Abstract
Background: Low back pain (LBP) is a leading cause of disability and healthcare utilization worldwide, yet management in primary care often remains inconsistent with clinical guidelines, with underuse of high-value care and persistent use of low-value interventions. The primary objective of this study is to evaluate the effectiveness of PRIME (PRImary care MultilEvel intervention for low back pain) compared with usual care in terms of cost-effectiveness (system level), back-related imaging rates (practitioner level), and self-reported disability (patient level), while concurrently examining implementation processes.
Methods: This study uses an effectiveness-implementation hybrid type 1 design (NCT07137065). Effectiveness will be evaluated through a pragmatic cluster randomized controlled superiority trial conducted in primary care in Switzerland, recruiting 500 patients with LBP from February 2026 to June 2027. General practitioner quality circles will be randomized to PRIME or usual care. PRIME combines clinician training, patient education resources, automated decision support, and a stepped care pathway aligned with patients' risk of chronicity. Implementation outcomes and determinants will be assessed in the intervention group using quantitative and qualitative methods guided by established implementation frameworks.
Discussion: This trial will provide a comprehensive evaluation of a multilevel intervention targeting both clinical and implementation gaps in LBP care. By integrating effectiveness and implementation outcomes, the study aims to generate actionable evidence on how high-value LBP care can be sustainably implemented in routine primary care and inform future scale-up strategies.