Telehealth-Clinical Advocacy Project

Substance Use Clinical Trial

— (T-CAP)  

Official title:

Telehealth-Clinical Advocacy Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911426
• Other study ID #: 5R21DA048232-02
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2023
• Source: Texas Christian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

Description:

Participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. The study design has been modified to provide the enhanced condition with coaching and the T-CAP app to all individuals consented to the study beginning January 1, 2023.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Individuals interested in joining the study will be

• Enrolled in the A Way Out Opioid Diversion Program (ODP),

• At least 18 years of age,

• Able to speak and understand English,

• Have a history of opioid, alcohol, or other substance use within last 12 months,

• Be willing to provide the research team with access to treatment records,

• Have access to a phone, tablet or computer for the informed consent activity, and

• Have a mailing address to receive a study phone issued to consented participants

Exclusion Criteria:

Individuals not eligible for the study are

• Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent,

• Under the age of 18 on the day of consent,

• Unable to speak and understand English,

• Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months,

• Unwilling to authorize the research team to access treatment records,

• Without access to a phone, tablet or computer to complete the informed consent activity,

• Without a mailing address

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Telehealth
The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.

Locations

Country	Name	City	State
United States	Lake County Public Health Department	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assertive Referrals Data	Assertive referrals data will provide evidence supporting participant utilization of the app and the coaching support model. Coach will report service type and provider name via on-line survey for every scheduled and unscheduled telehealth video session.	during the 12-week intervention.
Primary	Treatment Initiation Data	Researchers will obtain scheduled treatment dates and treatment initiation dates for opioid use disorder (OUD) treatment to create a dichotomized (yes/no) treatment initiation from agency records to evaluate the differences between study arms on the proportions of missed initial appointments.	These data will be collected for analysis at the end of the 12-week intervention.
Primary	Drug Use Severity	The Texas Christian University Drug Screen 5 (TCUDS 5) is a 19-question survey that gauges substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score corresponds with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and is based on a single disorder measured on the following continuum from mild to severe: mild disorder (presence of 2-3 symptoms); moderate disorder (presence of 4-5 symptoms); and severe disorder: (presence of 6 or more symptoms).	TCUDS 5 data are collected for analysis at the end of the 12-week intervention.
Primary	Urinalysis Test Data	Researchers will obtain urinalysis results from treatment providers agency records to compare the proportion of positive drug test results for opioid use between the two groups. The results will be dichotomized into yes for a positive test and no for a negative test.	These data will be collected for analysis at the end of the 12-week intervention.
Primary	Treatment Retention Data	Researchers will obtain agency records of appointment attendance dates during the 3-month post enrollment period and combining attendance frequency into a single 3-month measure of retention, with the dichotomized variable defined yes as having attended at least 2 scheduled appointments subsequent to the initial appointment.	These data will be collected for analysis at the end of the 12-week intervention.
Secondary	Texas Christian University (TCU) Client Evaluation of Self and Treatment (CEST) Scales	Participant responses on the TCU Client Evaluation of Self and Treatment (CEST) forms provide measures of motivation for treatment and psychosocial functioning to examine differences between study arms. CEST Scales are based on a 5-point Likert response set with higher scores reflecting a worse outcome.	CEST data is collected for analysis at the end of 12-week intervention.
Secondary	Frequency of Opioid Overdose	The Texas Christian University (TCU) Opioid Supplement is a 17 question survey that measures multiple types of opioids and self-reported use during the past 30 days and in the past 12 months. Self-reported frequency of overdose history in the past 12 months will evaluate the differences in the proportion of overdoses between study arms.	TCU Opioid Supplement data are collected for analysis at the end of the 12-week intervention.