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

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ClinicalTrials.gov Identifier: NCT02297581
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
AO Innovation Translation Center

Tracking Information
First Submitted Date November 17, 2014
First Posted Date November 21, 2014
Last Update Posted Date June 4, 2020
Study Start Date May 2015
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 19, 2014)
  • 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 ]
  • Activities of daily living [ Time Frame: Baseline, 12 weeks and 1 year postoperative ]
    Modified Barthel index pre-injury, at 12 weeks and 12 months
  • Number of re-admissions to an acute hospital [ Time Frame: From surgery up to 1 year follow-up ]
  • Timed up and go test (TUG) [ Time Frame: 12 weeks and 1 year follow-up ]
  • Parker Mobility Score [ Time Frame: Baseline, 12 weeks and 1 year follow-up ]
    Parker Mobility Score pre-injury, at 12 weeks and 12 months
  • Mortality [ Time Frame: From surgery up to 1 year follow-up ]
  • Quality of Life [ Time Frame: 12 weeks and 1 year postoperative ]
    Quality of life using the EuroQoL questionnaire (EQ-5D)
  • Pain [ Time Frame: From surgery up to1 year follow-up ]
    Pain using the numeric rating scale
  • 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)
  • Time from admission to start of pain medication [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  • Time from admission to start of fluid management [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  • Time from admission to surgery [ Time Frame: Baseline (admission to surgery), about 1-2 days ]
  • 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.
  • Residential status [ Time Frame: Baseline up to 1 year follow-up ]
    Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months
  • Falls [ Time Frame: From surgery up to 1 year follow-up ]
    Numbers of falls
  • 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
  • Number of patients receiving adequate secondary fracture prevention [ Time Frame: Baseline up to 1 year follow-up ]
  • Number of patients for which the nutrition status was evaluated / adapted [ Time Frame: Baseline (admission to discharge), about 1-2 days ]
  • Occurrence of a contralateral hip fracture [ Time Frame: Retrospective assessment of pre-injury status up to 1 year follow-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program
Official Title A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic (Usual Care clinic) Geriatric center
Condition Hip Fractures
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2017)
282
Original Estimated Enrollment
 (submitted: November 19, 2014)
266
Actual Study Completion Date May 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Netherlands,   Singapore,   Spain,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02297581
Other Study ID Numbers GFC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AO Innovation Translation Center
Study Sponsor AO Innovation Translation Center
Collaborators Not Provided
Investigators
Principal Investigator: Michael Blauth, Professor Medical University of Innsbruck
PRS Account AO Innovation Translation Center
Verification Date January 2019