Clinical trial NCT02208674: Early Identification and Action in CKD
Official title: Early Identification and Action in CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hypertension
Keywords: chronic kidney disease
albuminuria
hypertension
dyslipidemia
cardiovascular disease
pragmatic trial
cluster randomized trial
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Screening Urinary Albumin Excretion
timeFrame: At 12 months
Secondary outcomes:
measure: Dyslipidemia Screening
timeFrame: At least once after eGFR < 60 ml/min
measure: ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)
timeFrame: within 12 months of enrollment date
measure: Statin Treatment
timeFrame: Within 12 months of enrollment
measure: Blood Pressure Control-1
timeFrame: Average of last two readings prior to 12 months post-enrollment
measure: Blood Pressure--II
timeFrame: Average of all blood pressures within 12 month study period
measure: Blood Pressure--III
timeFrame: at 12 months post enrollment
measure: Biochemical Surveillance
timeFrame: two weeks after initiation or titration of ACEI or ARB
measure: Symptomatic Adverse Drug Event
timeFrame: At 12 months post-enrollment
measure: Patient and Provider Satisfaction
timeFrame: 9-12 months post study start date
measure: Cystatin C Supplementary Screening
timeFrame: within 12 months of enrollment date
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Alex Chang, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.