<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/NCT02258100</url>
  </required_header>
  <id_info>
    <org_study_id>EH14-325</org_study_id>
    <nct_id>NCT02258100</nct_id>
  </id_info>
  <brief_title>Anesthesia Information System vs Paper Anesthesia Records for Care Congruency</brief_title>
  <official_title>Retrospective Review of an Anesthesia Information System and Paper Anesthesia Records for Care Congruency in a Single Surgical Population.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NorthShore University HealthSystem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NorthShore University HealthSystem</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date the effect of AIMS on medical interventions has not been studied. We seek to&#xD;
      retrospectively evaluate paper and electronic anesthesia records among a single surgical&#xD;
      population (esophageal surgery) to ascertain any differences that may exist between cohorts&#xD;
      with regards to chart completion, anesthetic management and medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anesthesia information systems (AIMS) are increasingly used to electronically capture&#xD;
      physiologic and management data during anesthesia. Proponents tout an improved accuracy of&#xD;
      data yet this has not been formally evaluated. Furthermore, whether AIMS is associated with&#xD;
      changes in medical care is unknown. Studies with newer technologies have demonstrated&#xD;
      increased medical interventions as a result of implementation. The pulmonary artery catheter&#xD;
      was shown to increase medical interventions when used yet no improvement in outcomes are&#xD;
      observed and some suggest a deleterious effect. 1 Several studies suggest improved patient&#xD;
      care with electronic anesthesia records. 2,3 These all center around clinical decision&#xD;
      support that reminds clinicians to give certain medications or ensure chart completion.&#xD;
      Despite these advantages there are no studies evaluating the 'hawthorne effect' of AIMS.&#xD;
      Physiologic data is now recorded at each data point using AIMS. This differs significantly&#xD;
      from paper anesthesia records in which clinicians often chart physiologic trends choosing to&#xD;
      omit spurious values. It is possible that a Hawthorne effect may occur in this scenario with&#xD;
      increased data collection and an increased ability to scrutinize the medical record. Given&#xD;
      the litigious nature of medical practice today, there is concern about the impact of AIMS on&#xD;
      medicolegal liability. 4 Yet, to date the effect of AIMS on medical interventions has not&#xD;
      been studied. We seek to retrospectively evaluate paper and electronic anesthesia records&#xD;
      among a single surgical population (esophageal surgery) to ascertain any differences that may&#xD;
      exist between cohorts with regards to chart completion, anesthetic management and medical&#xD;
      care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anesthetic Care; Drugs delivered</measure>
    <time_frame>Anesthesia start to Anesthesia Stop</time_frame>
    <description>Intraoperative anesthetic medications; Total dose and number of interventions for all drugs; Fentanyl, ephedrine, phenylephrine, norepinephrine, labetalol, nicardidipine, esmolol, hydrazine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>documented hypotension</measure>
    <time_frame>Anesthesia start to Anesthesia End (Intraoperative)</time_frame>
    <description>Intraoperative hypotension; Each occurrence less then 20% of patient's baseline, calculated from preoperative systolic BP; Duration of hypotension; associated medical treatment</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">189</enrollment>
  <condition>Paper Versus EMR Generated Anesthesia Records</condition>
  <arm_group>
    <arm_group_label>Paper</arm_group_label>
    <description>Patients receiving care documented via paper anesthesia record.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIMS</arm_group_label>
    <description>Patients receiving care documented via electronic anesthesia record.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic Medical Record</intervention_name>
    <description>Advent of EMR use for documentation of anesthetic care</description>
    <arm_group_label>AIMS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent esophageal surgery with one surgeon from 2009-2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Underwent esophageal surgery and had anesthetic documented in medical record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases less than one hour&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torin D Shear, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NorthShore University HealthSystem</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evanston Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02258100
org study id: EH14-325
nct id: NCT02258100
lead sponsor: 
has dmc: No
To date the effect of AIMS on medical interventions has not been studied. We seek to
      retrospectively evaluate paper and electronic anesthesia records among a single surgical
      population (esophageal surgery) to ascertain any differences that may exist between cohorts
      with regards to chart completion, anesthetic management and medical care.
Anesthesia information systems (AIMS) are increasingly used to electronically capture
      physiologic and management data during anesthesia. Proponents tout an improved accuracy of
      data yet this has not been formally evaluated. Furthermore, whether AIMS is associated with
      changes in medical care is unknown. Studies with newer technologies have demonstrated
      increased medical interventions as a result of implementation. The pulmonary artery catheter
      was shown to increase medical interventions when used yet no improvement in outcomes are
      observed and some suggest a deleterious effect. 1 Several studies suggest improved patient
      care with electronic anesthesia records. 2,3 These all center around clinical decision
      support that reminds clinicians to give certain medications or ensure chart completion.
      Despite these advantages there are no studies evaluating the 'hawthorne effect' of AIMS.
      Physiologic data is now recorded at each data point using AIMS. This differs significantly
      from paper anesthesia records in which clinicians often chart physiologic trends choosing to
      omit spurious values. It is possible that a Hawthorne effect may occur in this scenario with
      increased data collection and an increased ability to scrutinize the medical record. Given
      the litigious nature of medical practice today, there is concern about the impact of AIMS on
      medicolegal liability. 4 Yet, to date the effect of AIMS on medical interventions has not
      been studied. We seek to retrospectively evaluate paper and electronic anesthesia records
      among a single surgical population (esophageal surgery) to ascertain any differences that may
      exist between cohorts with regards to chart completion, anesthetic management and medical
      care.
observational model: Cohort
time perspective: Retrospective
measure: Anesthetic Care; Drugs delivered
time frame: Anesthesia start to Anesthesia Stop
description: Intraoperative anesthetic medications; Total dose and number of interventions for all drugs; Fentanyl, ephedrine, phenylephrine, norepinephrine, labetalol, nicardidipine, esmolol, hydrazine
measure: documented hypotension
time frame: Anesthesia start to Anesthesia End (Intraoperative)
description: Intraoperative hypotension; Each occurrence less then 20% of patient's baseline, calculated from preoperative systolic BP; Duration of hypotension; associated medical treatment
arm group label: Paper
description: Patients receiving care documented via paper anesthesia record.
arm group label: AIMS
description: Patients receiving care documented via electronic anesthesia record.
intervention type: Other
intervention name: Electronic Medical Record
description: Advent of EMR use for documentation of anesthetic care
arm group label: AIMS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Torin D Shear, MD
role: Principal Investigator
affiliation: NorthShore University HealthSystem
facility: 
country: United States
responsible party type: Sponsor