Trial Outcomes & Findings for MHealth Incentivized Adherence Plus Patient Navigation (NCT NCT06027814)
NCT ID: NCT06027814
Last Updated: 2026-05-27
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
30 days post-discharge from hospital
Results posted on
2026-05-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MHealth Incentivized Adherence Plus Patient Navigation
Baseline characteristics by cohort
| Measure |
Treatment-as-usual (TAU)
n=20 Participants
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
n=20 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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
45.7 Years
STANDARD_DEVIATION 13.2 • n=51 Participants
|
41.2 Years
STANDARD_DEVIATION 11.9 • n=14 Participants
|
43.4 Years
STANDARD_DEVIATION 12.6 • n=65 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=51 Participants
|
16 Participants
n=14 Participants
|
33 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic American Indian/Alaska Native
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black/African American
|
4 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
9 Participants
n=51 Participants
|
16 Participants
n=14 Participants
|
25 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 30 days post-discharge from hospitalDefined 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.
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=20 Participants
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
n=20 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.
|
|---|---|---|
|
Patient Linkage to an Outpatient Program That Provides Medication for Opioid Use Disorder
|
10 Participants
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11 Participants
|
SECONDARY outcome
Timeframe: 90 days post-discharge from hospitalThis will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=20 Participants
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
n=20 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.
|
|---|---|---|
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Retention on Medication for Opioid Use Disorder
|
23.9 Days
Standard Deviation 26.6
|
18.7 Days
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 90 days post-discharge from hospitalThe number of hospital admissions will be extracted from statewide Medicaid claims data.
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=20 Participants
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
n=20 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.
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|---|---|---|
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Hospital Readmission
|
0.9 Hospital Admission Events
Standard Deviation 1.3
|
0.1 Hospital Admission Events
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 90 days post-discharge from hospitalThe number of emergency department visits will be extracted from statewide Medicaid claims data.
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=20 Participants
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
n=20 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.
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|---|---|---|
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Emergency Department Visits
|
0.7 Visits
Standard Deviation 1.1
|
0.4 Visits
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 30 days post-dischargeThe number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=12 Participants
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
n=13 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.
|
|---|---|---|
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Past 30-day Opioid Use
|
3.7 Days
Standard Deviation 8.6
|
4.7 Days
Standard Deviation 7.2
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SECONDARY outcome
Timeframe: 30 days post-dischargeThe number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.
Outcome measures
| Measure |
Treatment-as-usual (TAU)
n=12 Participants
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
n=13 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.
|
|---|---|---|
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Past 30-day Methamphetamine Use
|
5.8 Days
Standard Deviation 11.4
|
4.8 Days
Standard Deviation 7.6
|
Adverse Events
Treatment-as-usual (TAU)
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
PN+mHealth
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-as-usual (TAU)
n=20 participants at risk
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
n=20 participants at risk
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.
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|---|---|---|
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General disorders
Hospitalization
|
55.0%
11/20 • Number of events 18 • 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.
|
15.0%
3/20 • Number of events 3 • 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.
|
Other adverse events
| Measure |
Treatment-as-usual (TAU)
n=20 participants at risk
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
n=20 participants at risk
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.
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|---|---|---|
|
General disorders
Emergency Department Admissions
|
25.0%
5/20 • Number of events 12 • 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.
|
5.0%
1/20 • Number of events 1 • 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.
|
|
General disorders
Urgent Care Visit
|
0.00%
0/20 • 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.
|
5.0%
1/20 • Number of events 1 • 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.
|
|
General disorders
Outpatient Procedure
|
0.00%
0/20 • 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.
|
5.0%
1/20 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place