Patient Satisfaction With Tiered OR Versus Status Quo OR

November 10, 2023 updated by: Abdelrahman Lawendy, Lawson Health Research Institute

ACTION in the OR: Patient Satisfaction With High Efficiency OR Design in Orthopedic Surgery

Operating room (OR) costs consume a significant portion of hospital budgets. Standard or "Status Quo" ORs are equipped with the same, fixed set of assigned resources, regardless of case complexity or actual resource requirements. Allocation of resources in standard ORs is the same whether the participant is having heart surgery or bunion removal.

The investigators propose a strategy for OR design and set up wherein resources are carefully matched to procedure complexity as a novel means of healthcare delivery.

This prospective, comparative cohort pilot study will compare two operating room (OR) setup designs. The Tiered OR setup (study intervention) will be an efficiently staffed and equipped OR, geared to the complexity of the surgical procedure. The level of care provided would be equivalent to that of an out-patient day surgery setup. The Status Quo OR setup (control intervention) will be a standard fully equipped, fully staffed OR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is an unmet demand for surgical services in Ontario. The situation worsens as the population ages(9). Ontario healthcare costs account for a staggering 40% of the provincial budget(1).Provincial budget deficits mean an influx of healthcare resources are not forthcoming. The aging population costs Ontarians in excess of $2 billion dollars annually(1).

Constrained and overburdened OR resources can result in patients having surgery at night and sometimes surgical procedures being performed by staff not specialized for surgical procedure type(8). Moreover, patient outcomes often decline while they await their surgical date(4, 10-13).

Operating rooms are regarded as an area of intensive resource requirements. With no regard to the complexity of a given procedure or demonstrable resource requirements, ORs are typically managed at critical care levels. This is true for specialized support staff like nurses as well(14). Allocation of resources is not tailored to the individual scenario. This inefficient model of surgical care delivery has been the status quo for decades and the fiscal impact, as well as the challenges this poses to productivity, have taken a toll on hospital budgets and contributed to lengthy provincial wait times for surgical procedures stretching months and even years. For example, according to Health Quality Ontario, the average wait times for elective orthopaedic surgery procedures at London Health Science Center (LHSC) is 96 days to first surgical consultation and an average of 211 days to operating on the patient.

Faced with rising costs in an aging population, the investigators are compelled to find innovative solutions that will allow hospitals to accomplish more with less. These changes are necessary to maintain the standard of Canadian healthcare system and provide timely services in a cost-efficient manner.

Standard or "Status quo" OR set ups are always equipped with the same, fixed set of assigned resources, regardless of case complexity or actual resource requirements. Allocation of resources in standard ORs is the same whether one is having heart surgery or bunion removal.

To challenge these apparent incongruities, the investigators and the hospital pilot tested a tiered strategy for surgical procedures wherein resources were carefully matched to procedure complexity. Preliminary results suggested dramatic improvements in efficiency (up to 35%) and reductions in cost (up to 62%). This Academic Centre Tiered Operating Room strategy (ACTION-in-the-OR) presents a shift from the old, one-size-fits-all OR archetype to a novel, efficient model.

By reducing OR time for minor procedures, the surplus OR time saved could be made available for the more time consuming surgical procedures and for more patients overall. Specialization and standardization has the potential to improve access and quality of care.

This project evaluates an attempt to employ tiered ORs to redistribute finite surgical care resources with orthopedic surgery. While results from a pilot test of high efficiency OR was positive, demonstrating case cost reductions and increased efficiency in OR turnover, longer follow-up, larger sample size, an economic evaluation, and additional high quality evidence is needed to bolster this work.

The investigators propose a prospective, comparative cohort study to evaluate the viability of an altered surgical health care delivery model on participant satisfaction and clinical outcomes as well as economic impact of an innovative healthcare delivery model in orthopedic patients undergoing elective foot and ankle surgery. This project is a portion of a larger proposal which also will examine the impact of tiered OR design on other surgical procedures in arthroplasty and general surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4B9
        • LHSC, Victoria Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • ≥18 years of age

    • No significant co-morbidities preventing outpatient day surgery
    • Undergoing procedures considered a Low Surgical Resource Requirement of relatively short duration with minimal equipment needs (e.g. bunion, revisions, ankle fractures, removal of hardware etc.)
    • Procedures allowing for standardization of equipment and staff

Exclusion Criteria:

  • • Refusal to participate

    • Inability to provide informed consent
    • Likely problems maintaining follow-up in the opinion of the investigator
    • Undergoing multiple operative procedures
    • Unable to read/write English even with the aid of an interpreter (for consent and questionnaire completion).

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tiered OR Satisfaction
Patient satisfaction questionnaire with surgical experience in Tiered OR
Other: Patient satisfaction questionnaire
Patient satisfaction questionnaire
Other: Status Qou OR satisfaction
Patient satisfaction questionnaire with surgical experience in Tiered OR
Other: Patient satisfaction questionnaire
Patient satisfaction questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient surgical Experience Satisfaction survey
Time Frame: 2 weeks post surgery
patient satisfaction with surgical process
2 weeks post surgery
EQ5D- 5L
Time Frame: 2, 6 weeks, 3, 6 months
change in patient satisfaction with quality of life
2, 6 weeks, 3, 6 months
NSQIP Patient Reported Surgical Satisfaction Questionnaire
Time Frame: 6 weeks post surgery
patient satisfaction with surgical process
6 weeks post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resource Utilization Cost Data
Time Frame: baseline to 6 months
comparison of cost measures between the 2 OR designs
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abdel Lawendy, Lawson HRI

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 110936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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