MHealth Incentivized Adherence Plus Patient Navigation

Medication Adherence Clinical Trial

— MIAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027814
• Other study ID #: STUDY00016329
• Secondary ID: 1R34DA057609-01
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: September 22, 2025

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: Research Study Coordinator
• Phone: 206-744-1838
• Email: miappstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 22, 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Methamphetamine-dependence
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hospital readmission	The number of hospital admissions will be extracted from statewide Medicaid claims data.	90 days post-discharge from hospital
Secondary	Emergency department visits	The number of emergency department visits will be extracted from statewide Medicaid claims data.	90 days post-discharge from hospital
Secondary	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
Secondary	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