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 LBP 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. Trial Registry: Clini-calTrials.gov NCT02647658 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 disability were detected (difference -2¢1, 95% CI -4.9À0.6; p = 0.12). Opioids and imaging were prescribed in 22%À25% and 23%À26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups. Interpretation: There were no differences detected 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.

Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial

“…Our findings did not reflect the results of the STarT Back trial. The findings were more in line with the US MATCH study (Cherkin et al., 2018 ) and the TARGET study (Delitto et al., 2021 ), in which the intervention arm did not have a significant effect on patient outcomes, healthcare use or the development of chronic LBP, compared to the control arm.…”

Implementation of Psychologically Informed Physical Therapy for Low Back Pain: Where Do We Stand, Where Do We Go?

“…At the conclusion of the trial, patients in the PIPT intervention group showed no differences in disability, care utilization, or transition to chronic low back pain. 20 An earlier study, the MATCH trial (6 primary care clinics, n = 603 enrolled patients), investigated whether use of the STarT Back risk-stratification strategy for patients with low back pain resulted in superior outcomes for physical function and pain severity. 21 While clinicians used the STarT Back tool with half of participants, use of the tool did not change recommended treatments nor did the intervention have any significant effects on patient outcomes.…”

“…In TARGET, the authors report a significant "implementation shortfall" with the PIPT referral process resulting in only half of the patients in the stratified care group receiving a PIPT referral. 20 This implementation shortfall was attributed to electronic health record challenges with the referral process to PIPT clinicians, as well as a lack of study-funded resources for physical therapy visits. 20 Similarly, in MATCH, the authors discuss implementation difficulties due to the complexity of the PIPT intervention, as well as the nuances of the US healthcare system, when compared to the U.K. 21 Accordingly, this perspective addresses issues of PIPT implementation within US health systems.…”

“…20 This implementation shortfall was attributed to electronic health record challenges with the referral process to PIPT clinicians, as well as a lack of study-funded resources for physical therapy visits. 20 Similarly, in MATCH, the authors discuss implementation difficulties due to the complexity of the PIPT intervention, as well as the nuances of the US healthcare system, when compared to the U.K. 21 Accordingly, this perspective addresses issues of PIPT implementation within US health systems. The fact that the TARGET and MATCH trials had challenges implementing this type of intervention in a pragmatic trial is concerning for those interested in implementing PIPT in real-world clinical settings.…”

“…Indeed, the recent clinical trial experiences from the US provide an indication that scaling PIPT to meet the demands of routine clinical delivery is primarily implementation related. 20,21 Therefore, the purpose of this Perspective is twofold. First, we discuss the current state of PIPT training and implementation.…”