The 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
The 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
The NIH Collaboratory is partnering with the IMPACT Collaboratory to offer a pre-conference workshop on December 13 at AcademyHealth’s 14th Annual Conference on the Science of Dissemination and Implementation in Health.
The workshop, Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials, will provide an introduction to investigative opportunities for pragmatic clinical trials embedded in healthcare systems, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy.
The workshop is being offered free to conference attendees but requires a separate registration. The workshop will provide strategies for integrating implementation research methods in the design and conduct of ePCTs. Speakers will share firsthand experiences and case studies from the NIH Collaboratory and the IMPACT Collaboratory.
The learning objectives of the workshop include:
To identify key areas of synergy between ePCTs and implementation research
To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse healthcare systems, and to describe opportunities for integrating implementation research methods into ePCTs
To increase the capacity of health services researchers to address important clinical questions with ePCTs and implementation research methods
CONFERENCE DETAILS AND REGISTRATION
14th Annual Conference on the Science of Dissemination and Implementation in Health: Broadening Horizons for Impact: Incorporating Multisectoral Approaches into D&I Science
December 13, 2021
The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.
In this Friday’s session—“Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?”—Dr. David Chambers of the National Cancer Institute (NCI) will facilitate a discussion about lessons from implementation science for maximizing participant diversity in pragmatic clinical trials. Dr. Chambers is deputy director for implementation science in the Office of the Director in the NCI’s Division of Cancer Control and Population Sciences.
The panelists will include:
Dr. Amanda Midboe of the US Department of Veterans Affairs, chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory
Dr. Anne Trontell, associate director in the Clinical Effectiveness and Decision Science Program at the Patient-Centered Outcomes Research Institute (PCORI)
The Grand Rounds session will be held on Friday, July 16, at 1:00 pm eastern. Join the online meeting.
Other upcoming sessions in the diversity workshop series include:
AcademyHealth is accepting abstracts for the 14th Annual Conference on the Science of Dissemination and Implementation in Health until July 27, 2021. This year’s meeting will be held virtually from December 14 to 16.
Read the complete call for abstracts.
The theme of this year’s virtual online meeting is “Broadening Horizons for Impact: Incorporating Multisectoral Approaches into D&I Science.” The annual conference is cohosted by the NIH and AcademyHealth with the goal of realizing “the full potential of evidence to optimize health and health care by bridging the gap between research, practice, and policy.”
Douglas Zatzick, MD Professor of Psychiatry & Behavioral Sciences Harborview Level I Trauma Center University of Washington School of Medicine, Seattle
Topic
The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results
Keywords
Pragmatic clinical trials; Implementation Science; Healthcare policy; TSOS; Effectiveness research; Longitudinal health care
Key Points
Combining Implementation Science theories with results from pragmatic clinical trials may be useful to target changes in healthcare policy and reduce the 17 year lag on translation from research to practice.
TSOS is a hybrid pragmatic clinical trial studying the effect of PTSD screening and implementation of screening procedures in healthcare systems.
TSOS study sites that implemented the study interventions better showed significant positive results in the experimental group as compared to the control group.
The results of the TSOS study have prompted the American College of Surgeons to require psychological sequelae screening in trauma centers nationally.
Discussion Themes
Healthcare systems want to see beneficial changes from pragmatic clinical trials implemented more quickly.
To quickly implement procedures from a pragmatic clinical trial, we need a trial design that is feasible and easy to implement into clinical care and easy to incorporate into health care systems.
The focus should be on implementing the possible changes that you know you can get done in order to start a cascade of changes going forward.
A new section of the Living Textbook’s Dissemination and Implementation chapter describes how the Trauma Survivors Outcomes & Support (TSOS) pragmatic trial research team developed a rapid approach to implementation process assessments: the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE). Implementation assessments are typically time consuming and expensive, and the new approach embeds these procedures as part of the trial to increase efficiency and decrease cost.
Since its development within the NIH Health Care Systems Research Collaboratory, the RAPICE method has been used to address the Washington State COVID-19 outbreak to help rapidly identify primary and secondary COVID-19 prevention strategies that could be delivered using the TSOS care management platform.
Guest Moderator Wendy Weber, ND, PhD, MPH Branch Chief, Clinical Research in Complementary and Integrative Health Division of Extramural Research National Center for Complementary and Integrative Health, NIH
Panel Jeffrey (Jerry) G. Jarvik, MD, MPH LIRE NIH Collaboratory Trials Professor of Radiology, Neurological Surgery and Health Services Adjunct Professor of Pharmacy and Orthopedics & Sports Medicine Co-Director, Comparative Effectiveness, Cost and Outcomes Research Center Director, UW CLEAR Center for Musculoskeletal Disorders University of Washington School of Medicine
Lynn DeBar, PhD, MPH PPACT NIH Collaboratory Trials Senior Scientist Kaiser Permanente Washington Health Research Institute
Doug Zatzick, MD TSOS NIH Collaboratory Trial Professor, Department of Psychiatry and Behavioral Sciences University of Washington School of Medicine
Vince Mor, PhD PROVEN NIH Collaboratory Trial Florence Pirce Grant University Professor and Professor of Health Services, Policy and Practice Brown University School of Public Health
Topic
Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Experiences from the Collaboratory PCTs
Lessons and experiences from the NIH Collaboratory Trials include:
Pilot the intervention at the partnering health systems and work closely with site programmers who know the systems best.
Monitor the trial’s implementation at regular intervals to detect breakage.
Keep both the intervention and the outcomes as simple as possible.
Choose endpoints that matter to patients and providers and that are captured reliably as part of routine clinical care.
Enabling rapid outcome ascertainment in large pragmatic trials can be a game changer.
The Emergency Department Information Exchange (EDIE) in Washington state is an innovative technology platform that can help with the collection of population-level administrative data for acute care follow-up and ongoing care plans.
It might be better to uncouple some types of patient-reported outcome (PRO) data collection from the routine clinical care visit.
Discussion Themes
A common theme throughout all the NIH Collaboratory Trial PCTs is how dynamic and ever-changing health care delivery settings are. The reality is that the trial as planned is often not the trial as piloted or conducted.
What type of education is most effective about how to use a PRO to inform care plans and decision-making?
There is nothing like a crisis (eg, the coronavirus pandemic) for people to do things that were before thought impossible. Now, the concept of a “visit” is changing, and there will likely be more uncoupling.
The NIH published 3 new funding opportunity announcements to support innovative approaches to the implementation of evidence-based interventions and the de-implementation of ineffective interventions. The announcement also encourages studies that advance dissemination and implementation research methods. The 3 funding opportunities are as follows: