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Evaluation of a Computerized Opioid Overdose Prevention Program

Primary Purpose

Computer + Fluency, Computer Only, Treatment as Usual

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer + Fluency
Computer Only
Treatment as Usual
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Computer + Fluency focused on measuring opioid, overdose, OD, opiate, prescription opioids, prescription pain medication, heroin, detoxification, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University Bayview Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Computer + Fluency

Computer Only

Treatment as Usual

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 15, 2014
Last Updated
October 12, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02040077
Brief Title
Evaluation of a Computerized Opioid Overdose Prevention Program
Official Title
Development and Validation of a Computerized Opioid Overdose Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Computer + Fluency, Computer Only, Treatment as Usual
Keywords
opioid, overdose, OD, opiate, prescription opioids, prescription pain medication, heroin, detoxification, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer + Fluency
Arm Type
Experimental
Arm Description
Will receive computerized intervention and will be required to periodically demonstrate mastery of information before proceeding to the next module in the computerized intervention.
Arm Title
Computer Only
Arm Type
Active Comparator
Arm Description
Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer + Fluency
Intervention Type
Behavioral
Intervention Name(s)
Computer Only
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Knowledge Gain
Description
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.
Secondary Outcome Measure Information:
Title
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins University Bayview Medical Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Computerized Opioid Overdose Prevention Program

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