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Virtual MOUD Treatment- Virtual POC Toxicology

Primary Purpose

Substance Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual POC Toxicology Test
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorder focused on measuring Substance Use Disorder, Opioid Use Disorder, Telemedicine, Toxicology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting
  • VA Central Western Massachusetts Healthcare System, Leeds, MA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual POC Toxicology Testing

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 24, 2022
Last Updated
March 7, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05448118
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
Substance Use Disorder, Opioid Use Disorder, Telemedicine, Toxicology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual POC Toxicology Testing
Arm Type
Experimental
Arm Description
Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.
Intervention Type
Diagnostic Test
Intervention Name(s)
Virtual POC Toxicology Test
Intervention Description
Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.
Primary Outcome Measure Information:
Title
Acceptability of Intervention Measure
Description
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.
Time Frame
at enrollment and between 2 and 3 months following enrollment
Title
Semi-Structured Interview of Toxicology Testing Process Acceptability
Description
Semi-Structured interview of toxicology testing Process Acceptability based on the Consolidated Framework for Implementation Research, transcribed and analyzed qualitatively for key themes.
Time Frame
Through study completion or 3-months post enrollment, whatever comes first
Secondary Outcome Measure Information:
Title
The Substance Abuse Perceived Stigma Scale
Description
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.
Time Frame
at enrollment and between 2 and 3 months following enrollment
Title
Helping Alliance questionnaire
Description
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.
Time Frame
at enrollment and between 2 and 3 months following enrollment
Title
Health service use
Description
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.
Time Frame
6 months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Hermes, MD
Phone
(203) 932-5711
Email
Eric.Hermes@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly A Minnix
Phone
(203) 932-5711
Ext
2575
Email
Kimberly.Minnix@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hermes, MD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Hermes, MD
Phone
203-932-5711
Email
Eric.Hermes@va.gov
First Name & Middle Initial & Last Name & Degree
Eric Hermes, MD
Facility Name
VA Central Western Massachusetts Healthcare System, Leeds, MA
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053-9764
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorrie J Walker, MA BA
Phone
413-584-4040
Ext
6532
Email
Lorrie.Walker@va.gov
First Name & Middle Initial & Last Name & Degree
Henry E Rivera
Phone
(413) 584-4040
Ext
2143
Email
Henry.Rivera3@va.gov
First Name & Middle Initial & Last Name & Degree
Henry E Rivera

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual MOUD Treatment- Virtual POC Toxicology

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