Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia

Questionnaire Study to Evaluate Patient Satisfaction Between Digital, Telephonic and Conventional Obtaining of Consent for Anaesthesia

In this study, the investigators aim to evaluate patient satisfaction between three methods of obtaining informed consent for anaesthesia. Patients are asked to partake in a short survey after being informed about the anaesthetic procedure either conventionally in the anesthesia department, telephonically or digitally.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: digital consent

Detailed Description

Patient satisfaction plays an important role to improve the process of medical procedures as well as patient outcome. Evaluating the subjectively experienced satisfaction is challenging. The investigators will use a questionnaire and assess waiting times in the process to determine patient satisfaction between digital, telephonic and conventional obtaining of informed consent for anaesthesia.

In this questionnaire study, patients are asked to partake in a survey after the process of obtaining consent for anaesthesia is completed. The questionnaire covers aspects of patient satisfaction with the process, such as subjective assessment of comprehensibility, waiting time and privacy.

Patients are divided into three groups. In one group, consent is obtained conventionally, in form of a visit to our anaesthesia department. In the other two groups, consent is obtained telephonically and digitally, respectively. Patients are not randomised into these groups, but included into the study after the process of obtaining consent by one of the three methods mentioned above is completed.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Vienna General Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients for whom consent for anaesthesia is obtained for an elective procedure

Description

Inclusion Criteria:

• Patients for whom consent for anaesthesia is obtained

Exclusion Criteria:

• Age < 18 years
• Language barrier
• Patients with appointed legal guardians
• Patients unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
conventional; consent for anaesthesia is obtained as part of a conversation with physical attendance
telephonic; consent for anaesthesia is obtained telephonically
digital; a digital survey and video information is used to inform the patient about the anaesthetic procedure	Other: digital consent; the patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction after informed consent	Assessment of subjectively experienced satisfaction with the process of obtaining informed consent for anesthesia	Immediately after obtaining informed consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall waiting time of patients	Patient's overall waiting time in the process of obtaining consent	Up to three hours; from administration for informed consent until completion of informed consent
Time expense of informed consent	Overall time expense for the anaesthesiologist who is connsenting the patient	Up to 60 minutes; from start until end of informed consent
Intraoperative complications	Incidence of unexpected medical complications during the surgical procedure	Up to 12 hours; From start until end of the planned surgical procedure

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: David M. Baron, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 1, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1688/2018

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