Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study

Brian W. Coburn, T. Craig Cheetham, Nazia Rashid, John M. Chang, Gerald D. Levy, Artak Kerimian, Kimberly J. Low, David T. Redden, S. Louis Bridges, Kenneth G. Saag, Jeffrey R. Curtis, Ted R Mikuls

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background 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 < 6.0 mg/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. Methods 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 18 years 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 < 6.0 mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Conclusion Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.

Original languageEnglish (US)
Pages (from-to)106-115
Number of pages10
JournalContemporary Clinical Trials
Volume50
DOIs
StatePublished - Sep 1 2016

Fingerprint

Ambulatory Care
Uric Acid
Pharmacists
Gout
Allopurinol
Serum
Health Resources
Therapeutics
Practice Guidelines
Telephone
Outcome Assessment (Health Care)
Technology
Education
Health

Keywords

  • Allopurinol
  • Dose titration
  • Gout
  • Randomized trial
  • Serum urate

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study. / Coburn, Brian W.; Cheetham, T. Craig; Rashid, Nazia; Chang, John M.; Levy, Gerald D.; Kerimian, Artak; Low, Kimberly J.; Redden, David T.; Bridges, S. Louis; Saag, Kenneth G.; Curtis, Jeffrey R.; Mikuls, Ted R.

In: Contemporary Clinical Trials, Vol. 50, 01.09.2016, p. 106-115.

Research output: Contribution to journalArticle

Coburn, BW, Cheetham, TC, Rashid, N, Chang, JM, Levy, GD, Kerimian, A, Low, KJ, Redden, DT, Bridges, SL, Saag, KG, Curtis, JR & Mikuls, TR 2016, 'Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study', Contemporary Clinical Trials, vol. 50, pp. 106-115. https://doi.org/10.1016/j.cct.2016.07.019
Coburn, Brian W. ; Cheetham, T. Craig ; Rashid, Nazia ; Chang, John M. ; Levy, Gerald D. ; Kerimian, Artak ; Low, Kimberly J. ; Redden, David T. ; Bridges, S. Louis ; Saag, Kenneth G. ; Curtis, Jeffrey R. ; Mikuls, Ted R. / Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study. In: Contemporary Clinical Trials. 2016 ; Vol. 50. pp. 106-115.
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abstract = "Background 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 < 6.0 mg/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. Methods 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 18 years 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 < 6.0 mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Conclusion Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.",
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AU - Rashid, Nazia

AU - Chang, John M.

AU - Levy, Gerald D.

AU - Kerimian, Artak

AU - Low, Kimberly J.

AU - Redden, David T.

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AU - Curtis, Jeffrey R.

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N2 - Background 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 < 6.0 mg/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. Methods 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 18 years 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 < 6.0 mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Conclusion Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients.

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