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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care. | |
| Protocolized, pharmacist-delivered CKD Action Plan | Experimental | Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolized, pharmacist-delivered CKD Action Plan | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Screening Urinary Albumin Excretion | Completed test for urine albumin/creatinine (or urine protein/creatinine) | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dyslipidemia Screening | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Chang, MD, MS | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27825313 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D000419 | Albuminuria |
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| within 12 months of enrollment date |
| Statin Treatment | If age >= 50 | Within 12 months of enrollment |
| 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 |
| Blood Pressure--III | 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 | 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 | 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 | Based on administered surveys | 9-12 months post study start date |
| 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. | within 12 months of enrollment date |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |