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Идёт набор NCT07541417

Building Retention and Initiation Through Delivery of Peer-Guided Evidence-Based Practices

Без фазы С лечением Opioid Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Certified Peer Support Specialist Intervention.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities Via Mobile Health Clinics and Peer Support Services

Обзор

This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.

Подробное описание

This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention.

The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.

Вмешательства

  • Поведенческое Certified Peer Support Specialist Intervention
    Participants are recruited from mobile health clinics (MHC) delivered to communities using a predictive modeling framework to target areas for optimal MHC allocation to maximize prevention of overdose deaths. Patients randomized to the intervention arm are linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recov

Первичные конечные точки

  • Medications for Opioid Use Disorder (MOUD) Initiation [Срок оценки: 3 months]
  • Medications for Opioid Use Disorder (MOUD) Retention [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • Adherence to Buprenorphine [Срок оценки: Weekly; 24 weeks]
  • Barriers to Healthcare [Срок оценки: 90 days]
  • Frequency of Opioid Use [Срок оценки: Monthly; 24 weeks]
  • Overdose [Срок оценки: Weekly; 24 weeks]
  • Hospitalizations/Emergency Department Visits [Срок оценки: Weekly; 24 weeks]
  • Engagement in other Recovery Support Services [Срок оценки: Weekly; 24 weeks]
  • Naloxone/Narcan Administration [Срок оценки: Weekly; 24 weeks]
  • Fentanyl Test Strip Use [Срок оценки: Weekly; 24 weeks]
  • Recovery Capital [Срок оценки: 90 days]
  • Social Support [Срок оценки: 90 days]
  • Depression symptoms [Срок оценки: 90 days]
  • Anxiety symptoms [Срок оценки: 90 days]

Критерии участия

Критерии включения

  • Age 18+
  • Have diagnosis of OUD
  • New mobile health MOUD patient

Критерии исключения

  • Unable to read and comprehend the consent materials and other study materials
  • Currently working with a Certified Peer Support Specialist
  • Having severe medical or psychiatric disability that would hinder participation in the study, as determined by the clinical provider

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Prisma Health Upstate — Greenville

Идентификаторы

NCT: NCT07541417 · 2399199

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗