Chronic Kidney Disease, Hypertension
Conditions
Keywords
chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial
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.
Interventions
OTHERProtocolized, 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
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening Urinary Albumin Excretion | At 12 months | Completed test for urine albumin/creatinine (or urine protein/creatinine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic) | within 12 months of enrollment date | — |
| Statin Treatment | Within 12 months of enrollment | If age \>= 50 |
| Blood Pressure Control-1 | Average of last two readings prior to 12 months post-enrollment | — |
| Blood Pressure--II | Average of all blood pressures within 12 month study period | — |
| Dyslipidemia Screening | At least once after eGFR < 60 ml/min | One-time test for dyslipidemia (lipid panel) |
| 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. |
| 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 |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed