Greg Simon

October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions

Posted on by Karen Staman

Headshots of Richard Platt, Hayden Bosworth, and Greg SimonIn a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work.

Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary:

  • Trials need to be faster (2 to 3 years)
  • Trials should consider outcomes that healthcare system leaders care about (such as costs and subgroup analyses)
  • The evidence required for change should be at the level that healthcare system leaders use (such as not necessarily rejecting the null hypothesis at P < .05 but also considering results of Bayesian methods and interim analyses)

Read the full article.

“We believe it is possible to make pragmatic clinical trials of policies and procedures more useful to delivery systems by accommodating their priorities, introducing flexibility in the level of evidence trials require, shortening the duration of planning and implementation, addressing system leaders’ interest in multiple outcomes and subgroup analyses, encouraging modification of protocols during the implementation phase, and by providing timely interim analyses that can guide decisions about continuing or modifying an intervention,” the authors wrote.

This work was based on an NIH Pragmatic Trials Collaboratory workshop held in 2023, Getting the Right Evidence to Decision-Makers Faster. The workshop explored the critical cycle of evidence generation to decision by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

Platt is a cochair of the NIH Collaboratory’s Distributed Research Network and the Harvard Pilgrim Health Care Institute Distinguished Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. Bosworth is a cochair of the Implementation Science Core and a professor in population health sciences at Duke University. Simon is the chair of the Health Care Systems Interactions Core and a senior investigator at the Kaiser Permanente Washington Health Research Institute.

View the full workshop materials.

August 7, 2024: How to Investigate Whether Buprenorphine Prevents Suicidal Behavior, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Greg Simon and Dr. Susan ShortreedIn this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?”

The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern.

Simon is a senior investigator at KPWHRI and a research professor of psychiatry and behavioral sciences at the University of Washington. He is a member of the leadership team for the NIH Pragmatic Trials Collaboratory Coordinating Center and was the principal investigator for the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial. Shortreed is a senior biostatistics investigator at KPWHRI and an affiliate professor of biostatistics at the University of Washington.

Join the online meeting.

August 5, 2024: NIH Collaboratory Leaders Reflect on Healthcare System and Patient Engagement Challenges and Lessons Learned

Posted on by Elizabeth Mccamic

During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Greg Simon and Steve George sat down to discuss challenges and lessons learned from NIH Collaboratory Trials on healthcare system and patient engagement.

Simon said it is key for embedded pragmatic clinical trials to build long-term relationships with healthcare systems, starting with finding out what are the needs of the healthcare system, the clinicians, and the patients they care for, and then building trials that address the questions they care about.

But healthcare systems change rapidly, which can lead to challenges, such as turnover at different levels of leadership, including the top level of the healthcare system, the clinic management level, and the provider level.

“It is important for clinical trial investigators to think about how do I form relationships with those people who are likely to be here for a while? How do I form relationships at multiple levels with different people,” Simon said.

With patient engagement, George said the challenges have evolved with the NIH Collaboratory Trials. When the NIH Collaboratory started, the initial challenge was whether to do patient engagement or not. Today, patient engagement is more of an expectation for trials, so the questions have become more nuanced, George said. Now trials must consider at what phase of the trial are you going to do patient engagement; who are you going to involve; and are you going to do it throughout the trial?

The NIH Collaboratory’s Living Textbook includes a new chapter on Patient Engagement to help investigators think through these questions.

“One of the most effective resources is the reporting and the information sharing across trials. There are a lot of models of how this has been done. There are a lot of models of how I would do it differently if I did it again, and I think that open sharing is very powerful for people to see because people like examples,” George said.

Simon, a senior investigator at Kaiser Permanente Washington Health Research Institute, is the chair of the NIH Collaboratory’s Health Care Systems Interactions Core and a member of the Coordinating Center leadership team. George is the Laszlo Ormandy Distinguished Professor of Orthopaedic Surgery at Duke University.

Headshots of Dr. Gregory Simon and Dr. Steven George

August 14, 2023: Program Leaders Reflect on Cross-Core Collaboration and Opportunities for the Future

Posted on by Elizabeth Mccamic

Headshots of Dr. Kevin Weinfurt and Dr. Greg Simon
From left: Kevin Weinfurt and Greg Simon

In an interview during the program’s Annual Steering Committee Meeting, Drs. Kevin Weinfurt and Greg Simon reflected on cross-Core collaboration within the NIH Pragmatic Trials Collaboratory and opportunities for growth in the future.

More than a decade ago, when the NIH Pragmatic Trials Collaboratory got its start, the focus was on identifying and answering the big questions in terms of how to do research embedded in routine healthcare, said Weinfurt, co–principal investigator of the NIH Collaboratory’s Coordinating Center. As a result, during the founding years, the NIH Collaboratory’s Core Working Groups primarily worked on addressing the big questions that were specific to each Core (eg, ethics and regulatory issues, electronic health record challenges).

After working through many of the early questions, the program’s approach has evolved in recent years.

“As we tackled some of the bigger questions, the new questions we wanted to answer required contributions from across the Cores to address questions in a more comprehensive way,” said Weinfurt.

Many of the new questions that came up for the Core Working Groups originated from the NIH Collaboratory Trials.

“So many of the decisions about pragmatic trials involve compromise,” said Simon, chair of the Health Care Systems Interactions Core. “It is interesting how that compromise is reflected in terms of how and when the Cores work together because each Core has a focus but also needs to account for how an issue in one area of a trial also affects another area.”

For example, Simon said, a project might have a question related to working with the healthcare system, and that question may overlap with ethics and regulatory and healthcare access issues.

These overlapping issues have resulted in more collaborative work across Cores, explained Simon. “It is important to have these groups that have a focus as long as you realize that there are no sharp boundaries.”

The NIH Collaboratory’s Coordinating Center plays an important role in keeping track of the issues that arise from individual projects and following up with the Steering Committee and Cores.

“There is a web of information that is communicated through the project managers and communications specialists that allows a lot of issues to surface,” said Weinfurt. “Our NIH leaders will often raise issues that they are seeing either within the NIH Collaboratory or on the horizon as something that might be of interest to discuss.”

Looking to the future, Weinfurt said he expects to see more and more opportunities for the Cores to collaborate, find solutions, and create generalizable knowledge, especially as the new Community Health Improvement and Implementation Science Cores ramp up.

“Both the Community Health Improvement and the Implementation Science Cores have a similar reach across all of the various issues that come up for trials. It may be the case that it is very rare to have a Core work alone on a topic in the future,” said Weinfurt.

These collaborations have already been productive, as highlighted by recent cross-Core products tackling important issues:

September 15, 2021: PCT Grand Rounds to Announce Primary Results of NIH Collaboratory’s Suicide Prevention Outreach Trial (SPOT)

Posted on by Damon Seils

Side-by-side headshots of Dr. Greg Simon and Dr. Susan ShortreedIn this Friday’s PCT Grand Rounds, investigators from the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial, will announce the study’s primary results.

Principal investigator Dr. Greg Simon and biostatistician Dr. Susan Shortreed, both of the Kaiser Permanente Washington Health Research Institute, will present “Population-Based Outreach to Prevent Suicidal Behavior: A Pragmatic Randomized Trial (SPOT NIH Collaboratory Trial).” The Grand Rounds session will be held on Friday, September 17, at 1:00 pm eastern. Join the online meeting.

The SPOT NIH Collaboratory Trial is a pragmatic clinical trial embedded in Mental Health Research Network sites to test suicide prevention strategies among adult patients who have serious thoughts of suicide. The trial tested 2 strategies: a collaborative care management approach for depression, and an online skills training method designed to help people manage painful emotions and stressful situations. Both strategies were compared with usual care.

SPOT is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health.