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OpenTrials
Completed

NCT Number: NCT05734989

Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Aim 1:

Inclusion criteria

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

Exclusion criteria

  • Unable to be reached by telephone

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: up to 3 months after screening

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

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

  3. 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)

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

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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