Medication Adherence, Methamphetamine-dependence, Opioid Use Disorder, Polysubstance Drug Use (Indiscriminate Drug Use)
Conditions
Brief summary
Polysubstance use involving opioids and methamphetamine is emerging as a new public health crisis. Patients with opioids and methamphetamine use often experience serious medical complications requiring hospitalization, which provides an opportunity to offer addiction treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and methamphetamine exacerbates outcomes. The investigators propose to pilot test "MHealth Incentivized Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in the hospital. The investigators Aim is to perform a two-arm, pilot randomized clinical trial (n=40) comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on medications (secondary) among hospitalized patients with OUD and methamphetamine use.
Interventions
BEHAVIORALPatient Navigation and mHealth (PN+mHealth)
Intervention consists of patient navigation with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone.
Sponsors
University of Washington
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Participants will be randomized to treatment group. Group assignment will occur through computerized (REDCap) randomization procedures. The investigators will stratify randomization by whether the patient has buprenorphine treatment in the past year. Randomization lists will be prepared within each stratum using random block sizes of 4 to ensure balanced groups throughout the enrollment period. Participants will be informed of their assignment by research staff after completion of informed consent and the baseline survey.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult greater than or equal to 18 years of age * Admitted to Harborview Medical Center (HMC) on any inpatient service * Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient * Used methamphetamine within the past 30 days (any route of administration or frequency) * Willing to be randomized to video-DOT * Willing and able to use a smartphone (study can provide) and work with patient navigator * Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.)
Exclusion criteria
* Unable or unwilling to use smartphone (phones to be provided when needed) * Cognitive impairment (acute or chronic) resulting in inability to provide informed consent * Currently incarcerated and will discharge to jail or prison * Plans to discontinue buprenorphine in the near future (\<3 months) * Lives far away such that cannot keep study visit at 30 days post-discharge * Not English speaking * Behavioral risk per discretion of research staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder | 30 days post-discharge from hospital | Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention on Medication for Opioid Use Disorder | 90 days post-discharge from hospital | This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone). |
| Hospital Readmission | 90 days post-discharge from hospital | The number of hospital admissions will be extracted from statewide Medicaid claims data. |
| Emergency Department Visits | 90 days post-discharge from hospital | The number of emergency department visits will be extracted from statewide Medicaid claims data. |
| Past 30-day Opioid Use | 30 days post-discharge | The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index. |
| Past 30-day Methamphetamine Use | 30 days post-discharge | The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJudith I Tsui, MD, MPH
University of Washington
Participant flow
Recruitment details
This study enrolled 40 participants between January 3, 2024, and January 7, 2025. The study took place at a single, large urban safety net hospital in Seattle, Washington, which serves as a level 1 trauma hospital.
Pre-assignment details
After enrollment, participants completed a baseline assessment on demographics and substance use patterns which occurred in-person while the patient was hospitalized, after which they were randomized using a RedCap randomization module.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.7 Years STANDARD_DEVIATION 13.2 |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic American Indian/Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black/African American | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 25 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 5 / 20 | 3 / 20 |
| serious Total, serious adverse events | 11 / 20 | 3 / 20 |
Outcome results
None listed