DURATION |
AGENDA TOPIC
|
SPEAKERS
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GOALS |
8:00-8:50 am (50 min)
|
What are Embedded Pragmatic Clinical Trials (ePCTs)?
|
Wendy Weber
|
- Welcome and introduction of agenda and objectives
- Identify key considerations in the design and conduct of ePCTs and how they differ from explanatory trials
- Learn about the advantages and disadvantages of ePCTs, when a pragmatic approach can be used to answer the research question
- Q & A with attendees
|
8:50-9:30 am (40 min)
|
Engaging Stakeholders & Aligning with Health System Partners |
Emily O’Brien |
- Describe the breadth of stakeholders to engage as partners and approaches for engaging them through all phases of the study
- Understand the real-world priorities and perspectives of healthcare system leaders and how to obtain their support
- Identify engagement practices to obtain patient and community perspectives
- Highlight challenges of partnering with diverse healthcare systems
- Q & A with attendees
|
9:30-10:00 am (30 mins)
|
Objectives and Trial Design: An Overview of Hybrid Designs |
Patrick Heagerty
|
- Overview of the 3 types of effectiveness-implementation hybrid trial designs and when they may be appropriate for ePCTs
- Q & A with attendees
|
10:00-10:30 am (30 min)
|
Measuring Outcomes |
Emily O’Brien |
- Describe methods for measuring outcomes using data sources such as electronic health records (EHRs) and patient-reported outcomes (PROs)
- Discuss the integration of a health equity lens in evaluating outcomes
- Q & A with attendees
|
10:30-10:45 am (15 min)
|
Break
|
|
- Networking among attendees and presenters
|
10:45-11:55 am (70 min)
|
ePCT Design and Analysis
|
Patrick Heagerty
|
- Learn about cluster randomized and stepped-wedge study designs
- Recognize the analytical challenges and trade-offs of pragmatic study designs, focusing on what principal investigators (PIs) need to know
- Q & A with attendees
|
11:55 am- 12:55 pm (60 min)
|
ePCTs in Context: Panel Discussion with Collaboratory Demonstration Project PIs |
Moderator: Kevin Weinfurt
Panel: Arne Beck (GGC4H) Michael Ho (Nudge) Miguel Vazquez (ICD-Pieces) |
- Introduce PIs of 4 ongoing ePCTs to reflect on the morning topics and discuss challenges, solutions, lessons learned, and how they leveraged networks and resources to support trial success
- Q & A with attendees
|
12:55-1:40 pm (45 min)
|
Lunch |
|
- Networking among attendees and presenters
|
1:40-2:10 pm (30 min)
|
Pilot & Feasibility Testing |
Wendy Weber |
- Identify approaches to evaluating the capabilities of the partner healthcare system and testing key elements of various types of interventions
- Q & A with attendees
|
2:10-2:40 pm (30 min)
|
Ethical & Regulatory Oversight Considerations |
Stephanie Morain
|
- Learn about the regulatory and ethical challenges of conducting ePCTs
- Discuss unique needs of historically underrepresented and mistreated groups
- Q & A with attendees
|
2:40-2:55 pm (15 min)
|
Break |
|
- Networking among attendees and presenter
|
2:55-3:35 pm (40 min)
|
Writing a Compelling Grant Application |
Beda Jean-Francois
|
- Learn how to develop a compelling ePCT application
- Tips from Collaboratory PIs
- Q & A with attendees
|
3:35-4:35 pm (60 min)
|
ePCTs in Context: Panel Discussion with Collaboratory Demonstration Project PIs |
Moderator: Kevin Weinfurt
Panel: Arne Beck (GGC4H) Michael Ho (Nudge) Miguel Vazquez (ICD-Pieces)
|
- Introduce PIs of 4 ongoing ePCTs to reflect on the afternoon topics and discuss challenges, solutions, lessons learned, and how they leveraged networks and resources to support trial success
- Q & A with attendees
|
4:35-4:45 pm (10 min)
|
Next Steps |
Kevin Weinfurt |
- Final thoughts from the panelists
- Final Q & A
- Wrap-up including identifying sources for further learning
|