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

NCT05266755 | Unknown DMC

• 1 other identifier: IIBSP-FLS-2021-114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Barthel at the end of follow up

  1 year after discharge

Study Arms (2)

Patiens who will receive stanrdar care after hip fracture

PLACEBO COMPARATOR

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

Patiens who will receive FLS following after the hip fracture

ACTIVE COMPARATOR

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

Interventions

Fracture Territorial Liaison Service afert a Hip fracture OTHER

Give a diferent than the current one way of follow up to the patients with hip fracture

Patiens who will receive FLS following after the hip fracture; Patiens who will receive stanrdar care after hip fracture

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• All hip fractures older than 65 years

You may not qualify if:

• Politraumatic fractures
• Metastasic fractures

Sponsors & Collaborators

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

Study Sites (1)

Jordi Martin Marcuello

Barcelona, Catalonia, 08041, Spain

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Jordi M Marcuello, Doctor

CONTACT

629315207; jmartinma@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: March 15, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

ES (1)