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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK144008 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Providers (Phase 1) | Experimental | Providers prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics. |
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| Patients (Phase 1) | Experimental | Adult patients prescribed an IMM in the past 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIManage | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness | In Phase 1, qualitative data regarding perceived usefulness will be collected. | Day 1 (60 minutes) |
| Percentage of Patients who Complete Qualitative Measure - Perceived Usability | 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 | 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 | In Phase 1, qualitative data regarding perceived value will be collected. | Day 1 (60 minutes) |
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Inclusion Criteria:
Provider Eligibility Criteria (Phase 1)
Patient Eligibility Criteria (Phase 1)
Exclusion Criteria:
Provider Exclusion Criteria (Phase 1) • Refuse to participate
Patient Exclusion Criteria (Phase 1)
• Refuse or are unable to provide informed consent;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Stevens, PhD, MPH | Contact | 646-501-2558 | Elizabeth.Stevens@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Stevens, PhD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Elizabeth.Stevens@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Elizabeth.Stevens@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |