Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder

The primary Goal of the Phase II project is to compare participant retention in buprenorphine treatment for opioid use disorder (OUD) at 48 weeks for participants enrolled in Boulder Care (n=l00) to participants enrolled in treatment-as-usual (TAU) from OHSU (Oregon Health & Science University) clinics (n=100).

Retention in treatment will be assessed through the Electronic Medical Record for each patient and whether there is an active buprenorphine prescription for the patient at 48 weeks of care. Because of the protocols for each clinic, such a prescription will indicate that treatment is active for a given participant.

This is the most direct way to assess ongoing buprenorphine treatment as Oregon law prohibits use of its Prescription Drug Monitoring Program for research.

Participant satisfaction with telehealth comparing Boulder Care's fully digital integrated platform to OHSU's TAU approach which uses in-person treatment as well as ad-hoc telehealth due to the COVID-19 pandemic.

Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.

Patient satisfaction with treatment is assessed via a single-item: "How satisfied are you with your buprenorphine treatment?" with 5-point Likert scale (very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, very satisfied) adapted from treatment satisfaction measures used in the National Drug Abuse Treatment Clinical Trials Network studies.

Changes in cravings, health perception, and health care utilization.

Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.

Degree of craving will be assessed with the 17-item Brief Addiction Monitor (BAM) and the 4-item Treatment Effectiveness Assessment (TEA). Health perception will be assessed with the CDC's health-related quality of life (HRQoL) instrument. Health care utilization will be assessed from the medical record and patient report.

Changes in risk factors for substance use and for protective factors that support recovery.

Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.

The 17-item Brief Addiction Monitor (BAM) and the 4-item Treatment Effectiveness Assessment (TEA) will be used to evaluate these risk and protective factors.

Changes in demographics i.e., employment, education, housing, etc.

Assessment at baseline and weeks 4, 12, 24, 36 and 48 after enrollment in the study.

We assess functional outcome measures using the 17-item Brief Addiction Monitor (BAM), and the 4-item Treatment Effectiveness Assessment (TEA). These instruments incorporate patient-centered functional measures of recovery such as relationships, employment, spiritual comfort, and achievement of self-identified treatment goals in addition to assessments of drug use.

A second goal is to compare study participants from Boulder care to OHSU TAU participants for opioid use at baseline, 4, 12, 24, 36, and 48 weeks post study enrollment.

Self-reported use of any opioids (heroin, fentanyl, other non-prescribed opioids), will be derived from Addiction Severity Index-Lite (ASI-Lite) drug use questions and adapted to assess the number of days of use in the past 28 days. The primary outcome measure is dichotomized as ≥1 day of use versus no days of use at 48 weeks.