跳至主要内容
临床试验/NCT06208839
NCT06208839终止不适用

Mobile Technologies Extending Reach of Primary Care for Substance Use

Chess Mobile Health2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
117
试验地点
2
主要终点
NIDA Quick Screen

研究概览

简要总结

The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone.

详细描述

The investigators will recruit and randomize 200 individuals screening positive on the NIDA Quick Screen.

All participants will receive SBIRT as currently implemented at Western Michigan and as described above. Adult patients would be asked prior to appointments at Western Michigan, either in-person when in a waiting room and/or via email for virtual appointments if they'd would be willing to answer a brief, anonymous online survey regarding their substance use as part of a research study. Upon completing the survey, the results of the survey would be displayed for the patient to see. If the patient's answers to the screening tool indicate their use may be risky or indicates a serious problem regarding assessment, then they would be asked if they would consider participating in a research study (the investigators would provide an online description of the requirements of the study and the payments for participation). If they click through as being interested, the investigators will display more detail about the research study, explain that they will need to review and sign a consent form, and would be required to speak with a research assistant in the coming days. The investigators would present them an electronic consent form and require them to scroll through and, if necessary, could ask them a question or two to confirm their understanding, before allowing them to electronically sign the consent. The investigators would advise them that their participation will not be anonymous. If the patient consents, then the investigators would have them to complete the longer NIDA ASSIST or AUDIT screening tool. If the patient's answers indicate a risk score in the low-risk range for either alcohol or illicit drugs, the investigators will exclude them from continuing in the study.

If the patient's answers indicate a risk score in the moderate to high range, then they would be randomized to the intervention group or the control group. As part of the randomization process, the SBIRT/TAU and the SBIRT/eIntervention groups will have two sub-groups each: (1) those with moderate risk drug or alcohol use and those at high risk or with SUD as measured by the ASSIST and the AUDIT assessment tools). Thus, participants will have been randomized into four cohorts of about 50 subjects each.

If the patient is randomized to the intervention group, then they would be presented a set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, they will receive a 'brief intervention' based on the "Drinker's Checkup" licensed by CHESS Health from San Diego State University.

Whether in the intervention group or the control group, they would be recommended for a referral to treatment. If they're already in SUD treatment, then will exclude them from continuing in the study. If the patient is randomized to the intervention group, then in addition to the referral, they would be given use of the Envoy App with referral details and a TBD set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, then they would only get the referral to treatment plus a basic version of the app that consists solely of the survey engine used for primary data collection. The investigators will conduct a 3-month randomized clinical trial, with a 6-month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • adults aged 18 or over
  • receiving primary care at Western Michigan
  • identified as having a substance-specific NIDA Modified Assist score of 27 or greater.

排除标准

  • non-English speaking
  • cannot read at a 3rd grade level,
  • have current participation in addiction treatment
  • determined to be psychiatrically or medically unstable such that completion of the trial is unlikely.

结局指标

主要结局

NIDA Quick Screen

时间窗: Screening

The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used.

The Alcohol Use Disorders Identification Test (AUDIT)

时间窗: Screening, 3-month, and 6-month

The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. We will also administer the AUDIT for patients who screen positive for alcohol via the NIDA Quick Screen.

The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

时间窗: Screening, 3-month, and 6-month

The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of researchers and clinicians as a technical tool to assist with early identification of substance use related health risks and substance use disorders in primary health care, general medical care and other settings

Contemplation ladder

时间窗: Baseline, 3-month, and 6-month

To assess patient motivation

Satisfaction survey

时间窗: 3-month, 6 month

Evaluate patients' satisfaction with treatment and interventions

TimeLine Follow-back method

时间窗: Baseline, 3-month, and 6-month

Self-reports are collected using the TimeLine Follow-back method, a widely used and well-validated technique for collecting information on all types of substance use on a day-by day basis for the full period of each participants trial involvement (covering the 3 months prior to baseline through the end of the follow-up).

Healthcare utilization

时间窗: Baseline, 3-month, and 6-month

Self reported treatment utilization (including emergency department visits, hospitalization, specialty care visits, attendance at self-help meetings) in all conditions.

Demographics

时间窗: Baseline

Participant Age

次要结局

未报告次要终点

研究者

发起方
Chess Mobile Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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