In a survey of pragmatic clinical trials across 3 NIH research networks, the complexity of delivering nonpharmacological interventions was similar between pain-related trials and non–pain-related trials. However, pain trials tended to have more intervention components, add more new tasks, and require modifications to existing workflows.
The researchers surveyed study team members from trials in the NIH Pragmatic Trials Collaboratory, the IMPACT Collaboratory, and the Pain Management Collaboratory. All 3 programs support pragmatic clinical trials embedded in healthcare systems, including trials of nonpharmacological interventions for pain.
Though the trials examined in the study had similar intervention complexity, pain trials had slightly greater complexity overall, and the study teams for these trials reported needing to make more adaptations in workflows during the trial to improve the intervention’s fit or effectiveness in real-world settings.
“Change in workflow was an important consideration for intervention delivery for all trials in our study,” wrote lead author Lindsay Ballengee and her coauthors. “Future research should capture detailed, real-time information about the nature of intervention delivery complexity, adaptations, and implementation success to help improve delivery of nonpharmacologic pain interventions,” she wrote. Ballengee is a research fellow with the NIH Pragmatic Trials Collaboratory.
The Grand Rounds session will be held on Friday, February 28, 2025, at 1:00 pm eastern.
BEST-ICU, an NIH Collaboratory Trial supported by the National Heart, Lung, and Blood Institute, is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase ABCDEF bundle adoption in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care. Learn more about BEST-ICU.
Balas is the Dorothy Hodges Olson Distinguished Professor of Nursing and the associate dean of research at the University of Nebraska Medical Center College of Nursing. Vasilevskis is a professor of medicine at the University of Wisconsin-Madison.
New study snapshots and updated ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. The trials have transitioned from the UG3 planning phase to the UH3 implementation phase.
“There are many known disparities between urban and rural populations,” said Karen Kehl, a program director at the National Institute of Nursing Research (NINR), in an interview at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting. “And when we talk about chronic pain, we know that there’s a higher incidence and a higher severity of pain in rural populations, and yet they don’t have access to many of the effective solutions that we have,” Kehl added.
AIM-CP
AIM-CP is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The principal investigators are Sebastian Tong and Kushang Patel of the University of Washington. The study is supported by NINR.
ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. The principal investigators are Richard Skolasky and Kevin McLaughlin of Johns Hopkins University. The study is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
RAMP is evaluating the use of a 12-week mind-body skills training program for rural veterans with pain within the VA’s Whole Health initiative, including a one-on-one session with a Whole Health coach followed by 11 weekly group sessions to include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa. The study is supported by NINR.
The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern.
This Grand Rounds session will report the results of Chat 4 Heart Health, an NIH Collaboratory Trial. The trial evaluated the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors. The presenters will also share insights from Nudge, another NIH Collaboratory Trial, which tested a variety of text messaging strategies to encourage patients to refill their cardiovascular medications.
Ho is a senior clinician investigator at Kaiser Permanente Colorado’s Institute for Health Research. Bull is a professor of community and behavioral health at the Colorado School of Public Health.
The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.
ACP PEACE, an NIH Collaboratory Trial, is evaluating a comprehensive advance care planning program for older patients with advanced cancer that combines clinician communication skills training and patient video decision aids.
Volandes is a professor of medicine and the vice chair for research in the Department of Medicine at Dartmouth Health and the Geisel School of Medicine at Dartmouth. Tulsky is a professor of medicine at Harvard Medical School and the Poorvu Jaffe Chair of Supportive Oncology at the Dana-Farber Cancer Institute.
The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern.
ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. A secondary aim of the study is to compare the effectiveness of the study’s risk-stratification approach. Learn more about ARBOR-Telehealth.
Skolasky is a professor of orthopaedic surgery and the director of the Spine Outcomes Research Center, and McLaughlin is an assistant professor of physical medicine and rehabilitation—both at the Johns Hopkins University School of Medicine.
A new study snapshot and updated ethics and regulatory documentation are now available for the TAICHIKNEE trial. One year into the study, and after receiving approval to transition from the planning phase to the implementation phase, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.
TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis. The practice of tai chi integrates physical, psychosocial, and behavioral components and has exhibited clinically significant improvements in chronic knee osteoarthritis pain conditions. The results of the study will inform widespread adoption of mind-body approaches for knee osteoarthritis across healthcare systems.
TAICHIKNEE is supported within the NIH Pragmatic Trials Collaboratory through a cooperative agreement from the National Center for Complementary and Integrative Medicine. Learn more about TAICHIKNEE.
Dr. Corita Grudzen and Dr. Keith Goldfeld, principal investigators for PRIM-ER
An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial.
More than three-quarters of seriously ill older adults in the United States will visit an emergency department in their last 6 months of life. Palliative care specialists are not always available in emergency departments, and emergency clinicians may lack the training or tools to assist older adults who have serious, life-limiting illness in making complex medical decisions.
PRIM-ER, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial of a palliative care training program in 29 emergency departments in the United States. The program consisted of training in palliative care, simulation-based communication workshops, clinical decision support tools, and audit and feedback.
The study team, led by Corita Grudzen at Memorial Sloan Kettering Cancer Center and Keith Goldfeld at New York University, evaluated the initial emergency department visits of nearly 99,000 older adults with serious, life-limiting illness before and after implementation of the training program. The primary outcome was hospital admission from the emergency department. Secondary outcomes included subsequent healthcare use and survival.
There was no difference in the rate of hospital admission for seriously ill older adults after emergency department staff received the palliative care training intervention. The intervention also did not have an effect on subsequent health care use or short-term mortality.
“Our complex, multicomponent intervention designed to embed palliative care skills in emergency medicine practice for patients with serious, life-limiting illness did not show an effect on hospital admission, subsequent health care use, or short-term mortality,” said Grudzen, an emergency medicine physician and palliative care specialist. “Despite this, the development, implementation, and testing of primary palliative care interventions remain a priority, given the workforce shortages in hospice and palliative medicine,” Grudzen said.
An important and unanticipated experience in the conduct of the PRIM-ER trial between 2018 and 2022 was the COVID-19 public health emergency. Strain placed on the healthcare system by the pandemic limited the ability of home care and hospice agencies to accept patients and narrowed the referral options available to emergency department clinicians. These impacts may have influenced the trial’s results.
PRIM-ER was supported within the NIH Pragmatic Trials Collaboratory by a grant award from the National Institute on Aging.
“The NIH Collaboratory is a critical resource for the conduct of pragmatic trials,” Grudzen said. “The faculty willingly share their expertise in all aspects of pragmatic trial design, conduct, and analysis. Their recommendations are the rare combination of cutting edge, practical, and battle tested. The program’s additional electronic and virtual resources are invaluable to growing the pragmatic trial community,” she said.
Ethics and regulatory onboarding documentation for one of the NIH Pragmatic Trials Collaboratory’s newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the APA-SM trial.
The consultations took place by video conference and included representation from the study team, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.
APA-SM will test a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas. The study will also include implementation outcomes, a cost-effectiveness analysis, and an evaluation of predictive factors for treatment response.
APA-SM is supported through the NIH HEAL Initiative with administrative oversight by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke.
Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.
Only half of eligible patients in US federally qualified health centers were screened for cervical cancer in 2021. The COVID-19 pandemic exacerbated these disparities. Distribution of human papillomavirus (HPV) self-sampling kits to patients is a widely adopted strategy in other countries but is nascent in the United States.
The STEP-2 study team will conduct a cluster randomized trial in federally qualified health centers in Oregon and Washington to evaluate the comparative effectiveness and cost-effectiveness of in-clinic distribution of self-sampling kits, in-clinic plus mailed distribution, and usual care. The project is supported by a grant award from the National Cancer Institute.
Rachel Winer, Amanda Petrik, and Jasmin Tiro are the principal investigators for the STEP-2 trial. Winer is a professor of epidemiology at the University of Washington. Petrik is an investigator at the Kaiser Permanente Center for Health Research. Tiro is a professor of public health sciences at the University of Chicago.