MHealth Incentivized Adherence Plus Patient Navigation

NCT06027814 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000163291R34DA057609-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine-dependence; Medication Adherence; Opioid Use Disorder; Polysubstance Drug Use (Indiscriminate Drug Use)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Retention on medication for opioid use disorder

  90 days post-discharge from hospital

• Hospital readmission

  90 days post-discharge from hospital

• Emergency department visits

  90 days post-discharge from hospital

• Past 30-day opioid use

  30 days post-discharge

• Past 30-day methamphetamine use

  30 days post-discharge

Study Arms (2)

Treatment-as-usual (TAU)

NO INTERVENTION

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.

PN+mHealth

EXPERIMENTAL

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)

Interventions

Patient Navigation and mHealth (PN+mHealth) BEHAVIORAL

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.

PN+mHealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 39881397 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Medication Adherence

Interventions

Patient Navigation; Telemedicine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Delivery of Health Care

Study Officials

• Judith I Tsui, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine, General Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: January 3, 2024
• Primary Completion: April 14, 2025
• Study Completion (Estimated): September 22, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)