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Eligibility
for people ages 18–80
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Carmen A Peralta

Description

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.

Official Title

Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?

Details

Aim 1. To evaluate whether an automated CKD CDSS achieves lower BP levels, higher rates of BP control and appropriate use of ACE/ARB compared with usual care, among persons with eGFRcreat < 60 ml/min/1.73m^2 in primary care.

Hypothesis 1a. The CKD CDSS will result in improved BP levels and BP control, compared to usual care.

Hypothesis 1b. Within the CKD CDSS group, utilization of ACE/ARB among persons with albuminuria will increase during follow-up.

Aim 2. To evaluate the acceptability and feasibility of implementing a CDSS for improving disease awareness and staging by primary care providers, compared with usual care, among persons with eGFRcreat < 60 ml/min/1.73m^2.

Hypothesis 2a. The CKD CDSS will result in increased physician CKD awareness, staging and appropriate testing for albuminuria, cystatin C and CKD complications (anemia, hyperphosphatemia, hyperparathyroidisim) in persons with reduced eGFRcreat.

Hypothesis 2b. The CKD CDSS will require low expenditures and will be readily accepted by PCPs and patients.

Aim 3. To evaluate whether a CDSS PLUS pharmacist-led CKD management program can improve BP levels and patient disease knowledge in persons with higher-risk CKD, compared to CDSS alone.

Hypothesis 3a. The pharmacist-led CKD management strategy will result in lower BP levels and higher rates of appropriate use of ACE/ARB, compared to the CDSS alone.

Hypothesis 3b. The pharmacist-led BP management program will be acceptable to PCPs, and it will result in higher levels of patient CKD and NSAID-avoidance knowledge compared with CDSS alone.

Keywords

Hypertension

Eligibility

You can join if…

Open to people ages 18–80

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.

You CAN'T join if...

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.

Location

  • San Francisco Veteran Affairs Medical Center
    San Francisco, California, 94121, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02059408
Lead Scientist
Carmen A Peralta
Study Type
Interventional
Last Updated
April 1, 2017