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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Text Message Check-ins
* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Augmented Usual Care (AUC)<br>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. | |
| Active Comparator: Augmented usual care + text-message check-ins<br>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. | Behavioral: Text Message Check-ins<br>* 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.<br>|
| Active Comparator: Augmented Usual care + Contingency Management (CM)<br>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. | Behavioral: Contingency Management<br>* 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.<br>|
| Active Comparator: Augmented usual care + text-message check-ins + contingency management<br>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. | Behavioral: Text Message Check-ins<br>* 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.<br>Behavioral: Contingency Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in addiction treatment | Engagement in any addiction treatment at 14 days of randomization. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid use disorder, Contingency Management, text-based interventions