Evaluation of a Computerized Opioid Overdose Prevention Program

NCT ID: NCT02040077

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Computer + Fluency; Computer Only; Treatment as Usual

Keywords

opioid; overdose; OD; opiate; prescription opioids; prescription pain medication; heroin; detoxification; prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Computer + Fluency

Will receive computerized intervention and will be required to periodically demonstrate mastery of information before proceeding to the next module in the computerized intervention.

Group Type: EXPERIMENTAL

Computer + Fluency

Intervention Type: BEHAVIORAL

Computer Only

Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.

Group Type: ACTIVE_COMPARATOR

Computer Only

Intervention Type: BEHAVIORAL

Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Interventions

Computer + Fluency

Intervention Type: BEHAVIORAL

Computer Only

Intervention Type: BEHAVIORAL

Treatment as Usual

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R21DA035327

Identifier Type: NIH

Identifier Source: secondary_id

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Opioid Overdose

Identifier Type: -

Identifier Source: org_study_id