
No Video
n=53 Participants
Patients are not shown the informational video on the safe usage of opioids.
|
Video
n=50 Participants
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Development of Chronic Opioid Use
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Days until opioid cessation
Feasibility of collecting data on the number of days until opioid cessation
Outcome measures
| Measure |
No Video
n=30 Participants
Patients are not shown the informational video on the safe usage of opioids.
|
Video
n=29 Participants
Patients are shown an informational video on the safe usage of opioids.
Video: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
|
|---|---|---|
|
Number of Total Days to Opioid Cessation
|
13.9 days
Standard Deviation 17
|
13.9 days
Standard Deviation 20.9
|
Adverse Events
No Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Johnathan Goree, MD
University of Arkansas for Medical Sciences
Phone: (501) 686-8818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place