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Evaluation of a Computerized Opioid Overdose Prevention Program

12 oktober 2017 bijgewerkt door: Johns Hopkins University

Development and Validation of a Computerized Opioid Overdose Intervention.

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

75

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21224
        • Johns Hopkins University Bayview Medical Campus

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: Computer Only
Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knowledge Gain
Tijdsspanne: Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.

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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
Tijdsspanne: Immediately after the intervention (an average of 10 minutes).
Participant willingness (yes or no) to recommend the intervention to a family member or friend.
Immediately after the intervention (an average of 10 minutes).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2015

Primaire voltooiing (Werkelijk)

1 september 2015

Studie voltooiing (Werkelijk)

1 september 2015

Studieregistratiedata

Eerst ingediend

15 januari 2014

Eerst ingediend dat voldeed aan de QC-criteria

16 januari 2014

Eerst geplaatst (Schatting)

20 januari 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 november 2017

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

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