Early Identification and Action in CKD

N/ACompletedNCT02208674

Geisinger Clinic47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Screening Urinary Albumin Excretion

Completed test for urine albumin/creatinine (or urine protein/creatinine)

Time frame: At 12 months

Secondary Outcomes

Dyslipidemia Screening

One-time test for dyslipidemia (lipid panel)

Time frame: 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)

Time frame: within 12 months of enrollment date

Statin Treatment

If age \>= 50

Time frame: Within 12 months of enrollment

Blood Pressure Control-1

Time frame: Average of last two readings prior to 12 months post-enrollment

Blood Pressure--II

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: At 12 months post-enrollment

Patient and Provider Satisfaction

Based on administered surveys

Time frame: 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.