Virtual MOUD Treatment- Virtual POC Toxicology

NCT05448118 | Withdrawn

• 1 other identifier: SDR 21-114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorder

Keywords

Substance Use Disorder; Opioid Use Disorder; Telemedicine; Toxicology

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention Measure

  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.

  at enrollment and between 2 and 3 months following enrollment

• Semi-Structured Interview of Toxicology Testing Process Acceptability

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

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

Secondary Outcomes (3)

• 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

Study Arms (1)

Virtual POC Toxicology Testing

EXPERIMENTAL

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

Diagnostic Test: Virtual POC Toxicology Test

Interventions

Virtual POC Toxicology Test DIAGNOSTIC_TEST

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

Virtual POC Toxicology Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

West Haven, Connecticut, 06516-2770, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Eric Hermes, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 7, 2022
• Study Start: September 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)