NCT03439631

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

5.7 years

First QC Date

February 7, 2018

Last Update Submit

November 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient surgical Experience Satisfaction survey

    patient satisfaction with surgical process

    2 weeks post surgery

  • EQ5D- 5L

    change in patient satisfaction with quality of life

    2, 6 weeks, 3, 6 months

  • NSQIP Patient Reported Surgical Satisfaction Questionnaire

    patient satisfaction with surgical process

    6 weeks post surgery

Secondary Outcomes (1)

  • Resource Utilization Cost Data

    baseline to 6 months

Study Arms (2)

Tiered OR Satisfaction

ACTIVE COMPARATOR

Patient satisfaction questionnaire with surgical experience in Tiered OR

Other: Patient satisfaction questionnaire

Status Qou OR satisfaction

OTHER

Patient satisfaction questionnaire with surgical experience in Tiered OR

Other: Patient satisfaction questionnaire

Interventions

Patient satisfaction questionnaire

Status Qou OR satisfactionTiered OR Satisfaction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHSC, Victoria Hospital

London, Ontario, N6A4B9, Canada

Location

Study Officials

  • Abdel Lawendy

    Lawson HRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Tiered OR set up design will be compared to standard OR set up design as related to patient satisfaction with surgical experience
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 20, 2018

Study Start

February 28, 2018

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations