Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
Study Details
Study Description
Brief Summary
There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the ED. Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment post-discharge. We 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. We will randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily check-ins and contingency management. We 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
We 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. We 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. We plan to enroll 1,649 participants for this study.
Study Design
Arms and Interventions
| 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. |
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Primary outcome [14 days]
Engagement in any addiction treatment at 14 days of randomization.
Secondary Outcome Measures
- Patient reported outcomes [30 days]
We will measure SURE and BAM at intake and all follow-up assessments providing data on substance use, self-care, relationships, material resources, and outlook on life. We will also measure treatment appropriateness and acceptability 15 days using validated measures.
- ED and Hospital Utilization and mortality [6 months]
Subsequent ED and hospital utilization and mortality. We 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, as we have done previously, we 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 EHRs or HIEs.
Other Outcome Measures
- Exploratory [30 days]
For the exploratory outcomes at 30-days post-randomization, we will use similar logistic regression models to compare the groups on enrollment and receipt of treatment, and on UDS for illicit opioids. For ED visits and hospitalizations, we 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.
Eligibility Criteria
Criteria
Inclusion Criteria: To be considered eligible, participants must be 18 or older, have a diagnosis code for OUD or screen positive for OUD, Discharged with Buprenorphine RX , English reading ability, Have a mobile phone capable of receiving text messages
Exclusion Criteria:
- Not being up to date with requirements above
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Pennsylvania
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Kit Delgado, MD, MS, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 853153