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Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations.
Trials. 2021 Jan 28; 22(1):100.T

Abstract

BACKGROUND

The 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.

METHODS

To 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.

RESULTS

We 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.

CONCLUSIONS

Implementation 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 REGISTRATION

NCT02735707 . Registered on 13 April 2016.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

33509275

Citation

UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. "Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) Trial in a US Health System-lessons Learned and Recommendations." Trials, vol. 22, no. 1, 2021, p. 100.
UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations. Trials. 2021;22(1):100.
UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. (2021). Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations. Trials, 22(1), 100. https://doi.org/10.1186/s13063-020-04997-6
UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) Trial in a US Health System-lessons Learned and Recommendations. Trials. 2021 Jan 28;22(1):100. PubMed PMID: 33509275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations. A1 - ,, Y1 - 2021/01/28/ PY - 2020/08/08/received PY - 2020/12/22/accepted PY - 2021/1/29/entrez PY - 2021/1/30/pubmed PY - 2021/2/9/medline KW - Adaptive trial KW - COVID-19 KW - Clinical trial KW - Coronavirus KW - Platform trial KW - SARS-CoV-2 SP - 100 EP - 100 JF - Trials JO - Trials VL - 22 IS - 1 N2 - BACKGROUND: The 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. METHODS: To 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. RESULTS: We 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. CONCLUSIONS: Implementation 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 REGISTRATION: NCT02735707 . Registered on 13 April 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/33509275/Implementation_of_the_Randomized_Embedded_Multifactorial_Adaptive_Platform_for_COVID_19__REMAP_COVID__trial_in_a_US_health_system_lessons_learned_and_recommendations_ DB - PRIME DP - Unbound Medicine ER -