Clinical trial NCT04911426: Telehealth-Clinical Advocacy Project
Official title: Telehealth-Clinical Advocacy Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Opioids
Telehealth
Police diversion program
Lead sponsor: Texas Christian University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The two-arm randomization has been discontinued with new consented participants joining the study in 2023.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants Who Received One or More Referrals During the 12-week Intervention.
timeFrame: 12-week intervention period
measure: Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12
timeFrame: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Lake County Public Health Department
state: Illinois
Study officials:
affiliation: Texas Christian University
name: Jennifer Pankow, PhD
role: PRINCIPAL_INVESTIGATOR
References: