Clinical trial NCT05448118: Virtual MOUD Treatment- Virtual POC Toxicology
Official title: Virtual MOUD Treatment: Virtual Point-of-Care Toxicology Testing to Accompany Virtual Medication Assisted Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use Disorder
Keywords: Substance Use Disorder
Opioid Use Disorder
Telemedicine
Toxicology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: at enrollment and between 2 and 3 months following enrollment
measure: Semi-Structured Interview of Toxicology Testing Process Acceptability
timeFrame: Through study completion or 3-months post enrollment, whatever comes first
Secondary outcomes:
measure: The Substance Abuse Perceived Stigma Scale
timeFrame: at enrollment and between 2 and 3 months following enrollment
measure: Helping Alliance questionnaire
timeFrame: at enrollment and between 2 and 3 months following enrollment
measure: Health service use
timeFrame: 6 months following enrollment
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Eric Hermes, MD
role: PRINCIPAL_INVESTIGATOR
References: