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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05734989
Enrollment
248
Registered
2023-02-21
Start date
2023-05-18
Completion date
2025-04-04
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes, Chronic Kidney Diseases

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.

Interventions

DIAGNOSTIC_TESTBP

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.

DIAGNOSTIC_TESTHbA1c

HbA1c will screen to identify patients with Type 2 diabetes

BEHAVIORALPCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD

Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD.

Sponsors

Duke University
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visitup to 3 months after screening
Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) ScreeningWithin 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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMatthew Sinclair, MD

Duke University

Baseline characteristics

Characteristic
Age, Continuous63.5 years
STANDARD_DEVIATION 14.2
Ethnicity (NIH/OMB)
Hispanic or Latino
69 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
178 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
91 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
52 Participants
Region of Enrollment
United States
92 Participants
Sex: Female, Male
Female
155 Participants
Sex: Female, Male
Male
25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 590 / 970 / 92
other
Total, other adverse events
0 / 590 / 970 / 92
serious
Total, serious adverse events
0 / 590 / 970 / 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026