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临床试验/NCT04982627
NCT04982627已完成不适用

A Chatbot Utilizing Machine Learning and Natural Language Processing to Implement the Brief Negotiation Interview to Improve Engagement in Buprenorphine Treatment Among Justice-Involved Individuals

Center for Progressive Recovery, LLC2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Treatment Engagement

研究概览

简要总结

Primary Objective:

Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among individuals involved in the Connecticut criminal justice system with opioid use disorder (OUD).

Study Duration:

Approximately 2 years (1 year for study activities, 1 year for data analysis)

Study Design:

This is a prospective, randomized study to evaluate the effectiveness of a BNI Chatbot on patients with OUD compared with Standard Care (SC).

Number of Study Sites:

The offices of the Center for Progressive Recovery, LLC and the New Haven Police Department Detention Center (NHPD).

Study Population:

The study population includes adult individuals with OUD who are involved in the Connecticut criminal justice system and not currently receiving medication-assisted treatment for their OUD.

Number of Participants:

Sixty participants

Primary Outcome Variable:

Attendance at participants first treatment appointment within four weeks of referral among participants in the BNI Chatbot vs. Standard Care (SC) groups.

Secondary Outcome and Exploratory Outcome Variables:

Secondary outcomes include readiness and intention to engage in buprenorphine (bup) treatment, and urine toxicology test-confirmed drug use at four weeks among participants in BNI Chatbot vs. SC groups. Exploratory outcomes include ratings of feasibility, acceptability and satisfaction between study groups, and a comparison of study findings to engagement data from previous in-person studies, including BNI+bup, and other digital programs, such as reSET-O, and DynamiCare.

详细描述

Enrollment and Randomization:

Individuals meeting inclusion/exclusion criteria with the research associate (RA), who will be following a "Recruitment Script" (see below) will be offered participation and written informed consent will be obtained. Participants will be randomly assigned (via http://www.randomization.com) to receive either the BNI Chatbot or Standard Care (SC).

  • SC: The RA will provide participants with an electronic link, which provides OUD and bup education, and lists OUD treatment options and descriptions and locations, including bup prescribers. After reviewing, participants will be asked to choose from among the list of and a referral will be made based on the receiving treatment providers' procedures. These participants will not have access to the BNI chatbot. However, the referral facilitation, the electronic link will direct participants to a short Feasibility, Acceptability and Satisfaction (FAS) Assessment to obtain feedback on the process.
  • BNI Chatbot: Participants will receive a link to register for the chatbot. Following registration, they will complete the initial chat, which includes instructions for the entire study. The chatbot will then guide the participant through multiple BNIs focused on the goal of bup engagement, with the following steps: 1) Raise the Subject/Establish Rapport; 2) Enhance Motivation; 3) Provide & Elicit Feedback; and 4) Negotiate a Plan. The chatbot then reminds the participant of their reasons why they might engage in OUD treatment based on their responses to Steps 2 & 3, and their negotiated plan. The chatbot will electronically connect participants to a treatment provider of their choice, based on available options. Based on their choice, individuals in the BNI Chatbot group choosing to engage in bup treatment will be assessed by the Clinical Opiate Withdrawal Scale (COWS) and those in active withdrawal may be offered a telehealth appointment immediately (to the extent possible), which would occur during the enrollment and help facilitate a prescription for bup. The telehealth appointment may be with a different treatment provider than the one that they choose to meet with post-enrollment. If the participant is prescribed bup during this telehealth appointment, the RA will pick up the prescription for participant and deliver it to the participant immediately upon release from the police, courthouse or probation office (to the extent possible). At the end of the encounter, participants will be prompted to complete the feasibility, acceptability and satisfaction (FAS) assessment electronically to obtain feedback on the process.

Note: While participants are financially responsible for their own healthcare, we will only refer them to treatment options that are listed as being covered by their health insurance.

Baseline Assessment: Demographics and status of the participant's case in the criminal justice system will be collected by the RA via a mobile tablet.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Can speak, read and write in English
  • Provision of signed and dated informed consent form
  • Adult aged >18 years
  • Screened positive for opioid use disorder (OUD), moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
  • Have health insurance
  • Have an existing electronic medical record in Epic
  • Have a working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer)
  • Can provide a working email address
  • Can provide a working cell phone number

排除标准

  • Current use of buprenorphine (bup), methadone, or naltrexone for a substance use disorder
  • Known allergy to bup
  • Pregnancy or lactation
  • Known current suicide risk based on interview
  • Mandatory transport to a Department of Correction Facility, or strong likelihood of immediate transport, resulting from current legal case

结局指标

主要结局

Treatment Engagement

时间窗: 1-month post-randomization

Attendance at addiction treatment appointments

次要结局

  • Drug Use(1-month post randomization)
  • Intervention FAS(Immediately Post-Intervention)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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