Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program
NCT ID: NCT02297581
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
282 participants
OBSERVATIONAL
2015-05-31
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GFC: Geriatric Fracture Center
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
No interventions assigned to this group
UCC: Usual Care Center
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
70 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Michael Blauth, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck
Locations
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Saint Louis University
St Louis, Missouri, United States
Elmhurst Medical Center
New York, New York, United States
Medical University of Innsbruck
Innsbruck, , Austria
AKH Linz
Linz, , Austria
Ziekenhuisgroep Twente
Almelo, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
General Hospital Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Hospital Son LLatzer
Palma de Mallorca, Balearic Island, Spain
Hospital Universitario Costa del Sol
Marbella, , Spain
Bhumibol Adulyadej Hospital
Bangkok, , Thailand
Hospital Medical Center Bangkok
Bangkok, , Thailand
Countries
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References
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Joeris A, Sprague S, Blauth M, Gosch M, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Phillips MR. Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study. BMJ Open. 2023 Nov 2;13(11):e072744. doi: 10.1136/bmjopen-2023-072744.
Blauth M, Joeris A, Rometsch E, Espinoza-Rebmann K, Wattanapanom P, Jarayabhand R, Poeze M, Wong MK, Kwek EBK, Hegeman JH, Perez-Uribarri C, Guerado E, Revak TJ, Zohner S, Joseph D, Gosch M. Geriatric fracture centre vs usual care after proximal femur fracture in older patients: what are the benefits? Results of a large international prospective multicentre study. BMJ Open. 2021 May 10;11(5):e039960. doi: 10.1136/bmjopen-2020-039960.
Hurtado-Chong A, Joeris A, Hess D, Blauth M. Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results. BMJ Open. 2017 Jul 12;7(7):e014796. doi: 10.1136/bmjopen-2016-014796.
Joeris A, Hurtado-Chong A, Hess D, Kalampoki V, Blauth M. Evaluation of the geriatric co-management for patients with fragility fractures of the proximal femur (Geriatric Fracture Centre (GFC) concept): protocol for a prospective multicentre cohort study. BMJ Open. 2017 Jul 12;7(7):e014795. doi: 10.1136/bmjopen-2016-014795.
Other Identifiers
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GFC
Identifier Type: -
Identifier Source: org_study_id
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