title: Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study.
abstract: Despite the availability of effective therapies, most gout patients achieve suboptimal treatment outcomes. Current best practices suggest gradual dose-escalation of urate lowering therapy and serial serum urate (sUA) measurement to achieve sUA<6.0mg/dl. However, this strategy is not routinely used. Here we present the study design rationale and development for a pharmacist-led intervention to promote sUA goal attainment.
  
  
  
  To overcome barriers in achieving optimal outcomes, we planned and implemented the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) study. This is a large pragmatic cluster-randomized trial designed to assess a highly automated, pharmacist-led intervention to optimize allopurinol treatment in gout. Ambulatory clinics (n=101) from a large health system were randomized to deliver either the pharmacist-led intervention or usual care to gout patients over the age of 18years newly initiating allopurinol. All participants received educational materials and could opt-out of the study. For intervention sites, pharmacists conducted outreach primarily via an automated telephone interactive voice recognition system. The outreach, guided by a gout care algorithm developed for this study, systematically promoted adherence assessment, facilitated sUA testing, provided education, and adjusted allopurinol dosing. The primary study outcomes are achievement of sUA<6.0mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently.
  
  
  
  Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.
authors.affiliation: Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, United States.
authors.forename: Brian W
authors.initials: BW
authors.lastname: Coburn
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
authors.forename: T Craig
authors.initials: TC
authors.lastname: Cheetham
authors.affiliation: Drug Information Services, Kaiser Permanente Southern California, Downey, CA, United States.
authors.forename: Nazia
authors.initials: N
authors.lastname: Rashid
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
authors.forename: John M
authors.initials: JM
authors.lastname: Chang
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
authors.forename: Gerald D
authors.initials: GD
authors.lastname: Levy
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
authors.forename: Artak
authors.initials: A
authors.lastname: Kerimian
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Low
authors.affiliation: Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, United States.
authors.forename: David T
authors.initials: DT
authors.lastname: Redden
authors.affiliation: Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL, United States.
authors.forename: S Louis
authors.initials: SL
authors.lastname: Bridges
authors.affiliation: Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL, United States.
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Saag
authors.affiliation: Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL, United States.
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Curtis
authors.affiliation: Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, United States; Medicine, Veterans Affairs Nebraska-Western Iowa Health Care System, Omaha, NE, United States. Electronic address: tmikuls@unmc.edu.
authors.forename: Ted R
authors.initials: TR
authors.lastname: Mikuls
mesh_terms: D000493:Allopurinol / Q000627:therapeutic use*; D000553:Ambulatory Care / Q000458:organization & administration*; D001331:Automation; D006073:Gout / Q000097:blood / Q000188:drug therapy*; D006074:Gout Suppressants / Q000627:therapeutic use*; D006801:Humans; D010353:Patient Education as Topic; D010595:Pharmacists / Q000458:organization & administration*; D012107:Research Design; D013689:Telephone; D014527:Uric Acid / Q000097:blood
chemical_list: D006074:Gout Suppressants; D014527:Uric Acid; D000493:Allopurinol
keywords: Allopurinol; Dose titration; Gout; Randomized trial; Serum urate