A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
14. september 2026 oppdatert av: Boston Medical Center
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
648
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sarah Bagley, MD, MSc
- Telefonnummer: (617) 414-7399
- E-post: sarah.bagley@bmc.org
Studer Kontakt Backup
- Navn: Sarah N Kosakowski, MPH
- Telefonnummer: (617) 414-6906
- E-post: sarah.kosakowski@bmc.org
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Ta kontakt med:
- Sarah Bagley, MD
- Telefonnummer: 617-414-7399
- E-post: sarah.bagley@bmc.org
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-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
Providers:
- Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
- ≥ 1 clinic session per week
Youth:
- Ages 13 - 26
- Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
- English speaking
Exclusion Criteria:
Providers:
- Participated as an intervention provider in the R61 pilot RCT (H-45731)
- Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)
Youth:
- Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking
- Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research
- Young adults ages 18-26 with a legal guardian
- Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- Under legal custody of the Department of Children and Families (DCF)
- Participated in the intervention arm of the R61 pilot RCT (H-45731)
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention group
Providers randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference.
In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention.
In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment.
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Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose.
Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it.
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Aktiv komparator: Control group
Providers randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual.
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Youth participants will be provided usual care by providers in the control group.
As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Provider Fidelity to the Intervention
Tidsramme: 12 months
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Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years.
The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.
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12 months
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Youth Fidelity to the Intervention
Tidsramme: 12 months
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Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments.
The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.
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12 months
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Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Tidsramme: Baseline, 3 months, 6 months, 9 months, and 12 months.
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Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.
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Baseline, 3 months, 6 months, 9 months, and 12 months.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Youth knowledge of strategies to reduce overdose risk
Tidsramme: Baseline, 3 months, 6 months, 9 months, and 12 months.
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Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.
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Baseline, 3 months, 6 months, 9 months, and 12 months.
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Youth's ability to recognize and respond to an overdose
Tidsramme: Baseline, 3 months, 6 months, 9 months, and 12 months.
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Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.
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Baseline, 3 months, 6 months, 9 months, and 12 months.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Amy Yule, MD, Boston Medical Center, Psychiatry
- Hovedetterforsker: Sarah Bagley, MD, Boston Medical Center, Internal Medicine, Addiction Medicine
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 (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. desember 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
27. august 2026
Først innsendt som oppfylte QC-kriteriene
27. august 2026
Først lagt ut (Faktiske)
1. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-46999
- R61DA062217 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .