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OpenTrials
Completed

NCT Number: NCT04911426

Telehealth-Clinical Advocacy Project

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lake County Public Health Department

Waukegan, Illinois, 60085, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percent of Participants Who Received One or More Referrals During the 12-week Intervention.

    Time frame: 12-week intervention period

    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.

  2. Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12

    Time frame: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.

    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.

Sponsors and collaborators

Lead sponsor

Texas Christian University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: (T-CAP)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2021
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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