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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897788
• Other study ID #: 853153
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Maya Nelson, BS, MPH
• Phone: 267-438-7201
• Email: Maya.nelson[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1649
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Engagement in addiction treatment	Engagement in any addiction treatment at 14 days of randomization.	14 days
Secondary	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
Secondary	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