Telehealth-Clinical Advocacy Project

NCT04911426 | Completed Results

• 1 other identifier: 5R21DA048232-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use

Keywords

Opioids; Telehealth; Police diversion program

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Treatment plus telehealth

EXPERIMENTAL

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

Interventions

Telehealth BEHAVIORAL

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.

Treatment plus telehealth

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Christian University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Lake County Public Health Department

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

The T-CAP project explored the feasibility of implementing a telehealth model in a police diversion program that supports adults in recovery from opioid use disorder with treatment as an alternative to arrest. Inadequate data collection due to enrollment well below the target during the 2019 pandemic limits the ability to draw meaningful conclusions about the impact of the intervention to support people in recovery.

Results Point of Contact

• Title: Dr.Jennifer Pankow
• Organization: Texas Christian University Institute of Behavioral Research

j.pankow@tcu.edu

8172577226

Study Officials

• Jennifer Pankow, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The two-arm randomization has been discontinued with new consented participants joining the study in 2023.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: June 3, 2021
• Study Start: June 14, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)