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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA057609-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith I Tsui, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39881397 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 days post-discharge from hospital |
|
From enrollment until end of follow-up assessment, up to 120 days post-discharge
For this study, Adverse Events (AE) were defined as: Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department Admissions | General disorders | Non-systematic Assessment |
This was a pilot study, therefore, was not powered to detect statistically significant differences. The main goal of this study was to provide evidence of feasibility and acceptability of the MIAPP intervention and research procedures, as assessed by our ability to fully recruit the planned sample and deliver the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith I. Tsui | University of Washington | 206-744-1835 | tsuij@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2024 | Apr 9, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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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.
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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 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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. |
|
|
| Secondary | Retention on Medication for Opioid Use Disorder | This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone). | Posted | Mean | Standard Deviation | Days | 90 days post-discharge from hospital |
|
|
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| Secondary | Hospital Readmission | The number of hospital admissions will be extracted from statewide Medicaid claims data. | Posted | Mean | Standard Deviation | Hospital Admission Events | 90 days post-discharge from hospital |
|
|
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| Secondary | Emergency Department Visits | The number of emergency department visits will be extracted from statewide Medicaid claims data. | Posted | Mean | Standard Deviation | Visits | 90 days post-discharge from hospital |
|
|
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| 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. | Posted | Mean | Standard Deviation | Days | 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. | Posted | Mean | Standard Deviation | Days | 30 days post-discharge |
|
|
|
| 0 |
| 20 |
| 11 |
| 20 |
| 5 |
| 20 |
| EG001 | 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. 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. | 0 | 20 | 3 | 20 | 3 | 20 |
| Urgent Care Visit | General disorders | Non-systematic Assessment |
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| Outpatient Procedure | General disorders | Non-systematic Assessment |
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006298 | Health Services Administration |
| D003695 | Delivery of Health Care |