Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of a Computerized Opioid Overdose Prevention Program

12. oktober 2017 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

75

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Johns Hopkins University Bayview Medical Campus

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: Computer Only
Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knowledge Gain
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2015

Primær fullføring (Faktiske)

1. september 2015

Studiet fullført (Faktiske)

1. september 2015

Datoer for studieregistrering

Først innsendt

15. januar 2014

Først innsendt som oppfylte QC-kriteriene

16. januar 2014

Først lagt ut (Anslag)

20. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere