Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/13/2016 |
| Start Date: | August 2016 |
| End Date: | March 2017 |
| Contact: | Adam Hanina, MBA, MPhil |
| Email: | info@aicure.com |
| Phone: | 800-570-0448 |
Feasibility and Validity of Using a Novel Artificial Intelligence Platform to Monitor and Optimize Medication Adherence in Patients Receiving Opioid Replacement Therapy
This study uses an artificial intelligence platform to automatically confirm medication
ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant
platform can be downloaded as an 'app' onto any smartphone to automate directly observed
therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically
sent to a centralized web-based dashboard for use by healthcare professionals or research
staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to
confirm the process of medication administration; no human review is necessary.
The purpose of this study is to evaluate the feasibility and acceptability, and measure the
accuracy, of the AiCure platform ("platform") in patients being treated for opioid
dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1)
to assess the feasibility and acceptability to both participants and study staff in using
AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to
optimize care pathways; and 3) to measure the reliability and validity of AiCure in
detecting interruptions in treatment. To assess feasibility and acceptability of the
platform, we will measure rates of physician satisfaction and user acceptance. Optimization
of care pathways will be measured by assessing the sustainability of AiCure use over 12
weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to
historical data. Reliability and validity of AiCure will be measured by comparing AiCure
adherence against pharmacokinetic data.
All participants will be requested to take each of their prescribed doses using the app.
Participants will be able to download the app onto their own smartphone or will be
provisioned a device at the start of the study. The data captured during the medication
ingestion process will be automatically encrypted and stored on the participant smartphone
and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed
dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be
sent to study staff via email or SMS to prompt immediate intervention. In addition, all
participants will receive treatment as usual.
ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant
platform can be downloaded as an 'app' onto any smartphone to automate directly observed
therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically
sent to a centralized web-based dashboard for use by healthcare professionals or research
staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to
confirm the process of medication administration; no human review is necessary.
The purpose of this study is to evaluate the feasibility and acceptability, and measure the
accuracy, of the AiCure platform ("platform") in patients being treated for opioid
dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1)
to assess the feasibility and acceptability to both participants and study staff in using
AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to
optimize care pathways; and 3) to measure the reliability and validity of AiCure in
detecting interruptions in treatment. To assess feasibility and acceptability of the
platform, we will measure rates of physician satisfaction and user acceptance. Optimization
of care pathways will be measured by assessing the sustainability of AiCure use over 12
weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to
historical data. Reliability and validity of AiCure will be measured by comparing AiCure
adherence against pharmacokinetic data.
All participants will be requested to take each of their prescribed doses using the app.
Participants will be able to download the app onto their own smartphone or will be
provisioned a device at the start of the study. The data captured during the medication
ingestion process will be automatically encrypted and stored on the participant smartphone
and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed
dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be
sent to study staff via email or SMS to prompt immediate intervention. In addition, all
participants will receive treatment as usual.
This study will employ a multi-site, single-arm design. A total of approximately 50-100
participants - patients stable for at least 2 weeks on their current opioid replacement
medication - will be recruited for the study. All participants will receive their doctor's
treatment-as-usual. Patients not currently prescribed Zubsolv® will be switched to Zubsolv®.
Study visits include a screening visit, one baseline visit (which ideally will occur between
7 and 14 days after the screening visit), and bi-weekly visits for the 12 weeks (six visits)
following the baseline visit. During the baseline visit, participants will be trained on how
to use the AiCure app. Training consists of a number of interactive training steps to teach
the participant how to use the app correctly. Participants will be provided with three
placebo tablets for the training.
Study participants will be reimbursed to cover their time and transportation costs in
accordance with Institutional Review Board (IRB) guidelines. Participants will receive
contingency management (CM) to reinforce regular use of the app. Orexo AB will provide the
study drug, Zubsolv®, to all participants throughout the 12-week treatment duration.
For the length of the study, participants will be requested to take each dose of their
prescribed Zubsolv® regimen using the AiCure app. Each medication administration event will
be saved onto the participant's smartphone and encrypted data (including de-identified video
and time and date of administration) will be automatically transmitted to the centralized
dashboard. Research staff will have access to the dashboard to view real-time and detailed
dosing histories for each participant. Access to the dashboard is roles-based and
password-protected. If a participant does not dose using the AiCure app (misses/skips a
dose), self-reports on the device or over the phone, or is tagged for suspicious behavior,
the participant will receive a combination of automated SMS text messages and tailored SMS
text messages / phone calls from research staff based on the pre-defined escalation
protocol.
participants - patients stable for at least 2 weeks on their current opioid replacement
medication - will be recruited for the study. All participants will receive their doctor's
treatment-as-usual. Patients not currently prescribed Zubsolv® will be switched to Zubsolv®.
Study visits include a screening visit, one baseline visit (which ideally will occur between
7 and 14 days after the screening visit), and bi-weekly visits for the 12 weeks (six visits)
following the baseline visit. During the baseline visit, participants will be trained on how
to use the AiCure app. Training consists of a number of interactive training steps to teach
the participant how to use the app correctly. Participants will be provided with three
placebo tablets for the training.
Study participants will be reimbursed to cover their time and transportation costs in
accordance with Institutional Review Board (IRB) guidelines. Participants will receive
contingency management (CM) to reinforce regular use of the app. Orexo AB will provide the
study drug, Zubsolv®, to all participants throughout the 12-week treatment duration.
For the length of the study, participants will be requested to take each dose of their
prescribed Zubsolv® regimen using the AiCure app. Each medication administration event will
be saved onto the participant's smartphone and encrypted data (including de-identified video
and time and date of administration) will be automatically transmitted to the centralized
dashboard. Research staff will have access to the dashboard to view real-time and detailed
dosing histories for each participant. Access to the dashboard is roles-based and
password-protected. If a participant does not dose using the AiCure app (misses/skips a
dose), self-reports on the device or over the phone, or is tagged for suspicious behavior,
the participant will receive a combination of automated SMS text messages and tailored SMS
text messages / phone calls from research staff based on the pre-defined escalation
protocol.
Inclusion Criteria:
- Is a male or female at least 18 years of age.
- Has been on a stable dose of buprenorphine/naloxone for at least 2 weeks.
- Is willing to sign a consent form to allow research staff to receive information from
their healthcare provider that will verify above inclusion criteria (length of time
on stable dose), to administer blood draws, and to perform diagnostic assessments as
described in this protocol.
- Is willing to sign an agreement to return the AiCure provisioned device if not able
to download AiCure app onto personal smartphone.
- Is willing to use the AiCure app properly each time they ingest their daily dose of
buprenorphine/naloxone.
- Is willing to allow research staff (and good clinical practice-trained AiCure
personnel) to contact them via the app or other specified means regarding issues
related to medication non-adherence.
- Speaks and understands English well enough to participate in the informed consent
process and the study assessments and procedures.
- Agrees to come for a research visit monthly for 12 weeks (three visits) after being
accepted into the study and two times during screening/baseline.
Exclusion Criteria:
- Is unlikely to remain under the care of their healthcare provider for the duration of
the study.
- Appears to be incapable of learning the AiCure system.
- In the opinion of the investigator, is someone who should not be part of the study
due to behavioral, mental, physical, or other issues.
- Is under court mandate to obtain treatment.
- Has a known allergy to any of the substances comprising the study medication.
- Is planning to be detoxified from Zubzolv during the course of the study.
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