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The Use of Risk Prediction to Identify Patients at Risk for Chronic Kidney Disease: Patient and Provider Interventions for Patients at High Risk for Chronic Kidney Disease

Sponsor: Kaiser Permanente • ClinicalTrials.gov ID: NCT07857200

Registry updated: 2026-10-05

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Description

This prospective, cluster-randomized trial is structured as a pragmatic study, embedding the outreach intervention within routine clinical workflows. The intervention reflects real-world provider-patient communication methods. The primary research aim is to evaluate, under typical practice conditions, whether structured notification strategies improve follow-up screening. We will evaluate whether targeted provider and patient-directed communication increases completion of CKD disease lab testing (eGFR and uACR) among individuals identified as being at risk for having CKD based on the model developed in in Phase 1. We will identify up to 1,000 patients with high risk of having CKD. All patients' primary care providers (PCPs) will receive a message notifying them of patients' elevated risk status and the recommendation for CKD testing per standard practice. Additionally, we will randomly allocate providers whose patients will receive letters ( \~n=500 patients) and providers whose patients will receive a phone call ( \~n=250 patients).

Interventions

Letter Intervention (Other)
An estimated 140 PCPs will be randomized, for their patients (\~\<500 patients) to receive the letter via mail, developed by the research team and delivered by USPS. Letters will be
Letter + Phone Call Intervention: (Other)
Additionally, approximately 70 providers will be randomized for their patients (\~n\<250) to receive the phone intervention notifying them of their elevated risk and recommending CKD testing.
Augmented usual care (Other)
(\~n=280) of 1,000 eligible patients will receive a secure message, developed by the research team and delivered by a research team member with EHR access. The message will notify the PCP of the patients' elevated risk of developing CKD and need for standard CKD testing and provide a smart-set to order eGFR or UACR tests.

Eligibility criteria

Inclusion Criteria: * At high risk for CKD as determined by CKD model developed in Phase 1 * Age 18-80 as of date of data pull * At least 12 months of health plan coverage * Speaks English or Spanish * We will include both paneled and unpaneled patients Exclusion criteria: * On the research exclusion list between 1/1/2013 and date of the data pull * On hospice, or have conditions that indicate end of life (metastatic cancer, on dialysis, etc.) * Non-English / non-Spanish speaking (those who are excluded from the intervention arm solely due to language barriers will be reported to the IRB at continuing review). * Pregnant patients. * Patients who have a completed both the eGFR and uACR within the 12 months prior to the date of cohort identification.

Conditions

CKD - Chronic Kidney Disease

Locations

Center for Health Research, Kaiser Permanente NW — Portland, Oregon, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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