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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06280170
Other study ID # ST11480
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 19, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Eleos Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 280
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility FOR PROVIDERS: Participating providers must be Centerstone case managers. FOR CLIENTS: 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.

Study Design


Intervention

Other:
Artificial Intelligence platform for case managers
Providers will have access to the Eleos Health mobile AI platform to document their case management encounters.

Locations

Country Name City State
United States Centerstone Alton Illinois

Sponsors (2)

Lead Sponsor Collaborator
Eleos Health Centerstone Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Case manager satisfaction 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. Baseline, and 4 months after the rollout of the Eleos Health tool.
Primary Case manager productivity 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. 3 months before and 3 month after study start date
Primary Case manager note completion time We will record progress note completion time by hours since the time of service delivery (average, standard deviation, and range). 3 months before and 3 month after study start date
Secondary Clients' crisis services utilization Data on the clients' healthcare crisis encounters reported in the system will be collected 6 months before and 6 month after study start date
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