A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic

Clin Trials. 2021 Aug;18(4):514-517. doi: 10.1177/17407745211011577. Epub 2021 May 20.

Salomeh Keyhani^{1

2}, J Daniel Kelly^{3

4}, Stephen Bent^{1

2}, W John Boscardin^{1

3}, Michael G Shlipak^{1

2

3}, Sam Leonard⁵, Ann Abraham⁶, Emily Lum⁵, Nicholas Lau⁵, Charles Austin⁷, Catherine E Oldenburg^{3

4}, Allan Zillich^{7

8}, Lenny Lopez^{1

2}, Ying Zhang⁹, Tom Lietman^{3

4}, Dawn M Bravata^{10

11

12

13}

¹ Department of Medicine, University of California, San Francisco, CA, USA.
² San Francisco VA Medical Center, San Francisco, CA, USA.
³ Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
⁴ F.I. Proctor Foundation, University of California San Francisco, CA, USA.
⁵ Northern California Institute for Research and Education, The Veterans Health Research Institute, San Francisco, CA, USA.
⁶ UC San Francisco and UC Berkeley Joint Medical Program, San Francisco, CA, USA.
⁷ VA HSR&D Center for Health Information and Communication, Indianapolis, IN, USA.
⁸ Purdue University College of Pharmacy, West Lafayette, IN, USA.
⁹ Department of Biostatistics, College of Public Health University of Nebraska Medical Center, Omaha, NE, USA.
¹⁰ Center for Health Information and Communication (CHIC), Health Services and Development (HSR&D), U.S. Department of Veterans Affairs (VA), Washington, DC, USA.
¹¹ The Department of Medicine, Richard L. Roudebush VA Medical Center; Indianapolis, IN, USA.
¹² Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
¹³ Regenstrief Institute, Indianapolis, IN, USA.

Abstract

The study was registered at clinicaltrials.gov: NCT04363203