Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at
any given time and resulting in $100-$200 billion per year in total healthcare costs. LBP is one of the leading
causes of ambulatory care visits to US physicians; unfortunately, these visits often result in treatments such as
opioids that can lead to more harm than benefit. In 2017 the American College of Physicians (ACP) guideline
for LBP recommended patients receive non-pharmacological interventions as a first-line treatment but stopped
short of offering solutions regarding how such treatments should be integrated into routine patient care.
Roadmaps exist for multi-disciplinary collaborative care that includes doctors of chiropractic and physical
therapists, well-trained primary contact clinicians with specific expertise in the treatment of musculoskeletal
conditions, as first line providers for LBP. These clinicians routinely employ many of the non-pharmacological
approaches recommended by the ACP guideline, including spinal manipulation and exercise. Important
foundational work conducted by members of the study team has demonstrated that such care is feasible, safe,
and results in improved physical function, less pain, fewer opioid prescriptions, and reduced utilization of
healthcare services. However, this treatment approach for LBP has yet to be widely implemented or validated
using rigorous scientific methods. Our overarching goal is to refine and implement a multidisciplinary
collaborative care model for LBP (MC2LBP) in 3 academic Health Care Systems (HCS) and then evaluate its
effectiveness by comparing it to usual medical care in patients age 18 and older suffering from LBP.
Completion of project study aims will begin with a one-year UG3 planning phase involving completion of 22
milestones in 2 categories of phased activities - model implementation and clinical trial design. UH3 study aims
will be accomplished using a pragmatic, cluster-randomized, clinical trial design. The study will be managed
through a Clinical Coordinating Center and Data Coordinating Center, both housed at the Duke Clinical
Research Institute, in collaboration with Dartmouth-Hitchcock Medical Center and the University of Iowa.
During the planning phase, we will build implementation infrastructure across three HCS, finalize the clinical
trial protocol, and complete the tasks necessary to transition from the UG3 to UH3 phase. The UH3 phase will
be used to: 1) Operationalize the integration of new organizational policies and procedures required to facilitate
implementation of MC2LBP at intervention clinics; 2) Determine the comparative effectiveness of MC2LBP vs
usual care; 3) Estimate and compare medical resource use and costs of implementing MC2LBP; and 4)
Evaluate patient, provider, system and policy level barriers and facilitators to implementing MC2LBP, using a
mixed method, process evaluation approach. Results from this study have the potential to inform future
implementation and policy efforts to improve the quality of pain management for patients suffering from LBP
while simultaneously reducing opioid prescriptions, health care costs and utilization of services.
