Early Identification and Action in CKD

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed CKD Action Plan (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.

Official Title
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Early Identification and Action in CKD

Conditions
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Hypertension, Chronic Kidney Disease

Intervention / Treatment
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* Other: Protocolized, pharmacist-delivered CKD Action Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months scheduled laboratory appointment for serum creatinine testing within the next 30 days average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months. Exclusion Criteria: fewer than 2 blood pressure readings in the prior 12 months, pregnancy current hospitalization life expectancy less than 6 months as determined by the study investigators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care. | |
| Experimental: Protocolized, pharmacist-delivered CKD Action Plan<br>Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations. | Other: Protocolized, pharmacist-delivered CKD Action Plan<br>* The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD<br>* Other names: Health care delivery procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Urinary Albumin Excretion | Completed test for urine albumin/creatinine (or urine protein/creatinine) | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyslipidemia Screening | One-time test for dyslipidemia (lipid panel) | At least once after eGFR < 60 ml/min | 
| ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic) |  | within 12 months of enrollment date | 
| Statin Treatment | If age >= 50 | Within 12 months of enrollment | 
| Blood Pressure Control-1 |  | Average of last two readings prior to 12 months post-enrollment | 
| Blood Pressure--II |  | Average of all blood pressures within 12 month study period | 
| Blood Pressure--III | Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period | at 12 months post enrollment | 
| Biochemical Surveillance | Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration. | two weeks after initiation or titration of ACEI or ARB | 
| Symptomatic Adverse Drug Event | Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug | At 12 months post-enrollment | 
| Patient and Provider Satisfaction | Based on administered surveys | 9-12 months post study start date | 
| Cystatin C Supplementary Screening | One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g. | within 12 months of enrollment date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial