May 5, 2018: New Article Explores Opportunities for Funding the Training of Future Health Services Researchers

In a new article, Dr. Vincent Mor, an NIH Collaboratory investigator, and Dr. Paul Wallace describe the history, current status, and opportunities for funding training in health services research (HSR). While the number of organizations seeking to solve problems with health services research has been expanding, direct government support for HSR is declining. The authors project 5 key challenges for the field and its professional development:

  • Formulating and prioritizing research topics
  • Whether to use team- or individual-based approaches
  • How new data sources, analytic methods, and the need for faster results affect supply and demand for HSR
  • Shifts from public to institutional funding and the associated effects on generalizability
  • Balancing proprietary concerns regarding data, predictive models, and study results with the need to improve public health and rapidly disseminate information

According to the authors, sustainable solution will involve active collaboration between those who use HSR as a part of decision-making (and will likely pay for it) and those who produce it.

“We believe that the key change needed to productively address the above challenges will be a closer collaboration between HSR users, especially health systems, and academic HSR training programs to work towards producing timely, internally relevant, and externally generalizable knowledge (Mor and Wallace 2018).”

Dr. Mor is a principal investigator for the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) trial, one of the NIH Collaboratory Demonstration Projects.

Mor V, Wallace P. 2018.  Funding the Training of Future Health Services Researchers. Health Services Research. doi:10.1111/1475-6773.12844.

April 27, 2018: Collaboratory Investigators Pen Editorial Calling for Pragmatic Trials of Nonpharmacologic Dementia Interventions

NIH Collaboratory investigators Dr. Susan Mitchell and Dr. Vincent Mor coauthored an editorial for an upcoming issue of JAMDA highlighting the need for pragmatic trials of nonpharmacologic interventions in Alzheimer disease and related dementias. The editorial summarizes conclusions from a recent workshop at the National Institute on Aging (NIA), where experts discussed the state of the science for pragmatic trials to improve dementia care.

The goals of the NIA workshop were (1) to identify criteria for determining the readiness of dementia interventions for pragmatic trials, and (2) to describe the research infrastructure needed to support such trials.

Read the full editorial: Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop

Drs. Mitchell and Mor are co-principal investigators of the NIH Collaboratory’s Pragmatic Trial of Video Education in Nursing Homes (PROVEN), which is evaluating the effectiveness of advance care planning video tools in nursing home settings. The editorial mentions that a supportive infrastructure for pragmatic research in dementia could be modeled after the NIH Collaboratory’s Coordinating Center, including Core Working Groups “focused on building investigator capacity, supporting pragmatic trial design, and maintaining the resource and knowledge base.”

Full citation: Baier RR, Mitchell SL, Jutkowitz E, Mor V. Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop. J Am Med Dir Assoc. doi: 10.1016/j.jamda.2018.02.011.

April 24, 2018: NIH Collaboratory ePCT Training Workshop Resources Now Available

Interested in learning more about the complexities of designing and conducting embedded pragmatic clinical trials (ePCTs)? Now you can view and download the slide sets and handouts from the first NIH Collaboratory ePCT Training Workshop. Held on February 20-21, 2018, at Duke University, this pilot workshop offered training in the conduct of ePCTs to 27 mid- and senior-level investigators. Also present at the workshop were representatives from the NIH, NIH Collaboratory Demonstration Projects and Core Working Groups, and Coordinating Center staff. NIH Collaboratory subject matter experts used experiences from the program and chapters from the Living Textbook to develop workshop content.

The workshop comprised 10 topics across the 2 days and included hands-on exercises and case studies from the Demonstration Projects illustrating the particulars of designing and conducting ePCTs and providing resources for planning and overcoming challenges. Among the topics covered were Engaging All Stakeholders and Aligning with Healthcare System Partners, Design and Analytic Considerations, Pilot and Feasibility Testing, and Developing a Compelling Application. The NIH Collaboratory will be making additional training resources available to the public in the near future.

The training was funded as an NIH Roadmap Initiative 3U54AT007748-05S2.

April 16, 2018: Registration Now Open for Workshop on Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

Registration is now open for a one-day workshop sponsored by the NIH Common Fund and organized by NIH Collaboratory thought leaders. The workshop, to be held on May 16, will focus on expanding the understanding of a specific type of pragmatic trial, the A vs. B trial, which compares two or more distinct therapeutic medical interventions. Over the past 6 years, the NIH Collaboratory has launched Demonstration Projects that address questions of major public health importance in real-world settings with usual care as a control arm. Much has been learned about the design, conduct, and dissemination of pragmatic clinical trials through this work. As a next step, there is considerable excitement at the prospect of exploring pragmatic clinical trials for comparing medical interventions.

The workshop will include a series of moderated discussions of opportunities and approaches for partnering with healthcare systems, and other stakeholders, to conduct embedded A vs. B trials. Speakers will include representatives from NIH, FDA, OHRP, health systems, academia, and industry.

The workshop will take place from 8:00 AM – 4:15 PM ET on Wednesday, May 16. Participants can join in person at the Bethesda Marriott in Maryland or via webcast. Choose an option for attendance on the registration page.

The organizing committee for the workshop includes Adrian Hernandez & Richard Platt (Co-Chairs), Laura Dember, Susan Huang, Catherine Meyers, Wendy Weber, and Dave Wendler.

 

 

April 13, 2018: PCORI Launches Tool for Exploring Literature on Engagement in Health Research

Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. Articles are included in the database if they describe engagement experiences, report research findings on engagement practices, or present theories, concepts, or views on engagement. The database is updated monthly and is one way PCORI is helping to promote meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process.

Read more information about the explorer tool and how it was developed.

You can also learn more about stakeholder engagement in the Living Textbook chapter.

April 9, 2018: PPACT Study Design Paper Published

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

February 28, 2018: New Meeting Summary Examines How to Integrate Patient‐Reported Health Data for Pragmatic Research

A recently released summary from the ADAPTABLE Roundtable Meeting explores ways to better understand the sets of circumstances and considerations that could guide when and how to gather and integrate patient-reported health data with other data sources in pragmatic trials.

For outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is the unique and privileged source of information. Other patient-reported health data may not have a clear source of truth, such as co-morbidities and hospitalizations. In such cases, patient-reported health data may supplement, contradict, or agree with EHR and claims data. For example, medication data reported by patients might be a more accurate reflection of what patients are actually taking than medication data in the EHR, especially for over-the-counter medications.

Patient-reported health data come from various sources and can be feasibly collected in the conduct of a pragmatic clinical trial, but the optimal approaches for capturing and analyzing these data are unclear. Questions include how to integrate this information with other data collected as part of a study, including data from the EHR.

To better understand patient-reported health data and how to use them in pragmatic trials, 18 experts from 8 institutions convened at the roundtable meeting, coming from a wide variety of backgrounds including biostatistics, epidemiology, oncology, nursing, psychiatry, health policy, and regulation. Representatives from the NIH Collaboratory included Drs. Lesley Curtis and Rachel Richesson from the EHR Core and Dr. Kevin Weinfurt from the Patient-Reported Outcomes Core.

In addition to the meeting summary, two white papers are forthcoming. For more information about using patient-reported data in pragmatic trials, see the Living Textbook Chapter on Endpoints and Outcomes.

This effort was funded by Office of the Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services through a supplement provided to the NIH Collaboratory Coordinating Center.

February 22, 2017: NIH Collaboratory Launches First Embedded Pragmatic Clinical Trial Training Workshop

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.

Wendy Weber, ND, PhD, MPH, Acting Deputy Director of the National Center for Complementary and Integrative Health (NCCIH), presenting on pilot and feasibility testing in ePCTs.

“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.

 

February 15, 2018: Timely Tips from Demonstration Project Principal Investigators

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.

Download the PDF.

“Integrate really well with the key stakeholders from your sites.”
– Lynn DeBar, PhD

“Engage with senior mentors and people who have gone down this road before.” – Jerry Jarvik, MD, MPH

“Recognize that the perspectives of key stakeholders may be different than anticipated by investigators.” – Laura Dember, MD

 

February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators

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.

Advice to New Pragmatic Trial Investigators from NIH Research Collaboratory on Vimeo.

“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