- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280170
AI to Support Mental Health Case Management Providers
February 25, 2024 updated by: Eleos Health
AI for All: Harnessing the Power of Artificial Intelligence in Mental Health Case Management
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:
- Is the AI platform acceptable and feasible for case managers?
- 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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Alton, Illinois, United States, 62002
- Centerstone
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
FOR PROVIDERS:
Participating providers must be Centerstone case managers.
FOR CLIENTS:
Inclusion Criteria:
- Participants must be adults.
- Participants must be receiving case management services from a Centerstone provider
Exclusion Criteria:
- Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors.
- Participants with any medical conditions or medications that may significantly interfere with the study outcomes will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
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|
|
Experimental: 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.
|
Providers will have access to the Eleos Health mobile AI platform to document their case management encounters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Case manager satisfaction
Time Frame: Baseline, and 4 months after the rollout of the Eleos Health tool.
|
Providers will complete a self-report assessment about their experience providing case management services.
Providers will be asked to (a) report the number of of hours spent on documentation per week; (b) respond on a Likert Scale (1-5, 1="Not at all" and 5="highly stressed" regarding their stress level about documentation; and (c) respond on a Likert scale 1-5 (1="Not at all satisfied", 5="Highly satisfied"), indicating their satisfaction with their current role as a case manager.
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Baseline, and 4 months after the rollout of the Eleos Health tool.
|
|
Case manager productivity
Time Frame: 3 months before and 3 month after study start date
|
We will collect the number of encounters (i.e., case management visits provided) per month in the three months preceding the start of the study, and months 3-6 after the AI platform rollout.
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3 months before and 3 month after study start date
|
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Case manager note completion time
Time Frame: 3 months before and 3 month after study start date
|
We will record progress note completion time by hours since the time of service delivery (average, standard deviation, and range).
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3 months before and 3 month after study start date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clients' crisis services utilization
Time Frame: 6 months before and 6 month after study start date
|
Data on the clients' healthcare crisis encounters reported in the system will be collected
|
6 months before and 6 month after study start date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2024
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 25, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 25, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST11480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The confidentiality and privacy of the participants' data are paramount, and sharing individual-level data could compromise their privacy.
Therefore, the study does not include provisions for sharing IPD with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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