<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243747</url>
  </required_header>
  <id_info>
    <org_study_id>WAA</org_study_id>
    <nct_id>NCT03243747</nct_id>
  </id_info>
  <brief_title>Implementation of a Computer-based Questionnaire for Preoperative Evaluation in Anesthesia Ambulance</brief_title>
  <official_title>Implementation of a Computer-based Questionnaire for Preoperative Evaluation in Anesthesia Ambulance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preanesthetic evaluation is a clinical assessment process with purpose of increased patient&#xD;
      safety. One focus is review of patient medical history to reduce perioperative morbidity and&#xD;
      mortality as well as optimize the daily process in at anesthesia ambulance. The aim of that&#xD;
      study is the development and implementation of a practical computer-based individualized and&#xD;
      risk-adapted questionnaire for the daily routine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was a step-by-step process. In the first investigation in 2013 the investigators&#xD;
      included 50 patients and 81 patients in 2016. Questionnaires were identical in both testing&#xD;
      stages for comparability. Practicability of a computer-based questionnaire on patient medical&#xD;
      history, diagnosis as well as behavior guidelines was tested at anesthesia ambulance.&#xD;
      Moreover, the investigators evaluated the user satisfaction with the help of a separate&#xD;
      anonym paper-based questionnaire in 2013 as well as in 2016.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2016</start_date>
  <completion_date type="Actual">October 14, 2016</completion_date>
  <primary_completion_date type="Actual">October 14, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Utilization of computer-based questionnaire measured by duration time</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of assistance during filling-out in depending of age</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Question 1: All in all I am content</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 2: The usability of tablet-pc is easy</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 3: My medical history is well determined</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 4: The phrasing of questions is clearly understandable</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 5: The total count of questions is acceptable</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 6: The complete duration time is acceptable</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 7: In the future, I would prefer digital questionnaires</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>User satisfaction evaluation by the help of a paper-based questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question 8: In the future, I would prefer the questionnaire at home using internet.</measure>
    <time_frame>Time in the outpatient clinic of anesthesia, an average of 1 hour</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">81</enrollment>
  <condition>Patient Satisfaction</condition>
  <condition>In-hospital Process Optimization</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who undergo a procedure in anaesthesia and elective surgery at the Charité -&#xD;
        Univeristätsmedizin Berlin, Campus Charité Mitte&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Patients who undergo a procedure in anaesthesia and elective surgery&#xD;
&#xD;
          -  German speaking people&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification V and VI&#xD;
&#xD;
          -  Patients with guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Spies, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Charité - Univsersitätsmedizin Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Operative Intensive Care Medicne Berlin (CCM/CVK)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Clinical Director of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK)</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243747
org study id: WAA
nct id: NCT03243747
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Utilization of computer-based questionnaire measured by duration time
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
measure: Number of assistance during filling-out in depending of age
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
measure: Question 1: All in all I am content
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 2: The usability of tablet-pc is easy
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 3: My medical history is well determined
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 4: The phrasing of questions is clearly understandable
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 5: The total count of questions is acceptable
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 6: The complete duration time is acceptable
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: Question 7: In the future, I would prefer digital questionnaires
time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
description: User satisfaction evaluation by the help of a paper-based questionnaire
measure: 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
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, MD, Prof.
role: Study Director
affiliation: Charité - Univsersitätsmedizin Berlin
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Clinical Director of the Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK)
sharing ipd: No