NIH Collaboratory One-day Workshop

NOW BEING OFFERED VIRTUALLY AT NO CHARGE

Changing Trials for Changing Times:
Essentials of Embedded Pragmatic Clinical Trials Workshop
February 20, 2023
8:00 AM - 4:45 PM



Join workshop by Zoom: https://duke.zoom.us/j/93859922865?pwd=elR4SUZTWW1yRWtWTUxmODJFTWRvdz09
Meeting ID: 938 5992 2865; Passcode: 12345

We are pleased to announce that this workshop will now be available virtually to all conference registrants and all HCSRN members at no charge on the day preceding the HCSRN Annual Conference in Denver. This offering is outside of HCSRN Annual Conference content and workshop hosts have made this decision. This change does not affect HCSRN Annual Conference programming which remains in person.

A dedicated room will be available where you can congregate with the other NIH workshop registrants to attend and interact with the virtual presenters. Due to limited room capacity, please indicate whether you will join in person so that we can better plan for room set up and light refreshments, which will be provided onsite.

The workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), with a particular focus on methods relevant to health services researchers. ePCTs are randomized trials conducted within health care systems and use streamlined procedures and existing infrastructure to answer important medical questions for patients, providers, and health system leaders.

The workshop will provide an introduction to the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented and demonstrate the importance of leveraging networks throughout the course of ePCTs.

Learning Objectives

  1. To clarify the definition of ePCTs and explain their utility.
  2. To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse health care systems.
  3. To increase the capacity of health services researchers to address important clinical questions with ePCTs and to leverage networks and their resources to support trial success.

Agenda

DURATION

AGENDA TOPIC

SPEAKERS

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

CLICK HERE TO REGISTER

Please note this is a separate event from the 2023 Conference.