Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia

Sponsor
Medical University of Vienna (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04701450
Collaborator
(none)
750
1
25
30

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Questionnaire Study to Evaluate Patient Satisfaction Between Digital, Telephonic and Conventional Obtaining of Consent for Anaesthesia
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction after informed consent [Immediately after obtaining informed consent]

    Assessment of subjectively experienced satisfaction with the process of obtaining informed consent for anesthesia

Secondary Outcome Measures

  1. Overall waiting time of patients [Up to three hours; from administration for informed consent until completion of informed consent]

    Patient's overall waiting time in the process of obtaining consent

  2. Time expense of informed consent [Up to 60 minutes; from start until end of informed consent]

    Overall time expense for the anaesthesiologist who is connsenting the patient

  3. Intraoperative complications [Up to 12 hours; From start until end of the planned surgical procedure]

    Incidence of unexpected medical complications during the surgical procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna General Hospital Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David M Baron, MD, Assoc. Prof. PD Dr. David Baron, EDIC, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04701450
Other Study ID Numbers:
  • 1688/2018
First Posted:
Jan 8, 2021
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 11, 2022