NCT05897788

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,808

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Mar 2024Nov 2026

First Submitted

Initial submission to the registry

May 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

May 23, 2023

Last Update Submit

August 7, 2025

Conditions

Opioid Use DisorderOpioid Dependence With Current Use (Disorder)

Keywords

Opioid use disorderContingency Managementtext-based interventions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • ED and Hospital Utilization and mortality

    6 months

  • Engagement in addition treatment within 14 days

    15 days

Other Outcomes (1)

  • Comparative analysis across groups

    30 days

Study Arms (4)

Augmented Usual Care (AUC)

NO INTERVENTION

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.

Augmented usual care + text-message check-ins

ACTIVE COMPARATOR

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

Augmented Usual care + Contingency Management (CM)

ACTIVE COMPARATOR

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

Augmented usual care + text-message check-ins + contingency management

ACTIVE COMPARATOR

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-insBehavioral: Contingency Management

Interventions

Text Message Check-insBEHAVIORAL

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 + text-message check-insAugmented usual care + text-message check-ins + contingency management
Contingency ManagementBEHAVIORAL

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 + Contingency Management (CM)Augmented usual care + text-message check-ins + contingency management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not being up to date with requirements above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kit Delgado, MD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arielle Berk

CONTACT

609-248-0229arielle.berk@pennmedicine.upenn.edu

Hannah Dart, MS

CONTACT

hannah.dart@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine and Epidemiology

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 9, 2023

Study Start

March 20, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

US(1)