- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892865
Use of Predictive Modeling to Improve Operating Room Scheduling Efficiency
May 24, 2017 updated by: VA Office of Research and Development
This study compares two different methodologies of scheduling cases in the operating room.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goal of the proposed study is to address the efficacy of a scheduling methodology that uses a regression-based predictive modeling system (PMS) to calculate operative and anesthetic time length.
The investigators hypothesize that compared to the traditional scheduling system (TSS) that calculate operative length using historic means, case allocation in an operating room using the PMS will improve scheduling precision, increase operative volume and increase Operative Suite (OS) personnel satisfaction, without having adverse impact on patient outcomes.
The investigators will evaluate this hypothesis using a randomized block design in two operating rooms of a single surgical specialty for a total of 100 operative days per arm.
Study Type
Interventional
Enrollment (Actual)
735
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The only requirement for including a day in the study will be that all the procedures performed in that specific day have been previously performed in our hospital at least 5 times a year for each of the last three years. This rule will encompass the vast majority of the performed vascular procedures in our facility. Setting the threshold at a minimum of 5 cases per year is essential to assure that some data will be available to calculate the expected length of the case with either the traditional or the predictive modeling system. If a case is performed in a day when the scheduling imprecision is supposed to be calculated using the PMS but modeling data do not exist, then the anticipated length of this case will be calculated using the historic means.
- Surgery cancellation after the first case will not disqualify that day from inclusion in the study. If the cancellation occurs in the last case of the sequence for the specific day then no particular intervention will be taken. The anticipated end of the surgical day will reset to the end of the last case that took place, and all the imprecision calculations will be performed as described below. If the cancellation occurs in one of the intermediate cases, then the end of the operative day will reset to reflect the removal of the cancelled case.
Exclusion Criteria:
A day will be excluded from the study when any of the following occur (based on historical data the investigators anticipate 10-15% of the operative days to meet the exclusion criteria):
- Only one or no cases have been scheduled for the entire operative day
- An emergency case is added as first case, or in between the scheduled cases.
- The operative day falls during a major holiday week (Thanksgiving, Christmas, New Year). The schedule during these time periods tends to be fragmented, cancellation rates are high, and cases are frequently performed with back-up teams only. All these factors may distort the findings.
- There is an unusual case in the schedule that does not meet the minimum requirement of 5 previous operations on a yearly basis for the last three years.
- The first case of the day is cancelled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Historical means method
Operative time will be predicted using historical service means.
Schedule will be constructed using this time
|
Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
|
EXPERIMENTAL: Predictive Modeling System (PMS)
Operative time will be predicted using a regression model.
Schedule will be constructed using this time
|
A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Between the Actual and Predicted Length of Operative Day (in Minutes)
Time Frame: Three years
|
The scheduling imprecision between the two scheduling approaches will be compared.
Scheduling imprecision is defined as the difference between the actual and predicted length of operative day.
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Throughput
Time Frame: Three years
|
Difference in total number of cases scheduled per unit of time analyzed between the two study arms
|
Three years
|
Operative Suite Personnel Job Satisfaction
Time Frame: Three years
|
Comparison of job satisfaction between study arms using three domains of the Maslach Burnout Inventory: Depersonalization (range 0-17, score of 17 indicates worse depersonalization).
Emotional Exhaustion (range: 0-36, score of 36 is the worse).
Personal accomplishment (range 1-60, score of 60 is best).
|
Three years
|
Complications: A Composite Endpoint of Death, Myocardial Infarction, Bleeding, Amputation
Time Frame: Three years
|
Comparison of the perioperative (30-day postoperative) composite endpoint of death, myocardial infarction, bleeding, amputation between the two study groups
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Panagiotis Kougias, MD MSc, Michael E. DeBakey VA Medical Center, Houston, TX
- Principal Investigator: David H. Berger, MD, Michael E. DeBakey VA Medical Center, Houston, TX
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
July 1, 2013
First Submitted That Met QC Criteria
July 1, 2013
First Posted (ESTIMATE)
July 8, 2013
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2018
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIR 12-113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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