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The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.
Pogorzelski, David; McKay, Paula; Weaver, Michael J; Jaeblon, Todd; Hymes, Robert A; Gaski, Greg E; Fraifogl, Joanne; Ahn, James S; Bzovsky, Sofia; Slobogean, Gerard; Sprague, Sheila; Slobogean, Gerard P; Sprague, Sheila; Wells, Jeffrey; Bhandari, Mohit; O'Toole, Robert V; D'Alleyrand, Jean-Claude; Eglseder, Andrew; Johnson, Aaron; Langhammer, Christopher; Lebrun, Christopher; Nascone, Jason; Pensy, Raymond; Pollak, Andrew; Sciadini, Marcus; Slobogean, Gerard P; Degani, Yasmin; Demyanovich, Haley K; Howe, Andrea; O'Hara, Nathan N; Phipps, Heather; Hempen, Eric.
  • Pogorzelski D; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • McKay P; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • Weaver MJ; Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Jaeblon T; Department of Orthopaedics, University of Maryland, University of Maryland School of Medicine, Baltimore, MD, USA.
  • Hymes RA; Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
  • Gaski GE; Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
  • Fraifogl J; Department of Orthopaedics, The MetroHealth System, Cleveland, OH, USA.
  • Ahn JS; Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.
  • Bzovsky S; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • Slobogean G; Department of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Sprague S; Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • Slobogean GP; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
  • Sprague S; University of Maryland School of Medicine, Baltimore, MD, USA.
  • Wells J; McMaster University, Hamilton, ON, Canada.
  • Bhandari M; Trauma Survivors Network, Falls Church, VA, USA.
  • O'Toole RV; McMaster University, Hamilton, ON, Canada.
  • D'Alleyrand JC; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Eglseder A; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Johnson A; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Langhammer C; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Lebrun C; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Nascone J; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Pensy R; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Pollak A; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Sciadini M; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Slobogean GP; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Degani Y; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Demyanovich HK; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Howe A; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • O'Hara NN; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Phipps H; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
  • Hempen E; University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
Contemp Clin Trials Commun ; 29: 100973, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1982874
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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Contemp Clin Trials Commun Year: 2022 Document Type: Article Affiliation country: J.conctc.2022.100973

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Contemp Clin Trials Commun Year: 2022 Document Type: Article Affiliation country: J.conctc.2022.100973