Evaluation of an electronic clinical decision support system (DeSSBack) to improve low back pain management: a pilot cluster randomized controlled trial

Abstract

Abstract Background Low back pain (LBP) is a common reason for primary care consultation; yet doctors often find managing it challenging. An electronic decision support system for LBP (DeSSBack) was developed based on an evidence-based risk stratification tool to improve the management of patients with LBP in a Malaysian primary care setting. This pilot study aimed to assess the feasibility, acceptability, and preliminary effectiveness of DeSSBack for the conduct of a future definitive trial. Methods A pilot cluster randomized controlled trial (cRCT) with qualitative interviews was conducted. Each primary care doctor was considered a cluster and randomized to either the control (usual practice) or intervention (DeSSBack) group. Patient outcomes including Roland-Morris Disability Questionnaire (RMDQ), Hospital Anxiety and Depression Scale, and a 10-point pain rating scale were measured at baseline and 2-month postintervention. The doctors in the intervention group were interviewed to explore feasibility and acceptability of using DeSSBack. Results Thirty-six patients with nonspecific LBP participated in this study (intervention n = 23; control n = 13). Fidelity was poor among patients but good among doctors. The RMDQ and anxiety score had medium effect sizes of 0.718 and 0.480, respectively. The effect sizes for pain score (0.070) and depression score were small (0.087). There was appreciable acceptability and satisfaction with use of DeSSBack, as it was helpful in facilitating thorough and standardized management, providing appropriate treatment plans based on risk stratification, improving consultation time, empowering patient-centred care, and easy to use. Conclusions A future cRCT to evaluate the effectiveness of DeSSBack is feasible to be conducted in a primary care setting with minor modifications. DeSSBack was found useful by doctors and can be improved to enhance efficiency. Trial registration The protocol of the cluster randomized controlled trial was registered at ClinicalTrials.gov (NCT04959669).