Christine Goertz

July 31, 2025: Pragmatic Trialists Share Strategies for Monitoring Changes in Usual Care

Posted on by Karen Staman

Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites.

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the strategies they used to define and document usual care. The panelists included Rachel Winer, co–principal investigator (PI) of STEP-2;, Richard Platt, co-PI of INSPIRE; and Christine Goertz, co-PI of IMPACt-LBP.

Key Strategies

  • Establish a community of individuals who are interested in and committed to answering the research question
  • Develop relationships: visit each site and have monthly coaching calls
  • Get commitment in advance from sites to hold their practice constant for the duration of the trial
  • Have sites complete readiness surveys or feasibility assessments that include questions about potential upcoming quality improvement initiatives
  • Minimize burden on sites as much as possible

The Navigating the Unknown chapter of the Living Textbook includes  descriptions of unanticipated challenges that may occur during the years-long course of a study that can have profound effects on usual care, including:

These challenges all require close collaboration with research partners to develop solutions.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

July 1, 2025: As Their Studies Wrap Up, Researchers Share Lessons for Pragmatic Trials

Posted on by Damon Seils

Headshots of Drs. Christine Goertz, Andrea Cook, Shruti Gohil, and Stacy SterlingA key feature of the NIH Pragmatic Trials Collaboratory is its culture of learning and knowledge sharing among investigators who are planning and conducting pragmatic clinical trials. In a session at the program’s 2025 Annual Steering Committee Meeting, a panel of investigators discussed their recently completed NIH Collaboratory Trials and their thoughts about future directions for pragmatic research.

The panelists included Andrea Cook, co–principal investigator (PI) for BackInAction; Shruti Gohil, lead investigator for INSPIRE; and Stacy Sterling, co-PI for GGC4H. Christine Goertz, a co-PI for IMPACt-LBP, moderated the discussion.

Key Takeaways

What do investigators wish they had known before starting a pragmatic trial? Sterling highlighted a need for ongoing engagement with partnering healthcare systems’ senior leaders to ensure they understand the challenges of adopting and sustaining the study intervention. Cook stressed the importance of educating site personnel about what it means to participate in the trial, including the potential for randomization to a usual care arm.

“We also included nonphysician clinicians in the education about the intervention, because they are often doing the steps being targeted by the intervention,” Gohil added.

How can we apply these lessons in future pragmatic trials? “Doing an embedded pragmatic trial is sort of like having a child: You really need the guidance of people who have gone before you and have real-life experience,” Goertz said.

The panelists proposed the development of more standardized materials for the consent process and other trial elements. They also discussed the need for broader dissemination strategies and new ways to promote implementation tools from trials with successful interventions.

Gohil described her research team’s commitment to developing a dissemination toolkit so people will understand how to approach implementation. She noted that, as soon as the trial was completed but before publication, the research team presented the results to the participating sites.

Greg Simon, the PI for SPOT and a member of the NIH Collaboratory Coordinating Center’s leadership team, stressed the importance of including research partners in dissemination.

“Don’t write the discussion section [of your study results paper] until you’ve talked with your healthcare system partners; they might have something to teach us about what the results mean,” he said.

About the Trials

  • BackInAction, supported by the National Center for Complementary and Integrative Health (NCCIH), is comparing standard and advanced courses of acupuncture with usual care for older adults with chronic low back pain.
  • GGC4H, supported by NCCIH, is testing the feasibility and effectiveness of implementing within healthcare systems the Guiding Good Choices program for caregivers of early adolescents to prevent common behavioral problems, such as substance use.
  • IMPACt-LBP, supported by NCCIH, is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain.
  • INSPIRE, supported by the National Institute of Allergy and Infectious Diseases, used personalized clinical decision support to improve judicious antibiotic prescribing for non–critically ill patients hospitalized with abdominal infections or skin and soft tissue infections.
  • SPOT, supported by the National Institute of Mental Health, compared care management and dialectical behavior therapy skills training to usual care for adults at risk of self-harm or suicidal behavior.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

July 19, 2023: IMPACt-LBP Study Team Will Share Early Lessons in This Friday’s PCT Grand Rounds

Posted on by Damon Seils
Headshots of Dr. Christine Goertz and Dr. Adam Goode
From left: Dr. Christine Goertz and Dr. Adam Goode of the IMPACt-LBP NIH Collaboratory Trial

In this Friday’s PCT Grand Rounds, Dr. Christine Goertz and Dr. Adam Goode of Duke University will present “Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons From IMPACt-LBP.”

The Grand Rounds session will be held on Friday, July 21, 2023, at 1:00 pm eastern.

IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Trials, is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain vs usual care. The study will determine whether receiving first-line care from “primary spine practitioners” improves physical function, decreases pain and opioid prescriptions, improves patient satisfaction, and decreases costs and utilization of healthcare services.

Dr. Goertz is a professor in musculoskeletal research and the vice chair for implementation of spine health innovations in the Department of Orthopaedic Surgery, and Dr. Goode is an associate professor of orthopaedic surgery—both at Duke University.

Join the online meeting.

March 15, 2023: IMPACt-LBP Enrolls First Patient in Study of Collaborative Care for Low Back Pain

Posted on by Damon Seils

IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Trial, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone!

IMPACt-LBP investigators
Dr. Christine Goertz, Dr. Adam Goode, Dr. Jon Lurie, and Dr. Rishi Chakraborty

Led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care. In the intervention arm, patients with a primary complaint of low back pain are referred to physical therapists and chiropractic doctors as first-line providers. The study will determine whether receiving first-line care from these “primary spine practitioners” improves physical function, decreases pain and opioid prescriptions, improves patient satisfaction, and decreases costs and utilization of healthcare services.

Logo for the IMPACt-LBP Demonstration Project

Learn more about IMPACt-LBP in this interview with investigators Christine Goertz, Adam Goode, and Rishi Chakraborty. The study was awarded continuation to the UH3 implementation phase last summer.

IMPACt-LBP is supported within the NIH Pragmatic Trials Collaboratory by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.

August 22, 2022: IMPACt-LBP Awarded Continuation to Implementation Phase

Posted on by Damon Seils

IMPACt-LBP investigatorsThe NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in the United States.

Congratulations to the IMPACt-LBP investigators and their study teams for reaching this important milestone!

IMPACt-LBP will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes.

Logo for the IMPACt-LBP NIH Collaboratory TrialThe study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center.

Learn more about IMPACt-LBP.