DCRI principal investigators lead the clinical and data coordinating centers for a new study that will evaluate a model of care that centers on non-pharmacological treatment options.
A new pragmatic trial co-led by the DCRI will seek answers on the impact of a new model of care for low back pain that places primary spine practitioners—doctors of chiropractic and physical therapists—at the forefront of a multidisciplinary collaborative team approach.
The new trial, called IMPACt-LBP, has three primary goals:
- To compare the effectiveness of the multidisciplinary/Primary Spine Practitioner (PSP) model compared to usual care;
- To estimate the cost of implementation of the intervention; and
- To evaluate barriers and facilitators to implementing a multidisciplinary/PSP care model.
DCRI co-principal investigators Christine Goertz, DC, PhD, and Adam Goode, DPT, PhD, along with Jon Lurie, MD, MS, of Dartmouth-Hitchcock Medical Center, will lead the clinical coordinating center for the trial and DCRI’s Hrishikesh Chakraborty, DrPH (right), will lead the data coordinating center, which will be supported by DCRI’s Biostatistics team. These investigators will work alongside other scientists from Dartmouth-Hitchcock Medical Center, the University of Iowa, and Duke to conduct the trial.
The study is funded by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.
The study, which will be cluster randomized at the clinic level, plans to include approximately 22 family medicine, primary care, and general internal medicine clinics in three health care systems: Duke, Dartmouth, and University of Iowa. Investigators intend to enroll 1,800 patients who contact a primary care provider with a primary complaint of lower back pain.
“Current guidelines call for patients with lower back pain to be treated with non-pharmacological care options first,” Goertz (right) said. “This study seeks to evaluate guideline-based care by placing patients at the forefront and having a collaborative, multidisciplinary structure in place to support their care.”
Investigators hypothesize that patients who receive the intervention will experience improved physical function and decreased pain.
“Lower back pain is one of the most common musculoskeletal conditions, and it can be both expensive and debilitating for patients,” Goode (left) said. “We hope that this study will inform best practices in providing better care for these patients, as well as give us true answers about how much health care systems can expect to invest to implement this model.”
“Results from this study could also have long-ranging impacts, as the care we give patients today informs their outcomes tomorrow,” Lurie (right) said. “Two major outcomes we hope to see are decreases in opioid prescriptions and in costs and health care utilization.”
Pragmatic elements of the study include broad eligibility criteria—the majority of patients 18 years or older with a primary complaint of lower back pain will be eligible to enroll. Study outcomes include the collection of patient-reported outcomes and data obtained from electronic health records (EHRs).
This study will be supported by the NIH Health Care Systems Research Collaboratory, a resource for pragmatic trials supported by the National Institutes of Health and coordinated by the DCRI. As part of the NIH HCS Collaboratory, the study team will have access to shared learnings, discussions with a cohort of other investigators, and other study support services. The study will first enter a one-year planning phase before moving on to an implementation phase.