Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP.
In Aim 2, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes.
Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) and Black patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.
The goal of Aim 1 was to increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events. Aim 1 included adult Hispanic individuals in the Durham community screened for CKD. Urine protein/glucose screening, blood pressure measurements, and BMI measures were conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk were referred to PCP for follow up/treatment.
The goal of Aim 2 was to pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx and Black patients with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipated the study would identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx and Black individuals.
Electronic health record (EHR) information obtained to identify Hispanic and non-Hispanic Black individuals with T2D at two Duke clinics with an upcoming PCP appointment. A clinical champion (nurse practitioner) at each clinic site queried the information obtained from the EHR for all potentially eligible patients. Queries identified 1) if the patient was prescribed a RAAS inhibitor (yes/no), 2) if the patient was prescribed an SGLT2i or GLP-1 RA (yes/no), and 3) if the patient had received guideline concordant UACR screening (yes/no). Patients were not considered eligible for the intervention and were placed in the "optimal care" group if: 1) They met the "yes" criteria to all three queries above; 2) Had an up to date UACR screen and were determined not to be eligible for either of the medication groups (based on history of adverse events to the medication or contraindications as determined by the clinical champion). Patients were considered eligible for the intervention and were assigned to the "screening/treatment" group if they: 1) Did not have a UACR within 1-year prior to T0; 2) were not on either a RAAS inhibitor or a SGLT2i/GLP-1 RA and were determined by the clinical champion to be eligible, based on the most updated KDIGO and ADA guidelines. The clinical champions would then make recommendations to a pharmacy champion (one at each site) on our study team on whether the patient should get a UACR and/or one or more of the medication classes at visit T0. The pharmacy champion reviewed these recommendations, and if in agreement, delivered them via electronic message, including specific medication names and doses, in the EHR to the PCPs, prior to the upcoming appointment T0.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hispanic/Latinx patients at risk for CKD | Adult patients in the Hispanic/Latinx Durham community screened for CKD |
| |
| PCPs caring for Hispanic Latinx patients screened for CKD in the Durham Community | Primary Care Providers (PCPs) caring for Hispanic Latinx patients who agree to use the study guidelines and interventions for screening and monitoring their patients for CKD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP | Diagnostic Test | Blood pressure measurements and HbA1c tests will be conducted to identify participants with or at risk for high blood pressure and/or Type 2 Diabetes. Those identified will be referred to PCP for follow up/treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit | up to 3 months after screening | |
| Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening | Within three months of T0 (primary care appointment) | |
| Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA) | Within three months of T0 (primary care appointment) | |
| Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) | Within three months of T0 (primary care appointment) |
Not provided
Not provided
Aim 1:
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Aim 1:
Adults in the Durham, NC Hispanic/Latinx community at risk for hypertension and/or CKD
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Sinclair, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hispanic/Latinx Patients at Risk for CKD | Adult Hispanic individuals in the Durham community screened for CKD Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment. |
| FG001 | Screening/Treatment Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA) |
| FG002 | Optimal Care Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hispanic/Latinx Patients at Risk for CKD | Adult Hispanic individuals in the Durham community screened for CKD Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment. |
| 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 Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit | Only relevant to the Hispanic/Latinx patients at risk for CKD group; 28 participants were lost to follow-up. | Posted | Count of Participants | Participants | up to 3 months after screening |
|
Up to 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hispanic/Latinx Patients at Risk for CKD | Adult Hispanic individuals in the Durham community screened for CKD Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew R. Sinclair, MD, MHS | Duke University | 919-668-0113 | matthew.sinclair@duke.edu |
Not provided
| 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 31, 2024 | Apr 2, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2024 | Apr 9, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
Not provided
Not provided
Not provided
Not provided
Not provided
| HbA1c | Diagnostic Test | HbA1c will screen to identify patients with Type 2 diabetes |
|
| PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD | Behavioral | Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD. |
|
| BG001 | Screening/Treatment Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA) |
| BG002 | Optimal Care Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening | Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a uACR. | Posted | Count of Participants | Participants | Within three months of T0 (primary care appointment) |
|
|
|
| Primary | Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA) | Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a SGLT2i or GLP-1 RA. Participants in the Optimal Care Group were only included if deemed eligible to receive a SGLT2i or GLP-1 RA. | Posted | Count of Participants | Participants | Within three months of T0 (primary care appointment) |
|
|
|
| Primary | Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) | Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a RAASi. Participants in the Optimal Care Group were only included if deemed eligible to receive a RAASi. | Posted | Count of Participants | Participants | Within three months of T0 (primary care appointment) |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Screening/Treatment Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA) | 0 | 97 | 0 | 97 | 0 | 97 |
| EG002 | Optimal Care Group | Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions | 0 | 92 | 0 | 92 | 0 | 92 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |