Quality ImprovementNCT03941353
Care Pathways for Benchmarking on Fragile Hip Fractures Rapid Recovery
An observational study of Quality Improvement and Hip Fractures, run by European Pathway Association at 1 site in Belgium.
Trial summary
The aim of this project is to build an international community of centers of excellence in the care for Fragile Hip Fracture Rapid Recovery patients. These centers of excellence will benchmark and share their expertise and experiences based on clinical and managerial data. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality Improvement, Hip Fractures
- How many people
- 298 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient admitted with a proximal femur fracture
Who may be able to join
- Trauma related non-elective admission for hip fracture;
- Minimum age of 65 years;
- The following hip fractures are included: Femoral neck, femoral head, trochanteric and subtrochanteric fractures;
- Discharged or deceased before May 30th of 2019
Who cannot join
- Hip fracture is not the main reason for admission to emergency room;
- Additional ipsilateral fractures;
- Hip fracture resulting from in-hospital fall that occurred in the hospital where the patient receives hip fracture care.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to build an international community of centers of excellence in the care for Fragile Hip Fracture Rapid Recovery patients. These centers of excellence will benchmark and share their expertise and experiences based on clinical and managerial data. In project is designed in five different phase:
Phase 1: literature review: identifying relevant key interventions and indicators Phase 2: expert panel: expert panel for teams, management and policy makers Phase 3: data collection: collection managerial data through retrospective patient record analysis on clinical indicators Phase 4: statistical data analysis: data input, validation and statistical analysis Phase 5: feedback and knowledge sharing: feedback report with anonymous benchmarking and knowledge sharing of the results.
- Conditions
- Quality Improvement, Hip Fractures
- Being tested
- Usual care
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Benchmark study with retrospective patient analysis evaluating the actual care patients with a fragile hip fracture receive
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on quality indicators at patient level (Quality of Care and patient satisfaction) for patients admitted with a fragile hip fracture.
This study evaluates quality indicators at patient level as defined by the expert panel to determine appropriateness of fragile hip fracture indicators. The indicators will cover the pre-operative, peri-operative and post-operative care process. The data will be selected out of the patient record. Based on the expert panel quality of care is measured by time to surgery, information on pre-fall cognitive status, information on pre-fall mobility status, fasting time, administration of carbohydrate loading, administration of cortical steriods, use of tranexamic acid, urinary catheterization, administration of pain medication, time to post operative surgeon note for care team, time of drain duration, type of anesthesia, measurement of haemoglobin, mobilisation post-operative, following of pain protocol, plan for discharge, nutrition supplementation. he study is limited to the period in which the patients are hospitalized. No data is gathered before or after hospitalization.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jan 2020
- Primary completion27 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Pathway Association
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Dr. Kris Vanhaecht, European Pathway Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941353
- Sponsor's protocol ID
- CP4FHF
- Status last verified
- Jul 2021
- First submitted
- 6 May 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathways for Benchmarking on Fragile Hip Fractures Rapid Recovery
- ClinicalTrials.gov ID
- NCT03941353
- Acronym / sponsor ID
- CP4FHF
- Conditions
- Quality Improvement, Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- European Pathway AssociationUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to build an international community of centers of excellence in the care for Fragile Hip Fracture Rapid Recovery patients. These centers of excellence will benchmark and share their expertise and experiences based on clinical and managerial data. In project is designed in five different phase:
Phase 1: literature review: identifying relevant key interventions and indicators Phase 2: expert panel: expert panel for teams, management and policy makers Phase 3: data collection: collection managerial data through retrospective patient record analysis on clinical indicators Phase 4: statistical data analysis: data input, validation and statistical analysis Phase 5: feedback and knowledge sharing: feedback report with anonymous benchmarking and knowledge sharing of the results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient admitted with a proximal femur fracture
Key inclusion criteria (4 listed)
- Trauma related non-elective admission for hip fracture;
- Minimum age of 65 years;
- The following hip fractures are included: Femoral neck, femoral head, trochanteric and subtrochanteric fractures;
- Discharged or deceased before May 30th of 2019
Key exclusion criteria (3 listed)
- Hip fracture is not the main reason for admission to emergency room;
- Additional ipsilateral fractures;
- Hip fracture resulting from in-hospital fall that occurred in the hospital where the patient receives hip fracture care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careBenchmark study with retrospective patient analysis evaluating the actual care patients with a fragile hip fracture receive | Other | – |
Primary outcome
Performance on quality indicators at patient level (Quality of Care and patient satisfaction) for patients admitted with a fragile hip fracture.
Time frame: through study completion, an average of 1 year
This study evaluates quality indicators at patient level as defined by the expert panel to determine appropriateness of fragile hip fracture indicators. The indicators will cover the pre-operative, peri-operative and post-operative care process. The data will be selected out of the patient record. Based on the expert panel quality of care is measured by time to surgery, information on pre-fall cognitive status, information on pre-fall mobility status, fasting time, administration of carbohydrate loading, administration of cortical steriods, use of tranexamic acid, urinary catheterization, administration of pain medication, time to post operative surgeon note for care team, time of drain duration, type of anesthesia, measurement of haemoglobin, mobilisation post-operative, following of pain protocol, plan for discharge, nutrition supplementation. he study is limited to the period in which the patients are hospitalized. No data is gathered before or after hospitalization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality Improvement and Hip Fractures, run by European Pathway Association at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on quality indicators at patient level (Quality of Care and patient satisfaction) for patients admitted with a fragile hip fracture. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.