Congratulations to Dr. Lynn DeBar and the investigators of the Collaborative Care for Chronic Pain in Primary Care pragmatic trial for recently publishing their study design paper. One of the NIH Collaboratory Demonstration Projects, the trial is designed to test whether a primary care–based behavioral intervention the Pain Program for Active Coping and Training (PPACT)—will provide a “more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment” than usual care for patients on chronic opioid treatment (Debar et al 2018). Learn more about this innovative trial in the article in Contemporary Clinical Trials. You can also download a trial snapshot.
Full Citation: DeBar L, Benes L, Bonifay A, et al. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial. Contemporary Clinical Trials. 2018;67:91-99. doi:10.1016/j.cct.2018.02.015
On February 20-21, 2018, a group of 27 clinical investigators met in Durham to learn from the NIH Collaboratory about the design and conduct of embedded pragmatic clinical trials (ePCTs). Through the experiences of the NIH Collaboratory, much has been learned about how to launch and implement successful ePCTs. The workshop’s goal was to help investigators advance their ePCT research ideas and build a larger community of researchers capable of conducting high-quality ePCTs. Participants from across the country were selected based on a rigorous application process.
“ePCTS hold the promise of an efficient and powerful way to generate evidence. We’ve learned so much through the Collaboratory, but the knowledge is not helpful if we’re not passing it along to other clinical investigators so they can contribute even more evidence to the knowledge base,” said Kevin Weinfurt, PhD, a co-principal investigator of the NIH Collaboratory’s Coordinating Center who helped develop and organize the workshop along with a planning committee.
Representatives from the Coordinating Center, Demonstration Projects, and Core Groups were on hand to provide information, guidance, and lessons learned from their experience with the NIH Collaboratory ePCTs. The topics included an introduction to ePCTs, engaging stakeholders and aligning with healthcare system partners, designing with implementation in mind, design and analytic considerations, regulatory and ethical challenges, measuring outcomes, dissemination, and ePCT team composition. Representatives from the NIH were also in attendance and presented sessions about the importance of pilot and feasibility testing and developing a compelling application for funding. During the workshop, participants completed hands-on exercises and worked through trial design challenges with the experts and their colleagues.
“We’re trying to change the world, and to change the world you need generalizable data and interventions that are scalable. The chasm for implementation of clinical evidence is huge, and PCTs have the capacity to take great interventions and get them to the patients so that they can have impact and improve care,” said Wendy Weber, ND, PhD, MPH, acting deputy director of the National Center for Complementary and Integrative Health (NCCIH), and one of the workshop presenters. “While local improvements can be accomplished through quality improvement activities, if you have outcomes that matter, randomizing interventions and studying them on a large scale can provide the evidence that will make a real difference in the care of people across the United States.”
Another goal of the workshop was to pilot the educational materials and collect feedback on their quality and appropriateness from both attendees and subject matter experts. The Collaboratory Coordinating Center will use the feedback to refine the content for future workshops and educational materials. The NIH Collaboratory’s Living Textbook provided a foundation for much of the workshop, and a host of new information was presented that can be used in future materials and updates to the textbook.
The training was funded as an NIH Roadmap Initiative 3U54AT007748-05S2.
The NIH Collaboratory will soon welcome a new group of Demonstration Projects and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)—to share tips and advice for investigators who are new to ePCTs.
In the spring of 2018, the NIH Collaboratory will be welcoming a new set of Demonstration Projects and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice to the newcomers and other investigators new to conducting pragmatic trials.
“My greatest advice is to gain partners who are operational and have insight into particular areas—whether they be hospitals, or clinics, or nursing homes—who know about how they really work, how to best incorporate the intervention into workflow, how to get the right approvals, and how to get the best information technology support available to them.”—Susan Huang, MD
“One of the key things that we’ve received from being part of the Collaboratory—compared to an R01 grant—is the opportunity to interact across all of the institutes at NIH as well as learn about other projects that are working in pretty diverse health systems, including hospital systems, nursing homes, and dialysis centers.” —Gloria Coronado, PhD
We recently asked Dr. Kevin Weinfurt, Chair of the Patient-Reported Outcomes (PRO) Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. He says the biggest impact of the Core has been working with national initiatives to improve inclusion of PROs in the electronic health record (EHR). Further, Core members have contributed to new knowledge through white papers and chapters in the Living Textbook. In the coming years, he’s hoping the Core will be able to identify the value proposition of PROs.
“Because there are costs associated with collecting PROs, we need to determine when PROS are essential, supporting, or not at all informative for the clinical questions. This gets at the value proposition: When are they of value and to whom?” —Dr. Kevin Weinfurt.
As part of an article published in Annals of Internal Medicine, Dr. Greg Simon created a short video in which he describes concerns related to data sharing and embedded research, as well as potential solutions for those concerns. We recently added this video to the Living Textbook chapter on Data Sharing and Embedded Research. In the chapter, the authors expand on the ideas presented in the Annals article and fame them using lessons learned from the Collaboratory’s Demonstration Projects. Data collected as part of research embedded in a health system comes from a fundamentally different context than stand-alone explanatory trials. When they are taken out of context or used for comparisons, they have the potential to do harm—something that can potentially discourage health systems from volunteering to participate in embedded research. The authors suggest that data sharing plans for embedded research be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.
“Ultimately, it’s a practical question: if we want healthcare providers and healthcare systems to participate in research, we shouldn’t expect them to bear extra risk. In an ideal world, all information about the quality of health care and healthcare outcomes across the country would be completely open to everyone, but we don’t live in that world now. So if we are asking healthcare providers and healthcare systems to open up and be more transparent by participating in research, we certainly would not want to punish those who volunteer.” — Simon et al. in video for Ann Intern Med
In the final segment of their 2-part video interview, Cathy Meyers, MD, and Wendy Weber, PhD, MPH, of the National Center for Complementary and Integrative Health (NCCIH), reflect on challenges experienced during the first 5 years of the NIH Collaboratory program, such as ethical and regulatory issues of pragmatic clinical trials. They also share a few things that surprised them along the way. Dr. Meyers is the NIH Project Scientist for the NIH Collaboratory, and Dr. Weber is the NIH Project Officer.
Thank you, Drs. Meyers and Weber, for sharing your perspectives!
In part 1 of a new 2-part video interview, Cathy Meyers, MD, and Wendy Weber, PhD, MPH, of the National Center for Complementary and Integrative Health (NCCIH), discuss the accomplishments of the NIH Collaboratory in its first 5 years and what to expect in the next phase of the program. Dr. Meyers is the NIH Project Scientist for the NIH Collaboratory, and Dr. Weber is the NIH Project Officer.
Hear more from Drs. Meyers and Weber in part 2 of their interview, which will be posted later this week.
“Try to really learn from others who have done this—even if you are the first one doing your specific trial with your specific questions. It was helpful for us to learn from the other Collaboratory projects; they had already faced some problems, and we were able to anticipate and develop solutions proactively.” – Dr. Miguel Vazquez
In the second installment of a 2-part video interview, former NCCIH Director Josephine Briggs, MD, and former FDA Commissioner Robert Califf, MD, reflect on lessons learned from implementing the NIH Collaboratory’s innovative oversight model and discuss how those lessons can be applied in broader contexts.
We’ll be releasing more video interviews with NIH Collaboratory leadership in the weeks to come – stay tuned!