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Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement

Primary Purpose

Opioid Use Disorder, Opioid Dependence With Current Use (Disorder)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Text Message Check-ins
Contingency Management
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder focused on measuring Opioid use disorder, Contingency Management, text-based interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants must be 18 or older Have a diagnosis code for Opioid Use Disorder (OUD) or screen positive for OUD Discharged with Buprenorphine prescription (RX) English reading ability Have a mobile phone capable of receiving text messages Exclusion Criteria: Not being up to date with requirements above

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Augmented Usual Care (AUC)

    Augmented usual care + text-message check-ins

    Augmented Usual care + Contingency Management (CM)

    Augmented usual care + text-message check-ins + contingency management

    Arm Description

    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment.

    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment.

    Outcomes

    Primary Outcome Measures

    Engagement in addiction treatment
    Engagement in any addiction treatment at 14 days of randomization.

    Secondary Outcome Measures

    Patient reported outcomes
    The investigators will measure Substance Use Recovery Evaluator (SURE) and Brief Addiction Monitor (BAM) at intake and all follow-up assessments providing data on substance use, self-care, relationships, material resources, and outlook on life. The investigators will also measure treatment appropriateness and acceptability 15 days using validated measures.
    ED and Hospital Utilization and mortality
    Subsequent ED and hospital utilization and mortality. The investigators have developed standardized data queries to capture all ED visits, hospitalizations, and mortality out to 6 months from enrollment. To capture encounters outside study health systems, the study team will obtain linked records from the regional health information exchanges (HIEs) - HealthShare Exchange for Penn and Cooper, Care Everywhere for Alameda). Will subsequently link the patient data to the National Death Index to capture of out-of-hospital mortality not captured in Electronic Health Records (EHRs) or HIEs.

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    October 23, 2023
    Sponsor
    University of Pennsylvania
    Collaborators
    Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05897788
    Brief Title
    Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
    Official Title
    Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    July 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    Patient-Centered Outcomes Research Institute

    4. Oversight

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

    5. Study Description

    Brief Summary
    There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the Emergency Department (ED). Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment post-discharge. The investigators propose to adapt evidence-based interventions to support patients' complex needs and facilitate continued treatment, rather than discharging them and having them navigate outpatient treatment systems with limited support. The research team will randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily check-ins and contingency management. The investigators plan to examine the effects of check-ins and contingency management on engagement with addiction treatment and equity of treatment effects among racial and ethnic subgroups and assess important moderators of treatment effects.
    Detailed Description
    The investigators are proposing to conduct a randomized controlled trial to determine the effectiveness of various text-based and contingency management interventions on Opioid Use Disorder patients. Our goals are to measure their engagement with recovery treatment. The research team plan to enroll 1,649 participants into one of the following 4 arms. Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to: Augmented usual care (standard Way to HealthCareConnect text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Augmented usual care + text-message check-ins (standard Way to Health CareConnect Text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything. Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments. Augmented usual care + CM + Text-message check-ins (standard Way to Health CareConnect text line) AND text-message check-ins-patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND, participants will receive compensation for attending their follow-up appointments. Patients enrolled in the trial will also be invited to complete the intake survey and follow-up surveys. Patients will receive financial compensation for completing these surveys. The study team plans to enroll 1,649 participants for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder, Opioid Dependence With Current Use (Disorder)
    Keywords
    Opioid use disorder, Contingency Management, text-based interventions

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to: Augmented usual care, standard Way to Health CareConnect text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Augmented usual care + text-message check-ins, standard Way to Health CareConnect Text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything. Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1649 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Augmented Usual Care (AUC)
    Arm Type
    No Intervention
    Arm Description
    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.
    Arm Title
    Augmented usual care + text-message check-ins
    Arm Type
    Active Comparator
    Arm Description
    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.
    Arm Title
    Augmented Usual care + Contingency Management (CM)
    Arm Type
    Active Comparator
    Arm Description
    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment.
    Arm Title
    Augmented usual care + text-message check-ins + contingency management
    Arm Type
    Active Comparator
    Arm Description
    AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Text Message Check-ins
    Intervention Description
    Patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Contingency Management
    Intervention Description
    Patients will receive incentives for engagement with treatment. Participant will receive compensation for filling their buprenorphine scripts at discharge and attending their follow-up care appointments.
    Primary Outcome Measure Information:
    Title
    Engagement in addiction treatment
    Description
    Engagement in any addiction treatment at 14 days of randomization.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Patient reported outcomes
    Description
    The investigators will measure Substance Use Recovery Evaluator (SURE) and Brief Addiction Monitor (BAM) at intake and all follow-up assessments providing data on substance use, self-care, relationships, material resources, and outlook on life. The investigators will also measure treatment appropriateness and acceptability 15 days using validated measures.
    Time Frame
    30 days
    Title
    ED and Hospital Utilization and mortality
    Description
    Subsequent ED and hospital utilization and mortality. The investigators have developed standardized data queries to capture all ED visits, hospitalizations, and mortality out to 6 months from enrollment. To capture encounters outside study health systems, the study team will obtain linked records from the regional health information exchanges (HIEs) - HealthShare Exchange for Penn and Cooper, Care Everywhere for Alameda). Will subsequently link the patient data to the National Death Index to capture of out-of-hospital mortality not captured in Electronic Health Records (EHRs) or HIEs.
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Comparative analysis across groups
    Description
    For the exploratory outcomes at 30-days post-randomization, the investigators will use similar logistic regression models to compare the groups on enrollment and receipt of treatment, and on Urine Drug Screens (UDS) for illicit opioids. For ED visits and hospitalizations, the investigators will use zero-inflated negative binomial regression models if there is sufficient variability in these responses, and logistic regression models (for dichotomized versions of these responses) otherwise.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants must be 18 or older Have a diagnosis code for Opioid Use Disorder (OUD) or screen positive for OUD Discharged with Buprenorphine prescription (RX) English reading ability Have a mobile phone capable of receiving text messages Exclusion Criteria: Not being up to date with requirements above
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maya Nelson, BS, MPH
    Phone
    267-438-7201
    Email
    Maya.nelson@pennmedicine.upenn.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina Abdel-Rahman, BS
    Phone
    267-438-7201
    Email
    dina.abdel-rahman@pennmedicine.upenn.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kit Delgado, MD, MS
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement

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