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

NCT ID: NCT02297581

Last Updated: 2020-06-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-05-31

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.

Conditions

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Hip Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Innovation Translation Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Elmhurst Medical Center

New York, New York, United States

Site Status

Medical University of Innsbruck

Innsbruck, , Austria

Site Status

AKH Linz

Linz, , Austria

Site Status

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

General Hospital Singapore

Singapore, , Singapore

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Hospital Son LLatzer

Palma de Mallorca, Balearic Island, Spain

Site Status

Hospital Universitario Costa del Sol

Marbella, , Spain

Site Status

Bhumibol Adulyadej Hospital

Bangkok, , Thailand

Site Status

Hospital Medical Center Bangkok

Bangkok, , Thailand

Site Status

Countries

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United States Austria Netherlands Singapore Spain Thailand

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.

Reference Type DERIVED
PMID: 37918921 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33972329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28706090 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28706089 (View on PubMed)

Other Identifiers

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GFC

Identifier Type: -

Identifier Source: org_study_id

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