Contemporary Clinical Trials Communications (Oct 2022)
The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial
- David Pogorzelski,
- Paula McKay,
- Michael J. Weaver,
- Todd Jaeblon,
- Robert A. Hymes,
- Greg E. Gaski,
- Joanne Fraifogl,
- James S. Ahn,
- Sofia Bzovsky,
- Gerard Slobogean,
- Sheila Sprague,
- Gerard P. Slobogean,
- Sheila Sprague,
- Jeffrey Wells,
- Mohit Bhandari,
- Robert V. O'Toole,
- Jean-Claude D'Alleyrand,
- Andrew Eglseder,
- Aaron Johnson,
- Christopher Langhammer,
- Christopher Lebrun,
- Jason Nascone,
- Raymond Pensy,
- Andrew Pollak,
- Marcus Sciadini,
- Gerard P. Slobogean,
- Yasmin Degani,
- Haley K. Demyanovich,
- Andrea Howe,
- Nathan N. O'Hara,
- Heather Phipps,
- Eric Hempen
Affiliations
- David Pogorzelski
- Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Paula McKay
- Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Michael J. Weaver
- Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
- Todd Jaeblon
- Department of Orthopaedics, University of Maryland, University of Maryland School of Medicine, Baltimore, MD, USA
- Robert A. Hymes
- Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA
- Greg E. Gaski
- Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA
- Joanne Fraifogl
- Department of Orthopaedics, The MetroHealth System, Cleveland, OH, USA
- James S. Ahn
- Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA
- Sofia Bzovsky
- Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Gerard Slobogean
- Department of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Sheila Sprague
- Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Corresponding author. 293 Wellington St. N, Suite 110, Hamilton, Ontario, Canada.
- Gerard P. Slobogean
- University of Maryland School of Medicine, Baltimore, MD, USA
- Sheila Sprague
- McMaster University, Hamilton, ON, Canada
- Jeffrey Wells
- Trauma Survivors Network, Falls Church, VA, USA
- Mohit Bhandari
- McMaster University, Hamilton, ON, Canada
- Robert V. O'Toole
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Jean-Claude D'Alleyrand
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Andrew Eglseder
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Aaron Johnson
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Christopher Langhammer
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Christopher Lebrun
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Jason Nascone
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Raymond Pensy
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Andrew Pollak
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Marcus Sciadini
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Gerard P. Slobogean
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Yasmin Degani
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Haley K. Demyanovich
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Andrea Howe
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Nathan N. O'Hara
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Heather Phipps
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Eric Hempen
- University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA
- Journal volume & issue
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Vol. 29
p. 100973
Abstract
Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.
