A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
14. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
648
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sarah Bagley, MD, MSc
- Telefonnummer: (617) 414-7399
- E-mail: sarah.bagley@bmc.org
Undersøgelse Kontakt Backup
- Navn: Sarah N Kosakowski, MPH
- Telefonnummer: (617) 414-6906
- E-mail: sarah.kosakowski@bmc.org
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Kontakt:
- Sarah Bagley, MD
- Telefonnummer: 617-414-7399
- E-mail: sarah.bagley@bmc.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
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.
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Amy Yule, MD, Boston Medical Center, Psychiatry
- Ledende efterforsker: Sarah Bagley, MD, Boston Medical Center, Internal Medicine, Addiction Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
27. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-46999
- R61DA062217 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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