- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546357
AIManage Using an AI-driven CDS and Chatbot
AIManage: Using an AI-driven CDS and Chatbot for the Management of Patients on Incretin Mimetic Medications
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH.
The study is currently conducting formative data collection for tool refinement (Phase 1). Once completed, a cluster randomized controlled trial of the AIManage tool will be undertaken (Phase 2).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Stevens, PhD, MPH
- Phone Number: 646-501-2558
- Email: Elizabeth.Stevens@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Provider Eligibility Criteria (Phase 1)
- Primary or bariatric care provider (MD/DO, NP) practicing at the participating NYULH clinics,
- Provide care to at least 5 patients prescribed an IMM.
Patient Eligibility Criteria (Phase 1)
- (Phase 1) Currently taking an IMM or have taken an IMM in the past 6 months;
- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be > 18 years of age.
Exclusion Criteria:
Provider Exclusion Criteria (Phase 1) • Refuse to participate
Patient Exclusion Criteria (Phase 1)
• Refuse or are unable to provide informed consent;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Providers (Phase 1)
Providers prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics.
|
GenAI-powered CDS tool that provides a range of IMM management services, such as personalized guidance for patients on side effects management and clinical advisement to optimize dose titrations.
|
|
Experimental: Patients (Phase 1)
Adult patients prescribed an IMM in the past 6 months.
|
GenAI-powered CDS tool that provides a range of IMM management services, such as personalized guidance for patients on side effects management and clinical advisement to optimize dose titrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness
Time Frame: Day 1 (60 minutes)
|
In Phase 1, qualitative data regarding perceived usefulness will be collected.
|
Day 1 (60 minutes)
|
|
Percentage of Patients who Complete Qualitative Measure - Perceived Usability
Time Frame: Day 1 (60 minutes)
|
In Phase 1, qualitative data regarding perceived usability will be collected.
|
Day 1 (60 minutes)
|
|
Percentage of Patients who Complete Qualitative Measure - Perceived Use Challenges
Time Frame: Day 1 (60 minutes)
|
In Phase 1, qualitative data regarding perceived use challenges will be collected.
|
Day 1 (60 minutes)
|
|
Percentage of Patients who Complete Qualitative Measure - Perceived Value
Time Frame: Day 1 (60 minutes)
|
In Phase 1, qualitative data regarding perceived value will be collected.
|
Day 1 (60 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Stevens, PhD, MPH, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Chemically-Induced Disorders
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus
- Drug-Related Side Effects and Adverse Reactions
Other Study ID Numbers
- 25-00594
- 1R01DK144008 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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