Early Identification and Action in CKD

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Hypertension
• Interventions: Other: Protocolized, pharmacist-delivered CKD Action Plan

• Registration Number: NCT02208674
• Lead Sponsor: Geisinger Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2014-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocolized, pharmacist-delivered CKD Action Plan	Protocolized, pharmacist-delivered CKD Action Plan	Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.

Primary Outcome Measures

Name	Time	Method
Screening Urinary Albumin Excretion	At 12 months	Completed test for urine albumin/creatinine (or urine protein/creatinine)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States