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

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ClinicalTrials.gov Identifier: NCT02059408
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : December 4, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Screen-Educate Other: Screen-Educate and Intensify Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ?
Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
No Intervention: Usual Care
The patients in this arm will receive normal primary care.
Active Comparator: 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.
Other: Screen-Educate
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.

Active Comparator: 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.
Other: Screen-Educate
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.

Other: Screen-Educate and Intensify Treatment
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.




Primary Outcome Measures :
  1. Change in Blood Pressure [ Time Frame: 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 :
  1. ACE/ARB Prescription by a Clinician [ Time Frame: 12 months ]
    New use by end of the study


Other Outcome Measures:
  1. Testing Time [ Time Frame: 24 months ]
    Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.

  2. Testing Cost [ Time Frame: 24 months ]
    Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059408


Locations
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United States, California
San Francisco Veteran Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Carmen A Peralta, MD, MAS San Francisco Veterans Affairs Medical Center
Study Director: Erica Day, MPH San Francisco Veterans Affairs Medical Center
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02059408    
Other Study ID Numbers: CP2014R34
First Posted: February 11, 2014    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: January 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not currently a plan to make the IDP data available.
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency