Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program

Study Overview
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Brief Summary
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The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.

Detailed Description
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Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study. The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center. As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed. In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.

Official Title
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A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept

Conditions
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Hip Fractures

Participation Criteria
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Eligibility Criteria
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Preoperative Inclusion Criteria: Age ≥ 70 years Geriatric patients with hip fractures Treated either with oOsteosynthesis or oEndoprosthesis Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent Preoperative Exclusion Criteria: Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GFC: Geriatric Fracture Center<br>Patient treatment in a geriatric fracture center A GFC is defined as follows: General geriatrician or ortho-geriatrician available in trauma/orthopaedic department Geriatrician sees the patient prior to surgery (except if the patient is admitted over night or during weekends) Local medical guidelines, consented by orthopedic surgeons and geriatrician Pre-defined order set for assessing laboratory values Pre-defined patient pathway to guarantee a fast track in the emergency room Daily communication among involved specialists Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): Daily patient visit by geriatrician Daily patient visit by orthopedic surgeon in combination with nurse Daily therapy by physiotherapists, except for weekends Access to social workers, if required | |
| UCC: Usual Care Center<br>Patient treatment in an usual care center A UCC is defined as follows: No geriatrician available in trauma/orthopaedic department No pre-operative visit by a geriatrician as a standard No pre-defined medical guidelines for geriatric fracture patients Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): No daily patient visits by a geriatrician as a standard | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events related to treatment / residential status / immobilization | Major AEs related to treatment / residential status / immobilization: Delirium Congestive heart failure Pneumonia Deep venous thrombosis Pulmonary embolism Pressure ulcers Myocardial infarction | From surgery up to 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization |  | From surgery up to 1 year follow-up | 
| Activities of daily living | Modified Barthel index pre-injury, at 12 weeks and 12 months | Baseline, 12 weeks and 1 year postoperative | 
| Number of re-admissions to an acute hospital |  | From surgery up to 1 year follow-up | 
| Timed up and go test (TUG) |  | 12 weeks and 1 year follow-up | 
| Parker Mobility Score | Parker Mobility Score pre-injury, at 12 weeks and 12 months | Baseline, 12 weeks and 1 year follow-up | 
| Mortality |  | From surgery up to 1 year follow-up | 
| Quality of Life | Quality of life using the EuroQoL questionnaire (EQ-5D) | 12 weeks and 1 year postoperative | 
| Pain | Pain using the numeric rating scale | From surgery up to1 year follow-up | 
| Direct and indirect costs | All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc) | Baseline up to 1 year follow-up | 
| Time from admission to start of pain medication |  | Baseline (admission to surgery), about 1-2 days | 
| Time from admission to start of fluid management |  | Baseline (admission to surgery), about 1-2 days | 
| Time from admission to surgery |  | Baseline (admission to surgery), about 1-2 days | 
| Time from surgery to discharge 1 and 2 | Discharge 1 is defined as discharge from orthopaedic / trauma department Discharge 2 is defined as the timepoint when the patient is discharged to their definite residential status, i.e. residential status where no further change in residential status is planned . Discharge 1 and 2 may occur on the same date. | Baseline (admission to discharge), about 1-2 weeks | 
| Residential status | Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months | Baseline up to 1 year follow-up | 
| Falls | Numbers of falls | From surgery up to 1 year follow-up | 
| Medication | Number of different types of medication at admission, discharge 1, 12 weeks, 12 months and information whether analgesics, osteoporosis and other medications are administered at all study visit time points | Baseline up to 1 year follow-up | 
| Number of patients receiving adequate secondary fracture prevention |  | Baseline up to 1 year follow-up | 
| Number of patients for which the nutrition status was evaluated / adapted |  | Baseline (admission to discharge), about 1-2 days | 
| Occurrence of a contralateral hip fracture |  | Retrospective assessment of pre-injury status up to 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications, Geriatrics [MeSH], Osteoporotic fractures [MeSH], Hip fractures [MeSH], Cost benefit analysis [MeSH], Quality of life [MeSH], Mortality [MeSH]