This trial is active, not recruiting.

Conditions chronic kidney disease, hypertension
Treatment protocolized, pharmacist-delivered ckd action plan
Sponsor Geisinger Clinic
Start date September 2014
End date March 2016
Trial size 93 participants
Trial identifier NCT02208674, 2014-0251


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
(No Intervention)
Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.
Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.
protocolized, pharmacist-delivered ckd action plan Health care delivery procedure
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

Primary Outcomes

Screening Urinary Albumin Excretion
time frame: At 12 months

Secondary Outcomes

Dyslipidemia Screening
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
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
time frame: at 12 months post enrollment
Biochemical Surveillance
time frame: two weeks after initiation or titration of ACEI or ARB
Symptomatic Adverse Drug Event
time frame: At 12 months post-enrollment
Patient and Provider Satisfaction
time frame: 9-12 months post study start date
Cystatin C Supplementary Screening
time frame: within 12 months of enrollment date

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Identification and Action in CKD
Principal investigator Alex Chang, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Geisinger Clinic.