An interventional study of Computer + Fluency and Computer Only in Computer + Fluency, Computer Only and Treatment as Usual, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in the general population. Fatal OD from opioid analgesics specifically has increased over 400% between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD. Unintentional opioid OD is a public health crisis in several societal populations including drug users, patients being treated for chronic pain, elderly individuals, adolescents, and children. Educational interventions have been developed to increase knowledge regarding opioid OD risk factors, symptoms, and appropriate responses, however no randomized controlled evaluations of these interventions have been conducted. Within-subject evaluations report immediate and sustained increases in participant knowledge and behavior change, yet these programs suffer from limitations that may limit their widespread dissemination. Thus, there is an urgent, critical need to develop an opioid OD educational intervention that can be accessed by a broad audience, and produces immediate and sustained gains in knowledge in an easily administered and cost-effective way. This study will develop a web-based, computerized, interactive, opioid OD education training program that will incorporate multi-media learning components and fluency training to produce knowledge gains. This program will be evaluated using a randomized, controlled comparison of the active intervention against two control interventions. Participants will be recruited from a brief inpatient detoxification (n=75), will receive the intervention immediately upon completing the detoxification (post-treatment), and will complete 2 follow-up visits to evaluate sustained knowledge. The primary outcome will be percent change from baseline on a knowledge test that is administered immediately before and after the intervention, and at a 1 and 3-month follow-up visit. Secondary outcomes will include self-reported behavior change and participant acceptance of the intervention. The study hypothesis is that participants who receive the primary intervention will evidence the largest increase in knowledge gain and retention over time, compared to the control groups. The rationale and public health benefit of this research cannot be understated- this project will make available a brief, empirically-supported intervention that can be administered quickly and easily within hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers, primary care offices, schools), and to diverse patient populations (e.g., drug users, chronic pain patients, elderly, student, children, parents). These outcomes are expected to have a positive impact because they will provide cheap, easily-administered intervention strategy that will help reduce the current national epidemic of opioid OD, and will expand the use of computerized interventions to address public health issues more broadly.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's enrollment of 75 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Will receive computerized intervention and will be required to periodically demonstrate mastery of information before proceeding to the next module in the computerized intervention.
Behavioral: Computer + Fluency
Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.
Behavioral: Computer Only
Will receive publicly available pamphlets that contain same information as the computerized intervention. Will not have access to computerized intervention and will not be required to demonstrate mastery of information as part of the intervention.
Behavioral: Treatment as Usual
Knowledge Gain
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.
Time frame: Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
Participant willingness (yes or no) to recommend the intervention to a family member or friend.
Time frame: Immediately after the intervention (an average of 10 minutes).
| Milestone | Computer + Questions | Computer Only | Pamphlet |
|---|---|---|---|
| Started | 27 | 24 | 25 |
| Completed | 27 | 24 | 25 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Computer + Mastery | Computer Only | Pamphlet |
|---|---|---|---|
| Pre-Test | 30.6 ± 5.75 | 30.5 ± 5.80 | 27.56 ± 5.94 |
| Post-Test | 40.7 ± 6.22 | 40.5 ± 6.16 | 36.2 ± 10.88 |
Participant willingness (yes or no) to recommend the intervention to a family member or friend.
| Participants | Computer + Mastery | Computer Only | Pamphlet |
|---|---|---|---|
| Percent Participants Who Would Recommend the Intervention to a Family Member or Friend. | 27 | 24 | 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer + Mastery | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Computer Only | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Pamphlet | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Computer + Questions | Computer Only | Pamphlet | Total |
|---|---|---|---|---|
| Mean | 40.0 ± 13.1 | 37.8 ± 10.6 | 41.9 ± 14.1 | 39.9 ± 12.6 |
| Sex: Female, Male(Participants) | Computer + Questions | Computer Only | Pamphlet | Total |
|---|---|---|---|---|
| Female | 12 | 7 | 12 | 31 |
| Male | 15 | 17 | 13 | 45 |
| Region of Enrollment(Participants) | Computer + Questions | Computer Only | Pamphlet | Total |
|---|---|---|---|---|
| United States | 27 | 24 | 25 | 76 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University