March 5, 2024: Registration Opens for Pragmatic Trials Workshop at SCT 45th Annual Meeting

The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open.

The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on engaging stakeholders and measuring outcomes, including patient-reported outcomes.

The workshop will provide an introduction to the opportunities for embedded healthcare systems research, along with strategies for conducting patient-centered clinical trials that provide real-world evidence necessary to inform improvements in healthcare. The workshop format is as follows:

  • A series of didactic presentations, each with ample time for attendee Q & A with presenters. Firsthand experiences with embedded pragmatic clinical trials and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented. Live polling will be used to encourage attendee interaction around the topics.
  • Small group hands-on learning activity in which attendees work together to problem-solve real challenges encountered in embedded pragmatic clinical trials. A report out from the activity will further support collaborative learning.
  • Interactive, facilitated panel discussion with experienced principal investigators from the NIH Collaboratory Trials.

Goals of the workshop:

  1. To clarify the definition of pragmatic clinical trials embedded in healthcare systems and explain their utility.
  2. To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems.
  3. To increase the capacity to address important patient-centered questions with ePCTs in real-world settings.

The theme of this year’s SCT Annual Meeting is “It Takes a Village: Patient Centered Partnerships in Clinical Trials.” The conference brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.

WORKSHOP DETAILS AND REGISTRATION
Sunday, May 19, 8:00 am-12:00 pm
Boston Marriott Copley Place, Boston, Massachusetts

October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Raising Expectations for D&I Science: Challenges and Opportunities.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 10, 10:00 am-6:00 pm
Gateway Marriott, Arlington, Virginia

September 11, 2023: IMPACT Collaboratory Accepting Applications for Annual Training Workshop

On January 24-25, 2024, the IMPACT Collaboratory will hold its fourth annual virtual Training Workshop entitled Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners.

The 1.5-day virtual workshop features all new material to build a foundation in practical aspects of designing and conducting embedded pragmatic trials in Alzheimer disease and related dementias. The workshop will include a combination of activities, including panel discussions, small group sessions, and networking opportunities with experts in the field.

The IMPACT Collaboratory is inviting applications from early- to midcareer researchers who are seeking to develop competence in designing and conducting pragmatic trials of nonpharmacological interventions embedded in healthcare systems for people living with dementia and their care partners. Applications are due on October 20.

Upon completion of the workshop, participants will be able to:

  • Transmit knowledge about designing and conducting pragmatic trials among people living with dementia and their care partners in healthcare systems that integrates considerations related to estimating sample size requirements and establishing and sustaining key partnerships
  • Problem-solve common challenges in designing and conducting pragmatic trials for people living with dementia and their care partners
  • Apply the acquired knowledge to move their current and future research in pragmatic trials forward, including applying for competitive funding

Successful applicants will be expected to complete selected readings and online training prior to the workshop. All participants are expected to attend and participate in the entire 1.5-day event.

Read more about the Training Workshop and apply today.

More than 5 million Americans are living with Alzheimer disease and related dementias. They are particularly vulnerable to receiving uncoordinated and poor-quality care, which contributes to adverse health outcomes and misuse of resources. The mission of the IMPACT Collaboratory is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.

The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.

July 12, 2023: Workshop Materials Now Available From ‘Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings’

Photo of group discussion at the AcademyHealth WorkshopComplete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings.

The 2-day workshop, held in June at the 2023 AcademyHealth Annual Research Meeting in Seattle, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers. Presenters shared firsthand experiences and case studies from the NIH Collaboratory Trials.

The learning objectives of the workshop included:

  • To clarify the definition of embedded pragmatic clinical trials and explain their utility.
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing these trials within diverse healthcare systems.
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic trials in real-world settings, driving tomorrow’s research outcomes.

Access the complete workshop materials, including slides, speaker biographies, and the full participant guide.

June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

Access the complete workshop materials, including slides and videocast recordings, as well as the keynote presentation by Andrew Bindman, executive vice president and chief medical officer for Kaiser Permanente.

Discussions from each workshop session are summarized below.

Panel 1: How Have Health Systems Made Decisions Based on Evidence Collected in PCTs?

In pragmatic clinical trials, the study interventions are designed to align with healthcare system priorities, infrastructure, and operations, with the goal of easing implementation during the trial and increasing the likelihood that effective interventions will be translated into practice. Yet, in the NIH Collaboratory’s experience, effective interventions are not always adopted into routine practice, and interventions that did not achieve their intended effects sometimes are. Using examples from NIH Collaboratory Trials, panelists discussed reasons why healthcare system leaders might decide to adopt ineffective interventions, such as benefits for subgroups, improvements in secondary trial outcomes, and benefits for staff. Panelists also discussed reasons why healthcare system leaders might not elect to adopt or sustain interventions that were effective, including cost, feasibility, and alignment with policy incentives and other requirements or priorities. Access the complete workshop materials and videocast recordings.

Panelists: Devon Check, Vincent Mor, Lynn DeBar, Kathryn Glassberg, Douglas Zatzick, Eileen Bulger, Susan Huang, Kenneth Sands, Edward Septimus; Moderator: Gregory Simon

Panel 2: How Do We Generate the Right Evidence to Support Decision-Makers?

Researchers and healthcare system leaders who have worked on NIH Collaboratory pragmatic trials emphasized the importance of researchers being well connected to their healthcare delivery systems. Another major theme was the need to communicate usable results to healthcare system leaders, which may not always be reflected in the primary outcomes of traditional clinical trials. Panelists discussed considering composite and secondary outcomes as options during study design while still maintaining scientific rigor. Access the complete workshop materials and videocast recordings.

Panelists: Kenneth Sands, Eileen Bulger, Edward Septimus, Amy Kilbourne, Rosa Gonzalez-Guarda, Patrick Heagerty; Moderator: Hayden Bosworth

Panel 3: Learning Faster

A pragmatic clinical trial can provide generalizable effectiveness data about an intervention that is tested in the real-world settings where patients receive usual clinical care. These trials are at higher risk for failure when the goals of the research and healthcare system operations are not aligned. Panelists discussed implications for data monitoring and the different expectations for fidelity and adherence that may require careful consideration of the rules for modifying or stopping the trial. Careful attention to ethical and regulatory considerations is also important, especially given the dynamic and real-world contexts of pragmatic trials. Access the complete workshop materials and videocast recordings.

Panelists: Gloria Coronado, Natalia Morone, Corita Grudzen, Kevin Chan, Pearl O’Rourke, Cheryl Boyce, Andrea Cook; Moderator: Kevin Weinfurt

Panel 4: Potential Structures and Incentives for Faster Learning

The NIH Collaboratory has facilitated better, faster learning by helping individual pragmatic trials be successful. The Coordinating Center infrastructure helps build relationships and bring peers together to reflect on challenges. It is these types of partnerships that are a critical element of being able to problem solve in a pragmatic trial. Researchers shared that while principal investigators may be hesitant to speak with their trial’s NIH project officer, these conversations can be very productive in finding a way forward when roadblocks occur. Despite incredible efforts by investigators, studies often do not go according to plan. Rather than embracing failing faster, panelists advocated for a philosophy of learning sooner. In some cases, this may mean examining whether continuing a trial represents a good use of funding. Access the complete workshop materials and videocast recordings.

Panelists: George Sopko, David Chambers, Wynne Norton, Tisha Wiley, Kenneth Sands, Edward Septimus, Gloria Coronado, Natalia Morone, Corita Grudzen; Moderator: Richard Platt

May 8, 2023: Pragmatic Trials Workshop Offered at AcademyHealth Conference

Logo for AcademyHealthThe NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day preconference workshop at the 2023 Annual Research Meeting in Seattle, Washington.

The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings,” will cover the essentials of embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Attendees will participate in facilitated, hands-on learning activities and interact with principal investigators of pragmatic clinical trials embedded in healthcare systems, including NIH Collaboratory Trials.

Firsthand experiences and case studies from the NIH Collaboratory will support and illustrate the topics presented and demonstrate how pragmatic trials embedded in real-world settings are driving tomorrow’s outcomes. Speakers will include program officers and senior staff from NIH Institutes, Centers, and Offices and senior investigators from the NIH Collaboratory Trials and the Coordinating Center leadership.

The learning objectives of the workshop include:

  • To clarify the definition of embedded pragmatic clinical trials and explain their utility.
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing these trials within diverse healthcare systems.
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic trials in real-world settings, driving tomorrow’s research outcomes.

Workshop details and registration
Friday, June 23, 2023, 8:15 a.m.-4:25 p.m.
Saturday, June 24, 2023, 8:00 a.m.-12:00 p.m.
Seattle Convention Center
Seattle, Washington

February 9, 2023: Pragmatic Trials Workshop to Be Offered Virtually and Free of Charge to All HCSRN Members and Conference Attendees

HCSRN 2023 logoWe are pleased to announce that our workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will be available virtually and at no charge to all HCSRN Annual Conference registrants and all HCSRN members on the day preceding the conference in Denver. (This offering does not affect HCSRN Annual Conference programming, which will remain in person.)

Click here to register for the workshop.

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 healthcare 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.

For HCSRN Annual Conference attendees, a dedicated room will be available for congregating with other workshop participants and interacting 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.

Review the agenda and bios of the workshop’s expert faculty.

Click here to register.

December 22, 2022: HCSRN Extends Early-Bird Registration Deadline for 2023 Annual Conference

HCSRN 2023 logoThe Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2023 annual conference in Denver, Colorado, to January 9. The discounted registration rate will apply through this date.

The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials.” The workshop will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The opening plenary session of this year’s conference will feature keynote speaker Dr. Abdul Shaikh, population health analytics leader for the worldwide public sector at Amazon Web Services (AWS). New and emerging approaches to using AI/ML, harnessing federated data, and advancing equity-enabled innovation underscore Shaikh’s work.

CONFERENCE & WORKSHOP DETAILS AND REGISTRATION

2023 HCSRN Annual Conference
February 21-23, 2023
Sheraton Denver Downtown, Denver, Colorado

NIH Pragmatic Trials Collaboratory Preconference Workshop
“Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials”
February 20, 2023; 8:00 am-5:00 pm

November 21, 2022: HCSRN Opens Registration, Announces Opening Plenary Speaker

HCSRN 2023 logoThe Health Care Systems Research Network (HCSRN) opened registration and announced the opening plenary speaker for its 2023 annual conference in Denver, Colorado.

This year’s opening plenary session will feature keynote speaker Dr. Abdul Shaikh, population health analytics leader for the worldwide public sector at Amazon Web Services (AWS). New and emerging approaches to using AI/ML, harnessing federated data, and advancing equity-enabled innovation underscore Shaikh’s work.

The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials.” The workshop will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

CONFERENCE & WORKSHOP DETAILS AND REGISTRATION

2023 HCSRN Annual Conference
February 21-23, 2023
Sheraton Denver Downtown, Denver, Colorado

NIH Pragmatic Trials Collaboratory Preconference Workshop
“Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials”
February 20, 2023; 8:00 am-5:00 pm

November 3, 2022: Pragmatic Trials Workshop at 2022 D&I Science Conference Open for Registration

AcademyHealth and NIH logosThe NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic clinical trials and share lessons from implementation science for increasing engagement of diverse participants

The theme of this year’s D&I conference is “(Re)Building Better Systems: Being Proactive, Nimble, and Responsive.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 11, 8:00 am-4:45 pm
Walter E. Washington Convention Center, Washington, DC