Patient Protocol Engagement Toolkit

Set Up Patient Engagement
Considerations for Conducting In-Person Patient Engagement
Other Engagement Considerations (Method of Engagement Dependent)
Identify Key Roles
Defining Your Objectives
Refining the Questions to Ask
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Considerations for Conducting In-Person Patient Engagement
Considerations for Conducting In-Person Patient Engagement
Other Engagement Considerations (Method of Engagement Dependent)
Identify Key Roles
Defining Your Objectives
Refining the Questions to Ask

Considerations for Conducting In-Person Patient Engagement

Legal Considerations:
Legal Considerations:
  • HIPAA compliance considerations—photo releases/policy, use of first names only
  • Data privacy law considerations
Flow of the Meeting:
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

Other Engagement Considerations (Method of Engagement Dependent)

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.

Identify Key Roles

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

Defining Your Objectives

Refining the Questions to Ask