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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKaiser Permanente

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letter Intervention

    Other 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:

    Other 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

    Other intervention

    (\~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.

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: Augmented Usual CareOther 1 intervention
Group B: Letter InterventionOther 2 interventions
Group C: Letter + Phone Call InterventionOther 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Up to 12 months

Other outcomes

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