Virtual MOUD Treatment- Virtual POC Toxicology

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorder
• Intervention / Treatment: Diagnostic test: Virtual POC Toxicology Test

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Massachusetts
    • Leeds, Massachusetts, United States, 01053-9764
      • VA Central Western Massachusetts Healthcare System, Leeds, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual POC Toxicology Testing; Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.	Diagnostic test: Virtual POC Toxicology Test; Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Substance Abuse Perceived Stigma Scale	The Substance Abuse Perceived Stigma Scale (SAPSS) is a 12-item questionnaire that assesses the construct of perceived stigma. Items are scored on seven point Likert-type scale where 1 = never and 7 = always with agreement indicating non-stigmatizing behavior or attitudes. The scale is scored by reverse scoring each item, summing the items, and dividing by 12, thus higher scores indicate more perceived stigma.	at enrollment and between 2 and 3 months following enrollment
Helping Alliance questionnaire	Helping Alliance questionnaire (HAq-II) is a 19-item questionnaire that measures the strength of the patient-therapist therapeutic alliance. Each item is rated on a 6-point Likert scale (1 = I strongly feel it is not true, 6 = I strongly feel it is true). Negatively worded items are reverse scored.	at enrollment and between 2 and 3 months following enrollment
Health service use	toxicology testing episodes and substance use disorder treatment contacts will be extracted from the electronic medical record. Toxicology testing episodes will be measured as a proportion of SUD treatment encounters over a 6 month period following enrollment and Substance use disorder treatment contacts will be summed over a 6 month period following enrollment.	6 months following enrollment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Eric Hermes, MD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Opioid Use Disorder; Substance Use Disorder; Toxicology
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: SDR 21-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No