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

Primary Purpose

Substance Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telehealth
Sponsored by
Texas Christian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use focused on measuring Opioids, Telehealth, Police diversion program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Treatment as usual

    Treatment plus telehealth

    Arm Description

    Individuals in the treatment as usual condition will participate in substance use treatment as part of the standard police opioid diversion program model.

    Individuals in the treatment plus telehealth condition 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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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).
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    April 5, 2021
    Last Updated
    May 27, 2021
    Sponsor
    Texas Christian University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04911426
    Brief Title
    Telehealth-Clinical Advocacy Project
    Acronym
    (T-CAP)
    Official Title
    Telehealth-Clinical Advocacy Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 21, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Christian University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use
    Keywords
    Opioids, Telehealth, Police diversion program

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Individuals in the treatment as usual condition will participate in substance use treatment as part of the standard police opioid diversion program model.
    Arm Title
    Treatment plus telehealth
    Arm Type
    Experimental
    Arm Description
    Individuals in the treatment plus telehealth condition 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telehealth
    Intervention Description
    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 Outcome Measure Information:
    Title
    Assertive Referrals Data
    Description
    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.
    Time Frame
    during the 12-week intervention.
    Title
    Treatment Initiation Data
    Description
    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.
    Time Frame
    These data will be collected for analysis at the end of the 12-week intervention.
    Title
    Drug Use Severity
    Description
    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).
    Time Frame
    TCUDS 5 data are collected for analysis at the end of the 12-week intervention.
    Title
    Urinalysis Test Data
    Description
    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.
    Time Frame
    These data will be collected for analysis at the end of the 12-week intervention.
    Title
    Treatment Retention Data
    Description
    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.
    Time Frame
    These data will be collected for analysis at the end of the 12-week intervention.
    Secondary Outcome Measure Information:
    Title
    Texas Christian University (TCU) Client Evaluation of Self and Treatment (CEST) Scales
    Description
    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.
    Time Frame
    CEST data is collected for analysis at the end of 12-week intervention.
    Title
    Frequency of Opioid Overdose
    Description
    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.
    Time Frame
    TCU Opioid Supplement data are collected for analysis at the end of the 12-week intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Pankow, PhD
    Phone
    817-257-7226
    Ext
    6475
    Email
    j.pankow@tcu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kevin Knight, PhD
    Phone
    817-257-6475
    Ext
    6472
    Email
    k.knight@tcu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Pankow, PhD
    Organizational Affiliation
    Texas Christian University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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