Dataset Information

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

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.

SUBMITTER: Pogorzelski D

PROVIDER: S-EPMC9384338 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

Pogorzelski David D McKay Paula P Weaver Michael J MJ Jaeblon Todd T Hymes Robert A RA Gaski Greg E GE Fraifogl Joanne J Ahn James S JS Bzovsky Sofia S Slobogean Gerard G Sprague Sheila S Slobogean Gerard P GP Sprague Sheila S Wells Jeffrey J Bhandari Mohit M O'Toole Robert V RV D'Alleyrand Jean-Claude JC Eglseder Andrew A Johnson Aaron A Langhammer Christopher C Lebrun Christopher C Nascone Jason J Pensy Raymond R Pollak Andrew A Sciadini Marcus M Slobogean Gerard P GP Degani Yasmin Y Demyanovich Haley K HK Howe Andrea A O'Hara Nathan N NN Phipps Heather H Hempen Eric E

Contemporary clinical trials communications 20220817

<h4>Background</h4>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 resea ...[more]

PMID: 35989898

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Project description:The COVID-19 pandemic has caused tremendous disruptions to non-COVID-19 clinical research. However, there has been little investigation on how patients themselves have responded to clinical trial recruitment during the COVID-19 pandemic. To investigate the effect of the COVID-19 pandemic on rates of patient consent to enrollment into non-COVID-19 clinical trials, we carried out a cross-sectional study using data from the Nitric Oxide/Acute Kidney Injury (NO/AKI) and Minimizing ICU Neurological Dysfunction with Dexmedetomidine-Induced Sleep (MINDDS) trials. All patients eligible for the NO/AKI or MINDDS trials who came to the hospital for cardiac surgery and were approached to gain consent to enrollment were included in the current study. We defined "Before COVID-19" as the time between the start of the relevant clinical trial and the date when efforts toward that clinical trial were deescalated by the hospital due to COVID-19. We defined "During COVID-19" as the time between trial de-escalation and trial completion. 5,015 patients were screened for eligibility. 3,851 were excluded, and 1,434 were approached to gain consent to enrollment. The rate of consent to enrollment was 64% in the "Before COVID-19" group and 45% in the "During COVID-19" group (n = 1,334, P<0.001) (RR = 0.70, 95% CI 0.62 to 0.80, P<0.001). Thus, we found that rates of consent to enrollment into the NO/AKI and MINDDS trials dropped significantly with the onset of the COVID-19 pandemic. Patient demographic and socioeconomic status data collected from electronic medical records and patient survey data did not shed light on possible explanations for this observed drop, indicating that there were likely other factors at play that were not directly measured in the current study. Increased patient hesitancy to enroll in clinical trials can have detrimental effects on clinical science, patient health, and patient healthcare experience, so understanding and addressing this issue during the COVID-19 pandemic is crucial.

Dataset Information

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

Background

Methods

Results

Conclusion

Publications

The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

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