MHealth Incentivized Adherence Plus Patient Navigation
United States40 participantsStarted 2024-01-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder