Artificial Intelligence to Measure Adherence to Oral Medication

Study Overview
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Brief Summary
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The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.

Detailed Description
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The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.

Official Title
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Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication

Conditions
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First Episode Psychosis

Intervention / Treatment
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* Other: Smartphone App
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in a CSC program Prescribed an oral antipsychotic Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone App<br>artificial intelligence (AI) smartphone app to provide support for medication adherence | Other: Smartphone App<br>* artificial intelligence (AI) smartphone app to provide support for medication adherence<br>|
| Active Comparator: Usual Care<br>Usual care provided at CSC clinic | Other: Usual Care<br>* Usual Care provided by CSC clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Service Utilization Report Form | Provides participant utilization of psychiatric ER visits or psychiatric hospitalization | 12 months |