Stratified Care to Prevent Chronic Low Back Pain in High-Risk Patients: The TARGET Trial - A Multi-Site Pragmatic Cluster Randomized Trial

Abstract

Background: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability. Methods: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute low back pain were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Findings: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n=658) versus 51% of patients in the control arm (35 practices, n=635; OR=0.83 95% CI 0·64, 1·09; p=0·18). No differences in function were detected (difference -2·1, 95% CI -4·9-0·6; p=0·12). Opioids and imaging were prescribed 25% (21%, 28%) and 27% (23%, 31%) of initial visits, respectively. Twelve-month LBP utilization was similar in the two groups. Interpretation: There were no differences in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines. Trial Registration: ClinicalTrials.gov NCT02647658. Funding Statement: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867. Declaration of Interests: We declare that we have no conflicts of interest. Ethics Approval Statement: Approval of the study protocol by all site institutional research ethics boards specified: (1) for processes conducted at the primary care clinics, the study was viewed as a quality improvement initiative, (2) for the follow-up assessments at six months, the study was viewed as research requiring patient informed consent for collection of patient-reported primary outcomes, and (3) for the 12-month EMR review patient consent or waiver of HIPAA authorization and patient consent was required.