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临床试验/NCT01153373
NCT01153373已完成2 期

The Dynamic Assessment and Referral System for Substance Abuse: Evaluation

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 758 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
758
试验地点
1
主要终点
Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Minimal Intervention Control

Placebo Comparator

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.

干预措施: Self-administered computerized assessment for tobacco, substance abuse, and alcohol use. (Behavioral)

DARSSA Intervention

Active Comparator

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.

干预措施: Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse (Behavioral)

结局指标

主要结局

Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.

时间窗: 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.

次要结局

  • 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.(November 2009 - June 2013)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edwin Boudreaux

Study Principle Investigator

University of Massachusetts, Worcester

研究点 (1)

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