Clinical trial NCT06280170: AI to Support Mental Health Case Management Providers
Official title: AI for All: Harnessing the Power of Artificial Intelligence in Mental Health Case Management
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Substance Use Disorders
Post Traumatic Stress Disorder
Keywords: Case management
Artificial Intelligence
Provider productivity
Mental health services
Provider satisfaction
Lead sponsor: Eleos Health
Sponsor class: INDUSTRY
Collaborators: name: Centerstone Research Institute
First posted: 2024-02-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Case manager satisfaction
timeFrame: Baseline, and 4 months after the rollout of the Eleos Health tool.
measure: Case manager productivity
timeFrame: 3 months before and 3 month after study start date
measure: Case manager note completion time
timeFrame: 3 months before and 3 month after study start date
Secondary outcomes:
measure: Clients' crisis services utilization
timeFrame: 6 months before and 6 month after study start date
Other outcomes:
Locations:
city: Alton
country: United States
facility: Centerstone
state: Illinois
Study officials:
References:
citation: 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.
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.
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.