Trial Outcomes & Findings for Evaluation of a Computerized Opioid Overdose Prevention Program (NCT NCT02040077)
NCT ID: NCT02040077
Last Updated: 2017-11-17
Results Overview
The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention. At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as "true", "false", or "I don't know" (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses.
COMPLETED
NA
75 participants
Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.
2017-11-17
Participant Flow
Although the study expected to enroll and randomize 75 participants, an additional participant was randomized into the study - resulting in a final overall sample of 76 randomized participants.
Participant milestones
| Measure |
Computer + Questions
Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
|
Computer Only
Will receive computerized intervention with no embedded questions
|
Pamphlet
Receive a printed version of the same intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
25
|
|
Overall Study
COMPLETED
|
27
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Computerized Opioid Overdose Prevention Program
Baseline characteristics by cohort
| Measure |
Computer + Questions
n=27 Participants
Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
|
Computer Only
n=24 Participants
Will receive computerized intervention with no embedded questions
|
Pamphlet
n=25 Participants
Receive a printed version of the same intervention
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention. At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as "true", "false", or "I don't know" (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses.
Outcome measures
| Measure |
Computer + Mastery
n=27 Participants
Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
|
Computer Only
n=24 Participants
Will receive computerized intervention with no embedded questions.
|
Pamphlet
n=25 Participants
Receive a printed version of the same intervention
|
|---|---|---|---|
|
Knowledge Gain
Pre-Test
|
30.6 units on a scale
Standard Deviation 5.75
|
30.5 units on a scale
Standard Deviation 5.80
|
27.56 units on a scale
Standard Deviation 5.94
|
|
Knowledge Gain
Post-Test
|
40.7 units on a scale
Standard Deviation 6.22
|
40.5 units on a scale
Standard Deviation 6.16
|
36.2 units on a scale
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: Immediately after the intervention (an average of 10 minutes).Participant willingness (yes or no) to recommend the intervention to a family member or friend.
Outcome measures
| Measure |
Computer + Mastery
n=27 Participants
Will receive computerized intervention and will be required to periodically answer questions embedded within the program correctly to proceed into the next module.
|
Computer Only
n=24 Participants
Will receive computerized intervention with no embedded questions.
|
Pamphlet
n=25 Participants
Receive a printed version of the same intervention
|
|---|---|---|---|
|
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
|
27 Participants
|
24 Participants
|
25 Participants
|
Adverse Events
Computer + Mastery
Computer Only
Pamphlet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place