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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02059408
First received: January 17, 2014
Last updated: November 15, 2016
Last verified: November 2016

January 17, 2014
November 15, 2016
September 2015
January 2017   (final data collection date for primary outcome measure)
Change in blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
Same as current
Complete list of historical versions of study NCT02059408 on ClinicalTrials.gov Archive Site
ACE/ARB prescription by a clinician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent of persons with controlled blood pressure, defined as less than 140/90 at 2 consecutive visits.
Same as current
  • testing time [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.
  • Testing Cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.
Same as current
 
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 ?
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Other: Screen-Educate
    A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.
  • Other: Screen-Educate and Intensify Treatment
    The CKD CDSS plus pharmacist (CDSS PLUS) extends beyond CDSS alone. 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.
  • No Intervention: Usual Care
    The patients in this arm will receive normal care.
  • Active Comparator: Screen-Educate
    Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate CDSS arm will recommend using creatinine, cystatin C and albuminuria for risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
    Intervention: Other: Screen-Educate
  • 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 is the CDSS plus a pharmacist-led CKD management program (CDSS PLUS) will attempt to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.
    Interventions:
    • Other: Screen-Educate
    • Other: Screen-Educate and Intensify Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
135
May 2017
January 2017   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Carmen Peralta, MD, MAS 415-221-4810
Contact: Erica Day, MPH 415-221-4810 ext 3383 erica.day@va.gov
United States
 
NCT02059408
CP2014R34
No
No
There is not currently a plan to make the IDP data available.
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Carmen A Peralta, MD, MAS San Francisco Veterans Affairs Medical Center
Study Director: Erica Day, MPH San Francisco Veterans Affairs Medical Center
University of California, San Francisco
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP