Telehealth-Clinical Advocacy Project ((T-CAP))

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Telehealth

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Lake County Public Health Department

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: Treatment plus telehealth; Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants Who Received One or More Referrals During the 12-week Intervention.	The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model.	12-week intervention period
Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12	The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem.	Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Texas Christian University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer Pankow, PhD, Texas Christian University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Telehealth; Opioids; Police diversion program
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 5R21DA048232-02 (U.S. NIH Grant/Contract)

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