title: Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans.
abstract: Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital.
  
  
  
  Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months.
  
  
  
  A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%.
  
  
  
  We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD.
  
  
  
  NCT01978951 ; Date or Registration: 1/17/2014.
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA. carmenalicia.peralta@ucsf.edu.
authors.forename: Carmen A
authors.initials: CA
authors.lastname: Peralta
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Martin
authors.initials: M
authors.lastname: Frigaard
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Anna D
authors.initials: AD
authors.lastname: Rubinsky
authors.affiliation: University of California, San Francisco, 533 Parnassus Avenue, San Francisco, CA, 94117, USA.
authors.forename: Leticia
authors.initials: L
authors.lastname: Rolon
authors.affiliation: University of California, San Francisco, 533 Parnassus Avenue, San Francisco, CA, 94117, USA.
authors.forename: Lowell
authors.initials: L
authors.lastname: Lo
authors.affiliation: University of California, San Francisco, 533 Parnassus Ave, UC Hall, San Francisco, CA, 94143, USA.
authors.forename: Santhi
authors.initials: S
authors.lastname: Voora
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Seal
authors.affiliation: San Francisco General Hospital, 1001 Potrero Ave, SFGH 100, San Francisco, CA, 94110, USA.
authors.forename: Delphine
authors.initials: D
authors.lastname: Tuot
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Shirley
authors.initials: S
authors.lastname: Chao
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Lui
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Phillip
authors.initials: P
authors.lastname: Chiao
authors.affiliation: San Francisco General Hospital, 1001 Potrero Ave, SFGH 100, San Francisco, CA, 94110, USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Powe
authors.affiliation: San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Shlipak
mesh_terms: D000368:Aged; D000419:Albuminuria; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D003404:Creatinine / Q000378:metabolism; D055316:Cystatin C / Q000378:metabolism; D005260:Female; D006787:Hospitals, Veterans; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000453:epidemiology*; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010348:Patient Care Team; D010353:Patient Education as Topic; D010595:Pharmacists; D011320:Primary Health Care; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis* / Q000453:epidemiology; D014481:United States; D014493:United States Department of Veterans Affairs; D014728:Veterans
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D055316:Cystatin C; D003404:Creatinine
keywords: Blood pressure; Chronic kidney disease; Hypertension; Screening