|Changes to research processes||Facilitators and lessons learned|
All study procedures have transitioned to a secure and patient-centered virtual system, including consent, data collection, training and supervision and all follow-ups. E.g.,|
• we are no longer asking participants to mail back signed consent forms during COVID-19.
• Participants are giving verbal consent over the phone and via REDCap™, while research staff is keeping detailed logs of the process, or using e-signatures, depending on the site.
To facilitate this challenge,|
• Materials are sent to participants electronically with some exceptions pending the site-specific context.
• Guided participants via phone and written instructions to ensure a timely and patient-centered approach in sending and receiving consent forms
• Ensuring regular communication with trial participants and checking in with them to make sure they are completing surveys and/or address any questions that they may have.
|Study design and sensitivity analyses||
• Randomizing participants to in-person sessions was no longer acceptable or feasible at most sites|
• Randomization was temporarily modified to suspend in-person sessions and randomize only to telemedicine arms (see Fig. 2)
• Expedited approvals by our statisticians, DSMB, IRBs, and stakeholders|
• Our statistician will conduct sensitivity analyses to examine whether individuals who are exposed to this COVID-19 are potentially different from randomized to the study pre- and post-COVID
We have added the following measures:|
• EQ 5D-5L is used to measure quality of life
• PCL-6 measures trauma symptoms. Participants who have experienced previous trauma may experience exacerbated symptoms during COVID-19
• Treatment preference will be used to examine patient preferences in light of the recent, temporary modification of suspending in-person sessions
• Due to collecting new outcome data after a small group of participants had already been recruited, there will be a small portion of trial participants (n = 28 at baseline; < 2% of overall sample size) who do not have data for the new measures, and this will be accounted for as missing data during statistical analyses.|
• Additional measures will improve the scientific and pragmatic nature of the overall study and its potential implications for assessing these outcomes during COVID-19. These measures will allow us to compare participants’ experience during and after COVID-19.
|Recruitment||In-person recruitment has been paused to uphold recommended social distancing guidelines for both participants and research staff||
• All sites had established referral pathways with psychiatry and OB clinics prior to COVID-19, and once cold-recruitment paused, recruitment continued through those referral pathways.|
• All sites strengthened their referral pathways once in-person recruitment was no longer an option.
|All research staff working remotely||All research staff are working remotely according to institutional guidelines, and have obtained remote access to secure servers||
• The study was considered ‘essential research’ by department and hospital leadership. Redeployment was negotiated with individual sites|
• We ensured all team members had what they needed to work effectively, such as remote access to secure servers, regular check-ins and headphones.
• Treatment providers were instructed (via written instruction and Zoom training) how to securely store their telemedicine sessions on their encrypted laptops and upload to the secured server once they can log in remotely.
• One study site switched from their EMR-based telemedicine platform to using WebEx, as they were facing many technical issues with the former. Using WebEx is easier but required rolling out a new plan and platform for the providers and RAs.