The RESOLVE Trial: A Stepped-Wedge, Cluster-Randomized Clinical Trial Evaluating the Effects of Clinical Practice
Emma H Beisheim-Ryan1,2,3, Brad D Hendershot1,3,4, Charity G Patterson5
1Extremity Trauma and Amputation Center of Excellence, Defense Health Agency, Falls Church, VA, United States.
Importance:
Low back pain (LBP) clinical practice guidelines (CPGs) recommend using evidence-based active and manual treatments within a psychologically informed physical therapy (PIPT) framework, but the effectiveness of a combined, CPG-adherent approach remains understudied.
Objective:
This trial evaluated the effectiveness of a CPG and PIPT (CPG+PIPT) implementation strategy in reducing LBP-related disability, pain, and downstream health care utilization.
Design:
This was a multisite, stepped-wedge, cluster-randomized trial.
Setting:
The locations were military and veteran health care settings.
Participants:
Data from patients seeking LBP care were collected during usual care, training, and post-training (CPG+PIPT) periods.
Interventions:
Physical therapists from 6 clinics received CPG+PIPT training and monthly feedback reports regarding practice patterns and patient outcomes.
Main Outcomes And Measures:
Primary outcomes were the Oswestry Disability Index (ODI) and the Defense and Veterans Pain Rating Scale (DVPRS), obtained at intake and regular intervals throughout treatment. LBP-related health care utilization data (opioid prescriptions, spinal injections, specialty care visits, hospitalizations, imaging) were extracted from medical databases 12 months after the index visit. Linear mixed models were used to test whether ODI and DVPRS trajectories improved after training. Generalized linear mixed models were used to compare LBP-related health care utilization between usual care and CPG+PIPT periods.
Results:
Analysis included data from 2320 patients seen by 74 physical therapists. Patients reported moderate disability (ODI) and pain (DVPRS) at intake, which persisted throughout follow-up. Patients treated during the CPG+PIPT period had slightly more ODI and DVPRS improvements over time but no clinically meaningful differences at 6 and 12 weeks. The CPG+PIPT period was associated with a 30% reduction in 12-month opioid prescriptions, but patterns of other LBP-related encounters and physical therapist treatments were similar across periods.
Conclusions:
Despite promising improvements in opioid prescription rates, minimal changes in other practice patterns were observed, and differences in outcomes did not translate to clinically meaningful improvements.
Relevance:
Findings underscore the complexity of implementing high-value LBP management strategies in military and veteran health care settings.
