跳至主要内容
临床试验/NCT07810322
NCT07810322招募中不适用

Pilot Testing of the emPath Intervention to Improve MOUD Linkage and Retention in Durham, NC

Duke University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
feasibility, as measured by retention in care

研究概览

简要总结

This pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina.

详细描述

This emPath pilot program will test the V1.0 app's core features (field-first app registration with access via personal device or a tablet stationed at community outreach sites, a secure telemedicine video visit portal designed for drop-in visits during outreach sessions, a secure in-app patient-provider messaging feature) combined with outreach staff facilitation at Project MAPS Durham mobile and fixed-site outreach sessions, to complete these aims:

Aim 1: Pilot the emPath prototype platform to initiate and maintain participants receiving community-based outreach services on all-virtual delivery of medications for opioid-use disorder (MOUD) using a low barrier care strategy.

Investigators will enroll up to 50 people with opioid use disorder for participation in the pilot program using a pilot feasibility-implementation trial. The primary feasibility outcome of interest is retention in care, defined by at least one virtual visit conducted before and after the expected 6-month time-point from enrollment.

Aim 2: Elucidate implementation determinants for the emPath pilot program. Study investigators will perform semi-structured qualitative interviews with up to 20 people who use drugs (PWUD) participants and 10 outreach staff participants to evaluate program implementation, as guided by Forney's conceptual framework for care access (PWUD) and the Consolidated Framework for Implementation Research (staff).

Researchers will use descriptive statistics to describe the baseline characteristics of the sample, including sociodemographics and substance use patterns (e.g., R). Retention defined as telemedicine visit attendance at baseline and before and after the 3 and/or 6-month follow-up time-point (whichever later timepoint is available based on when the participant was recruited) will be summarized with descriptive statistics following analysis of abstracted app paradata and electronic medical record data. As an exploratory question, there will be comparison of retention-in-care and secondary outcomes (e.g., participants who reported personal smartphone ownership at baseline vs not), as well as several baseline demographics (e.g., active injection drug use, housing status, criminal legal involvement in last year). Survey measures for implementation evaluation will be analyzed using descriptive statistics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • for Outreach program PWOUD (n=50):
  • Age 18 or older
  • Screen positive for moderate to high risk opioid use by WHO-ASSIST
  • Not currently prescribed any form of MOUD
  • Able to speak and understand English
  • Able and willing to provide informed consent
  • Inclusion Criteria for Outreach Staff (n=10):
  • Age 18 or older
  • Employed by the preceding 1 month or longer at time of enrollment
  • Able and willing to provide informed consent

排除标准

  • 未提供

研究组 & 干预措施

emPath Intervention

Experimental

Participants receive access to the emPath telemedicine platform and virtual MOUD care.

干预措施: emPath Intervention (Behavioral)

结局指标

主要结局

feasibility, as measured by retention in care

时间窗: up to 6 month visit

Retention in care is defined by at least one virtual visit conducted before and after the expected 3- or 6-month timepoint from enrollment, whichever later timepoint is available based on the participant's timing of enrollment during the study period.

次要结局

  • acceptability(3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete)
  • appropriateness(3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes)
  • intervention fidelity(Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes)
  • Intervention reach, as measured by weekly and monthly rates of participant platform feature engagement (dashboard, messaging, queue, video portal)(From enrollment through the end of the study period, up to 12 months)
  • Intervention adoption, as measured by weekly and monthly rates of staff platform feature engagement (dashboard, messaging, queue, video portal)(From enrollment through the end of the study period, up to 12 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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