Paper Versus EMR Generated Anesthesia RecordsNCT02258100
Anesthesia Information System vs Paper Anesthesia Records for Care Congruency
An observational study of Paper Versus EMR Generated Anesthesia Records, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paper Versus EMR Generated Anesthesia Records
- What is being tested?
- Electronic Medical Record
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent esophageal surgery with one surgeon from 2009-2014
Who may be able to join
- Underwent esophageal surgery and had anesthetic documented in medical record
Who cannot join
- Cases less than one hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Electronic Medical Record
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Medical RecordOther
Advent of EMR use for documentation of anesthetic care
| Study group | Role | What they receive |
|---|---|---|
| Paper | Patients receiving care documented via paper anesthesia record. | |
| AIMS | Patients receiving care documented via electronic anesthesia record. Receives: Other: Electronic Medical Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic Care; Drugs delivered
Intraoperative anesthetic medications; Total dose and number of interventions for all drugs; Fentanyl, ephedrine, phenylephrine, norepinephrine, labetalol, nicardidipine, esmolol, hydrazine
Measured: 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
Measured: Anesthesia start to Anesthesia End (Intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paper Versus EMR Generated Anesthesia RecordsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torin D Shear, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258100
- Sponsor's protocol ID
- EH14-325
- Status last verified
- Sep 2019
- First submitted
- 1 Oct 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of an Anesthesia Information System and Paper Anesthesia Records for Care Congruency in a Single Surgical Population.
- ClinicalTrials.gov ID
- NCT02258100
- Acronym / sponsor ID
- EH14-325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper | – | –Patients receiving care documented via paper anesthesia record. |
| AIMS | – | Other: Electronic Medical RecordPatients receiving care documented via electronic anesthesia record. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent esophageal surgery with one surgeon from 2009-2014
Key inclusion criteria (1 listed)
- Underwent esophageal surgery and had anesthetic documented in medical record
Key exclusion criteria (1 listed)
- Cases less than one hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Medical RecordAdvent of EMR use for documentation of anesthetic care | Other | AIMS |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torin D Shear, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paper Versus EMR Generated Anesthesia Records, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic Care; Drugs delivered (time frame: Anesthesia start to Anesthesia Stop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.