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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Bup-MBCExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reach

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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