Shared responsibility between general practitioners and highly specialized physicians in chronic spinal cord injury: Study protocol for a nationwide pragmatic nonrandomized interventional study

INTRODUCTION: To improve the continuity of care for persons with spinal cord injury (SCI) living in peripheral areas, collaboration between general practitioners (GPs) and specialists is needed. This pragmatic non-randomized interventional study assesses feasibility and effectiveness of a new primary care model based on this collaboration. METHODS: The intervention is medical education on SCI related topics offered by specialists to GPs practicing in rural areas. Outcomes are assessed and analyzed in physicians and patients. Group allocation of persons with SCI follows intention-to-treat principle with intervention group being those in close proximity to a participating GP. RESULTS: It is expected that ten GPs and sixteen specialists will take part in the study's intervention. An average difference in “Doctor's opinion on collaboration questionnaire” score (mean 44; SD ± 12) from baseline after two years post-intervention in the group of participating GPs is hypothesized at P-value level <0.05; meanwhile, the control group remains at an average score of 56. Of persons with SCI (n = 395), 230 are expected to take part in the study at baseline. An average modified “Spinal Cord Injury-Secondary Conditions Scale” change in score from baseline to 24 months post intervention is expected to fall from 12.0 to 9.0 in the intervention group and to stay at 12.0 in the control group. CONCLUSION: The study aims to improve patients' outcomes and providers’ experience with delivery of care for persons with SCI, as compared to current best practice. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04071938. Registered August 28, 2018, https://www.clinicaltrials.gov/ct2/show/NCT04071938.