CKD - Chronic Kidney DiseaseRISKNCT07857200
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
A study testing Letter Intervention and Letter + Phone Call Intervention: in people with CKD - Chronic Kidney Disease, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CKD - Chronic Kidney Disease
- What is being tested?
- Letter Intervention and Letter + Phone Call Intervention:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Health Research, Kaiser Permanente NW
Portland, Oregon, 97227
About this study
Official title: The Use of Risk Prediction to Identify Patients at Risk for Chronic Kidney Disease (Short Name: RISK [Risk InterventionS for Chronic Kidney Disease])
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
- Being tested
- Letter Intervention, Letter + Phone Call Intervention:, Augmented usual care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter InterventionOther
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 careOther
(~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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Usual Care | Other | 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. Receives: Other: Augmented usual care |
| 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 sent to each patient notifying them of their elevated risk of developing CKD and information regarding standard CKD testing. Receives: Other: Letter Intervention; Other: Augmented usual care |
| Letter + Phone Call Intervention | Other | 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. Receives: Other: Letter Intervention; Other: Letter + Phone Call Intervention:; Other: Augmented usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Up to 12 months
Secondary outcomes (1)
Time to CKD diagnosis
The time from index date to CKD diagnosis will be assessed using electronic health record (EHR) data.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start20 Aug 2026
- Primary completion20 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD - Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857200
- Sponsor's protocol ID
- IRB:2274455
- Acronym
- RISK
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified analytic dataset may be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Risk Prediction to Identify Patients at Risk for Chronic Kidney Disease (Short Name: RISK [Risk InterventionS for Chronic Kidney Disease])
- ClinicalTrials.gov ID
- NCT07857200
- Acronym / sponsor ID
- RISK / IRB:2274455
- Conditions
- CKD - Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Augmented Usual Care | Other | Other: Augmented usual careAll 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. |
| Letter Intervention | Other | Other: Letter Intervention, Other: Augmented usual careAn 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. |
| Letter + Phone Call Intervention | Other | Other: Letter Intervention, Other: Letter + Phone Call Intervention:, Other: Augmented usual careApproximately 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letter InterventionAn 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, Letter Intervention |
| 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 | Letter + Phone Call Intervention |
| 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. | Other | Augmented Usual Care, Letter + Phone Call Intervention, Letter Intervention |
Primary outcome
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.
1 secondary outcome
Time to CKD diagnosis
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. A de-identified analytic dataset may be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter Intervention and Letter + Phone Call Intervention: in people with CKD - Chronic Kidney Disease, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda F Pretrik, PhD (503-335-2400, Amanda.F.Petrik@kpchr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.