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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Opioid Dependence With Current Use (Disorder)
• Intervention / Treatment: Behavioral: Text Message Check-ins; Behavioral: Contingency Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 1808
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arielle Berk; Phone Number: 609-248-0229; Email: arielle.berk@pennmedicine.upenn.edu
• Study Contact Backup: Name: Hannah Dart, MS; Email: hannah.dart@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: M. Kit Delgado, MD, MS; Email: Mucio.Delgado@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must be 18 or older
• Screen positive for OUD
• Bridge buprenorphine prescription (emergency department (ED) enrollment - Buprenorphine prescription at ED discharge; Bridge clinic enrollment - new buprenorphine prescription associated with on-demand or drop-in encounter
• English reading ability
• Have a mobile phone capable of receiving text messages

Exclusion Criteria:

• Not being up to date with requirements above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Augmented Usual Care (AUC); 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; 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; 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.
Active Comparator: Augmented Usual care + Contingency Management (CM); 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; 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.
Active Comparator: Augmented usual care + text-message check-ins + contingency management; 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; 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.; Behavioral: Contingency Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in any addiction treatment at 30 days of randomization	Engagement in any addiction treatment within 30 days of randomization (measured on day 31)	31 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Engagement in addition treatment within 14 days	Engagement in any addiction treatment within 14 days of randomization (measured on day 15)	15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative analysis across groups	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.	30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Kit Delgado, MD, MS, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Contingency Management; Opioid use disorder; text-based interventions
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: 853153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No