Clinical trial NCT02040077: Evaluation of a Computerized Opioid Overdose Prevention Program
Official title: Development and Validation of a Computerized Opioid Overdose Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computer + Fluency
Computer Only
Treatment as Usual
Keywords: opioid
overdose
OD
opiate
prescription opioids
prescription pain medication
heroin
detoxification
prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-01-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age (\>18yrs old)
* Past yr diagnosis of opioid dependence
* Recent completion of opioid detoxification

Exclusion Criteria:

* Completion of local overdose prevention programs and/or beta-testing of the computerized intervention
* Physical limitations that will prevent adequate seeing/hearing of the intervention, or from using computer

Primary outcomes:
measure: Knowledge Gain
timeFrame: Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.
Secondary outcomes:
measure: Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
timeFrame: Immediately after the intervention (an average of 10 minutes).
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Campus
state: Maryland
Study officials:
References: