Hospital Readmission After HIPr Fracture. Impact of a Territorial Fracture Liason Service (FLSSantPau)

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:

1. Identify fragility fractures and people at risk for a fracture
2. Fracture risk assessment
3. Indication for treatment or referral
4. Improvement in therapeutic compliance
5. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Other: Fracture Territorial Liaison Service afert a Hip 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordi M Marcuello, Doctor; Phone Number: 629315207; Email: jmartinma@santpau.cat

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08041
      • Jordi Martin Marcuello
      • Contact: Jordi M Marcuello; Phone Number: 629315207; Email: jmartinma@santpau.cat
      • Contact: Email: jmartinma@santpau.cat
      • Principal Investigator: Jordi M Marcuello, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All hip fractures older than 65 years

Exclusion Criteria:

• Politraumatic fractures
• Metastasic fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Patiens who will receive stanrdar care after hip fracture; 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	Other: Fracture Territorial Liaison Service afert a Hip fracture; Give a diferent than the current one way of follow up to the patients with hip fracture
Active Comparator: Patiens who will receive FLS following after the hip fracture; 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	Other: Fracture Territorial Liaison Service afert a Hip fracture; Give a diferent than the current one way of follow up to the patients with hip fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths	% of Number of deaths after 1st year o follow up	1 year after discharge
Number of Falls	Number of Falls 1st year o follow up	1 year after discharge
Percentage of patients with adequated Osteoporotic treatment	Percentage of patients with adequated osteoporotic treatment	1 year after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after discharge

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: IIBSP-FLS-2021-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No