JMIR Publications

ABSTRACT

Background:

The SARS-2-coronavirus (aka covid-19) pandemic caused disruptions in ongoing clinical trials and likely accelerated interest in conducting research studies remotely.

Objective:

A quasi-experimental, mixed method approach was utilized to examine the opinions and experiences of participants enrolled in an on-going clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or phone conferencing due to the covid-19 pandemic.

Methods:

For quantitative comparisons we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, covid-19 cohort) to a comparable cohort of participants followed over a similar time period in calendar years 2018 & 2019 (n=51, pre-covid-19 cohort) to examine rates for completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from “in-person” to “remote visits”.

Results:

Participants in the covid-19 cohort completed an average of 83.6% of remote clinic visits, which was not significantly different than the in-person completion rate of 89.8% in the pre-covid-19 cohort. Participants in the covid-19 cohort returned an average of 93.2% of salvia specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100%) in the pre-covid-19 cohort. Two broad themes emerged from the qualitative data: 1) the benefits of remote visits and 2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most expressed a willingness to engage in remote visits in the future.

Conclusions:

Even in the context of a rapid transition from in-person to remote visits necessitated by the covid-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes might impact study outcomes. Clinical Trial: This research was supported in part by the National Cancer Institute (R01 CA206193); additional research infrastructure support was provided by the National Center for Advancing Translational Sciences/NIH (UL1TR001412) to the University at Buffalo.