MHealth Incentivized Adherence Plus Patient Navigation (MIAPP)

Patient Navigator Plus Remote mHealth Adherence Support With Incentives to Improve Linkage and Retention Among Hospitalized Patients With Opioid and Methamphetamine Use Who Initiate Buprenorphine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Medication Adherence; Methamphetamine-dependence; Opioid Use Disorder; Polysubstance Drug Use (Indiscriminate Drug Use)
• Intervention / Treatment: Behavioral: Patient Navigation and mHealth (PN+mHealth)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment-as-usual (TAU); TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.
Experimental: PN+mHealth; The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.	Behavioral: Patient 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder	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.	30 days post-discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention on Medication for Opioid Use Disorder	This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).	90 days post-discharge from hospital
Hospital Readmission	The number of hospital admissions will be extracted from statewide Medicaid claims data.	90 days post-discharge from hospital
Emergency Department Visits	The number of emergency department visits will be extracted from statewide Medicaid claims data.	90 days post-discharge from hospital
Past 30-day Opioid Use	The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.	30 days post-discharge
Past 30-day Methamphetamine Use	The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.	30 days post-discharge

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Judith I Tsui, MD, MPH, University of Washington

Publications and helpful links

General Publications

• Bhatraju EP, Kennedy DN, Gojic AJ, Iles-Shih M, Merrill JO, Samet JH, Hallgren KA, Tsui JI. mHealth Incentivized Adherence Plus Patient Navigation (MIAPP): protocol for a pilot randomized controlled trial to improve linkage and retention on buprenorphine for hospitalized patients with methamphetamine use and opioid use disorder. Addict Sci Clin Pract. 2025 Jan 29;20(1):6. doi: 10.1186/s13722-025-00538-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): April 14, 2025
• Study Completion (Estimated): September 22, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Opioid-Related Disorders; Medication Adherence; Health Services Administration; Delivery of Health Care; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Telemedicine; Patient Navigation
• Other Study ID Numbers: STUDY00016329; 1R34DA057609-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No