Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD)

Posted on by Hannah Webster

Speakers

Christine Goertz, DC, PhD
Professor in Musculoskeletal Research
Vice Chair for Implementation of Spine Health Innovations
Department of Orthopaedic Surgery
Duke University 

Adam Goode, DPT, PhD
Associate Professor in Orthopaedic Surgery
Vice Chair of Clinical Research and Epidemiology
Department of Orthopaedic Surgery
Duke University

 

Keywords

Pragmatic trials; research; Low Back Pain; Primary Care; Physical Therapy; Chiropractic

Key Points

  • The IMPACt-LBP trial’s project goal is to implement the American College of Physicians low back pain (LBP) guideline by evaluating the impact of the Primary Spine Practitioner (PSP) model in three academic Health Care Systems (HCS). The study then evaluates the model’s effectiveness by comparing the intervention to usual medical care.
  • The American College of Physicians guideline states that “physicians and patients should treat acute, sub-acute and chronic LBP with non-drug therapies.” The Primary Spine Provider (PSP) model is a multi-disciplinary collaborative care model that includes Doctors of Chiropractic (DC) and physical therapists (PT) as first line care for LBP. Their treatment approaches will focus on non-pharmacological approaches recommended by the guideline, including spinal manipulation and exercise.
  • The IMPACt-LBP study design is a pragmatic, multi-site, two-arm cluster-randomized trial with randomization at the primary care provider (PCP) clinic level. It includes 22 family medicine, primary care and general internal medicine clinics affiliated with Duke University, the University of Iowa or Dartmouth-Hitchcock health systems. The study team plans to enroll 1,800 adult patients with a primary complaint of LBP who contacted a participating primary care clinic to make an appointment with a primary care provider.
  • The study pathway involves a patient contacting a primary care clinic and then being transferred to an IMPACt-LBP scheduling assistant who provides a scripted introduction to the study and a baseline survey. Patients in the usual care arm clinics are then scheduled to see a PCP. Patients at the intervention care arm clinics are introduced to a DC or PT appointment option, while still being able to select a PCP appointment.
  • The study’s primary endpoints are a change in PROMIS physical function from baseline to 3 months and change in PROMIS pain interference from baseline to 3 months. The study is also composed of an enrolled cohort of patients that agree to complete PRO surveys for pain interference and functional status for primary analysis. There is also a longitudinal cohort of EHR data for all patients at participating PCP clinics to assess utilization and other broad outcomes.
  • The study has enrolled 187 patients since enrollment began in March 2023, and the study team has pulled together its initial lessons learned.
  • In terms of administrative and regulatory lessons learned, the team reflected that the integration of PT/DC at the forefront of the patient experience is often different from many typical processes. There have also been hiring challenges related to the current job market, as well as regulatory challenges related to consent waivers and IRBs.
  • Presenters also shared challenges regarding scheduling and patient insurance coverage. While not anticipated, it was also necessary to have dedicated research staff to ensure adequate recruitment. Additionally, the study team noted that patients do not all enter the health system the same way, which is an ongoing challenge.
  • Differences in Cauda Equina screening by sites, which required a protocol amendment, proved to be another challenge.
  • There were also lessons learned regarding data collection, as many sites are not collecting and integrating PRO outcomes to a sufficient degree for the study. The study is now using two REDCap systems to collect data, which increases the potential for data entry errors.
  • From a clinical perspective, the team learned the importance of keeping providers up to date on the study progress in an efficient and streamlined way and experienced unforeseen difficulties with engaging with community PSPs.
  • Patient-specific issues encountered include: patients don’t want to be approached about research during an acute pain episode; many patients have concerns about co-pays to see PT/DC; sometimes patients have multiple reasons for a PCP visit; and patients are sometimes frustrated after going through the HCS phone triage system

Discussion Themes

–How has the experience been regarding dual oversight and a single IRB? There can be many challenges related to dual oversight and a single IRB. While the single IRB streamlines some steps, there are still different and specific processes at the different sites, which can create challenges and hurdles to overcome. With IMPACt-LBP, we have been able to move forward in an efficient manner; however, we have had a few additional steps that were not initially anticipated. 

–Is working with large academic health systems a help or a hinderance? Academic health centers have the potential to drive change, so if we were able to pull it off at these sites, we felt that these interventions could be scaled to many different settings. We are learning together in real-time because we are trying to change how people think about clinical practice for low back pain. That is a real challenge. High-level administrators and clinicians are recognizing that there is a huge opportunity to provide better care for people with LBP and that we are attempting to implement evidence-based care pathways. Having this high-level support is critical and allows us to problem solve in real-time.

–Are you looking to engage with patients who have had imaging, and how does that impact the care path? We do have some sub-group analyses plans for the trial, not specific to imaging, but it is something we could consider.  Inappropriate early imaging is included in our outcome measures, but we could consider some deeper work and analyses.

–Do you think that this intervention is sustainable? We think so because we are building a playbook for this. There is continued discussion as a nation about how we treat patients for low back pain, so we think there is potential. People care about this issue, so we feel that developing this evidence is a critical next step to promote change for better care. 

Tags

#pctGR, @Collaboratory1