Anesthesia Information System vs Paper Anesthesia Records... | NCT02258100

Studies
Anesthesia Information System vs Paper Anesthesia Records for Care Congruency

NCT02258100

Sponsor

Endeavor Health

Status

Completed

Last Update Posted

Sep 11, 2019Actual

Enrollment

189Actual

Phase

Not provided

Conditions

Paper Versus EMR Generated Anesthesia Records

Interventions

Electronic Medical Record

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Oct 1, 2014

First Submission Date that Met QC Criteria

Oct 2, 2014

First Posted Date

Oct 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paper		Patients receiving care documented via paper anesthesia record.
AIMS		Patients receiving care documented via electronic anesthesia record.	Other: Electronic Medical Record

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electronic Medical Record	Other	Advent of EMR use for documentation of anesthetic care	AIMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anesthetic Care; Drugs delivered	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	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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Underwent esophageal surgery and had anesthetic documented in medical record

Exclusion Criteria:

Cases less than one hour

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent esophageal surgery with one surgeon from 2009-2014

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torin D Shear, MD	Endeavor Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evanston Hospital		Evanston	Illinois	60201	United States

Intervention Browse Module

MeSH Terms

ID	Term
D057286	Electronic Health Records

Ancestor Terms

ID	Term
D016347	Medical Records Systems, Computerized
D008499	Medical Records
D011996	Records
D003625	Data Collection

Browse Leaves

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Browse Branches

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