Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Other: Screen-Educate and Intensify Treatment
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ?|
- 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,
- 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.
- 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.
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
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.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02059408
|Contact: Carmen Peralta, MD, MAS||415-221-4810|
|Contact: Erica Day, MPH||415-221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco Veteran Affairs Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Carmen A Peralta, MD, MAS 415-221-4810|
|Contact: Erica Day, MPH 415-221-4810 ext 3382 email@example.com|
|Principal Investigator: Carmen Peralta, MD, MAS|
|Principal Investigator:||Carmen A Peralta, MD, MAS||San Francisco Veterans Affairs Medical Center|
|Study Director:||Erica Day, MPH||San Francisco Veterans Affairs Medical Center|