A multilevel intervention for low back pain management in primary care: An effectiveness-implementation hybrid study (PRIME back study)

Background and rationale
Low back pain (LBP) is one of the most common and burdensome health problems with large direct and indirect costs. It is the leading cause of disability worldwide and causes a large proportion of patients to seek primary care. Improving primary care management is a key opportunity to reduce the LBP burden but the implementation of high value care is poorly understood. Despite two decades of consistent clinical practice guideline recommendations, low-value care is still common in practice. Innovative, context-specific and multilevel interventions are needed to implement high-value care in primary care practice.

Overall objectives and specific aims
Using an effectiveness-implementation hybrid type I design, this project aims to test the effectiveness of a multilevel intervention in primary care for patients with LBP and investigate the implementation processes.

Methods
A multilevel intervention has been developed based on the best evidence, discussions with health professionals, and pilot testing. For this project, quality improvement circles (QC) of general practitioners (GP) from a health network will be cluster-randomized into intervention or control groups. Patients will receive care aligned with the group to which their GP is allocated. We aim to recruit 20 QC, 140 GPs and 500 patients in French-speaking Switzerland. The multilevel intervention will address practitioners' and patients' beliefs about LBP, support GPs to implement high-value care and propose a clear and effective pathway that matches care to the patient's clinical need, based on their risk factors for chronicity. The effectiveness of the intervention will be tested on self-reported disability at 6 months measured with the Roland Morris Disability Questionnaire (RMDQ) (patient-level), back-related imaging prescription rate during the three first months (practitioner-level) and cost-effectiveness over a one-year period (system-level). Patients will fill out online questionnaires at baseline, 6 weeks, and 3, 6 and 12 months. Administrative data will be extracted for health costs and care prescriptions. The project will also evaluate the acceptability, appropriateness, feasibility, and adoption of the multilevel intervention among GPs with questionnaires, administrative data, and focus groups. Barriers and facilitators to implementation will be explored through focus groups with healthcare practitioners.

Expected results
We expect that the multilevel intervention will be more effective than usual care, with a reduction in disability (2.5 points differences in the RMDQ) and imaging prescription rate (absolute 15% decrease). We also expect that the multilevel intervention will decrease healthcare costs, due to the reduced use of unnecessary treatment and diagnostic procedures in the intervention group. Furthermore, we expect to gain new insights into implementation processes that will provide important knowledge to inform future implementation efforts.

Impact
This project will have a significant impact on care decisions both in Switzerland and internationally, and will offer new directions to reduce the burden of LBP. It will provide critical new knowledge on how to improve the integration of high-value care for LBP into primary care practice. Important information on implementation processes that reduce knowledge-practice gaps will also be gained. Locally, it will help healthcare practitioners manage this complex condition, improve the health and wellbeing of patients with LBP, and reduce the pressure on the overburdened healthcare system.

• Christe Guillaume, Maître d'enseignement, HESAV

• FNS - Fonds National Suisse