European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF)

NCT00962910 | Completed DMC

• 1 other identifier: EPA-EQCP002
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

Brief Summary

Care pathways, a complex intervention to (re)organise, standardize and evaluate care processes, are used worldwide and in different kinds of settings. Although their international use, the impact is unclear. The European Quality of Care Pathways Study is the first international cluster Randomized Controlled Trial on the effect of care pathways for proximal femur fracture patients (PFF). The hypothesis is that teams who work with care pathways for PFF patients deliver care that is more compliant to evidence based key interventions, have better patient outcomes and higher scores on team indicators than teams who do not work with care pathways.

Conditions

Femoral Fractures

Keywords

Femoral Fractures; Critical Pathway; Cluster Randomized Controlled Trial; Safety; Efficiency

Outcome Measures

Primary Outcomes (1)

• Mortality

  6 month

Secondary Outcomes (2)

• Length of stay

  in hospital

• Pain score

  in hospital

Study Arms (2)

Pathway

EXPERIMENTAL

A care pathway will be implemented in this experimental group.

Other: PFF evidence based pathway

Usual Care

NO INTERVENTION

Usual Care will be provided.

Interventions

PFF evidence based pathway OTHER

A care pathway, as complex intervention, will be implemented.

Also known as: pathway, care pathway, clinical pathway, critical pathway, integrated care pathway

Pathway

Eligibility Criteria

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

You may qualify if:

• Written agreement to participate in the study;
• Agreement that a care pathway for PFF will not be developed and used within the time frame of the study when randomized in the control group.
• Written informed consent;
• All consecutive admissions with PFF;
• Minimum age of 65 years;
• Closed fracture;
• Eligible for surgical intervention;
• ASA-score of 1, 2 or 3;
• Each patient was included only once in the study at initial hospitalization, even if the patient has been hospitalized more than once.

You may not qualify if:

• Patients with severe dementia (DSM IV);
• Bone metastatic diseases (pathologic fractures);
• Second fracture on the same hip (i.e. peri-prosthetic fracture)
• Team members are involved in direct patient care responsibilities for PFF;
• Minimum representation of the core disciplines according to PFF literature;

Sponsors & Collaborators

• European Pathway Association: lead
• KU Leuven: collaborator
• University of Eastern Piedmont: collaborator

Related Publications (3)

• Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.

  PMID: 34766330 DERIVED

• Panella M, Seys D, Sermeus W, Bruyneel L, Lodewijckx C, Deneckere S, Sermon A, Nijs S, Boto P, Vanhaecht K. Minimal impact of a care pathway for geriatric hip fracture patients. Injury. 2018 Aug;49(8):1581-1586. doi: 10.1016/j.injury.2018.06.005. Epub 2018 Jun 4.

  PMID: 29884319 DERIVED

• Vanhaecht K, Sermeus W, Peers J, Lodewijckx C, Deneckere S, Leigheb F, Boonen S, Sermon A, Boto P, Mendes RV, Panella M; EQCP study group. The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial. BMC Health Serv Res. 2012 May 24;12:124. doi: 10.1186/1472-6963-12-124.

  PMID: 22640531 DERIVED

Related Links

• European Pathway Association

MeSH Terms

Conditions

Femoral Fractures

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Kris Vanhaecht, PhD

  KU Leuven

  STUDY DIRECTOR

• Walter Sermeus, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Massimiliano Panella, PhD

  Amedeo Avogadro University of Eastern Piemont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kris Vanhaecht, Secretary General, European Pathway Association, ivzw

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: January 1, 2017
• Last Updated: February 7, 2024

Record last verified: 2024-02