Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study
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
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| Veröffentlicht in: | Contemporary clinical trials 2016-09, Vol.50, p.106-115 |
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| container_title | Contemporary clinical trials |
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| creator | 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. |
| description | 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 |
| doi_str_mv | 10.1016/j.cct.2016.07.019 |
| format | Article |
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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.</description><identifier>ISSN: 1551-7144</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2016.07.019</identifier><identifier>PMID: 27449546</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Allopurinol ; Allopurinol - therapeutic use ; Ambulatory Care - organization & administration ; Automation ; Dose titration ; Gout ; Gout - blood ; Gout - drug therapy ; Gout Suppressants - therapeutic use ; Humans ; Patient Education as Topic ; Pharmacists - organization & administration ; Randomized trial ; Research Design ; Serum urate ; Telephone ; Uric Acid - blood</subject><ispartof>Contemporary clinical trials, 2016-09, Vol.50, p.106-115</ispartof><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-e6338616ae0363df3fb34099a4b6e03d748be77f4149a071feb4285e26a3ba673</citedby><cites>FETCH-LOGICAL-c451t-e6338616ae0363df3fb34099a4b6e03d748be77f4149a071feb4285e26a3ba673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.cct.2016.07.019$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,315,781,785,886,3551,27928,27929,45999</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27449546$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Coburn, Brian W.</creatorcontrib><creatorcontrib>Cheetham, T. Craig</creatorcontrib><creatorcontrib>Rashid, Nazia</creatorcontrib><creatorcontrib>Chang, John M.</creatorcontrib><creatorcontrib>Levy, Gerald D.</creatorcontrib><creatorcontrib>Kerimian, Artak</creatorcontrib><creatorcontrib>Low, Kimberly J.</creatorcontrib><creatorcontrib>Redden, David T.</creatorcontrib><creatorcontrib>Bridges, S. Louis</creatorcontrib><creatorcontrib>Saag, Kenneth G.</creatorcontrib><creatorcontrib>Curtis, Jeffrey R.</creatorcontrib><creatorcontrib>Mikuls, Ted R.</creatorcontrib><title>Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>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.</description><subject>Allopurinol</subject><subject>Allopurinol - therapeutic use</subject><subject>Ambulatory Care - organization & administration</subject><subject>Automation</subject><subject>Dose titration</subject><subject>Gout</subject><subject>Gout - blood</subject><subject>Gout - drug therapy</subject><subject>Gout Suppressants - therapeutic use</subject><subject>Humans</subject><subject>Patient Education as Topic</subject><subject>Pharmacists - organization & administration</subject><subject>Randomized trial</subject><subject>Research Design</subject><subject>Serum urate</subject><subject>Telephone</subject><subject>Uric Acid - blood</subject><issn>1551-7144</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kd2O0zAQhSMEYpeFB-AG-XL3IsWOf9IICamq-Fmp0lYLvbYmyaR1ldjFdroqL8Lr4rbLCm648mjmO8djnyx7y-iEUabebydNEydFKie0nFBWPcsumZRVXlBOn59qlpdMiIvsVQhbSrmSSr7MLopSiEoKdZn9uodonIUeCdiWtBjM2hLXkbhB4lPLDeYntgT30I8n9DgES2ZDPfYQnT-QOXgkyw34ARoTYr5I_K2N6PdoT4royN0umqMTWXmISBbuAb2xa7KEuHmAQyDX97Nhma-WN-RbHNvD6-xFB33AN4_nVbb6_On7_Gu-uPtyO58t8kZIFnNUnE8VU4DpbbzteFdzQasKRK1Sqy3FtMay7AQTFdCSdViLYiqxUMBrUCW_yj6efXdjPWDbpI099HrnzQD-oB0Y_e_Emo1eu72WlEvFZDK4fjTw7seIIerBhAb7Hiy6MWg2LXhCi1IllJ3RxrsQPHZP1zCqj4HqrU6B6mOgmpY6BZo07_7e70nxJ8EEfDgDmH5pb9Dr0Bi0DbbGYzJrnfmP_W9aQ7O-</recordid><startdate>20160901</startdate><enddate>20160901</enddate><creator>Coburn, Brian W.</creator><creator>Cheetham, T. Craig</creator><creator>Rashid, Nazia</creator><creator>Chang, John M.</creator><creator>Levy, Gerald D.</creator><creator>Kerimian, Artak</creator><creator>Low, Kimberly J.</creator><creator>Redden, David T.</creator><creator>Bridges, S. Louis</creator><creator>Saag, Kenneth G.</creator><creator>Curtis, Jeffrey R.</creator><creator>Mikuls, Ted R.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20160901</creationdate><title>Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-e6338616ae0363df3fb34099a4b6e03d748be77f4149a071feb4285e26a3ba673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Allopurinol</topic><topic>Allopurinol - therapeutic use</topic><topic>Ambulatory Care - organization & administration</topic><topic>Automation</topic><topic>Dose titration</topic><topic>Gout</topic><topic>Gout - blood</topic><topic>Gout - drug therapy</topic><topic>Gout Suppressants - therapeutic use</topic><topic>Humans</topic><topic>Patient Education as Topic</topic><topic>Pharmacists - organization & administration</topic><topic>Randomized trial</topic><topic>Research Design</topic><topic>Serum urate</topic><topic>Telephone</topic><topic>Uric Acid - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Coburn, Brian W.</creatorcontrib><creatorcontrib>Cheetham, T. 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Louis</creatorcontrib><creatorcontrib>Saag, Kenneth G.</creatorcontrib><creatorcontrib>Curtis, Jeffrey R.</creatorcontrib><creatorcontrib>Mikuls, Ted R.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Contemporary clinical trials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Coburn, Brian W.</au><au>Cheetham, T. Craig</au><au>Rashid, Nazia</au><au>Chang, John M.</au><au>Levy, Gerald D.</au><au>Kerimian, Artak</au><au>Low, Kimberly J.</au><au>Redden, David T.</au><au>Bridges, S. Louis</au><au>Saag, Kenneth G.</au><au>Curtis, Jeffrey R.</au><au>Mikuls, Ted R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study</atitle><jtitle>Contemporary clinical trials</jtitle><addtitle>Contemp Clin Trials</addtitle><date>2016-09-01</date><risdate>2016</risdate><volume>50</volume><spage>106</spage><epage>115</epage><pages>106-115</pages><issn>1551-7144</issn><eissn>1559-2030</eissn><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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27449546</pmid><doi>10.1016/j.cct.2016.07.019</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1551-7144 |
| ispartof | Contemporary clinical trials, 2016-09, Vol.50, p.106-115 |
| issn | 1551-7144 1559-2030 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Allopurinol Allopurinol - therapeutic use Ambulatory Care - organization & administration Automation Dose titration Gout Gout - blood Gout - drug therapy Gout Suppressants - therapeutic use Humans Patient Education as Topic Pharmacists - organization & administration Randomized trial Research Design Serum urate Telephone Uric Acid - blood |
| title | Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study |
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