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Clinical Trials/NCT02208674
NCT02208674
Completed
Not Applicable

Early Identification and Action in CKD

Geisinger Clinic1 site in 1 country47 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Geisinger Clinic
Enrollment
47
Locations
1
Primary Endpoint
Screening Urinary Albumin Excretion
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexander Chang

Clinical Investigator

Geisinger Clinic

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

Outcomes

Primary Outcomes

Screening Urinary Albumin Excretion

Time Frame: At 12 months

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

Secondary Outcomes

  • Blood Pressure--II(Average of all blood pressures within 12 month study period)
  • Blood Pressure Control-1(Average of last two readings prior to 12 months post-enrollment)
  • Blood Pressure--III(at 12 months post enrollment)
  • Symptomatic Adverse Drug Event(At 12 months post-enrollment)
  • Statin Treatment(Within 12 months of enrollment)
  • Biochemical Surveillance(two weeks after initiation or titration of ACEI or ARB)
  • Patient and Provider Satisfaction(9-12 months post study start date)
  • Cystatin C Supplementary Screening(within 12 months of enrollment date)
  • Dyslipidemia Screening(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)

Study Sites (1)

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