- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243747
Implementation of a Computer-based Questionnaire for Preoperative Evaluation in Anesthesia Ambulance
June 21, 2018 updated by: Claudia Spies, Charite University, Berlin, Germany
Preanesthetic evaluation is a clinical assessment process with purpose of increased patient safety.
One focus is review of patient medical history to reduce perioperative morbidity and mortality as well as optimize the daily process in at anesthesia ambulance.
The aim of that study is the development and implementation of a practical computer-based individualized and risk-adapted questionnaire for the daily routine
Study Overview
Status
Completed
Detailed Description
The study was a step-by-step process.
In the first investigation in 2013 the investigators included 50 patients and 81 patients in 2016.
Questionnaires were identical in both testing stages for comparability.
Practicability of a computer-based questionnaire on patient medical history, diagnosis as well as behavior guidelines was tested at anesthesia ambulance.
Moreover, the investigators evaluated the user satisfaction with the help of a separate anonym paper-based questionnaire in 2013 as well as in 2016.
Study Type
Observational
Enrollment (Actual)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10117
- Department of Anesthesiology and Operative Intensive Care Medicne Berlin (CCM/CVK)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients who undergo a procedure in anaesthesia and elective surgery at the Charité - Univeristätsmedizin Berlin, Campus Charité Mitte
Description
Inclusion Criteria:
- 18 years and older
- Patients who undergo a procedure in anaesthesia and elective surgery
- German speaking people
Exclusion Criteria:
- Emergency surgery
- American Society of Anesthesiologists (ASA) classification V and VI
- Patients with guardianship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Utilization of computer-based questionnaire measured by duration time
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Number of assistance during filling-out in depending of age
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Question 1: All in all I am content
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 2: The usability of tablet-pc is easy
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 3: My medical history is well determined
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 4: The phrasing of questions is clearly understandable
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 5: The total count of questions is acceptable
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 6: The complete duration time is acceptable
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 7: In the future, I would prefer digital questionnaires
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Question 8: In the future, I would prefer the questionnaire at home using internet.
Time Frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
|
User satisfaction evaluation by the help of a paper-based questionnaire.
The evaluation was based on rating scale: 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=poor, 6=fail.
|
Time in the outpatient clinic of anesthesia, an average of 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Claudia Spies, MD, Prof., Charité - Univsersitätsmedizin Berlin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2016
Primary Completion (Actual)
October 14, 2016
Study Completion (Actual)
October 14, 2016
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 8, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WAA
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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