Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02059408|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment|
|Hypertension||Other: Screen-Educate Other: Screen-Educate and Intensify Treatment|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||July 2018|
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.
- 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,
- 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.
- 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.
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
|United States, California|
|San Francisco Veteran Affairs Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Carmen A Peralta, MD, MAS||San Francisco Veterans Affairs Medical Center|
|Study Director:||Erica Day, MPH||San Francisco Veterans Affairs Medical Center|