Study design
A controlled intervention will be executed to compare the clinical effectiveness of the new comprehensive care pathway for the treatment of hip fractures with care as usual. Initially a RCT was planned for this purpose. A RCT within one hospital was not justified, because patients are clustered in one ward with a dedicated team. To treat patients with the same diagnosis in two different ways, it was decided to compare patients to be treated with the care pathway at UMCG with care as usual in other hospitals in the Groningen area. To assess if such a RCT was feasible a pilot study was done to test the randomization process. This showed that randomization on the spot performed by ambulance personnel was not feasible. Of the 154 elderly patients with a hip fracture eligible for randomization, only 14 (9%) gave informed consent. It was therefore decided to perform a controlled trial with propensity score adjustment. Propensity scores can be used to adjust for differences at baseline between the intervention and control group in situations in which a classical RCT is not feasible.
The study has been approved by the Medical Ethical Committee of University Medical Center Groningen and is registered in the Dutch trial register (
NTR3171).
Setting
The study will be executed in three hospitals in the northeastern part of the Netherlands. UMCG is a tertiary university hospital, located in the city center of Groningen. Martini Hospital Groningen (MHG) is a large teaching hospital in the southern part of the city and Ommelander Hospital Winschoten (OHW) is a smaller, rurally-located hospital situated in the town of Winschoten, 40 km east of the city of Groningen. Although these three hospitals differ in certain aspects such as size, medical specialty services and educational assignments, they all offer the same standard care for patients with a hip fracture. In the Netherlands, standard care for patients with a hip fracture is based on a national professional guideline [
7]. Therefore, it can be assumed that the usual care in the three hospitals prior to the intervention study is comparable. Patients are taken to one of the hospitals on basis of proximity and availability, not based on the characteristics of the hospital. Especially with respect to the UMCG, it must be mentioned that this hospital does not only provide academic or tertiary care but due to its position as one of the few hospitals in the Northern Netherlands, also provides general (secondary) medical and surgical care. Patients admitted to UMCG for treatment will be treated in the new comprehensive care pathway. Patients transported to Martini Hospital Groningen and Ommelander Hospital Winschoten will receive care as usual.
Participants
Patients aged 60 years and older with a hip fracture defined as a femoral neck fracture (dislocated or not dislocated) and pertrochanteric and intertrochanteric fractures (AO Comprehensive Classification 31.A.1; 31.A.2; 31.A.3) will be included. Exclusion criteria are patients with multi-trauma injuries (thoracic and/or abdominal) and patients who are not able to fill in questionnaires, who are not able to understand the Dutch language, or who are not able to give informed consent. Patients with mild dementia, who do not fully understand the study, but are able to fill in the questionnaires with the help of close relatives can be included when these close relatives give their informed consent and the patient agrees.
Measurements
Measurements will be taken preoperatively, perioperatively, and at 6 weeks and 3 and 6 months after surgery. Preoperative demographic data, preoperative diagnosis, height, weight, Body Mass Index and ASA classification will be recorded. Hip fractures will be classified as femoral neck fractures and pertrochanteric or intertrochanteric fractures. Average surgical time, intraoperative blood loss, in-hospital transfusion rate and complications will be recorded perioperatively. Mortality will also be recorded.
Self-reported limitations in ADL will be measured with the Katz index and Lawton Instrumental Activities of Daily Living (IADL) scoring list [
8,
9]. The Katz index is based on an evaluation of the functional dependence or independence of patients in bathing, dressing, going to the toilet, transferring, continence and feeding. ADL index A indicates independence in all six functions, index B independence in all but one of the six functions. Indexes C–G indicate dependence in bathing and at least one additional function. The IADL scoring list is an evaluation of the abilities of patients in eight activities: using the telephone and transportation, shopping, preparing food, housekeeping and laundry, responsibility for their own medications and handling finances. On the basis of the score patients are divided into different categories that state something about their degree of independence.
Health-related quality of life will be measured using the EQ-5D (EQ-5D™ Dutch© 1987 Euroquol Group). The EQ-5D has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is divided into three degrees of severity: no problem, some problems, and major problems. Actual quality of life must also be signed on the EQ VAS scale. The Katz index and IADL scoring list are measured at the hospital (to determine the situation before the fracture) and at 6 weeks and 6 months after the operation. The EQ-5D will be assessed on the same occasions and at 3 months after the operation.
At the outpatient clinic, at 6 weeks and 6 months after the operation, fracture consolidation, complications and Harris Hip Score will be assessed [
10]. The Harris Hip Score (HHS) is a validated functional hip score that measures four items: pain, function, range of motion and deformity, in that order of importance. A score between 90 and 100 points means an excellent outcome, a score lower than 70 means a poor outcome. Six months after the operation the living and independence situation (percentage of people living in their own home again) of the patient is evaluated.
Sample size
The power calculation is based on the hypothesis that 15% more patients treated with the new comprehensive care pathway compared with patients in the care-as-usual condition will have recovered at least as well at 6 months follow-up to pre-fracture levels in terms of ADL as measured with the Katz index. In order to detect this 15% difference with 80% power at a significance level of 0.05 (one-sided), 130 patients are needed in the new comprehensive care pathway condition and 130 in the usual care condition. Since a comparison will be made between UMCG and MHG as well as between UMCG and OHW, 130 patients will be included in MHG and 130 in OHW. Taking into account an expected drop out-rate of 15% a total of 450 patients have to be included.
Statistical analyses
Statistical analysis will be performed with IBM SPSS Statistics 19.0 (IBM, Amonk, NY). As conventional randomization is not feasible in this patient group, propensity score adjustment will be applied. Propensity scores, or the likelihood to be in the treatment condition or control condition, will be estimated with the following (pre-fracture) variables: age, gender, marital status, living situation, functional status, co morbidity, cognitive function, number of medications, need for home care, need for day care. Propensity scores will be used as an independent variable in the multivariate analysis.
Descriptive statistics will be used to describe the main characteristics of the population. For comparison between UMCG and MHG and OHW a multivariate analysis of variance (MANOVA) will be applied. The Katz index, Lawton Instrumental Activities of Daily Living (IADL) scoring list, the EQ-5D and HHS will be included as dependent variables and hospital and the propensity score as independent variables. A p-value lower than 0.05 will be considered as statistically significant.