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 scrip

SUBMITTER: Pogorzelski D 

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

REPOSITORIES: biostudies-literature