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Clinical Trials/NCT05734989
NCT05734989
Completed
N/A

Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease

Duke University2 sites in 1 country248 target enrollmentMay 18, 2023

Overview

Phase
N/A
Intervention
PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD
Conditions
Type 2 Diabetes
Sponsor
Duke University
Enrollment
248
Locations
2
Primary Endpoint
Number of patients referred to PCPs (Primary Care Providers) for CKD screening
Status
Completed
Last Updated
8 days ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 18, 2023
End Date
April 4, 2025
Last Updated
8 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria:
  • Age 18 or older at time of screening
  • Self-identifying as Hispanic/Latinx ethnicity.

Exclusion Criteria

  • Unable to be reached by telephone

Arms & Interventions

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.

Intervention: PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD

Hispanic/Latinx patients at risk for CKD

Adult patients in the Hispanic/Latinx Durham community screened for CKD

Intervention: BP

Hispanic/Latinx patients at risk for CKD

Adult patients in the Hispanic/Latinx Durham community screened for CKD

Intervention: HbA1c

Outcomes

Primary Outcomes

Number of patients referred to PCPs (Primary Care Providers) for CKD screening

Time Frame: 3 months from referral

Increase rates of screening and monitoring of Chronic Kidney Disease (CKD) and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events

Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA)

Time Frame: Within three months of T0 (primary care appointment)

Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit

Time Frame: up to 3 months after screening

Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening

Time Frame: Within three months of T0 (primary care appointment)

Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi)

Time Frame: Within three months of T0 (primary care appointment)

Study Sites (2)

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