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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02958293
Other study ID # 16-049
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date June 8, 2018

Study information

Verified date October 2022
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC) database to evaluate if there are any differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed.


Description:

Surgical complications are a significant cause of morbidity and mortality. Surgical complications account for up to 40% of hospital complications. Complications and adverse events are also becoming increasingly important for measuring health care quality. Many physician practices notice a surge of patients seeking care at the end of the year compared to other times of the year. Patients who meet their insurance deductibles are likely more eager to proceed with an elective procedure. Patients who have met their deductible likely utilize more healthcare resources because they have more health problems, or have had more procedures performed during that year. Thus there may be potential for sicker and more complicated patients to undergo surgery at the end of the year as compared to other times of the year. Prior studies have often evaluated the "July effect" which is the beginning of a new academic year at teaching hospitals. Not only are new interns involved in patient care but trainees at all levels are in participating in a new role. Several prior studies have found high morbidity and mortality rates in July-August compared to April-June. There is paucity of research evaluating the measures for the months of November-December. Identifying which patients are at a higher risk for perioperative morbidity is important to help prevent surgical complications and lower healthcare costs. Proper patient selection and appropriate timing for elective procedures will positively impact these adverse outcomes. This study is a retrospective cohort study investigating whether there are differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed. The results of this project could impact counseling for patient regarding timing of their surgery based on calendar month. This could also help implement changes in how systems based care is provided regarding insurance deductibles and maximums.


Recruitment information / eligibility

Status Completed
Enrollment 19872
Est. completion date June 8, 2018
Est. primary completion date March 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients aged 18 and older undergoing surgical procedures in the main operating room between July 1, 2012 and July 1, 2016. Exclusion Criteria: - Patients under the age of 18 - Procedures done outside of the main operating suites (Endoscopy suite, Labor and Delivery)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Surgical Complication All patients 18 years and older who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital between January 1, 2015 and December 31, 2016. 90 days after surgery
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