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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02059408
First received: January 17, 2014
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
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 Intervention
Hypertension Other: Screen-Educate Other: Screen-Educate and Intensify Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ?

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: 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:
  • ACE/ARB prescription by a clinician [ Time Frame: 12 months ]
    Percent of persons with controlled blood pressure, defined as less than 140/90 at 2 consecutive visits.


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

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


Estimated Enrollment: 135
Study Start Date: September 2015
Estimated Study Completion Date: December 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059408

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

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02059408     History of Changes
Other Study ID Numbers: CP2014R34
Study First Received: January 17, 2014
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is not currently a plan to make the IDP data available.

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 23, 2017