Reliability and Validity of a New Postoperative Track Assessment Tool (POTraTool)

Reliability and Validity of a New Postoperative Track Assessment Tool - a Prospective Observational Study

This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Second, we hypothesized that a) health care providers of IMC or postoperative anaesthesia care unit (PACU) have similar estimations using this tool and b) that this estimation is accurately established in the first 2 hours.

Study Overview

• Status: Completed
• Conditions: Perioperative Complication
• Intervention / Treatment: Other: Po Tra tool

Detailed Description

The tool includes 2 visual analog scale (VAS) scores estimating indication of an IMC admission and benefit of an IMC stay. The tool was tested in a PACU and in an IMC unit of a Swiss tertiary centre in 2019/2020 (before COVID pandemic). Three raters: one nurse, one physician in charge and the consultant physician, were asked to fill the VAS at the same time for each included patient. The score was done in the 2 first hours following admission in the unit and during the multi professional morning round at day 1.

Reliability was estimated by testing internal consistency (homogeneity), interrater reliability and agreement and test-retest validity (stability). Validity included content validity, construct validity and criterion validity.

• Study Type: Observational
• Enrollment (Actual): 879

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study was a random sample from the PACU and IMC patients' population. Included patients' variables for demographic description of the population of interest and for the validity testing were: Age in years, gender (male / female), ASA physical score classification (ASA PS), do not resuscitate order (DNR), duration of intervention (min), severity of intervention (minor/intermediate/major), type of surgery (abdominal, orthopedic, trauma and other surgical and non-surgical interventions), elective or non-elective, palliative intervention, SAPS II (admission (2 h after arrival in IMC)), NEMS (admission (2 h after arrival) and during stay in IMC), SAS.

Participating raters were voluntary health care providers working in the peri-interventional unit (PACU and IMC).

Description

Inclusion Criteria:

• PACU patients admitted on Mondays
• IMC patients admitted 7:30am-7:30pm on weekdays

Exclusion Criteria:

• night admission
• PACU patient ASA < 3 or minor intervention

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate Care (IMC) indication (VASi)	Health care raters graded the IMC indication (or allocative efficiency) for each patient on a visual analog scale grading from 0 (very low indication of an IMC management) to 100 (very high indication of an IMC management), namely VASi.	2019/2020
Intermediate Care benefit (VASb)	Health care raters graded the IMC benefit (or health gain) for each patient on a visual analog scale grading from 0 (very low benefit from an IMC management) to 100 (very high benefit from an IMC management), namely VASb.	2019/2020

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Study Director: Walder, Professor, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Decision making; Clinical pathways; Post-Anesthesia Care Unit; Intermediate Care Unit
• Other Study ID Numbers: 14032019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No