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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04701450
Other study ID # 1688/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2022

Study information

Verified date October 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 750
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
digital consent
the patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material

Locations

Country Name City State
Austria Vienna General Hospital Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Intraoperative complications Incidence of unexpected medical complications during the surgical procedure Up to 12 hours; From start until end of the planned surgical procedure
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