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Dynamic Assessment and Referral System - Evaluation (DARSSA)

2015年4月8日 更新者:Edwin Boudreaux、University of Massachusetts, Worcester

The Dynamic Assessment and Referral System for Substance Abuse: Evaluation

The investigators study will use a randomized controlled design. Eligible and consenting participants will be randomly assigned to one of two conditions: (1) DARSSA Intervention condition, or (2) Minimal Intervention Control condition. All enrolled participants will undergo the DARSSA baseline assessment and will be interviewed immediately following their ED discharge to assess relevant outcomes, such as whether they were asked about substance use and given a referral during their visit. This is referred to as the post-visit interview. All risky substance users enrolled during all phases will be interviewed again at 1- and 3-months post-visit to assess substance use, treatment engagement, and other outcomes. The primary difference between the two conditions is that, for the DARSSA Intervention condition, the subjects will have their reports printed and will be given the option of receiving the dynamic referral, while for the Minimal Intervention Control condition the subjects will undergo the assessment and will receive the standard substance abuse treatment referral list currently in use clinically at each site. The number of assessments and interactions with research staff will remain equal between the two conditions, with the only difference being the active intervention of the DARSSA reports and referrals, and any counseling by healthcare providers this engenders. The remainder of this section describes each phase of the study and enrollment procedures.

調査の概要

詳細な説明

Screening process. All patients who verbally consent to being screened by the RA will undergo a computer assisted screening for substance abuse (Rapid Screener) administered by the research assistant. Patients who use tobacco, misuse alcohol, or use illicit drugs will be further screened for eligibility to participate in the randomized trial. Eligible patients will be invited to participate and will sign the consent form. Participants will then be assigned to one of the two conditions by the computer using a random number generator. Results obtained as part of the Rapid Screener will be for research purposes only. They will not be reported to healthcare providers, unless the participant is enrolled into the study and is assigned to the DARSSA Intervention condition (see below).

Minimal Intervention Control. All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only. The reports will not be printed or dynamic referrals generated, and all patients will receive treatment-as-usual by their ED providers. This will preserve the treatment-as-usual nature of the baseline while maintaining consistency in the administration of the DARSSA between phases of the study. Although ED clinicians will know that a study is being conducted in the ED, they will not be informed of the results of the research assessment, nor will they be given any instruction or training beforehand to change their standard screening, counseling, and referral practices. This means that substance use screening is likely to be inconsistent and counseling or referrals by provider rare. To maintain ethical standards, the RAs will provide a substance abuse treatment resource list (passive referral list) to all subjects who screen positive, even though this often does not happen during routine clinical practice. Additionally, suicidal ideation is not directly assessed as part of the study, but it is possible that participants will spontaneously report suicidal ideation. If this happens, the RA will notify the treating physician. Both of these efforts could conceivably introduce interventions the patient may not otherwise have received, but there is no viable alternative if the investigators are to ensure patient safety.

DARSSA Intervention. All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Since the DARSSA is self-administered and, like all Polaris products, does not require computer literacy, instructions will be simple and do not require a clinician to administer. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals. Any additional assessment or counseling will be optional and left to individual provider practice. We considered creating a standardized counseling protocol but decided against it. We want to maintain an ecologically valid evaluation. In the "real world," providers would not be given extensive health behavior counseling training or asked to follow a standardized counseling protocol when implementing the DARSSA. Training providers on health behavior counseling would act as an additional intervention in its own right, and it could potentially mask our ability to determine what effect the DARSSA alone is having.

研究の種類

介入

入学 (実際)

758

段階

  • フェーズ2

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

    • Massachusetts
      • Worcester、Massachusetts、アメリカ、01655
        • UMass Memorial Medical Center - University Campus

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

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

- Age 18 years or older and receiving treatment in the ED

Exclusion Criteria:

  • sustained altered mental status (e.g., psychosis, delirium, disorientation, unresponsive)
  • hostile or agitated behavior
  • sexual assault victims
  • trauma patients who are on backboards or who must remain supine
  • severe illness that would preclude conversation or interface with a computer (e.g., intubation, persistent vomiting, severe pain)
  • or factors precluding follow-up, like transient residence or lack of a telephone.

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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター:Minimal Intervention Control
All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only. The reports will not be printed or dynamic referrals generated, and all patients will receive treatment-as-usual by their ED providers.
All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only.
アクティブコンパレータ:DARSSA Intervention
All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.
All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.

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
Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.
時間枠:November 2009 - June 2013
When comparing the intervention (DARSSA) group to the treatment as usual group, is there an increase in the detected prevalence of tobacco use, alcohol use, and drug abuse.
November 2009 - June 2013

二次結果の測定

結果測定
メジャーの説明
時間枠
Increase in delivery of health care (i.e. - education/counseling/referral) for emergency room patients that report tobacco use, alcohol use, and/or substance abuse.
時間枠:November 2009 - June 2013
When the intervention (DARSSA) group is compared to the treatment as usual group, is there an increase in the amount of education/counseling/referral for emergency room patients who report tobacco use, alcohol use, and/or substance abuse.
November 2009 - June 2013

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。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2010年6月1日

一次修了 (実際)

2015年4月1日

研究の完了 (実際)

2015年4月1日

試験登録日

最初に提出

2010年6月24日

QC基準を満たした最初の提出物

2010年6月29日

最初の投稿 (見積もり)

2010年6月30日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年4月9日

QC基準を満たした最後の更新が送信されました

2015年4月8日

最終確認日

2015年4月1日

詳しくは

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