The effectiveness and cost-effectiveness of an integrated osteoporosis care programme for postmenopausal women in Flanders: study protocol of a quasi-experimental controlled design

Summary Osteoporosis causes high individual and societal burden, due to limited attention to fracture prevention. Integrated care for chronic conditions has shown to facilitate management of these conditions, improving clinical outcomes alongside quality of life and cost-effectiveness. This manuscript describes an integrated osteoporosis care programme that will be implemented in primary care. Objective To provide a comprehensive description of a quasi-experimental study design in which a newly developed integrated osteoporosis care (IOC) programme for the management of postmenopausal osteoporosis (PO) in primary care (PC) is implemented and will be compared with care as usual (CAU). Methods A literature research was performed and expert meetings have been taking place, which has led to the development of a complex PC intervention based on framework for integrated people-centred health services (IPCHS). Results This manuscript describes the developmental process of the preclinical phase of a quasi-experimental real-world design and the interventions as a result of this process that will be implemented during the clinical phase, along with the evaluation that will take place alongside the clinical phase: An integrative approach for the management of PO in primary care was developed and will be implemented in greater region of Ghent (GRG), Belgium. The approach consists of a complex intervention targeting patients and PC stakeholders in osteoporosis care (e.g. general practitioners (GPs), physiotherapists, nurses, pharmacists). A comparison will be made with CAU using medication possession ratios (MPR) of included patients as primary outcome. These data will be obtained from the national health database. Secondary outcomes are physician outcomes, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMs). A cost-effectiveness evaluation will be performed if the programme appears to be effective in terms of MPR. Trial Registration ClinicalTrials.gov : NCT03970902