Clinical trial NCT06569667: Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids
Official title: Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Peer Recovery Coach
AI-driven text tool
mobile health (mHealth)
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Nathan Kline Institute for Psychiatric Research
name: NYU Langone Health
name: Weill Medical College of Cornell University
First posted: 2024-08-26
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age;
2. fluent in English and/or Spanish;
3. self-reported non-prescription opioid use \<30 days prior to consent;
4. provision of informed consent;
5. planned stay in NYC ≥12 month;
6. self-identified Black and/or Latinx race/ethnicity;
7. positive urine toxicology for opioids per EMR records;
8. diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5
9. self-reported interest in initiating buprenorphine in primary care
10. must have a mobile phone data plan.

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of self-reported linkage to OUD services
timeFrame: 1 year
Secondary outcomes:
measure: Number of Office-Based Opioid Treatment with buprenorphine.
timeFrame: 1 year
measure: Number of social services received
timeFrame: 1 year
measure: Number of interactions and time spent (in minutes) engaged with the intervention
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: NYC Health + Hospitals
state: New York
Study officials:
References: