Evaluation of a Computerized Opioid Overdose Prevention Program

NCT02040077 | Completed Results DMC

• 2 other identifiers: Opioid OverdoseR21DA035327
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.

Secondary Outcomes (1)

• Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.

  Immediately after the intervention (an average of 10 minutes).

Study Arms (3)

Computer + Fluency

EXPERIMENTAL

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

Computer Only

ACTIVE COMPARATOR

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

Behavioral: Computer Only

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Computer + Fluency BEHAVIORAL

Computer + Fluency

Computer Only BEHAVIORAL

Computer Only

Treatment as Usual BEHAVIORAL

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Kelly Dunn
• Organization: Johns Hopkins University School of Medicine

kdunn9@jhmi.edu

410-550-2254

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 17, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-10

Locations

US (1)