Patient Protocol Engagement Toolkit

Legal Considerations:

• HIPAA compliance considerations—photo releases/policy, use of first names only
• Data privacy law considerations

Flow of the Meeting:

• Proposed agenda items: Welcome, Introductions, Overview/Purpose of Engagement, Meeting Format & Ground Rules
• Provide a clear purpose for the engagement
• Allow room in the agenda for general discussion time with patients. If time allotted during the engagement does not allow for this, consider a pre-engagement interaction to allow patients to discuss general topics in advance
• Consider methods that will enhance open discussion, such as ice-breaker exercise, dropping titles and using first names, giving the patients the opportunity to share their personal disease journey

Number of participants—the ratio of patients vs. sponsor staff. Ensure a patient-friendly session: The patient engagement planning stage is your first opportunity to engage with patients—to be patient-centric. Ask them what they need! Patients are people: Identify if there are specific participant needs that should be accommodated during the engagement. For example:

• For patients with IBD, ensure that restrooms are located near the meeting room
• For patients with lupus, start the meeting later in the day and allow several breaks
• Understand if patients have any dietary restrictions, ambulatory restrictions, etc

The atmosphere should be comfortable and casual. Engagement sessions should be appropriate in length with frequent breaks

• When creating agenda, consider the patients’ need to “share their story” and experience
• Ensure sufficient time is built into the agenda to have appropriate interactions (every interaction is an opportunity to learn from the patients)

Consider providing pre-read materials to the patient engagement participants.

• Agenda, Informed Consent document, example of questions that will be asked, example of patient recruitment materials.

LOCAL CONSIDERATIONS

• Consider regional government, Health Authority and/or sponsor internal policies around recording/videotaping patient interactions. Ensure these are noted in the informed consent form
• Consider the impact of individual patient environments such as privacy needs/ability, technology demands/bandwidth
• Consider translation needs (both written and verbal) based on familiarity with engagement type and cultural expectations. Be sure to account for time and cost of a translator/translation services.

Timing Considerations

• Understand time zone differences amongst participants
• Understand your participants’ specific (disease-related) needs to determine total engagement time and breaks
• Consider the best day & time to host a virtual meeting based on patient participant and caregiver availability
• Consider limiting virtual engagements to no longer than 2 hours/session, inclusive of breaks, in order to reduce the potential for virtual meeting fatigue/distraction

PLANNING CONSIDERATIONS

• Maximize the meeting experience by integrating activities to boost engagement (e.g., live polling, breakout sessions, etc.)
• If utilizing a 3rd party vendor to manage the virtual engagement, understand the following information about the virtual platform:
  • name of virtual platform being utilized
  • privacy/security provided
  • platform features (e.g., chat, polling, raising hand, etc.)
  • the type of technical support included
  • whether everyone can access the platform being used (e.g., some sponsors can’t use certain platforms
• Attendees
  • Setup an effective environment for patients to focus on sharing their opinions
  • Limit multi-tasking
  • Ask everyone to be on mute when not talking
  • Test your technology prior to the meeting
• Sponsor Coordinators/Facilitators
  • Have one person available to manage any connection difficulties with patients/caregivers on day of meeting
  • Identify 1 to 2 active team members to lead the virtual PAB (cameras on, microphone off mute)
• Consider keeping sessions to under 12 patients maximum to allow for robust discussion
• Understand if the participating patients are clinical study alumni or first-time participants. It’s important to foster continuous interaction among participants without biasing the thoughts of another.
• Avoid putting too many topics into one virtual session
• Encourage discussion, avoid just a Q&A
• When preparing the role list for the engagement, include a PC screen operator and technical support person
• Consider providing participants a hard copy of meeting materials to follow during the virtual session
• Provide the option to test the technology before the meeting. For additional technology items and to setup the meeting for success, see Technology Considerations in next section.

TECHNOLOGY CONSIDERATIONS

• Conduct dry-runs (rehearsals) with sponsor team including location of any speakers to test for noise, interference, and connectivity.  Practice hand-offs between speakers
• Conduct technology and connectivity tests (pre-meeting). If possible, include the patients to:
  • Provide ways to connect, such as meeting platform link and call-in information
  • Confirm device/wi-fi availability
  • Get them comfortable with technology and meeting structure
  • Introduce the purpose of the meeting and provide an opportunity for questions
  • Build initial relationships among the patients
• Ensure you have technical support before and DURING the engagement
• Consider additional technology support materials and resources to help patients manage the virtual interaction, such as step-by-step instructions on how to get into the virtual platform with tips on a successful experience
• Consider accessibility of tools needed by patients, sponsors, and vendors (if applicable) for virtual events
• Consider a mixed group of tech-savvy and naive patients for any study technology
• Consider physical/cognitive abilities and home environments
• Ensure audio technology functions properly.  Video may be less of a priority
• Mute any presenters who are not talking to reduce background noise and distractions
• Consider a slide loop with things to think about to support a successful interaction as attendees join – to minimize time spent in the meeting
• Consider how multiple participants can give feedback and how they can react to each other
• Provide alternative ways to connect to the meeting (i.e., dial-in number)

OTHER CONSIDERATIONS (DAY OF PATIENT ENGAGEMENT):

• Make it easy for attendees to join – the day of the event, resend the link so people don’t have to go searching through their email inboxes.
• Have team members and participants join in advance of the start of the meeting (recommended 10-15 minutes early)
• Have someone monitor the participant interactive features, such as raise hand or chat, to allow for robust engagement and inclusive discussions.
• Be cognizant of looking at the camera lens while speaking, to provide a more personal interaction experience.
• Consider using a pointer feature when reviewing slide material for participants to follow.
• Consider whether materials shared can be viewed by all appropriately. Consider participants’ internet speed, delaying the presentation slides on some participants’ screens.

Patient Engagement Lead/Project Manager: someone to drive the planning and execution of the patient engagement activity

Subject Matter Expert in Patient Engagement: sponsor company advisor

Study Team Member(s): ensure the ratio of patients vs. team members is appropriate

Patients: via a patient advocacy organization

Moderator/Facilitator/Interviewer:

• Find an experienced moderator who knows how to engage participants and can bring out relevant patient experience, can explain concepts and goals in digestible terms, and can facilitate patient engagement in a controlled, meaningful, and balanced manner

Meeting Scribe: for taking notes/recording feedback during engagement and collating patient feedback/raw data

Translator and/or Interpreter

Other roles, as applicable