Funding for this research was provided by:
Agency for Healthcare Research and Quality (R01HS025071)
National Institute of Nursing Research (K24NR018621)
Received: 1 September 2020
Accepted: 13 October 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: This protocol has been approved by the Institutional Review Board of Columbia University (IRB-AAAQ9957) with written informed consent. Study participants complete a written informed consent prior to participation in research activities. Current protocol version: September 4, 2019. Any modifications to the protocol are submitted to and approved by the IRB prior to implementation. Spontaneously reported adverse events and unintended effects of the trial are tracked by the study Principal Investigators and reported to the IRB. This study is monitored by a Data Safety and Monitoring Board (DSMB), the composition of which may be obtained from the study principal investigator. No criteria for discontinuing or modifying the intervention or trial stopping rules were defined for this study.
: Not applicable.
: The authors declare that they have no competing interests.