Patient SatisfactionNCT04701450
Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia
An observational study of Patient Satisfaction, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- digital consent
- How many people
- 750 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients for whom consent for anaesthesia is obtained for an elective procedure
Who may be able to join
- Patients for whom consent for anaesthesia is obtained
Who cannot join
- Age < 18 years
- Language barrier
- Patients with appointed legal guardians
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- digital consent
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital consentOther
the patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: digital consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction after informed consent
Assessment of subjectively experienced satisfaction with the process of obtaining informed consent for anesthesia
Measured: Immediately after obtaining informed consent
Secondary outcomes (3)
Overall waiting time of patients
Patient's overall waiting time in the process of obtaining consent
Measured: 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
Measured: Up to 60 minutes; from start until end of informed consent
Intraoperative complications
Incidence of unexpected medical complications during the surgical procedure
Measured: Up to 12 hours; From start until end of the planned surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Baron, MD, PhD, Medical University of Vienna
- Investigators
- David M. Baron, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701450
- Sponsor's protocol ID
- 1688/2018
- Status last verified
- Oct 2023
- First submitted
- 1 Jan 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Study to Evaluate Patient Satisfaction Between Digital, Telephonic and Conventional Obtaining of Consent for Anaesthesia
- ClinicalTrials.gov ID
- NCT04701450
- Acronym / sponsor ID
- 1688/2018
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional | – | –consent for anaesthesia is obtained as part of a conversation with physical attendance |
| telephonic | – | –consent for anaesthesia is obtained telephonically |
| digital | – | Other: digital consenta digital survey and video information is used to inform the patient about the anaesthetic procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for whom consent for anaesthesia is obtained for an elective procedure
Key inclusion criteria (1 listed)
- Patients for whom consent for anaesthesia is obtained
Key exclusion criteria (4 listed)
- Age < 18 years
- Language barrier
- Patients with appointed legal guardians
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital consentthe patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material | Other | digital |
Primary outcome
Patient satisfaction after informed consent
Time frame: Immediately after obtaining informed consent
Assessment of subjectively experienced satisfaction with the process of obtaining informed consent for anesthesia
3 secondary outcomes
Overall waiting time of patients
Time frame: Up to three hours; from administration for informed consent until completion of informed consent
Time expense of informed consent
Time frame: Up to 60 minutes; from start until end of informed consent
Intraoperative complications
Time frame: Up to 12 hours; From start until end of the planned surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Baron, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction after informed consent (time frame: Immediately after obtaining informed consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.