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

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ClinicalTrials.gov Identifier: NCT02297581
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:
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.

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 282 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 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

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



Primary Outcome Measures :
  1. Major Adverse Events related to treatment / residential status / immobilization [ Time Frame: From surgery up to 1 year follow-up ]

    Major AEs related to treatment / residential status / immobilization:

    • Delirium
    • Congestive heart failure
    • Pneumonia
    • Deep venous thrombosis
    • Pulmonary embolism
    • Pressure ulcers
    • Myocardial infarction


Secondary Outcome Measures :
  1. Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization [ Time Frame: From surgery up to 1 year follow-up ]
  2. Activities of daily living [ Time Frame: Baseline, 12 weeks and 1 year postoperative ]
    Modified Barthel index pre-injury, at 12 weeks and 12 months

  3. Number of re-admissions to an acute hospital [ Time Frame: From surgery up to 1 year follow-up ]
  4. Timed up and go test (TUG) [ Time Frame: 12 weeks and 1 year follow-up ]
  5. Parker Mobility Score [ Time Frame: Baseline, 12 weeks and 1 year follow-up ]
    Parker Mobility Score pre-injury, at 12 weeks and 12 months

  6. Mortality [ Time Frame: From surgery up to 1 year follow-up ]
  7. Quality of Life [ Time Frame: 12 weeks and 1 year postoperative ]
    Quality of life using the EuroQoL questionnaire (EQ-5D)

  8. Pain [ Time Frame: From surgery up to1 year follow-up ]
    Pain using the numeric rating scale

  9. Direct and indirect costs [ Time Frame: Baseline up to 1 year follow-up ]
    All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc)

  10. Time from admission to start of pain medication [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  11. Time from admission to start of fluid management [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  12. Time from admission to surgery [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  13. Time from surgery to discharge 1 and 2 [ Time Frame: Baseline (admission to discharge), about 1-2 weeks ]
    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.

  14. Residential status [ Time Frame: Baseline up to 1 year follow-up ]
    Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months

  15. Falls [ Time Frame: From surgery up to 1 year follow-up ]
    Numbers of falls

  16. Medication [ Time Frame: Baseline up to 1 year follow-up ]
    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

  17. Number of patients receiving adequate secondary fracture prevention [ Time Frame: Baseline up to 1 year follow-up ]
  18. Number of patients for which the nutrition status was evaluated / adapted [ Time Frame: Baseline (admission to discharge), about 1-2 days ]
  19. Occurrence of a contralateral hip fracture [ Time Frame: Retrospective assessment of pre-injury status up to 1 year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic (Usual Care clinic) Geriatric center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297581


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New York
Elmhurst Medical Center
New York, New York, United States, 11373
Austria
Medical University of Innsbruck
Innsbruck, Austria, 6020
AKH Linz
Linz, Austria, 4020
Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands, 7609 SZ
Maastricht University Medical Center
Maastricht, Netherlands, 6202 AZ
Singapore
General Hospital Singapore
Singapore, Singapore, 169608
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Spain
Hospital Son LLatzer
Palma de Mallorca, Balearic Island, Spain, 07198
Hospital Universitario Costa del Sol
Marbella, Spain, 29603
Thailand
Bhumibol Adulyadej Hospital
Bangkok, Thailand, 10220
Hospital Medical Center Bangkok
Bangkok, Thailand, 10310
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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Principal Investigator: Michael Blauth, Professor Medical University of Innsbruck

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02297581     History of Changes
Other Study ID Numbers: GFC
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by AO Clinical Investigation and Documentation:
Geriatrics [MeSH]
Osteoporotic fractures [MeSH]
Hip fractures [MeSH]
Cost benefit analysis [MeSH]
Quality of life [MeSH]
Mortality [MeSH]
Complications
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries