Abstract
Background
This update describes changes to the Brief Educational Tool to Enhance Recovery (BETTER) trial in response to the COVID-19 pandemic.
Methods/design
The original protocol was published in Trials. Due to the COVID-19 pandemic, the BETTER trial converted to remote recruitment in April 2020. All recruitment, consent, enrollment, and randomization now occur by phone within 24 h of the acute care visit. Other changes to the original protocol include an expansion of inclusion criteria and addition of new recruitment sites. To increase recruitment numbers, eligibility criteria were expanded to include individuals with chronic pain, non-daily opioid use within 2 weeks of enrollment, presenting musculoskeletal pain (MSP) symptoms for more than 1 week, hospitalization in past 30 days, and not the first time seeking medical treatment for presenting MSP pain. In addition, recruitment sites were expanded to other emergency departments and an orthopedic urgent care clinic.
Conclusions
Recruiting from an orthopedic urgent care clinic and transitioning to remote operations not only allowed for continued participant enrollment during the pandemic but also resulted in some favorable outcomes, including operational efficiencies, increased enrollment, and broader generalizability.
Trial registration
ClinicalTrials.gov NCT04118595. Registered on October 8, 2019.
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Details
1 University of North Carolina at Chapel Hill, Department of Emergency Medicine, Chapel Hill, USA (GRID:grid.10698.36) (ISNI:0000000122483208)
2 Ophirex, Inc., Corte Madera, USA (GRID:grid.10698.36)
3 University of North Carolina at Chapel Hill, Department of Emergency Medicine, Chapel Hill, USA (GRID:grid.10698.36) (ISNI:0000000122483208); University of North Carolina Hospitals, Department of Anesthesiology, Chapel Hill, USA (GRID:grid.429995.a)
4 University of North Carolina at Chapel Hill, Department of Health Policy and Management, Gillings School of Global Public Health, Chapel Hill, USA (GRID:grid.10698.36) (ISNI:0000000122483208)
5 Indiana University, Regenstrief Institute and Department of Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919)
6 Yale University, Departments of Psychiatry, Neurology and Psychology, New Haven, USA (GRID:grid.47100.32) (ISNI:0000000419368710)
7 Elon University, Department of Mathematics and Statistics, Elon, USA (GRID:grid.255496.9) (ISNI:0000 0001 0686 4414)
8 Duke University, Department of Psychology and Neuroscience, Durham, USA (GRID:grid.26009.3d) (ISNI:0000 0004 1936 7961)
9 University of North Carolina at Chapel Hill, Department of Orthopedics, Chapel Hill, USA (GRID:grid.10698.36) (ISNI:0000000122483208)




