- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986399
Fast Track Hip Fracture - an Optimized Pathway for Hip Fracture Patients
February 2, 2018 updated by: Asbjorn Aroen, University Hospital, Akershus
Influence of a Fast Track Pathway for Hip Fracture Patients on Mortality and Quality of Life
The study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and American Society of Anesthesiologists (ASA) score.
The register also collects quality of life data 4 and 12 months after surgery.
Using the unique Norwegian personal identification number the data from the Norwegian hip fracture register will be connected with data from the electronic patient record at Akershus University hospital (AHUS).
Fast track surgery for hip fracture patients was introduced at the end of 2013.
Mortality and quality of life data will be compared for all hip fracture patients operated at AHUS two years before and two years after this change in standard care.
The combined data from the register and the electronic patient records will be used for regression analysis.
Study Type
Observational
Enrollment (Actual)
2495
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult hip fracture patients operated at Akershus university hospital in 2012, 2013, 2014 and 2015.
Description
Inclusion Criteria:
- Operated at Akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015
- 18 years or older
Exclusion Criteria:
- stress fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Standard care
Hip fracture patients operated at Akershus University hospital in 2012 and 2013.
|
|
|
Fast track patient pathway
Hip fracture patients operated at Akershus University hospital in 2014 and 2015.
|
Admittance: Ambulance - Radiology - Orthopaedic ward.
Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 day mortality rate
Time Frame: Within 30 days from surgery
|
Percentage of patients who die within 30 days from hip fracture surgery
|
Within 30 days from surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1 year mortality rate
Time Frame: Within 1 year from surgery
|
Percentage of patients who die within 1 year from hip fracture surgery
|
Within 1 year from surgery
|
|
Quality of life
Time Frame: 4 and 12 months from surgery
|
Quality of life measured by EQ-5D
|
4 and 12 months from surgery
|
|
Readmissions
Time Frame: Within 30 days from discharge
|
Unscheduled, all-cause readmission within 30 days from discharge from the index admission
|
Within 30 days from discharge
|
|
Postoperative infection
Time Frame: Within 1 year from surgery
|
Superficial and / or deep surgical site infection
|
Within 1 year from surgery
|
|
Re-operation
Time Frame: Within 1 year from surgery
|
All-cause re-operation at the site of the index surgery
|
Within 1 year from surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Asbjorn Aaroen, Professor, Akershus University Hospital and Faculty of Medicine, University of Oslo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2012
Primary Completion (ACTUAL)
September 14, 2017
Study Completion (ACTUAL)
September 14, 2017
Study Registration Dates
First Submitted
December 6, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (ESTIMATE)
December 8, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2018
Last Update Submitted That Met QC Criteria
February 2, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 284907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.