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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK118205 | 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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Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources.
Based on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention clinic | Active Comparator | Patients with prediabetes seen for routine care at intervention clinic |
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| Control clinic | No Intervention | Patients with prediabetes seen for routine care at control clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| START diabetes prevention clinical pathway | Other | The diabetes prevention clinical pathway will focus on the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit | Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period | 12 months |
| Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days | 12 months | |
| Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period | Fasting glucose or Hemoglobin A1c | 12 months |
| Achieve 5% or Greater Reduction in Weight Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Tseng, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins General Internal Medicine clinic at Green Spring Station | Lutherville | Maryland | 21204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Clinic | Patients with prediabetes seen for routine care at intervention clinic START diabetes prevention clinical pathway: The diabetes prevention clinical pathway will focus on the following steps:
|
| FG001 | Control Clinic | Patients with prediabetes seen for routine care at control clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Clinic | START diabetes prevention clinical pathway |
| BG001 | Control Clinic | Routine usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit | Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period | Posted | Number | pcp visits | 12 months | pcp visits | pcp visits |
|
|
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Adverse event data not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Clinic | START diabetes prevention clinical pathway | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eva Tseng | Johns Hopkins University School of Medicine | 410-583-2774 | etseng3@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2023 | May 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Proportion achieving 5% or greater weight reduction
| Baseline and 12 months |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
| pcp visits |
|
|
| Primary | Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days | Posted | Number | pcp visits | 12 months | pcp visits | pcp visits |
|
|
|
| Primary | Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days | Posted | Number | pcp visits | 12 months | pcp visits | pcp visits |
|
|
|
| Secondary | Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period | Fasting glucose or Hemoglobin A1c | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Achieve 5% or Greater Reduction in Weight Compared to Baseline | Proportion achieving 5% or greater weight reduction | Posted | Count of Participants | Participants | Baseline and 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Clinic | Routine usual care | 0 | 0 | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |