A decision making model for hip fractures

OBJECTIVE: The major aim of this study is to develop risk profiles for negative outcome after hip surgery in the elderly patients. This risk profiles will form the basis for a shared decision making process in fracture treatment in the elderly. STUDY DESIGN: First part of the study will be a literature review of comparisons between operative and conservative treatment in elderly patients with a proximal femur fracture. Second part will be a retrospective study, in which the short and long term mortality, accident, injury, admission and treatment data of patients with a proximal femur fracture aged 75 or older in the region Noord-Brabant will be collected from several medical and hospital registrations over the last 5 years. Third part will be a prospective, observational, follow-up study in which mortality, costs, functional outcome and (HR)QoL within elderly with a proximal femur fracture will be assessed during 24 months follow-up admitted in a hospital in the region Noord-Brabant. In the fourth and last part we will develop risk- and cost profiles, and a risk score chart. STUDY POPULATION/DATASET: For the retrospective part patients aged 75 year and older admitted in the period 2009-2013 after an isolated proximal femur fracture and registered in the Brabant Trauma Registry are included. Patients who are dead upon arrival or who deceased in the ED are excluded. For the prospective part patients aged 75 year and older who will have surgery due to an isolated proximal femur fracture are included. Patients who are dead upon arrival or who decease in the Emergency Department are excluded. Other exclusion criteria are high impact trauma and pathological fracture. Patients who die in the hospital will drop out the study and will not be included in the analyses. In our trauma database 7.000 patients between 2009 and 2013 will meet the inclusion criteria for the retrospective part. In our region Brabant about 1600 patients aged 75 years or older with a proximal femur fracture and an ISS 11 or lower are admitted to a hospital annually. In the last two years almost 5% died in the hospital. We expect a response rate of 70%. Based on these assumptions we will include about 1100 patients in the prospective study. OUTCOME MEASURES: The primary outcome parameters of this study are short and long term mortality, functional outcome, (health related) quality of life (HRQoL) and health care costs. Secondary outcome parameters are Quality Adjusted Life Years (QALY’s) and Incremental Cost Effectiveness Ratio (ICER) . DATA ANALYSIS: Regarding mortality survival analyses will be conducted for the different risk profiles. Mixed between-within repeated measures ANOVA will be performed to examine the course of morbidity and (HR)QoL over time and between low and high risk group. Socio-demographic and clinical characteristics were tested as risk factors on mortality, morbidity and (HR)QoL, measured 1,3, 6, 12 and 24 months after injury in multiple regression analysis. To develop risk profiles and a score chart we will calculate the predictive risk for each statistically significant determinant obtained from the multiple regression analyses. These predictive risks can be translated in scores, which can be used for assessing a high and low risk profile and a score chart. For economic evaluation costs profiles for each of the risk profiles will be constructed. From health related quality of life measure we can calculate the utilities and QALY’s. With these QALY’s together with the costs of the distinguished risk profiles an ICER can be calculated after each follow up period. COLLABORATION/CONNECTION: The study will be performed in the St Elisabeth hospital, where research and clinical application can be combined, in collaboration with CoRPS of Tilburg University for quality of life research questions and with the Institute of Health Policy and Management, Department Health Economics of the Erasmus University in Rotterdam for cost-effectiveness study questions. Participation of all hospitals in Brabant will be asked. TIME SCHEDULE: Month 1-4 Systematic review Month 1-12 collecting data, analyzing and reporting retrospective study - Prospective study Month 1-3 Preparing the prospective study Month 4-16: Inclusion (one year) of the patients and collecting data from Trauma registry and Electronic Medical Records Month 4-42: Sending questionnaires and reminders Month 40-48: Analysing and reporting results