Measurement-Based Care to Support Buprenorphine-Naloxone Treatment in Outpatient Addiction Clinics

NCT07839182 | Not Yet Recruiting

• 1 other identifier: K08HS029695
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

People receiving buprenorphine-naloxone (bup-nx) for opioid use disorder often face changes in cravings, withdrawal, and return to use risk between clinic visits, but their care team may not know about these changes until the person misses an appointment or returns to drug use. Measurement-based care (MBC) uses brief, repeated check-ins from patients to make these between-visit changes visible. This study tests "Bup-MBC," a strategy that sends patients short questionnaires through their patient portal or by text before and between visits, gives them immediate supportive feedback, shares summary information with their prescriber in the electronic health record, and offers an option to request earlier contact if concerns arise. The study will include providers and patients at outpatient addiction clinics at Vanderbilt University Medical Center, randomly assigned to either receive Bup-MBC or usual care, and followed for 6 months. The main goal is to determine whether Bup-MBC can be practically delivered in routine addiction clinics and whether patients and providers use it.

Conditions

Opioid Use Disorder

Keywords

patient-reported outcome measures; implementation science; measurement-based care

Outcome Measures

Primary Outcomes (1)

• Reach

  Proportion of eligible patients randomized to Bup-MBC who complete ≥1 questionnaire; monthly completion rates with 95% confidence intervals

  From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter

Study Arms (2)

Bup-MBC

EXPERIMENTAL

Patients seen by a provider randomized to Bup-MBC receive automated between-visit PROMs via patient portal or secure text, immediate tailored non-punitive feedback after completion, eligibility for clinician-facing EHR summaries with non-directive prompts, and an opt-in option to request earlier contact between visits, with predefined safety overrides for critical disclosures.

Behavioral: Bup-MBC

Usual care

NO INTERVENTION

Patients seen by a provider randomized to usual care continue to receive standard buprenorphine-naloxone treatment and routine clinic services without PROM invitations or Bup-MBC components.

Interventions

Bup-MBC BEHAVIORAL

Electronic health record-embedded implementation strategy comprising four components: (1) brief repeated PROMs delivered via patient portal or secure text (domains: withdrawal, craving, bup-nx adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, recovery community connection); (2) automated non-punitive tailored patient feedback following each PROM; (3) longitudinal EHR-embedded clinician-facing summaries with non-directive clinical decision support prompts; (4) opt-in between-visit outreach pathway with predefined safety triggers for urgent follow-up. PROM frequency is adapted to treatment phase and clinical stability.

Bup-MBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥18)
• Active bup-nx prescription under a participating prescriber at one of the VUMC addiction clinics
• Enrolled in and active in the respective clinic
• Activated patient portal account

You may not qualify if:

• Patients who are incarcerated or under correctional custody such that research procedures cannot be conducted.
• Patients unable to provide informed consent because of severe cognitive impairment or acute intoxication at the time of approach, as judged by the treating clinician.
• Patients whose clinicians judge that participation would pose undue risk or burden (e.g., acute psychiatric crisis where additional questionnaires would be inappropriate).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Thomas Reese, PharmD, PhD

CONTACT

6153228682; thomas.reese@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible patients with an active bup-nx prescription under a participating prescriber are individually randomized 1:1 to receive Bup-MBC or usual care, stratified by prescriber. Clinicians are unblinded after assignment and may care for patients in both arms; Bup-MBC summaries and outreach options are available only for patients randomized to the intervention arm.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)