Reliability and Validity of a New Postoperative Track Assessment Tool

Perioperative Complication Clinical Trial

— POTraTool  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05092867
• Other study ID #: 14032019
• Status: Completed
• Start date: August 12, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 879
• Est. completion date: October 30, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Complication

Intervention

Other:
• Po Tra tool
Healthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational)

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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