Clinical trial NCT02958293: Perioperative Morbidity in Elective Surgery Based on the Time of the Year
Official title: Does Procedural Timing Impact Perioperative Morbidity in Elective Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Complication
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 19872
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Surgical Complication
timeFrame: 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: