Effect of a Fracture Liaison Service on the Rate of Subsequent Fracture Among Patients With a Fragility Fracture in the Norwegian Capture the Fracture Initiative (NoFRACT)
| Autor: | Cecilie Dahl, Lars Michael Hübschle, Jan-Erik Gjertsen, Tove Tveitan Borgen, Ragnar Martin Joakimsen, Lars Nordsletten, Ellen M Apalset, Wender Figved, Trude Basso, Jan Elvenes, Erik Fink Eriksen, Lene Bergendal Solberg, Gunhild Hagen, Tone Kristin Omsland, Åshild Bjørnerem, Unni Syversen, Torbjørn Wisløff, Frede Frihagen, Camilla Andreasen, Jens-Meinhard Stutzer |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Research design
Male medicine.medical_specialty VDP::Medical disciplines: 700::Clinical medical disciplines: 750::Orthopedic surgery: 784 Osteoporosis Psychological intervention MEDLINE 030209 endocrinology & metabolism Disease cluster VDP::Medisinske Fag: 700::Klinisk medisinske fag: 750::Ortopedisk kirurgi: 784 law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Intervention (counseling) medicine Secondary Prevention Humans 030212 general & internal medicine Original Investigation Aged Randomized Controlled Trials as Topic Aged 80 and over Intention-to-treat analysis business.industry Norway Research General Medicine Middle Aged medicine.disease Online Only Orthopedics Research Design Physical therapy Female business Osteoporotic Fractures |
| Zdroj: | JAMA Network Open |
| ISSN: | 2574-3805 |
| Popis: | This trial protocol of the Norwegian Capture the Fracture Initiative (NoFRACT) intends to use registry data from Norway and a stepped wedge cluster design to investigate the effect of a standardized intervention program on the rate of subsequent fracture among patients with a fragility fracture. Key Points Question What is the effect of a fracture liaison service on the rate of subsequent fractures? Findings This trial protocol intends to use merged outcome data from national registers to include 82 000 women and men 50 years and older with a fragility fracture treated in 7 hospitals in Norway in a stepped wedge cluster randomized clinical trial introducing a standardized intervention program. The use of outcome data from national registers, which include all patients in the analysis regardless of whether they are exposed to the intervention (intention to treat), should ensure that outcomes are assessed in a standardized way. Meaning The design of this trial is intended to overcome the ethical challenges associated with traditional randomized clinical trials and to generate new knowledge on how to improve the current standard of care. Importance Fragility fracture is a major health issue because of the accompanying morbidity, mortality, and financial cost. Despite the high cost to society and personal cost to affected individuals, secondary fracture prevention is suboptimal in Norway, mainly because most patients with osteoporotic fractures do not receive treatment with antiosteoporotic drugs after fracture repair. Objectives To improve secondary fracture prevention by introducing a standardized intervention program and to investigate the effect of the program on the rate of subsequent fractures. Design, Setting, and Participants Trial protocol of the Norwegian Capture the Fracture Initiative (NoFRACT), an ongoing, stepped wedge cluster randomized clinical trial in 7 hospitals in Norway. The participating hospitals were cluster randomized to an intervention starting date: May 1, 2015; September 1, 2015; and January 1, 2016. Follow-up is through December 31, 2019. The outcome data were merged from national registries of women and men 50 years and older with a recent fragility fracture treated at 1 of the 7 hospitals. Discussion The NoFRACT trial is intended to enroll 82 000 patients (intervention period, 26 000 patients; control period, 56 000 patients), of whom 23 578 are currently enrolled by January 2018. Interventions include a standardized program for identification, assessment, and treatment of osteoporosis in patients with a fragility fracture that is led by a trained coordinating nurse. The primary outcome is rate of subsequent fracture (per 10 000 person-years) based on national registry data. Outcomes before (2008-2015; control period) and after (2015-2019; intervention period) the intervention will be compared, and each hospital will act as its own control. Use of outcomes from national registry data means that all patients are included in the analysis regardless of whether they are exposed to the intervention (intention to treat). A sensitivity analysis with a transition window will be performed to mitigate possible within-cluster contamination. Results Results are planned to be disseminated through publications in peer-reviewed journals and presented at local, national, and international conferences. Conclusions By introducing a standardized intervention program for assessment and treatment of osteoporosis in patients with fragility fractures, we expect to document reduced rates of subsequent fractures and fracture-related mortality. Trial Registration ClinicalTrials.gov Identifier: NCT02536898 |
| Databáze: | OpenAIRE |
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