Recruiting

CKD NotificationThe 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

Code:

NCT07857200

Conditions

CKD - Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Letter Intervention

Letter + Phone Call Intervention:

Augmented usual care

Study Details

Brief summary:

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).

Conditions

CKD - Chronic Kidney Disease

Study ID

NCT07857200

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 20, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Augmented Usual Care

All PCPs (\~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.

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 sent to each patient notifying them of their elevated risk of developing CKD and information regarding standard CKD testing.

other: Letter + Phone Call Intervention

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.

Interventions

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

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.

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 measure

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 ]

Central Contacts and Locations

Central contacts

Amanda F Pretrik, PhD

503-335-2400 Amanda.F.Petrik@kpchr.org

Locations

Center for Health Research, Kaiser Permanente NW

Recruiting

Portland, Oregon, United States, 97227

More Information

Sponsor

Kaiser Permanente

Last update posted

Oct 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.