AI to Support Mental Health Case Management Providers

NCT ID: NCT06280170

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2025-12-31

Brief Summary

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The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:

1. Is the AI platform acceptable and feasible for case managers?
2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation.

Detailed Description

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Conditions

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Depressive Disorder Anxiety Disorders Substance Use Disorders Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The masking in this study involves a differential approach between providers and clients. Providers will be aware of whether they are in the Services-As-Usual (SAU) or Artificial Intelligence (AI) phase. However, participating clients will not be informed about the platform their provider is using to document their therapy sessions.

Study Groups

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Services-as-usual (SAU)

During the services-as-usual (SAU) phase of this study, providers will deliver the routine case management services offered by Centerstone and report these services in the usual way they do.

Group Type NO_INTERVENTION

No interventions assigned to this group

Artificial Intelligence (AI)

Once randomized to start using the AI-based platform for documenting their services, providers will have access to the Eleos Health platform, a secure and HIPAA-compliant tool specifically designed for documenting behavioral health encounters. This AI-powered platform enables providers to complete progress notes more quickly. Providers will complete the progress notes on their phones, and these notes will be integrated into the client's electronic health records.

Group Type EXPERIMENTAL

Artificial Intelligence platform for case managers

Intervention Type OTHER

Providers will have access to the Eleos Health mobile AI platform to document their case management encounters.

Interventions

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Artificial Intelligence platform for case managers

Providers will have access to the Eleos Health mobile AI platform to document their case management encounters.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participants must be adults.
2. Participants must be receiving case management services from a Centerstone provider

Exclusion Criteria

1. Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors.
2. Participants with any medical conditions or medications that may significantly interfere with the study outcomes will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centerstone Research Institute

OTHER

Sponsor Role collaborator

Eleos Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centerstone

Alton, Illinois, United States

Site Status

Countries

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United States

References

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Kellogg KC, Sadeh-Sharvit S. Pragmatic AI-augmentation in mental healthcare: Key technologies, potential benefits, and real-world challenges and solutions for frontline clinicians. Front Psychiatry. 2022 Sep 6;13:990370. doi: 10.3389/fpsyt.2022.990370. eCollection 2022.

Reference Type BACKGROUND
PMID: 36147984 (View on PubMed)

Sadeh-Sharvit S, Hollon SD. Leveraging the Power of Nondisruptive Technologies to Optimize Mental Health Treatment: Case Study. JMIR Ment Health. 2020 Nov 26;7(11):e20646. doi: 10.2196/20646.

Reference Type BACKGROUND
PMID: 33242025 (View on PubMed)

Sadeh-Sharvit S, Camp TD, Horton SE, Hefner JD, Berry JM, Grossman E, Hollon SD. Effects of an Artificial Intelligence Platform for Behavioral Interventions on Depression and Anxiety Symptoms: Randomized Clinical Trial. J Med Internet Res. 2023 Jul 10;25:e46781. doi: 10.2196/46781.

Reference Type BACKGROUND
PMID: 37428547 (View on PubMed)

Related Links

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https://eleos.health/science/

Link to Eleos Health's science page

https://centerstone.org/locations/institute/

Link to Centerstone Research Institute

Other Identifiers

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ST11480

Identifier Type: -

Identifier Source: org_study_id

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