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

Completed

Conditions

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

Interventional

Enrollment (Actual)

200

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

    • 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

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
Intervention / Treatment
Active Comparator: Tiered OR Satisfaction
Patient satisfaction questionnaire with surgical experience in Tiered OR
Patient satisfaction questionnaire
Other: Status Qou OR satisfaction
Patient satisfaction questionnaire with surgical experience in Tiered OR
Patient satisfaction questionnaire

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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)

February 28, 2018

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID 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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