Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Screen-Educate; Other: Screen-Educate and Intensify Treatment

• Registration Number: NCT02059408
• Lead Sponsor: University of California, San Francisco

Brief Summary

The overall hypothesis of this trial is that screening for chronic kidney disease, followed by education or treatment program will improve blood pressure control among hypertensive non-diabetic persons.

Detailed Description

To evaluate a CKD screen-and-educate program in primary care for improving blood pressure management compared with usual care, among non-diabetic adults with hypertension.

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2015-09
• Primary Completion: 2017-01
• Study Completion: 2018-12
• Results First Submitted: 2019-11-12
• Results First Submitted QC: 2019-11-13
• Status Verified: 2019-12
• Results First Posted: 2019-12-04
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1819

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screen-Educate	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.
Screen-Educate and Intensify Treatment	Screen-Educate	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.
Screen-Educate and Intensify Treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure	baseline, 12 months	Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,

Secondary Outcome Measures

Name	Time	Method
ACE/ARB Prescription by a Clinician	12 months	New use by end of the study

Trial Locations

Locations (1)

San Francisco Veteran Affairs Medical Center; 🇺🇸 San Francisco, California, United States