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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 282

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
  • Linz, Austria, 4020
    • AKH Linz
• Netherlands
  • Almelo, Netherlands, 7609 SZ
    • Ziekenhuisgroep Twente
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht University Medical Center
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 169608
    • General Hospital Singapore
• Spain
  • Marbella, Spain, 29603
    • Hospital Universitario Costa del Sol
  • Balearic Island
    • Palma de Mallorca, Balearic Island, Spain, 07198
      • Hospital Son Llatzer
• Thailand
  • Bangkok, Thailand, 10220
    • Bhumibol Adulyadej Hospital
  • Bangkok, Thailand, 10310
    • Hospital Medical Center Bangkok
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University
  • New York
    • New York, New York, United States, 11373
      • Elmhurst Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic (Usual Care clinic) Geriatric center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 geriatricianDaily patient visit by orthopedic surgeon in combination with nurseDaily therapy by physiotherapists, except for weekendsAccess to social workers, if required
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Michael Blauth, Professor, Medical University of Innsbruck

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Complications; Geriatrics [MeSH]; Osteoporotic fractures [MeSH]; Hip fractures [MeSH]; Cost benefit analysis [MeSH]; Quality of life [MeSH]; Mortality [MeSH]
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: GFC