Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Association of Sex With Guideline-based Perioperative Care in Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03422497
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.

Condition or disease Intervention/treatment
Hip Fractures Gender Bias Surgery Anesthesia Other: Male sex Other: Female sex

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Association of Sex With Provision of Guideline-based Perioperative Care for Hip Fracture Surgery Patients: a Population-based Study
Actual Study Start Date : May 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Male sex
Male sex-as listed in the discharge abstract database

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
Other: Female sex
Male sex-as listed in the discharge abstract database




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Preoperative anesthesiology consult [ Time Frame: Hospital admission to date of surgery, or 365 days after admission, whichever came first ]
    Physician billing code for preoperative, inpatient anesthesiology consult

  2. Wait for surgery greater than 2 days [ Time Frame: Hospital admission to date of surgery, or 365 days after admission, whichever came first ]
    Hospital admission to surgery wait for greater than 2 days

  3. Perioperative regional analgesia [ Time Frame: Hospital admission to 3 days after surgery ]
    Peripheral nerve block or epidural administered in the perioperative period, identified from physician billing data codes

  4. Neuraxial anesthesia [ Time Frame: Day of surgery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Sex based on that listed in the discharge abstract database (not self-reported)
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency hip fracture surgery patients
Criteria

Inclusion Criteria:

  • Non-elective hospital admission
  • Hip fracture diagnosis
  • Hip fracture surgery

Exclusion criteria

-None


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03422497     History of Changes
Other Study ID Numbers: DM7
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Privacy policies in our institution preclude data sharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries