Lindsay Ballengee

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.

July 2, 2024: NIH Collaboratory Fellows Share Updates From the Program

Posted on by Elizabeth Mccamic

During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, 2 of the program’s research fellows described their research and discussed the value of the fellowship experience.

Lindsay Ballengee, a physical therapist and doctoral student in population health sciences at Duke University, said her fellowship research builds on previous NIH Collaboratory work on the intervention delivery complexity tool.

“We surveyed members of this Collaboratory and others to find out where they landed on the different domains of intervention delivery complexity and any changes they made during their trial process,” Ballengee said. “We are analyzing that data and hope to use it to inform other pragmatic trials about the different domains of complexity and how those might come into play when implementing in future trials.”

Kaitlyn McLeod, a cardiovascular disease fellow at the University of Michigan, has worked on 2 projects during her fellowship. One project is helping the Health Equity Core better understand how health equity has been integrated into NIH Collaboratory Trials. The second project is taking the health equity framework and applying it to the Nudge study, an NIH Collaboratory Trial, where McLeod has been looking at how the area deprivation index is an effect modifier for the trial’s primary outcome.

Ballengee and McLeod agreed that one of the strengths of the NIH Collaboratory fellowship is the open learning environment and mentoring that is available from investigators and leaders.

“The most valuable experience from being a part of the Collaboratory has been not only being able to build upon previous work and put my own spin on it and ask my own questions, but just the openness of the members of the Collaboratory to mentoring and brainstorming and them really wanting to see me grow as an investigator and fellow,” Ballengee said.