Early Identification and Action in CKD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Screening Urinary Albumin Excretion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Usual Care
Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.
Protocolized, pharmacist-delivered CKD Action Plan
Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.
干预措施: Protocolized, pharmacist-delivered CKD Action Plan (Other)
结局指标
主要结局
Screening Urinary Albumin Excretion
时间窗: At 12 months
Completed test for urine albumin/creatinine (or urine protein/creatinine)
次要结局
- Statin Treatment(Within 12 months of enrollment)
- Blood Pressure--II(Average of all blood pressures within 12 month study period)
- Blood Pressure Control-1(Average of last two readings prior to 12 months post-enrollment)
- Blood Pressure--III(at 12 months post enrollment)
- Symptomatic Adverse Drug Event(At 12 months post-enrollment)
- Biochemical Surveillance(two weeks after initiation or titration of ACEI or ARB)
- Patient and Provider Satisfaction(9-12 months post study start date)
- Cystatin C Supplementary Screening(within 12 months of enrollment date)
- Dyslipidemia Screening(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)(within 12 months of enrollment date)
研究者
Alexander Chang
Clinical Investigator
Geisinger Clinic