- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258100
Anesthesia Information System vs Paper Anesthesia Records for Care Congruency
September 9, 2019 updated by: NorthShore University HealthSystem
Retrospective Review of an Anesthesia Information System and Paper Anesthesia Records for Care Congruency in a Single Surgical Population.
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
189
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
-
-
Illinois
-
Evanston, Illinois, United States, 60201
- Evanston Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent esophageal surgery with one surgeon from 2009-2014
Description
Inclusion Criteria:
- Underwent esophageal surgery and had anesthetic documented in medical record
Exclusion Criteria:
- Cases less than one hour
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Paper
Patients receiving care documented via paper anesthesia record.
|
|
AIMS
Patients receiving care documented via electronic anesthesia record.
|
Advent of EMR use for documentation of anesthetic care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anesthetic Care; Drugs delivered
Time Frame: Anesthesia start to Anesthesia Stop
|
Intraoperative anesthetic medications; Total dose and number of interventions for all drugs; Fentanyl, ephedrine, phenylephrine, norepinephrine, labetalol, nicardidipine, esmolol, hydrazine
|
Anesthesia start to Anesthesia Stop
|
documented hypotension
Time Frame: Anesthesia start to Anesthesia End (Intraoperative)
|
Intraoperative hypotension; Each occurrence less then 20% of patient's baseline, calculated from preoperative systolic BP; Duration of hypotension; associated medical treatment
|
Anesthesia start to Anesthesia End (Intraoperative)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Torin D Shear, MD, NorthShore University HealthSystem
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
September 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 1, 2014
First Submitted That Met QC Criteria
October 2, 2014
First Posted (Estimate)
October 7, 2014
Study Record Updates
Last Update Posted (Actual)
September 11, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- EH14-325
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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