In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we sat down for an interview with Drs. Karen Sherman and Lynn DeBar to get an update on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) NIH Collaboratory Trial. BackInAction is a pragmatic randomized trial to evaluate the safety and effectiveness of treatments for older adults with chronic low back pain. The study team is conducting a 3-arm trial of adults 65 years or older with low back pain to evaluate acupuncture vs usual care.
What is the current status of the BackInAction trial?
BackInAction has recruited about two-thirds of its participants and is on track to complete recruitment next fall. We also are providing acupuncture and doing follow-up interviews, so the trial is in the “ongoing phase.”
What challenges have you faced, and how have you dealt with them?
Our biggest challenges have been associated with COVID-19 impacts. Given the higher risk and vulnerability for our older adult target population and the requirement for in-person treatment (acupuncture), we delayed the start of recruitment by many months to ensure that those outreached had ample opportunity to be vaccinated beforehand and have also paused recruitment commensurate with regional surges of COVID variants at one or more of our clinical sites as needed. We also vetted the community acupuncturists who provide acupuncture to our study participants to ensure adequate COVID-safe office practices.
Unrelated to COVID-19, escalating thresholds for regulatory and security features resulted in a previously approved event tracking and recruitment and assessment software system not passing the Technology Resource Office (TRO) review at multiple clinical sites and the consequent need to align data collection and aggregation from site-specific systems. TRO reviews established for clinical care software and processes for our healthcare systems increasingly restrict clinical research practices as well.
What impact do you hope your trial will have on real-world healthcare?
The grant was funded as part of the NIH HEAL Initiative's PRISM program, and the specific funding opportunity announcement was issued because Medicare was interested in additional nonpharmacological treatment options for older adults with chronic low back pain. We had thought that they would be using data from the trial for a coverage decision, since few data on acupuncture existed for older adults. We hope that the trial results will assist the Centers for Medicare & Medicaid Services in any further refinements related to coverage of acupuncture for older adults with chronic low back pain.
How has being part of the NIH Pragmatic Trials Collaboratory shaped your project?
It’s helpful to have the sounding board of regular contact with principal investigators and research teams grappling with often similar issues that arise in implementing pragmatic trials (Steering Committee meetings, annual meetings, and Core Working Groups). Feedback from the Biostatistics and Study Design Core has been particularly helpful, as has the PRISM-wide help selecting and coordinating an appropriate data repository for required HEAL common data elements. Although there have been a few instances when we’ve been surprised by and needed to correct study-specific information included in cross-site dissemination products (always given ample opportunity to do so), we’re very aware and grateful for the functionality of the program’s Coordinating Center and infrastructure in contrast to some of the more recently established Coordinating Center infrastructures for related NIH sub-initiatives. The NIH Pragmatic Trials Collaboratory is much more an aid than a hindrance!