跳至主要内容
临床试验/NCT05448118
NCT05448118撤回不适用

Virtual MOUD Treatment: Virtual Point-of-Care Toxicology Testing to Accompany Virtual Medication Assisted Treatment for Opioid Use Disorder

VA Office of Research and Development4 个研究点 分布在 1 个国家开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Acceptability of Intervention Measure

研究概览

简要总结

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of SUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. This research will develop a Virtual Point-of-Care Toxicology Testing Process for VA. This Pilot Trial will evaluate the feasibility, acceptability, and proximal effects of the process by evaluating provider and patient testing uptake, qualitative feedback, and health service use.

详细描述

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of MOUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. The objectives of this pilot project are to develop, feasibility test, and describe the proximal outcomes of a Virtual Point-of-Care Toxicology Testing Process for VA patients in MOUD care.

The process will be evaluated in a pilot trial among providers and patients at VA Connecticut (VACT) and VA Central Western Massachusetts (VACWM). Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined using a priori benchmarks of utilization. These findings will be used to inform modifications of virtual toxicology testing procedures.

Mixed-methods will be used to develop and evaluate the testing process, which will use an oral-fluid test for common drugs of abuse. The test is FDA approved for at home patient use. Patients will self-administer the test during virtual SUD visits and assess results with providers. In the pilot trial, a single-arm mixed-methods pilot trial will evaluate the process among patients and providers at two VA facilities. Feasibility will be evaluated by examining process uptake. Acceptability will be evaluated through semi-structured interviews with patients and providers based on Consolidated Framework for Implementation Research (CFIR) constructs. Health service use will be evaluated by analyzing data on patient characteristics, test utilization, and treatment contacts extracted from the electronic medical record.

研究设计

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

  • To participate VA patients must
  • be recruited by their provider through a discussion about the project
  • be interested in participating after the discussion
  • have used VA video-based care at least once
  • receive buprenorphine from a VACT or VAWCM provider (50% will have started buprenorphine within the last 3 months)
  • have the ability to receive mail from the VA for the purposes of receiving oral fluid test kits)

排除标准

  • Veterans must not be receiving inpatient or day-program treatment

结局指标

主要结局

Acceptability of Intervention Measure

时间窗: at enrollment and between 2 and 3 months following enrollment

The Acceptability of intervention measure is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.

Semi-Structured Interview of Toxicology Testing Process Acceptability

时间窗: Through study completion or 3-months post enrollment, whatever comes first

Semi-Structured interview of toxicology testing Process Acceptability based on the Consolidated Framework for Implementation Research, transcribed and analyzed qualitatively for key themes.

次要结局

  • The Substance Abuse Perceived Stigma Scale(at enrollment and between 2 and 3 months following enrollment)
  • Helping Alliance questionnaire(at enrollment and between 2 and 3 months following enrollment)
  • Health service use(6 months following enrollment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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