Early Identification and Action in CKD
Primary Purpose
Chronic Kidney Disease, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protocolized, pharmacist-delivered CKD Action Plan
Sponsored by
About this trial
This is an interventional screening trial for Chronic Kidney Disease focused on measuring chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial
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
Sites / Locations
- Geisinger Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Protocolized, pharmacist-delivered CKD Action Plan
Arm Description
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.
Outcomes
Primary Outcome Measures
Screening Urinary Albumin Excretion
Completed test for urine albumin/creatinine (or urine protein/creatinine)
Secondary Outcome Measures
Dyslipidemia Screening
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)
Statin Treatment
If age >= 50
Blood Pressure Control-1
Blood Pressure--II
Blood Pressure--III
Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period
Biochemical Surveillance
Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.
Symptomatic Adverse Drug Event
Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug
Patient and Provider Satisfaction
Based on administered surveys
Cystatin C Supplementary Screening
One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02208674
Brief Title
Early Identification and Action in CKD
Official Title
Early Identification and Action in CKD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.
Arm Title
Protocolized, pharmacist-delivered CKD Action Plan
Arm Type
Experimental
Arm Description
Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.
Intervention Type
Other
Intervention Name(s)
Protocolized, pharmacist-delivered CKD Action Plan
Other Intervention Name(s)
Health care delivery procedure
Intervention Description
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 Outcome Measure Information:
Title
Screening Urinary Albumin Excretion
Description
Completed test for urine albumin/creatinine (or urine protein/creatinine)
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Dyslipidemia Screening
Description
One-time test for dyslipidemia (lipid panel)
Time Frame
At least once after eGFR < 60 ml/min
Title
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
Title
Statin Treatment
Description
If age >= 50
Time Frame
Within 12 months of enrollment
Title
Blood Pressure Control-1
Time Frame
Average of last two readings prior to 12 months post-enrollment
Title
Blood Pressure--II
Time Frame
Average of all blood pressures within 12 month study period
Title
Blood Pressure--III
Description
Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period
Time Frame
at 12 months post enrollment
Title
Biochemical Surveillance
Description
Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.
Time Frame
two weeks after initiation or titration of ACEI or ARB
Title
Symptomatic Adverse Drug Event
Description
Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug
Time Frame
At 12 months post-enrollment
Title
Patient and Provider Satisfaction
Description
Based on administered surveys
Time Frame
9-12 months post study start date
Title
Cystatin C Supplementary Screening
Description
One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g.
Time Frame
within 12 months of enrollment date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Chang, MD, MS
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
27825313
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.
Results Reference
background
Links:
URL
https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-016-0383-7
Description
Related Info
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Early Identification and Action in CKD
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