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

NCT ID: NCT05897788

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1808 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2026-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Text Message Check-ins

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Contingency Management

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Text Message Check-ins

Intervention Type: BEHAVIORAL

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.

Contingency Management

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

M. Kit Delgado, MD

Assistant Professor of Emergency Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kit Delgado, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Arielle Berk

Role: CONTACT

arielle.berk@pennmedicine.upenn.edu

609-248-0229

Hannah Dart, MS

Role: CONTACT

hannah.dart@pennmedicine.upenn.edu

Facility Contacts

M. Kit Delgado, MD, MS

Role: primary

Mucio.Delgado@pennmedicine.upenn.edu

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

853153

Identifier Type: -

Identifier Source: org_study_id