A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sarah Bagley, MD, MSc
- 電話番号：(617) 414-7399
- メール：sarah.bagley@bmc.org
研究連絡先のバックアップ
- 名前：Sarah N Kosakowski, MPH
- 電話番号：(617) 414-6906
- メール：sarah.kosakowski@bmc.org
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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コンタクト：
- Sarah Bagley, MD
- 電話番号：617-414-7399
- メール：sarah.bagley@bmc.org
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Provider Fidelity to the Intervention
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Youth knowledge of strategies to reduce overdose risk
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Amy Yule, MD、Boston Medical Center, Psychiatry
- 主任研究者：Sarah Bagley, MD、Boston Medical Center, Internal Medicine, Addiction Medicine
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。