Steering Committee

August 23, 2021: BeatPain Utah Takes Pragmatic Research to New Frontiers

Posted on by Damon Seils

BeatPain Utah, an NIH Collaboratory Trial, is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain. Dr. Julie Fritz, the principal investigator of BeatPain Utah, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

“[BeatPain Utah] is focused on overcoming access barriers and providing nonpharmacologic options for individuals in our state and in under-resourced communities who have chronic back pain,” said Fritz, who is a distinguished professor of physical therapy and athletic training and the associate dean for research at the University of Utah College of Health.

The project is part of the NIH HEAL Initiative, which aims to reduce reliance on prescription opioid medications.

View the full video.

Fritz highlighted the project’s partnerships with federally qualified health centers throughout the state of Utah. “Some are in urban areas serving under-resourced communities,” she said, “and others, given the geography of Utah, are in very rural and remote communities where access to specialists and allied health professionals is particularly limited.” The communities also include a significant number of patients who are Hispanic or Latino and communicate primarily in Spanish.

When asked why a pragmatic clinical trial was the best approach for BeatPain Utah, Fritz noted the urgency of the need for alternative pain management strategies, especially in low-resource populations.

“Accelerating the real-world applicability of our research is particularly critical in this area of clinical research,” Fritz said. “So for us, in addressing the needs of populations that need resources—and they need them now—a pragmatic trial that focuses on real-world solutions was a particularly attractive option,” she said.

On being part of the NIH Collaboratory, Fritz said, “So many of the things that we encounter, someone’s already dealt with or is currently working on. It’s just invaluable to have those colleagues and professionals who are trying similar aims to what we’re doing. Being part of this Collaboratory has been of tremendous value for our project.”

View the full video.

BeatPain Utah is supported by the NIH through the NIH HEAL Initiative under a grant from the National Institute of Nursing Research and receives logistical and technical support from the PRISM Resource Coordinating Center.

Screen shot of interview with Dr. Julie Fritz

August 19, 2021: Biostatistics Core Helps Projects ‘Roll With the Punches’ of the Pandemic

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Biostatistics and Study Design Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials, including the 2 newest projects, BeatPain Utah and GRACE.

“BeatPain Utah and GRACE are fascinating studies, as all our NIH Collaboratory Trials are, and are giving us lots of food for thought at the Biostatistics Core,” said Dr. Liz Turner, associate professor of biostatistics and bioinformatics at Duke University and a cochair of the Core. View the full video.

The 2 studies “have been pretty well positioned to roll with some of the distancing required or the lack of in-person visits,” said Dr. Patrick Heagerty, professor of biostatistics at the University of Washington and the other cochair of the Core. “The BeatPain project had a remote delivery from the beginning, so I think the impact of COVID was not as dramatic as it’s been for other projects. But GRACE, where acupuncture is part of it, they have to figure out what are the elements of the research protocol they can do remotely but still need to get folks in person to do that acupuncture,” Heagerty said.

“There really have been some considerable challenges for several of the other NIH Collaboratory Trials,” said Turner. “Good examples of these challenges are those faced by 2 stepped-wedge cluster randomized trials, ACP PEACE and PRIM-ER. …They had to really restructure the design and respond very quickly to what was happening in practice out in the field. Interestingly, on the flip side, the disruptions last spring in 2020 did provide opportunities to address other research questions and perhaps generate other interesting evidence,” Turner said.

(Learn more about the ACP PEACE study’s COVID-19 supplement: “Can a Primary Care Telehealth Intervention Change the Paradigm for Advance Care Planning?”)

Heagerty and Turner also described ongoing projects of the Core to support pragmatic research, including guidance on longitudinal analysis in randomized trials, considerations for studies with multiple outcomes, and handing of studies with variable cluster sizes. Learn more about the Biostatistics and Study Design Core.

 

Screen shot of interview with Patrick Heagerty and Liz Turner

August 11, 2021: EHR Core Facing Familiar Challenges, Intensified by Pandemic

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Electronic Health Records (EHR) Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on pragmatic trials. They also talked about upcoming projects and a recent survey of the NIH Collaboratory Trials.

 

“The pandemic amplified themes that we’ve heard all along, which is how to get resources, how to get support for the data that we need for these trials or to configure EHRs as we need for these trials,” said Dr. Rachel Richesson, a professor of learning health sciences at the University of Michigan and a cochair of the EHR Core. “The pandemic just shifted priorities tremendously and made it quite challenging. As a result, we’ve had discussions about…really making the value case for pragmatic research and embedded research,” Richesson said.

View the full video.

Dr. Keith Marsolo, also a cochair of the Core, added, “The pandemic obviously was a big challenge for health systems in general as they transitioned to telehealth, dealt with shutdowns, things of that nature.” Marsolo is an associate professor in population health sciences at Duke University.

“Things are starting to move forward a little bit more. In one [NIH Collaboratory Trial], they were able to leverage some infrastructure that was purchased to help provide telehealth services for their region. So they’ve been able to bootstrap their trial off of that infrastructure,” Marsolo said.

Richesson also described an upcoming paper reporting the results of a recent survey of the NIH Collaboratory Trials. The survey focused on the challenges of using EHR data in pragmatic trials embedded in healthcare systems.

“No surprise on the challenges we encountered: It’s still challenging to get data from organizations for research, the data are still heterogeneous,…and there are challenges on the research team to ensure that that information is equivalent and how these data can be pulled together to support the research question,” Richesson said. “There’s a particular emphasis with the newer studies on patient-reported outcomes and how to get those collected as part of routine care,” she said.

View the full video.

 

Screen shot of video interview with Dr. Rachel Richesson and Dr. Keith Marsolo
Dr. Rachel Richesson and Dr. Keith Marsolo

August 9, 2021: ‘Pause’ for COVID-19 Complicates Research Embedded in Healthcare Systems

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Health Care Systems Interactions Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials.

“Some of the projects are facing healthcare systems that are on pause for research,” said Leah Tuzzio, a senior research associate at Kaiser Permanente Washington Health Research Institute (KPWHRI) and a member of the Core. “It’s happened before when policy changes or when [electronic health record] systems change or when someone important leaves, but the pandemic has had a huge impact,” she said.

“Healthcare systems are strongly influenced by the environment and by changes in their environment, and so any pragmatic trial that’s really embedded in the healthcare system will be affected by the environment around it,” said Dr. Eric Larson, a KPWHRI senior investigator and the chair of the Core. Healthcare systems participating in the NIH Collaboratory NIH Collaboratory Trials have been overwhelmed by their number one priority, which—in addition to caring for their patients—is adapting to COVID, Larson said.

In addition to guiding the NIH Collaboratory Trials through pandemic-related challenges, the Health Care Systems Interactions Core has been working on several long-term projects.

“One of the things that we’re currently working on is a typology of the healthcare systems that have participated in [the GRACE and BeatPain Utah NIH Collaboratory Trials] as well as the projects that came before,” said Core project manager Rachel Hays. The Core is surveying NIH Collaboratory Trial investigators about what lessons they would pass on to future pragmatic trial investigators about building partnerships with their participating healthcare systems, she said.

 

Screen shot of interview with Eric Larson, Leah Tuzzio, and Rachel Hays
Dr. Eric Larson, Leah Tuzzio, and Rachel Hays

August 5, 2021: GRACE Trial Seeks More Options for Sickle Cell Pain

Posted on by Damon Seils

The GRACE trial, an NIH Collaboratory Trial, is studying real-world implementation of nonpharmacologic pain management strategies for patients with sickle cell disease. Dr. Robert Molokie, a GRACE co–principal investigator, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

One innovation the GRACE trial is bringing to the NIH Collaboratory’s portfolio of pragmatic trials is its use of a sequential, multiple-assignment, randomized trial (SMART) design. In this adaptive approach, patients are randomly assigned to treatment groups, and those who do not respond to the treatment undergo a secondary randomization to either continue with the initial intervention or switch to the other group.

The GRACE trial is studying acupuncture and guided relaxation with the goals of reducing pain and reducing patients’ reliance on opioid medication.

Using a pragmatic, adaptive design, Molokie said, “I think we will get the most realistic findings of how these therapeutic interventions work, whereas in more classic trials they’re going to end up with such a group of selected patients that it may not be as generalizable as a pragmatic clinical trial.” Molokie is a clinical associate professor of medicine at the University of Illinois Chicago.

GRACE is supported by the NIH through the NIH HEAL Initiative under a grant from the National Center for Complementary and Integrative Health and receives logistical and technical support from the PRISM Resource Coordinating Center.

 

Screen shot of interview with Dr. Robert Molokie
Dr. Robert Molokie

August 2, 2021: Can a Primary Care Telehealth Intervention Change the Paradigm for Advance Care Planning?

Posted on by Damon Seils

A supplemental grant to the ACP PEACE study team will test the ability of a telehealth program to improve rates of advance care planning among older patients in primary care in a large healthcare system. Dr. Angelo Volandes and Dr. James Tulsky discussed the new study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

Volandes said colleagues contacted him early in the COVID-19 pandemic because they felt unprepared to have conversations with patients and their caregivers about advance care planning in primary care. So, he wondered, “What If we could create a telehealth program where we trained clinicians to have these conversations and also empowered patients and caregivers to better understand their options when it came time to making decisions about serious illness like COVID-19?” Volandes is a physician at Brigham and Women’s Hospital and an associate professor of medicine at Harvard Medical School.

The new study will expand on ACP PEACE, an NIH Collaboratory Trial, which is testing implementation of an advance care planning program that combines clinician communication skills training and patient video decision aids. ACP PEACE is focused on patients with advanced cancer and their clinicians in oncology settings.

Both the new study and ACP PEACE will assess how advance care planning practices changed after the start of the COVID-19 pandemic. View the full video.

“The fact that we’re studying time periods before and after COVID…will help us see the extent to which advance care planning shifted during this time period and will help us understand better the results we see in the oncology community [and] what’s happening in the primary care community,” said Tulsky, a co–principal investigator for both studies. Tulsky is chief of psychosocial oncology and palliative care at the Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School.

Tulsky added that the study team will learn the value of implementing advance care planning over telehealth. Also, he said, “many of the conversations oncologists are planning for are quite late in the course of care, and this is much earlier, and so we’ll see if that makes a difference.”

“Advance care planning isn’t going to be something just for the purview of people with an advanced serious illness…but rather this is something that we all will need to talk about,” said Volandes. “So I really do think this is going to be a culture shift for healthcare more broadly, but also we’re going to see healthcare systems start prioritizing it beyond, say, patients with advanced serious illness to make it the new normal for everybody.”

ACP PEACE is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging and receives logistical and technical support from the NIH Collaboratory Coordinating Center.

 

Screen shot of an interview with Dr. Angelo Volandes
Dr. Angelo Volandes

July 29, 2021: COVID-19 Brings Another Real-World Challenge to Pragmatic Research

Posted on by Damon Seils

Principal investigators of the NIH Collaboratory Trials reported several common challenges to implementation of their studies as a result of the COVID-19 pandemic, according to a recent survey. Dr. Emily O’Brien discussed the results of the survey in an interview after the NIH Collaboratory’s annual steering committee meeting.

 

 

“Last spring, we started to hear reports of changes in things like care-seeking behavior, research staff working from home, pauses in recruitment at an institutional level,” said O’Brien. “But there wasn’t a lot of information on how these changes affected pragmatic clinical trials specifically,” she said.

O’Brien is a an associate professor in population health sciences at Duke University and a cochair of the NIH Collaboratory’s Patient-Centered Outcomes Core Working Group. View the full interview.

O’Brien and her colleagues at the NIH Collaboratory Coordinating Center conducted a brief survey about the impacts of the pandemic on the NIH Collaboratory Trials, such as challenges they had encountered, solutions they had implemented, and any new measures the study teams had started using. The most common findings were related to delays in trial activities, including training, modifications in the electronic health record, recruitment, and intervention delivery.

“Fortunately, pragmatic trials have a few inherent features that allow them to flex to disruptions that come about from extraneous factors, like those associated with COVID-19,” O’Brien said.

Some study investigators reported that changes in trial implementation had improved their ability to reach a wider audience through virtual interventions. Some also reported renewed commitment from partnering healthcare systems to work together as they encountered challenges in implementation.

“We really think that these silver linings represent lessons learned that can be applied more broadly when we get through the pandemic to help make research more efficient, in line with the Collaboratory’s broader goals,” O’Brien said.

 

Screen shot from an interview with Dr. Emily O'Brien
Dr. Emily O’Brien

July 26, 2021: NIH Collaboratory Leaders Discuss PRISM Projects, New Initiatives, and the Future of the Program

Posted on by Damon Seils

In a recent interview, Dr. Wendy Weber shared that the National Advisory Council for Complementary and Integrative Health has approved a concept for the NIH Collaboratory to continue with the support of NIH Institutes and Centers, as the program completes its term as an NIH Common Fund initiative.

 

 

“We’re quite excited for some new directions in where we’re going to head with this program, and really excited that we’ve identified a number of partners across the NIH as different Centers, Institutes, and Offices that want to continue this program and want to continue to do research embedded in healthcare systems,” Weber said.

Weber is the branch chief for the Clinical Research in Complementary and Integrative Health Branch in the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH) and serves as the program officer for the NIH Collaboratory.

“I think one new direction for us is looking at how do we address health disparities in healthcare systems, what types of interventions can actually improve those disparities and improve the quality of care so that we have less differences in the way patients are treated within the healthcare delivery system,” Weber said.

We interviewed Weber after the NIH Collaboratory’s annual steering committee meeting, along with Dr. Robin Boineau, the project scientist for the NIH Collaboratory, and Dr. Kevin Weinfurt, a professor in population health sciences at Duke University and a co–principal investigator for the NIH Collaboratory Coordinating Center. View the full interview.

The 3 leaders talked about the program’s newest NIH Collaboratory Trials—BeatPain Utah and GRACE—and their role in advancing the goals of the NIH Collaboratory. They also discussed focus areas for the coming year, including greater attention to implementation science outcomes, diversity in pragmatic trials, and lessons from the COVID-19 pandemic.

“[BeatPain Utah and GRACE] are helping the Collaboratory to learn how to design, analyze, and interpret adaptive designs,” said Weinfurt. “These are our 2 first trials where we’re using adaptive designs. One of the goals of the Collaboratory is to generate generalizable knowledge about how to do pragmatic trials, so we like these types of learning opportunities,” he said.

Boineau highlighted the Diversity Workshop Grand Rounds Series, which began in May and is ongoing. The series is focused on strategies for improving diversity in pragmatic clinical trials and is “an important next step to really think together about where we can go and what we can do to really build this community of investigators and participants,” Boineau said.

 

Screen shot of Dr. Wendy Weber interview
Dr. Wendy Weber of NCCIH, program officer for the NIH Collaboratory

April 29, 2020: Materials from the Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 22 and 23, 2020, more than 90 participants joined the online Steering Committee meeting to hear about the evolution of the embedded PCT (ePCT) ecosystem, discuss how to strengthen partnerships across the ecosystem, and identify approaches and lessons that will help inform and broaden the ecosystem. All presentations are available for downloading.