Operating Room SchedulingNCT01892865
Use of Predictive Modeling to Improve Operating Room Scheduling Efficiency
A study testing Scheduling using historical means and Scheduling using regression modeling system in people with Operating Room Scheduling, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study compares two different methodologies of scheduling cases in the operating room. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Operating Room Scheduling
- What is being tested?
- Scheduling using historical means and Scheduling using regression modeling system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
This study compares two different methodologies of scheduling cases in the operating room.
Read the 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.
- Conditions
- Operating Room Scheduling
- Being tested
- Scheduling using historical means, Scheduling using regression modeling system
- Keywords
- Operating room utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduling using historical meansOther
Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
Scheduling using regression modeling systemOther
A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
| Study group | Role | What they receive |
|---|---|---|
| Historical means method | Active comparator | Operative time will be predicted using historical service means. Schedule will be constructed using this time Receives: Other: Scheduling using historical means |
| Predictive Modeling System (PMS) | Experimental | Operative time will be predicted using a regression model. Schedule will be constructed using this time Receives: Other: Scheduling using regression modeling system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the Actual and Predicted Length of Operative Day (in Minutes)
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.
Measured: Three years
Secondary outcomes (3)
Difference in Throughput
Difference in total number of cases scheduled per unit of time analyzed between the two study arms
Measured: Three years
Operative Suite Personnel Job Satisfaction
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).
Measured: Three years
Complications: A Composite Endpoint of Death, Myocardial Infarction, Bleeding, Amputation
Comparison of the perioperative (30-day postoperative) composite endpoint of death, myocardial infarction, bleeding, amputation between the two study groups
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Operating Room SchedulingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Panagiotis Kougias, MD MSc, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TXDavid H. Berger, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892865
- Sponsor's protocol ID
- IIR 12-113
- Status last verified
- May 2017
- First submitted
- 1 Jul 2013
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kougias P, Tiwari V, Sharath SE, Garcia A, Pathak A, Chen M, Ramsey D, Barshes NR, Berger DH. A Statistical Model-driven Surgical Case Scheduling System Improves Multiple Measures of Operative Suite Efficiency: Findings From a Single-center, Randomized Controlled Trial. Ann Surg. 2019 Dec;270(6):1000-1004. doi: 10.1097/SLA.0000000000002763.
PubMed 29697450
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Predictive Modeling to Improve Operating Room Scheduling Efficiency
- ClinicalTrials.gov ID
- NCT01892865
- Acronym / sponsor ID
- IIR 12-113
- Conditions
- Operating Room Scheduling
- Keywords
- Operating room utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares two different methodologies of scheduling cases in the operating room.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical means method | Active comparator | Other: Scheduling using historical meansOperative time will be predicted using historical service means. Schedule will be constructed using this time |
| Predictive Modeling System (PMS) | Experimental | Other: Scheduling using regression modeling systemOperative time will be predicted using a regression model. Schedule will be constructed using this time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Scheduling using historical meansScheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time | Other | Historical means method |
| Scheduling using regression modeling systemA regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length | Other | Predictive Modeling System (PMS) |
Primary outcome
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.
3 secondary outcomes
Difference in Throughput
Time frame: Three years
Operative Suite Personnel Job Satisfaction
Time frame: Three years
Complications: A Composite Endpoint of Death, Myocardial Infarction, Bleeding, Amputation
Time frame: Three years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29697450Kougias P, Tiwari V, Sharath SE, Garcia A, Pathak A, Chen M, Ramsey D, Barshes NR, Berger DH. A Statistical Model-driven Surgical Case Scheduling System Improves Multiple Measures of Operative Suite Efficiency: Findings From a Single-center, Randomized Controlled Trial. Ann Surg. 2019 Dec;270(6):1000-1004. doi: 10.1097/SLA.0000000000002763.
- Individual participant dataSharing planned: No
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.
Panagiotis Kougias, MD MSc principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
David H. Berger, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduling using historical means and Scheduling using regression modeling system in people with Operating Room Scheduling, run by VA Office of Research and Development at 1 site in United States.
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 2 inclusion and 6 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference Between the Actual and Predicted Length of Operative Day (in Minutes) (time frame: Three years). 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 NCT01892865, 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 2 Jan 2018.