Clinical trial NCT05897788: 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
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Opioid Dependence with Current Use (Disorder)
Keywords: Opioid use disorder
Contingency Management
text-based interventions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-06-09
Enrollment: 1649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Engagement in any addiction treatment at 30 days of randomization
timeFrame: 31 days
Secondary outcomes:
measure: ED and Hospital Utilization and mortality
timeFrame: 6 months
measure: Engagement in addition treatment within 14 days
timeFrame: 15 days
Other outcomes:
measure: Comparative analysis across groups
timeFrame: 30 days
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kit Delgado, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: