Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94121
- San Francisco Veteran Affairs Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
The entire primary care medical practice at SFVAMC will be considered. Randomization will occur at the team (nurse) level. Within each team, individual patients will be considered eligible for chronic kidney disease screening by this protocol and inclusion in our trial if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of chronic kidney disease. Hypertension will be defined as systolic blood pressure >140 or diastolic blood pressure >90 mmHg at more than two encounters (any encounter) within the previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9 code). Diagnosed chronic kidney disease will be defined as a documentation of chronic kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We define diagnosed chronic kidney disease without consideration of estimated glomerular filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the medical record, since work from our group and others has shown that awareness and recognition of chronic kidney disease is extremely low, even among persons with documented reduced estimated glomerular filtration rate or albuminuria. Persons will be required to have seen their physician at least one time within the past 18 months.
Exclusion Criteria:
Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular filtration rate <15 ml/min/1.73 m2 will be excluded from this study as they likely need specialty care for uncontrolled hypertension. Persons aged >80 will be excluded because data on aggressive blood pressure lowering in this population are less clear and adverse effects associated with aggressive blood pressure control have been well documented. We will exclude persons with New York Heart Association class III or IV heart failure, known ejection fraction <25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin II Receptor Blockers. Other exclusion criteria relate to the required ability to communicate with providers and provide informed consent: prevalent dementia, impaired cognition or severe mental illness; expected life expectancy <6 months; severe visual impairment in the absence of an available caretaker who can read.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Usual Care
The patients in this arm will receive normal primary care.
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有源比较器:Screen-Educate
Education program to improve blood pressure control among hypertensive non-diabetic persons.
The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
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Education program to improve blood pressure control among hypertensive non-diabetic persons.
The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
Recommendations are sent to the primary care provider via an electronic note.
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有源比较器:Screen-Educate and Intensify Treatment
Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons.
The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.
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Education program to improve blood pressure control among hypertensive non-diabetic persons.
The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
Recommendations are sent to the primary care provider via an electronic note.
This arm adds option of a pharmacist.
PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys <45, or eGFR 45-59 and ACR ≥ 30 mg/g).
The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Blood Pressure
大体时间:baseline, 12 months
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Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
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baseline, 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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ACE/ARB Prescription by a Clinician
大体时间:12 months
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New use by end of the study
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12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Testing Time
大体时间:24 months
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Time in minutes to order and interpret tests.
Reported by Primary Care Providers and pharmacists.
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24 months
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Testing Cost
大体时间:24 months
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Reported by Primary Care Providers and pharmacists.
Cost in dollars of testing and pharmacist time.
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24 months
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合作者和调查者
调查人员
- 首席研究员:Carmen A Peralta, MD, MAS、San Francisco Veterans Affairs Medical Center
- 研究主任:Erica Day, MPH、San Francisco Veterans Affairs Medical Center
出版物和有用的链接
一般刊物
- Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
- Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.
- Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11.
- Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available.
- Peralta CA, Frigaard M, Rubinsky AD, Rolon L, Lo L, Voora S, Seal K, Tuot D, Chao S, Lui K, Chiao P, Powe N, Shlipak M. Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans. BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Screen-Educate的临床试验
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University of WashingtonNational Institute of Mental Health (NIMH); Seattle Children's Hospital完全的
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George Washington UniversityPatient-Centered Outcomes Research Institute; University of Bristol; West Virginia University...尚未招聘