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なぜ待つのですか?入院中に外傷性の負傷した患者の緊急時管理を開始します

2026年9月15日 更新者:Queen's Medical Center

This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients.

The goals are:

  • Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury
  • To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program.
  • To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants.
  • To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital.

For total of 12 weeks, participants will:

  • Be visited on Mondays/Thursdays or Tuesdays/Fridays by the research team to complete urine analysis during the hospitalization
  • Visit a follow up clinic up to 2 times per week on Mondays/Thursdays or Tuesdays/Fridays to complete urinalysis following discharge from the hospital
  • Complete Treatment Effectiveness Assessments at 6 and 12 weeks
  • Engage in qualitative interview at the end of the CM program

調査の概要

研究の種類

介入

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Hawaii
      • Honolulu、Hawaii、アメリカ、96813
        • The Queen's Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Admitted trauma patients
  • Age greater than 18 years old
  • Urine drug screen positive for methamphetamines during the current hospitalization
  • Report at least weekly methamphetamine use
  • First methamphetamine use greater than 6 months prior to injury
  • Report at least 4 Diagnostic and Statistical Manual of Mental Disorders 5th Edition, Amphetamine-Type Substance Use Disorder symptoms (at least moderate disease)
  • Glasgow Coma Scale ≥13 upon arrival to the emergency department
  • Ability to understand and participate in study procedures
  • Ability to communicate in English
  • Expected discharge date within 45 days on the day of screening / recruitment

Exclusion Criteria:

  • Active psychosis (reporting auditory or visual hallucinations)
  • Under ongoing cardiorespiratory monitoring
  • Evidence of moderate or severe traumatic brain injury
  • Patients who are known to be pregnant
  • Prisoners
  • Individuals incarcerated at the time of their hospitalization
  • Individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • 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
実験的:Contingency management intervention

Intervention is total of 12 weeks. During the hospitalization, participants will be visited by study personnel and will be asked to complete a urine drug screen that will screen for presence of methamphetamine on Mondays/Thursdays or Tuesdays/Fridays (M/Th or T/F). Once discharged, participants will be asked to come into the out patient clinic 2 times per week (M/Th or T/F) to complete a urine drug screen that will screen for presence of methamphetamine. If the specimen is negative for methamphetamine, the participants will be rewarded. Participants will also be asked to complete the Treatment Effectiveness Assessment (TEA) with study personnel.

If the urine sample is methamphetamine negative, participant will be positively reinforced and offered incentives. Participants immediately draw the reinforcement slip of paper to receive a prize from a selection kept on-site. Approximately 50% of the slips offer written praises (i.e. "great job!"). The other 50% of slips are the divided between low value (i.e. food gift cards, bus passes), medium value (i.e. prepaid cellphone, clothing gift cards), and a few large value rewards (i.e. electronic tablet, jewelry). Should the sample be positive for methamphetamine, no reinforcement and/or incentive to be provided. Participant will be encouraged to continue to participate in CM program and follow-up on the next CM date.

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
Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment
時間枠:From enrollment to 6 and 12 weeks

TEA (Treatment Effectiveness Assessment) at 6- and 12-weeks post-enrollment to assess both patient-reported medium-term program effectiveness. TEA asks individuals to respond to changes in four domains following a drug treatment program: Substance use, health, lifestyle, and community. The score for each domain can range from 1 (no change or not much) to 10 (much better), for total score of 4-40. This score allows for the prioritization of each participants values, and therefore does not require strict abstinence to demonstrate benefit from drug treatment.

From enrollment to 6 and 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Conduct qualitative interviews with participants post-program
時間枠:At the end of the treatment at 12 weeks

Interviews will be conducted as semi-structured qualitative interviews with participants post-program and will be transcribed and analyzed using a Template Analysis approach. Coders will conduct coding of the interview data to ultimately identify themes that will be used as the basis for interpretation. The final analysis of the qualitative data will include contrasts and comparisons made across interviews to examine overlaps and divergences across any relevant sub-samples (i.e. sex, age). Results will present thematic patterns, how frequently each code occurs, and any contradictory evidence. This will allow for the identification of common themes and perspectives, which will provide necessary cultural insights and possible adaptations for further implementation efforts.

At the end of the treatment at 12 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Assessment of rate of AMA and treatment completion in acute hospital setting in participants
時間枠:From enrollment to the end of treatment at 12 weeks

To assess the rate of AMA and treatment completion in acute hospital setting in participants

To assess the optimal timing of CM initiation for trauma injury hospitalized patients by comparing patient outcomes to the Schumann's pilot project 2024 (7/2024-6/2025) (NCT06532370 - Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii). We will compare the duration of CM participation and the rates of CM program completion and providing negative urine samples.

From enrollment to the end of treatment at 12 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月1日

一次修了 (実際)

2026年9月13日

研究の完了 (実際)

2026年9月13日

試験登録日

最初に提出

2025年4月1日

QC基準を満たした最初の提出物

2025年4月9日

最初の投稿 (実際)

2025年4月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月15日

最終確認日

2026年9月1日

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

米国FDA規制機器製品の研究

いいえ

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