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临床试验/NCT06569667
NCT06569667终止不适用

Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids

Friends Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
94
试验地点
1
主要终点
Rate of self-reported linkage to OUD services

研究概览

简要总结

Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black / Latinx people who use opioids.

详细描述

The investigators have validated a theory-driven, artificial intelligence (AI)-driven texting tool using natural language processing to facilitate real-time text responses to patient queries combined with automated texts facilitating receipt of buprenorphine in office-based opioid treatment (OBOT) and social services that address social determinants of health (SDH). This open-source texting tool offers passive reminders, informational content, and interactive two-way response algorithms without personal staff contact. In addition, the investigators have adapted an efficacious cultural and structural humility training for PRCs that goes beyond SDH to also address stigma reduction, discrimination, health habitus, and patient navigation to enhance uptake of primary care and social services for PWUO.

Using a three-arm, comparative effectiveness trial design, the specific aims are to: (1) Assess the efficacy of PRC supported text-based care/services coordination with PWUO + AI-driven SDH-enhanced text messaging (intervention arm-1) vs. AI-driven SDH-enhanced text messaging only (intervention arm-2) vs. Treatment as Usual (TAU) or printed social/medical services referrals (control) to enhance the receipt of buprenorphine in OBOT among community and ED-enrolled Black / Latinx PWUO (N=252); (2) Evaluate the implementation of the multimodal intervention (arm-1) guided by the RE-AIM and CFIR frameworks using in-depth interviews among 3 stakeholder groups: (a) frontline providers (n=10); (b) administrators (n=10); and (c) a subset of the Black and Latinx PWUO from the multimodal intervention arm-1 (n=30); and (3) Identify the resources and estimate the associated cost of implementing and sustaining the multimodal intervention and incorporate this information into a customizable budget-impact tool and conduct a comprehensive economic evaluation to calculate the relative economic value (e.g., cost-per quality-adjusted life years, cost-per OUD treatment days) of each study arm from the healthcare sector, state policymaker, and societal perspectives which will also inform implementation framed by RE-AIM.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥18 years of age;
  • •fluent in English and/or Spanish;
  • •self-reported non-prescription opioid use <30 days prior to consent;
  • •provision of informed consent;
  • •planned stay in NYC ≥12 month;
  • •self-identified Black and/or Latinx race/ethnicity;
  • •positive urine toxicology for opioids per EMR records;
  • •diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5
  • •self-reported interest in initiating buprenorphine in primary care
  • •must have a mobile phone data plan.

排除标准

  • •inability to comprehend text content written at a 3rd grade reading level;
  • •physical or visual disability preventing mobile phone use;
  • •self-reported receipt of medications for OUD in past 30 days.

研究组 & 干预措施

Control Arm 3- Treatment as Usual

Placebo Comparator

Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).

干预措施: Treatment as Usual (TAU) (Behavioral)

Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text

Experimental

Participants in this arm will receive a combination of Peer Recovery Coaches (PRCs) supported text-based care/services coordination alongside AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids.

干预措施: PRC supported text + AI driven SDH-enhanced text (Behavioral)

Intervention Arm-2: AI driven SDH-enhanced text only

Experimental

Participants in this arm will receive AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids. Unlike Arm-1, this intervention does not include the additional support and coordination provided by Peer Recovery Coaches.

干预措施: AI driven SDH-enhanced text only (Behavioral)

结局指标

主要结局

Rate of self-reported linkage to OUD services

时间窗: 1 year

The primary outcome for this efficacy study is self-reported linkage to OUD services (i.e., time to initial buprenorphine prescription that is prescribed in OBOT programs or other OUD treatment providers per the Non-study Medical and Other Services form.

次要结局

  • Number of Office-Based Opioid Treatment with buprenorphine.(1 year)
  • Number of social services received(1 year)
  • Number of interactions and time spent (in minutes) engaged with the intervention(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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