How trials units can use online resources to communicate with hospital sites during a pandemic

Overview 

Working remotely means that more site communication activities such as Site Initiation Visits (SIV), training and information sharing will now be done virtually. 

Online Resources

There are lots of useful online resources that you can use to help you communicate with your sites, including:

• Visual training such as videos using websites such as...
• Slideshows/ Presentations using PowerPoint of Canva.
• Infographics created using Canva.
• Downloadable copies pack.
• Trello board with all of the relevant information on.
• Storyboard of the process.
• Timeline of the trial.
• Site files.

Top tip: When hosting an online meeting via Microsoft Teams or Zoom, make sure to send the slides around beforehand and then ask the hospital team what their thoughts were. Any questions etc. DO NOT read off of the slides or from the protocol! 

Communication

During set up, it is important to have more frequent catch up meetings, provide the sites with regular updates via email and hold an SIV to ensure the group understand the purpose of the trial. 

During recruitment it is important to have an oversight of schedules, hold catch up meetings at key milestones, connect with the site/ check in with them. To do this, you could create a study Whatsapp group (with clear rules of engagement).

During the trial

• Remember not to bombard the hospital sites with emails. 
• Talk to sites beforehand so you know whether they have the time capacity to complete your request.
• Ensure they have all of the equipment to participate in remote meetings. 
• Remote monitoring visits

 Remote Site Initiation Visit (SIV) experience

Ivy Raymundo , ORiF Trial Manager remote SIV experience

Due to the COVID-19 lockdown and strict hospital visiting restrictions, the ORiF study has performed a number of remote Site Initiation Visits (SIVs) and refresher training. Having previously only travelled to hospital sites to perform SIVs face-to-face, I felt a slight change in approach was needed with virtual visits. My main concern was how video-conferencing would affect my interaction with the site teams during the meeting. For example, when sharing slides in Microsoft Teams you cannot see any of the attendees on screen and therefore, unlike in a face-to-face setting, are unable to gauge the level of engagement with the information you are presenting. Have they zoned out or been lulled to sleep? Has anyone dropped off the call due to technical issues? These are the thoughts that often run through my head while presenting.  

My tips for preparing for a remote SIV include:

1. Bear in mind there may be issues with WiFi and internet speeds at different hospitals. Some site staff may not have access to laptops, webcams or have the luxury of a private office/conference room to call in from. Allocate enough time at the beginning of the meeting to iron out any technical issues. Ask everyone at the start of the call if they are comfortable with having their cameras on (so that names can be put to faces) and, depending on the size of the group, it may be necessary to set some rules around muting and the using the virtual ‘hand up’ function for any questions.   
2. Although it’s good practice to do this even for face-to-face SIVs, ensure you send the site teams copies of the following in advance of the meeting: the trial protocol, other key trial documents and SIV presentation – especially crucial, in case they are unable to see your screen in the meeting for any reason. Ask attendees to try and review them ahead of time and to come prepared with any questions. This will encourage active discussion throughout the meeting.
3. More than ever with a virtual meeting, try to avoid ‘death by PowerPoint.’ Remember that, while it’s important for you to appropriately train the site team on the trial, there is value in getting to know the them and the ins and outs of how they plan to deliver the trial.  Again, this also encourages interaction and shows you are interested in getting to know them.
4. Depending on your trial, use interactive resources where possible (e.g. a video demonstration of the intervention) to mix up the presentation format.  
5. The level of site engagement during the meeting can vary massively. For quieter teams, periodically encourage discussion and ask them questions throughout the meeting – not just at the end. When someone is speaking, un-share your screen for a moment so you can engage with them virtually ‘face-to-face.'

JAMES VAN SANTEN, CPINBOSS TRIAL COORDINATOR REMOTE SIV EXPEREINCE

Due to limited funding, CPinBOSS has always conducted SIVs remotely. Pre-COVID, all SIVs were conducted over the phone which has many hurdles. First of all, I couldn’t gauge site reactions to the presentation and I couldn’t place a face to a name. The level of interaction and discussions massively varied between sites and I could definitely notice which site were more invested in the study by the volume of questions asked. It feels very strange to present over the phone when the other end of the line is silent throughout.

One benefit of COVID is the addition of Microsoft Teams. This meant that I could put a face to a name (which I like to do), see if they are connected during the presentation and identify if they are not sure about any items on the slides. I would never go back to telephone SIVs, but overall I would prefer face-to-face SIVs for sure!

The key points I try to do before/during a remote SIV are:

• It may sound obvious, but ensure that all members of the Site team are included in the Teams invite. It is quite easy to miss someone out and that makes for an awkward start to the meeting!
• Send the SIV slides at least a week before to all members of the Site team. This provides each member of the team with time to read through the slides, understand the study a little more and jot down any questions they might have. The best SIV I had was when the PI and physio actually ran through the presentation for me and I took a back seat and answered any questions they had. They have also been one of the better engaged sites which is not a surprise!
• Send over the Investigator Site File (ISF) prior to the SIV so they have this to hand during the call. I could then highlight where things were located in the ISF and which bits needed to be competed from our perspective.
• During the presentation, always pause at the end of each slide and ask if they have any questions. This is always slightly awkward (especially over the phone) as most of the sites have no questions. You can guarantee these sites will then have plenty of questions when actually running the study.
• Try and have a discussion either before or after the presentation to try and get to know the team a little. This might not be appropriate as some Principle Investigators need to leave but is beneficial to get a good early rapport with the Research Nurses and members of the team.

There are definite pros and cons to remote SIVs. The pros include saving money, save time on travel, easy to set up as you don’t need everyone in the same room. The cons are that it can be harder to build a good rapport with the team remotely and it is more difficult to gauge reactions to the presentation.