Hip FracturesNCT03422497
The Association of Sex With Guideline-based Perioperative Care in Hip Fracture Surgery
An observational study of Hip Fractures and Gender Bias, run by Ottawa Hospital Research Institute.
Trial summary
The investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in Ontario. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Gender Bias, Surgery
- What is being tested?
- Male sex and Female sex
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Mar 2016
- 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: Emergency hip fracture surgery patients
Who may be able to join
- Non-elective hospital admission
- Hip fracture diagnosis
- Hip fracture surgery
Who cannot join
- -None
About this study
Official title: The Association of Sex With Provision of Guideline-based Perioperative Care for Hip Fracture Surgery Patients: a Population-based Study
The investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in Ontario.
Read the detailed description
In 2013, the Ontario Ministry of Health and Longterm Care published a 'Quality Based Procedures' guideline for care of hip fracture patients. The adjusted association of sex with receipt of 5 perioperative processes of care that can be accurately measured in health administrative data within this guideline will be investigated.
- Conditions
- Hip Fractures, Gender Bias, Surgery, Anesthesia
- Being tested
- Male sex, Female sex
- Medical subject headings
- Hip Fractures, Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male sexOther
Male sex-as listed in the discharge abstract database
Female sexOther
Male sex-as listed in the discharge abstract database
| Study group | Role | What they receive |
|---|---|---|
| Male hip fracture surgery patients | Individuals 65 years or older admitted non-electively to hospital with a diagnosis of hip fracture who have surgery for their hip fracture and have male sex listed in their discharge abstract Receives: Other: Male sex | |
| Female hip fracture surgery patients | Individuals 65 years or older admitted non-electively to hospital with a diagnosis of hip fracture who have surgery for their hip fracture and have female sex listed in their discharge abstract Receives: Other: Female sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative geriatric medicine consult
Physician billing code for perioperative, inpatient geriatric medicine consult or comprehensive assessment
Measured: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
Secondary outcomes (4)
Preoperative anesthesiology consult
Physician billing code for preoperative, inpatient anesthesiology consult
Measured: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Wait for surgery greater than 2 days
Hospital admission to surgery wait for greater than 2 days
Measured: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Perioperative regional analgesia
Peripheral nerve block or epidural administered in the perioperative period, identified from physician billing data codes
Measured: Hospital admission to 3 days after surgery
Neuraxial anesthesia
Spinal or epidural anesthesia, without concurrent general anesthesia, administered for the hip fracture surgery and identified from the discharge abstract database section which describes anesthesia techniques for surgery.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startMay 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422497
- Sponsor's protocol ID
- DM7
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy policies in our institution preclude data sharing
Publications
Cho N, Boland L, McIsaac DI. The association of female sex with application of evidence-based practice recommendations for perioperative care in hip fracture surgery. CMAJ. 2019 Feb 11;191(6):E151-E158. doi: 10.1503/cmaj.180564.
PubMed 30745399
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Sex With Provision of Guideline-based Perioperative Care for Hip Fracture Surgery Patients: a Population-based Study
- ClinicalTrials.gov ID
- NCT03422497
- Acronym / sponsor ID
- DM7
- Conditions
- Hip Fractures, Gender Bias, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Feb 2018 (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 investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in Ontario.
Detailed description
In 2013, the Ontario Ministry of Health and Longterm Care published a 'Quality Based Procedures' guideline for care of hip fracture patients. The adjusted association of sex with receipt of 5 perioperative processes of care that can be accurately measured in health administrative data within this guideline will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male hip fracture surgery patients | – | Other: Male sexIndividuals 65 years or older admitted non-electively to hospital with a diagnosis of hip fracture who have surgery for their hip fracture and have male sex listed in their discharge abstract |
| Female hip fracture surgery patients | – | Other: Female sexIndividuals 65 years or older admitted non-electively to hospital with a diagnosis of hip fracture who have surgery for their hip fracture and have female sex listed in their discharge abstract |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Emergency hip fracture surgery patients
Key inclusion criteria (3 listed)
- Non-elective hospital admission
- Hip fracture diagnosis
- Hip fracture surgery
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Male sexMale sex-as listed in the discharge abstract database | Other | Male hip fracture surgery patients |
| Female sexMale sex-as listed in the discharge abstract database | Other | Female hip fracture surgery patients |
Primary outcome
Perioperative geriatric medicine consult
Time frame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
Physician billing code for perioperative, inpatient geriatric medicine consult or comprehensive assessment
4 secondary outcomes
Preoperative anesthesiology consult
Time frame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Wait for surgery greater than 2 days
Time frame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Perioperative regional analgesia
Time frame: Hospital admission to 3 days after surgery
Neuraxial anesthesia
Time frame: Day of surgery
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 5 Feb 2018.
- Derived from this study: PubMed 30745399Cho N, Boland L, McIsaac DI. The association of female sex with application of evidence-based practice recommendations for perioperative care in hip fracture surgery. CMAJ. 2019 Feb 11;191(6):E151-E158. doi: 10.1503/cmaj.180564.
- Individual participant dataSharing planned: No. Privacy policies in our institution preclude data sharing
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Gender Bias, run by Ottawa Hospital Research Institute.
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 3 inclusion and 1 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Perioperative geriatric medicine consult (time frame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422497, which also lists 1 linked publication.
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 5 Feb 2018.