Early Identification and Action in CKD

November 14, 2016 updated by: Alexander Chang, Geisinger Clinic
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.
Experimental: Protocolized, pharmacist-delivered CKD Action Plan
Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.
Other: Protocolized, pharmacist-delivered CKD Action Plan
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
Other Names:
  • Health care delivery procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening Urinary Albumin Excretion
Time Frame: At 12 months
Completed test for urine albumin/creatinine (or urine protein/creatinine)
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyslipidemia Screening
Time Frame: At least once after eGFR < 60 ml/min
One-time test for dyslipidemia (lipid panel)
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
within 12 months of enrollment date
Statin Treatment
Time Frame: Within 12 months of enrollment
If age >= 50
Within 12 months of enrollment
Blood Pressure Control-1
Time Frame: Average of last two readings prior to 12 months post-enrollment
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
Average of all blood pressures within 12 month study period
Blood Pressure--III
Time Frame: 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
at 12 months post enrollment
Biochemical Surveillance
Time Frame: 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.
two weeks after initiation or titration of ACEI or ARB
Symptomatic Adverse Drug Event
Time Frame: At 12 months post-enrollment
Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug
At 12 months post-enrollment
Patient and Provider Satisfaction
Time Frame: 9-12 months post study start date
Based on administered surveys
9-12 months post study start date
Cystatin C Supplementary Screening
Time Frame: 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.
within 12 months of enrollment date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Alex Chang, MD, MS, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data for this study may be obtained upon request, after permission to do so is granted by the Geisinger IRB and information security office. Readers should contact the principal investigator (achang@geisinger.edu) for further information.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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