NIH-DoD-VA Pain Management Collaboratory

March 3, 2025: Intervention Complexity a Consistent Theme Across Pragmatic Trial Collaboratories

Posted on by Damon Seils
Headshot of Lindsay Ballengee
Lindsay Ballengee

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 results of the study were published online ahead of print in Contemporary Clinical Trials Communications.

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.

Read the full report.

“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.

September 4, 2024: NIH HEAL Initiative Supports New Funding Opportunity for Pragmatic Trials in the Pain Management Collaboratory

Posted on by Damon Seils

Notice of Funding Opportunity - NIH HEAL Initiative - NIH-DOD-VA Pain Management CollaboratoryThe National Center for Complementary and Integrative Health (NCCIH), with support from the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, published a notice of funding opportunity for pragmatic clinical trials within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC).

Read the full notice of funding opportunity (RFA-AT-24-011).

The PMC was established in 2017 with an initial cohort of 11 pragmatic trials to develop and improve pain management approaches for veterans, military personnel, and their families. The PMC has established a coordinating center that provides national leadership and technical expertise for all aspects of research conducted within healthcare systems.

The new funding opportunity leverages the experience, expertise, and leadership of the PMC Coordinating Center to support the conduct of large-scale pragmatic clinical trials and implementation science demonstration projects to study nonopioid approaches to the management of pain and other comorbid conditions, including complementary and integrative approaches used alone and in combination with standard care. Supported projects will be conducted within healthcare systems serving veterans, military personnel, and their families.

The application receipt date is November 7, 2024. Applications are expected to:

  • Support the design and execution of additional high-impact demonstration projects that will conduct pragmatic clinical trials focusing on effectiveness research, implementation research, or hybrid effectiveness-implementation research on nonopioid approaches for the management of pain and comorbid conditions with patients in healthcare delivery systems that provide care to veterans, military personnel, and their families.
  • Make available data, tools, best practices, and resources that will facilitate a research partnership with healthcare delivery systems that provide care to veterans, military personnel, and/or their families.

The NIH Institutes participating in this funding opportunity include NCCIH, the National Institute on Aging (NIA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Read the full notice of funding opportunity.

May 20, 2024: BeatPain Utah and AIM-Back Trials Offer Insights Into Telehealth Delivery of Physical Therapy

Posted on by Damon Seils
Headshot of Dr. Julie Fritz
Dr. Julie Fritz, principal investigator for BeatPain Utah

In a new article, investigators from 2 pragmatic clinical trials of telehealth-delivered physical therapy share insights into the challenges they faced in implementing the study interventions, especially in historically underserved communities.

The article was published last month in Frontiers in Pain Research.

Telehealth delivery of nonpharmacologic pain management has expanded opportunities to overcome access barriers. However, telehealth delivery of physical therapy presents challenges related to technology, intervention adaptations, and cultural competence.

Both BeatPain Utah, an NIH Collaboratory Trial, and AIM-Back, a trial supported through the NIH-DOD-VA Pain Management Collaboratory, are pragmatic trials testing physical therapist–led telehealth interventions for persons with chronic low back pain who are from communities that experience healthcare disparities. In the new article, the investigators describe the challenges they encountered when implementing telehealth physical therapy programs in these communities. They also discuss strategies for overcoming barriers to improve access to telehealth physical therapy and reduce pain management disparities.

Read the full article.

BeatPain Utah is supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Nursing Research. Learn more about the NIH Collaboratory Trials.

July 31, 2023: NIH Announces Funding Opportunity for Pain Management Collaboratory Pragmatic Trials

Posted on by Damon Seils

The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC).

Read the full notice of funding opportunity (RFA-AT-24-004).

The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. The new funding opportunity leverages the experience, expertise, and leadership of the PMC Coordinating Center with a new round of pragmatic trials evaluating nonpharmacologic solutions to address pain and comorbid conditions in veterans, United States Armed Forces service members, and their families.

The NIH Institutes participating in this funding opportunity include the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Nursing Research (NINR). Applications may be cofunded by the Office of Disease Prevention (ODP) and the Office of Behavioral and Social Sciences Research (OBSSR).

Learn more about the PMC.

July 13, 2021: Diversity Workshop Continues With Lessons From Implementation Trials

Posted on by Damon Seils

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?”—Dr. David Chambers of the National Cancer Institute (NCI) will facilitate a discussion about lessons from implementation science for maximizing participant diversity in pragmatic clinical trials. Dr. Chambers is deputy director for implementation science in the Office of the Director in the NCI’s Division of Cancer Control and Population Sciences.

The panelists will include:

  • Dr. Amanda Midboe of the US Department of Veterans Affairs, chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory
  • Dr. Anne Trontell, associate director in the Clinical Effectiveness and Decision Science Program at the Patient-Centered Outcomes Research Institute (PCORI)

The Grand Rounds session will be held on Friday, July 16, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

Headshots of Drs. David Chambers, Amanda Midboe, and Anne Trontell
Left to right: Drs. David Chambers, Amanda Midboe, and Anne Trontell

June 13, 2019: Experience With Pragmatic Clinical Trials Gains Momentum

Posted on by Karen Staman

At the NIH Collaboratory Steering Committee Meeting in May 2019, participants shared their perspectives on the evolving landscape of embedded pragmatic clinical trials (ePCTs). Three initiatives were presented: the Patient-Centered Outcomes Research Institute (PCORI), the NIH-DoD-VA Pain Management Collaboratory, and the HEAL (Helping to End Addiction Long-term) Initiative. Although many challenges remain, the conduct of ePCTs is gaining momentum, and the synergy between the initiatives, along with the fellowship they engender, will continue to help pave the way for more embedded pragmatic research in the future.

Dr. Ann Trontell, Associate Director of Clinical Effectiveness and Decision Science at PCORI, shared PCORI’s experience with pragmatic clinical studies. Since 2014, PCORI has awarded $494 million dollars for 43 pragmatic studies that range in size from 425 to 100,000 participants (median, approximately 1700). The studies include 2 observational, 27 individually randomized, and 14 cluster randomized trials in a wide range of therapeutic areas.

Dr. Trontell urged those developing proposals for pragmatic trials to make them fit for purpose, as opposed to emphasizing pragmatism, a theme echoed in the Developing a Compelling Grant Application chapter of the Living Textbook.

 

 

 

 

Dr. Robert Kerns, a director of the NIH-DoD-VA Pain Management Collaboratory, shared progress with pragmatic trials designed to evaluate whether evidence-based nonpharmacological approaches are effective for pain management among US military personnel and veterans.

Modeled after the NIH Collaboratory, the Pain Management Collaboratory is supporting 11 projects through a 2-year planning phase and a 2- to 4-year implementation phase. Subject matter experts at the Pain Management Collaboratory Coordinating Center (PMC3) support the projects by sharing tools, best practices, and resources.

 

Dr. Wendy Weber, Program Officer for the NIH Collaboratory Coordinating Center, introduced the HEAL initiative, which is designed to enhance pain management and improve prevention and treatment strategies for opioid misuse and addiction. The goal of the initiative is to provide scientific solutions to the opioid crisis. It includes a set of large-scale pragmatic trials that will receive logistical and technical support from the NIH Collaboratory Coordinating Center.

 

While experience with ePCTs is growing, many distinct challenges remain. As the conduct of ePCTs gains momentum, there is a rich opportunity to use collective experiences to refine best practices to real-world evidence generation and help solve urgent public health problems.