Type 2 Diabetes, Chronic Kidney Diseases
Conditions
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
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 will screen to identify patients with Type 2 diabetes
Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD.
Sponsors
Study design
Eligibility
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
| Measure | 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) |
Countries
United States
Contacts
Duke University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.5 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 97 | 0 / 92 |
| other Total, other adverse events | 0 / 59 | 0 / 97 | 0 / 92 |
| serious Total, serious adverse events | 0 / 59 | 0 / 97 | 0 / 92 |