Journal article
Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations
Trials, v 22(1), 100
28 Jan 2021
PMID: 33509275
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
BackgroundThe Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial is a global adaptive platform trial of hospitalized patients with COVID-19. We describe implementation at the first US site, the UPMC health system, and offer recommendations for implementation at other sites.MethodsTo implement REMAP-COVID, we focused on six major areas: engaging leadership, trial embedment, remote consent and enrollment, regulatory compliance, modification of traditional trial management procedures, and alignment with other COVID-19 studies.ResultsWe recommend aligning institutional and trial goals and sharing a vision of REMAP-COVID implementation as groundwork for learning health system development. Embedment of trial procedures into routine care processes, existing institutional structures, and the electronic health record promotes efficiency and integration of clinical care and clinical research. Remote consent and enrollment can be facilitated by engaging bedside providers and leveraging institutional videoconferencing tools. Coordination with the central institutional review board will expedite the approval process. Protocol adherence, adverse event monitoring, and data collection and export can be facilitated by building electronic health record processes, though implementation can start using traditional clinical trial tools. Lastly, establishment of a centralized institutional process optimizes coordination of COVID-19 studies.ConclusionsImplementation of the REMAP-COVID trial within a large US healthcare system is feasible and facilitated by multidisciplinary collaboration. This investment establishes important groundwork for future learning health system endeavors.Trial registrationNCT02735707. Registered on 13 April 2016.
Metrics
Details
- Title
- Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations
- Creators
- Kelsey Linstrum - CRISMA Ctr, Pittsburgh, PA USAStephanie Montgomery - CRISMA Ctr, Pittsburgh, PA USAKim Basile - CRISMA Ctr, Pittsburgh, PA USADara Stavor - CRISMA Ctr, Pittsburgh, PA USADylan Burbee - CRISMA Ctr, Pittsburgh, PA USAAmanda McNamara - CRISMA Ctr, Pittsburgh, PA USARenee Wunderley - CRISMA Ctr, Pittsburgh, PA USANicole Bensen - CRISMA Ctr, Pittsburgh, PA USAAaron Richardson - CRISMA Ctr, Pittsburgh, PA USAPeter Adams - MACRO Ctr, Pittsburgh, PA USATina Vita - MACRO Ctr, Pittsburgh, PA USAMegan Buhay - MACRO Ctr, Pittsburgh, PA USADenise Scholl - MACRO Ctr, Pittsburgh, PA USAMatthew Gilliam - MACRO Ctr, Pittsburgh, PA USAJames Winters - MACRO Ctr, Pittsburgh, PA USAKaleigh Doherty - MACRO Ctr, Pittsburgh, PA USAEmily Berryman - MACRO Ctr, Pittsburgh, PA USAMehrdrad Ghaffari - UPMC AltoonaMeghan Fitzpatrick - UPMC East, Monroeville, PA USAKavitha Bagavathy - UPMC Jameson, New Castle, PA USAMahwish Hussain - Sisters of Mercy Health SystemChenell Donadee - Sisters of Mercy Health SystemEmily Brant - UPMC Williamsport, Williamsport, PA USAKayla Bryan-Morris - UPMC McKeesportJohn Arnold - UPMC McKeesportBob Reynolds - UPMC McKeesportGregory Beard - UPMC HamotBryan McVerry - UPMC PresbyterianDavid T. Huang - UPMC PresbyterianJanice Dunsavage - UPMC Central PaSalim Saiyed - UPMC Central PaErik Hernandez - UPMC Central PaJohn Goldman - UPMC Central PaCynthia Brown - UPMC Central PaSusan Comp - UPMC Central PaJames Raczek - UPMC Central PaJenny Lynne Morris - UPMC Central PaJesus Vargas - UPMC Central PaDaniel Weiss - UPMC Central PaJoseph W. Hensley - UPMC Central PaErik Kochert - UPMC Central PaChris Wnuk - UPMC Central PaChristopher Nemeth - UPMC Central PaBrent Mowery - UPMC Central PaChristina Hutchinson - UPMC Central PaLauren Winters - UPMC Central PaErin McCreary - UPMC Pharm, Pittsburgh, PA USAElise Martin - UPMC Pharm, Pittsburgh, PA USARyan Bariola - UPMC Pharm, Pittsburgh, PA USAAlex Viehman - UPMC Pharm, Pittsburgh, PA USAJessica Daley - UPMC Pharm, Pittsburgh, PA USAAlyssa Lopus - UPMC Pharm, Pittsburgh, PA USAMark Schmidhofer - UPMC Pharm, Pittsburgh, PA USARachel Sackrowitz - UPMC ICU Serv Ctr, Pittsburgh, PA USAAimee Skrtich - UPMC ICU Serv Ctr, Pittsburgh, PA USATami Minnier - UPMC Wolff Ctr, Pittsburgh, PA USAMary Kay Wisniewski - UPMC Wolff Ctr, Pittsburgh, PA USAKatelyn Mayak - UPMC Wolff Ctr, Pittsburgh, PA USARichard Ambrosino - UPMC eRecord Team, Pittsburgh, PA USASherbrina Keen - UPMC eRecord Team, Pittsburgh, PA USASue Della Toffalo - UPMC eRecord Team, Pittsburgh, PA USAMartha Stambaugh - UPMC eRecord Team, Pittsburgh, PA USAKen Trimmer - UPMC eRecord Team, Pittsburgh, PA USAReno Perri - UPMC eRecord Team, Pittsburgh, PA USASherry Casali - UPMC eRecord Team, Pittsburgh, PA USARebecca Medva - UPMC eRecord Team, Pittsburgh, PA USABrent Massar - UPMC eRecord Team, Pittsburgh, PA USAAshley Beyerl - UPMC eRecord Team, Pittsburgh, PA USAJason Burkey - UPMC eRecord Team, Pittsburgh, PA USASheryl Keeler - UPMC eRecord Team, Pittsburgh, PA USAMaryalyce Lowery - UPMC eRecord Team, Pittsburgh, PA USALynne Oncea - UPMC eRecord Team, Pittsburgh, PA USAJason Daugherty - UPMC eRecord Team, Pittsburgh, PA USAChanthou Sevilla - UPMC eRecord Team, Pittsburgh, PA USAAmy Woelke - UPMC eRecord Team, Pittsburgh, PA USAJulie Dice - UPMC eRecord Team, Pittsburgh, PA USALisa Weber - UPMC eRecord Team, Pittsburgh, PA USAJason Roth - UPMC eRecord Team, Pittsburgh, PA USACindy Ferringer - UPMC eRecord Team, Pittsburgh, PA USADeborah Beer - UPMC eRecord Team, Pittsburgh, PA USAJessica Fesz - UPMC eRecord Team, Pittsburgh, PA USALillian Carpio - UPMC eRecord Team, Pittsburgh, PA USASalim Malakouti - University of PittsburghEdvin Music - CRISMA Ctr, Pittsburgh, PA USADan Ricketts - CRISMA Ctr, Pittsburgh, PA USAAndrew King - University of PittsburghGilles Clermont - College Station Medical CenterRobert Bart - UPMC Hlth Serv Div, Pittsburgh, PA USAOscar Marroquin - UPMC Clin Analyt, Pittsburgh, PA USAKevin Quinn - UPMC Clin Analyt, Pittsburgh, PA USAWilliam Garrard - UPMC Clin Analyt, Pittsburgh, PA USAKyle Kalchthaler - UPMC Clin Analyt, Pittsburgh, PA USADerek Angus - UPMC Off Healthcare Innovat, Pittsburgh, PA USAAlexandra Weissman - College Station Medical CenterDonald Yealy - College Station Medical CenterDavid Barton - College Station Medical CenterNadine Talia - College Station Medical CenterFlorian Mayr - College Station Medical CenterAndrew Schoenling - College Station Medical CenterMark Andreae - College Station Medical CenterVarun Shetty - College Station Medical CenterBrian Malley - College Station Medical CenterChristopher Horvat - College Station Medical CenterChristopher Seymour - College Station Medical CenterTimothy Girard - College Station Medical CenterGhady Haidar - Div Infect Dis, Pittsburgh, PA USAWilliam Bain - College Station Medical CenterIan Barbash - College Station Medical CenterChristopher Franz - College Station Medical CenterGeorgios Kitsios - College Station Medical CenterKaveh Moghbeli - College Station Medical CenterBrian Rosborough - College Station Medical CenterFaraaz Shah - College Station Medical CenterTomeka Suber - College Station Medical CenterRoger Lewis - Berry Consultants, Austin, TX USAMichelle Detry - Berry Consultants, Austin, TX USAAnna McGlothlin - Berry Consultants, Austin, TX USAChristina Saunders - Berry Consultants, Austin, TX USAMark Fitzgerald - Berry Consultants, Austin, TX USAAshish Sanil - Berry Consultants, Austin, TX USAScott Berry - Berry Consultants, Austin, TX USAMeredith Buxton - Global Coalit Adapt Res GCAR, Los Angeles, CA USABrian Alexander - Global Coalit Adapt Res GCAR, Los Angeles, CA USATracie Roberts - Global Coalit Adapt Res GCAR, Los Angeles, CA USASteve Webb - Capital UniversityCameron Green - Capital UniversityColin McArthur - Capital UniversityUPMC REMAP-COVID Grp
- Publication Details
- Trials, v 22(1), 100
- Publisher
- Springer Nature
- Number of pages
- 11
- Grant note
- Amgen, Inc.; Amgen Eisai Inc.; Eisai Co Ltd Operation Warp Speed Breast Cancer Research Foundation Translational Breast Cancer Research Consortium REMAP-COVID US ACTIV-4
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Emergency Medicine
- Web of Science ID
- WOS:000616045300003
- Scopus ID
- 2-s2.0-85133927503
- Other Identifier
- 991021903402404721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Medicine, Research & Experimental