About the project
Patients with prior fragility fracture have a 2-5 fold increased risk of recurrent fractures. Still, the majority of fragility fracture patients are neither assessed, nor treated for osteoporosis. The Norwegian Capture the Fracture Initiative (NoFRACT) is a stepped-wedge cluster randomized trial (RCT) of a standardized fracture prevention program introduced in seven Norwegian hospitals.
Fracture patients 50 years and older will have their recurrent fracture risk assessed and high-risk patients will be offered treatment. The patients are captured and followed by coordinating nurses at the hospitals. The interventions involves systematic follow-up and includes osteoporosis medications, fall prevention and life-style advice.
Objectives
Selected hypotheses and questions:
- The incidence of fragility fractures (hip, proximal humerus and wrist) will be reduced at hospitals with a standardized intervention program compared to hospitals without.
- The mortality rate after fragility fractures (hip, proximal humerus and wrist) will be reduced at hospitals with a standardized program compared to hospitals without.
- Are there any hospital related factors associated with one-year mortality post fracture such as hospital size (number of beds), travel distance to hospital, waiting time for surgery?
- Can the intervention reduce social inequalities in health? We want to study whether better post fracture care can reduce social gradients in fracture risk and mortality post fracture.
- Study of causes of death post hip fracture (from the Norwegian Cause of Death Register). Are there any differences between hospitals in which the intervention program has been implemented versus not implemented?
Outcomes
The project is currently in its analysis phase. By the end of 2018, 34 976 fracture patients had been approached, of which 6 631 (19%) were hip fractures , 992 (3%) were lost to follow up, 1 975 (6%) were considered too frail for inclusion, and 2 740 (8%) refused participation. 25 345 (72%) patients were offered fracture liaison service, and of these 22 349 (88%) were examined for osteoporosis. More than half (59%) of those examined received a prescription or medical treatment. Within NoFRACT, 72% of patients have reported adherence to anti-osteoporosis medications after 3 and 12 months (results from the Tromsoporosis quality assurance study). Over 90% of those who were recommended medications, were treatment-naïve at the time of fracture.
Background
In Norway and many other countries there is a large care gap, leaving millions of patients with a bone fracture at serious risk of future fractures. By introducing a standardized intervention program (fracture liaison service) for assessment and treatment of fracture patients in hospitals, we expect to document reduced rates of fractures and fracture related mortality. Inclusion criteria are: age ≥ 50 years, all types of fracture cases (except fingers, toes, face and skull). Seven Norwegian hospitals are randomized for the starting date of the study in a Stepped Wedge Cluster Randomized Controlled Trial design. The effect of the intervention will be measured based on endpoints from national registers (NPR, KUHR, Statistics Norway, Cause of death register, Norwegian hip fracture register). Each hospital will act as their own control, and endpoints will be compared before and after the intervention. Rigorous evaluation of fracture liaison service is important to determine whether secondary fracture prevention should be standard procedure in Norwegian hospitals.
Sub-projects
1. Consent-based study
Six out of seven hospitals (all except Haukeland University Hospital, Bergen) have invited fracture patients to participate in a sub-study. The patients who are able and willing to provide written informed consent prior to participating will be asked to fill in questionnaires about lifestyle, smoking, physical activity, alcohol intake, use of medication, history of diseases, previous fractures, falls and EQ-5D for assessment of health related quality of life at baseline and after one year follow-up. For more information contact Lene Bergendal Solberg.
2. Consent-based study with longer follow-up
At one hospital (Drammen) additional data will be collected for the sub-study: Bone mineral density measure (DXA scan) with Vertebral Fracture Assessment (VFA) and Trabecular Bone Structure (TBS) assessed at baseline and after 2 years. Serum bone markers (PINP and CTX) will be assessed at baseline and after 1 year. For more information contact Tove Borgen.
3. Validation study of forearm fractures
A validation study of forearm fracture diagnoses in the Norwegian Patient Register (NPR) and the Control and Reimbursement of Healthcare Claims registry (KUHR) database is ongoing. The aim is to estimate the completeness and correctness of the ICD-10 (S52) and ICPC-2 (L72) diagnosis codes, and determine which medical procedure codes can be used to increase the validity of the fracture diagnoses. In addition, the number of forearm fractures only being treated in primary care will be estimated. For more information contact Cecilie Dahl.
Financing
- Regional Health Authorities (HELSEFORSK). Helseforsk rapporten 2018
Collaboration
Oslo University Hospital
Prof Lars Nordsletten, orthopedic surgeon (Ullevål), Lene B. Solberg, PhD,orthopedic surgeon, Frede Frihagen, PhD, orthopedic surgeon, Prof Erik Fink Eriksen, endocrinologist, Ida Lund, MD, Ruth Aga, MD, Janne Blegen Høglund, Ingvild Hestnes, Ellen Johansson, Mette Bentdal Larsen, nurses, Elise B. Vesterhus, BA
Bærum Hospital
Wender Figved, PhD, orthopedic surgeon, Ellen Tverå Langslet, orthopedic surgeon, Merete Finjar, nurse.
Drammen Hospital
Tove Tveitan Borgen, rheumatologist, key contact person, Lars Michael Hubschle, orthopedic surgeon, Hanne Louise Hoelstad and May-Britt Stenbro are nurses.
Bergen, Haukeland University Hospital
Jan-Erik Gjertsen, PhD, orthopedic surgeon, Clara Gjesdal, PhD, rheumatologist, Ellen Margrete Apalset,PhD, rheumatologist, Mariann Hansen, BA
Molde
Jens Stutzer, orthopedic surgeon, Charlotte Råmkes and Solveig Solberg, nurses,Lasse Ørsal, BA.
Trondheim, St. Olavs University Hospital
Trude Basso, PhD, orthopedic resident, Lars Gunnar Johnsen, PhD, orthopaedic surgeon, Prof Unni Syversen, endocrinologist, Mari Hoff, PhD, rheumatologist, Sølvi Liabakk, physiotherapist, Nina Raaness Larsen, Kristine Aavik Haugen, Gry Mette Torstensen and Hilde Kjøsnes Thoresen, nurses.
Norwegian University of Science and Technology
Gunhild Hagen PhD student, health economist
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Tromsø, University Hospital of North Norway (UNN)
Åshild Bjørnerem, PhD, gynecologist, Prof Ragnar Joakimsen, endocrinologist, Marit Osima, MD, PhD student, Gunnar Knutsen, PhD, Jan Elvenes, PhD, Karl-Ivar Lorentzen, Ann Kristin Hansen, all orthopaedic surgeons, and nurse Anita Kanniainen, Camilla Andreasen, MD, PhD student
Start - finish
The project was started in 2015, and completed the inclusion phase in 2018. The analysis phase will continue through March 2025.