NCT07857200 · Kaiser Permanente
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
(RISK)
What this study is about
This forward-looking, cluster-randomly assigned 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.
View original scientific 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
OTHER
Letter Intervention
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
OTHER
Letter + Phone Call Intervention:
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.
OTHER
Augmented usual care
(\~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.
Primary outcome measures
Number of days from index date (date of first provider notification) to the screening completion date by either eGFR(creatinine) or UACR, whichever comes earlier, during the follow-up period. The primary outcome will be assessed up to 12 months.
Time frame: Up to 12 months
We will group populations based on risk score, demographics (including historically underserved groups such as Medicaid beneficiaries and individuals of diverse race/ethnicity), comorbidities, and the presence and recency of urine albumin-to-creatinine ratio (uACR) and estimated Glomerular Filtration Rate (eGFR) testing to identify those at high risk for CKD. All patients will have a message sent to the provider to complete steps to screen for CKD per CDC and KPNW clinical guidlines. A randomized portion of providers will have e-portal messages or letters sent to their patients with elevated risk, and an additional portion will receive a phone call recommending CKD lab tests.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations