Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service (FLSSantPau)
Primary Purpose
Hip Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fracture Territorial Liaison Service afert a Hip fracture
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- All hip fractures older than 65 years
Exclusion Criteria:
- Politraumatic fractures
- Metastasic fractures
Sites / Locations
- Jordi Martin Marcuello
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Patiens who will receive stanrdar care after hip fracture
Patiens who will receive FLS following after the hip fracture
Arm Description
All the patients who will be on surgery after a hip fracture will receive after the hospital discharge the standar following we are doing now in our hospital
All the patients who will be on surgery after a hip fracture will receive after the hospital discharge a FLS following, multidisciplinary, with a web and mobile app aplication
Outcomes
Primary Outcome Measures
Number of Deaths
% of Number of deaths after 1st year o follow up
Number of Falls
Number of Falls 1st year o follow up
Percentage of patients with adequated Osteoporotic treatment
Percentage of patients with adequated osteoporotic treatment
Secondary Outcome Measures
Barthel at the end of follow up
Compare Barthel after hospital discharge with the end of follow up barthel. Minimum is 0 maximum is 100.
Full Information
NCT ID
NCT05266755
First Posted
February 23, 2022
Last Updated
March 4, 2022
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT05266755
Brief Title
Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service
Acronym
FLSSantPau
Official Title
Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The International Osteoporosis Foundation (IOF) and the American Society for Bone Research and Mineral Metabolism recommend the creation and implementation of fracture coordination services (FLS) as the most efficient way to address the problem. FLS has emerged as a new clinical approach that uses coordinated, multidisciplinary care to improve post-fracture outcomes and reduce recurrent fractures. It is a multidisciplinary and protocolized care model that must guarantee:
Identify fragility fractures and people at risk for a fracture
Fracture risk assessment
Indication for treatment or referral
Improvement in therapeutic compliance
Reduce the risk of falls It is known that patients who have undergone a FLS model (vs no FLS), have lower mortality, lower risk of fracture, with a reduction of 35% and 56%, respectively, during two years of follow-up. One of the most important objectives of the FLS is the proper recognition and treatment of osteoporosis (OP) in patients with fragility fractures. A major problem is the lack of adherence to treatment for OP, and inclusion in an FLS program increases the prescription of bisphosphonates from 17.9% to 76%. In addition, a specific follow-up program means that 73% of patients followed by FLS continue to undergo anti-resorptive treatment after 2 years of having suffered a femur fracture.
Detailed Description
Hypothesis After a femur fracture due to fragility, upon discharge from surgery at the Hospital de la Santa Creu i Sant Pau, including patients in a regional FLS program will make it possible to complete the study of the patient with fracture, improve adherence to treatment of OP (secondary prevention), and obtain better functional recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter clinical trial. Adult patients who consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for an FxF PSM as a primary or secondary diagnosis will be selected and will be randomized with a 1:1 distribution to be included in the FLS -CTSPau (intervention group) or to receive usual care (control group). The result of the intervention will be evaluated in terms of health outcomes (re-consultations, hospital readmissions and quality of life).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patiens who will receive stanrdar care after hip fracture
Arm Type
Placebo Comparator
Arm Description
All the patients who will be on surgery after a hip fracture will receive after the hospital discharge the standar following we are doing now in our hospital
Arm Title
Patiens who will receive FLS following after the hip fracture
Arm Type
Active Comparator
Arm Description
All the patients who will be on surgery after a hip fracture will receive after the hospital discharge a FLS following, multidisciplinary, with a web and mobile app aplication
Intervention Type
Other
Intervention Name(s)
Fracture Territorial Liaison Service afert a Hip fracture
Intervention Description
Give a diferent than the current one way of follow up to the patients with hip fracture
Primary Outcome Measure Information:
Title
Number of Deaths
Description
% of Number of deaths after 1st year o follow up
Time Frame
1 year after discharge
Title
Number of Falls
Description
Number of Falls 1st year o follow up
Time Frame
1 year after discharge
Title
Percentage of patients with adequated Osteoporotic treatment
Description
Percentage of patients with adequated osteoporotic treatment
Time Frame
1 year after discharge
Secondary Outcome Measure Information:
Title
Barthel at the end of follow up
Description
Compare Barthel after hospital discharge with the end of follow up barthel. Minimum is 0 maximum is 100.
Time Frame
1 year after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All hip fractures older than 65 years
Exclusion Criteria:
Politraumatic fractures
Metastasic fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi M Marcuello, Doctor
Phone
629315207
Email
jmartinma@santpau.cat
Facility Information:
Facility Name
Jordi Martin Marcuello
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08041
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi M Marcuello
Phone
629315207
Email
jmartinma@santpau.cat
Ext
Marcuello
Email
jmartinma@santpau.cat
First Name & Middle Initial & Last Name & Degree
Jordi M Marcuello, Doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service
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