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Virtual MOUD Treatment- Virtual POC Toxicology

NCT ID: NCT05448118

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance Use Disorder

Keywords

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Substance Use Disorder Opioid Use Disorder Telemedicine Toxicology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A virtual point-of-care toxicology testing process will be evaluated in a single arm pilot trial among providers and patients at VACT and VACWM. Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined by evaluating virtual toxicology testing utilization, as well as the frequency of toxicology testing and of addiction treatment contacts.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Virtual POC Toxicology Testing

Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.

Group Type EXPERIMENTAL

Virtual POC Toxicology Test

Intervention Type DIAGNOSTIC_TEST

Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.

Interventions

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Virtual POC Toxicology Test

Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

* Veterans must not be receiving inpatient or day-program treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Hermes, MD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

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VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SDR 21-114

Identifier Type: -

Identifier Source: org_study_id