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
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
段階
- 適用できない
連絡先と場所
研究場所
-
-
Hawaii
-
Honolulu、Hawaii、アメリカ、96813
- The Queen's Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- RA-2025-012
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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