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AnesthesiaNCT01179932

Anesthesia Charting Fidelity Study

An observational study of Anesthesia, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2010to Aug 2011
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Deidentified patients undergoing a cardiac surgical procedure or undergoing select electrophysiologic procedures as well as the corresponding clinical staff caring for them.

  1. Inclusion criteria:
  2. Male or female patients ≥ 18 years of age
  3. Patients and the hospital staff that are caring for them, scheduled to undergo any cardiac surgical procedure that involves the use of both general anesthesia (with planned computer assisted charting using the PISCES system) and cardiopulmonary bypass, including postoperative intensive care unit monitoring -or- Patients and the hospital staff caring for them scheduled to undergo select electrophysiologic procedures (detailed below 1 - 3) involving the administration of general anesthesia in the electrophysiology laboratory with planned manual paper charting
  4. Defibrillation threshold testing using non-invasive programmed stimulation of an implantable cardiovertor defibrillator (ICD)
  5. Transesophageal echocardiography guided electrical cardioversion of patients with supraventricular arrhythmias
  6. Electrical cardioversion of patients with supraventricular arrhythmias

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Acute Anesthesia Charting Fidelity Quality Assessment Pilot Study

Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a customized error scoring system that focuses on the magnitude of errors among multiple continuous, categorical and dichotomous variables. The errors are being assessed in order to identify the most common charting inaccuracies so that target areas appropriate for testing of improvement strategies may be isolated.

Read the detailed description
  1. Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a customized error scoring system that focuses on the magnitude of errors among multiple continuous, categorical and dichotomous variables. The errors are being assessed in order to identify the most common charting inaccuracies so that target areas appropriate for testing of improvement strategies may be isolated.
  2. Cardiac surgical operating room: Any cardiac surgical procedure that involves the use of cardiopulmonary bypass and planned postoperative intensive care unit admission in an electronic supplemented anesthesia charting environment
  3. Cardiac surgical intensive care unit: The cardiac surgical intensive care unit environment during the first 2-3 hours following procedures referenced in section I,A,1
  4. Electrophysiology laboratory: select electrophysiology laboratory based procedures that employ a paper anesthesia chart
  5. Secondary and Exploratory Objectives:
  6. Identify environmental variables that contribute significantly to medical record errors.
  7. Identify clinical role of individual responsible for charting
  8. Investigate time of day/patterns that charting errors occur
  9. Relationship of clinical acuity and event occurrences
  10. Role of equipment malfunction and event frequency
  11. Role of social distracters and event frequency
  12. Role of monitor infidelity and event frequency
  13. Role of delayed charting of event and frequency of errors
  14. Identify/quantify the awareness of clinicians to their execution of medical record errors through use of simple, multiple choice 4 question survey that clinicians will be asked to fill out following a case study
  15. Examine the relationship between the assessed environments and the frequency of medical charting errors
  16. Identify the areas of anesthesia charting most in need of improvement in order to address designing ways to potentially improve these weaknesses.

Error scoring system:

  1. The degree of charting fidelity error in this study will be converted via a classification system to make data analysis more efficient. All types of errors that involve continuous variables will be assessed with mean, median and standard deviation as well as range. Numerical data points related to time will be classified into four separate categories.
  2. Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from actual time of event/observation.
  3. Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation from actual time of event/observation.
  4. Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation from actual time of event/observation.
  5. Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from actual time of event/observation.
  6. The degree of charting fidelity error observed with respect to hemodynamic parameters will be classified as follows:
  7. Class Ih: accurate hemodynamic data with less than 3% deviation from the representative value recorded by the scribe.
  8. Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the representative value recorded by the scribe.
  9. Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the representative value recorded by the scribe.
  10. Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the representative value recorded by the scribe.
  11. The degree of charting fidelity error observed with respect to whether a procedure which was performed by anesthesia provider was charted will be assessed as a dichotomous variable, Yes or No.
  12. The degree of charting fidelity error observed with respect to whether a significant intraoperative event, or intra-procedural event for the electrophysiology laboratory, was charted will be assessed as a dichotomous variable, Yes or No.
  13. The degree of charting fidelity error observed with respect to drug dosing will be assessed as a dichotomous variable, Yes or No.
  14. The degree of charting fidelity error as related to procedural details will be assessed as a dichotomous variable, Yes or No.
  15. Full statistical analysis making all possible comparisons of collected data will be performed with the assistance of a trained statistician.
Conditions
Anesthesia
Being tested
No Intervention Used
Keywords
Pilot, Charting, Anesthesia Record, Cardiac surgical operating room, Cardiac surgical intensive care unit, Electrophysiology lab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention UsedOther

    Our study is observational; therefore, there is no type of intervention being used.

Study groups in NCT01179932
Study groupRoleWhat they receive
Anesthesia RecordThe nursing and anesthesia records will be examined for accuracy and completeness
Receives: Other: No Intervention Used

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency/severity of anesthesia charting fidelity weaknesses in cardiac care based clinical environments as assessed by an error scoring system.

    A single dedicated observer with focused clinical education will continually scribe observations made with close attention to detail (e.g., time of event, drug administered, dose of drug, route of administration of drug) using a prospectively designed data collection tool. This record of events will then be compared to the clinician charted anesthesia record in order to assess the frequency and severity of errors ocurring within the anesthesia record. A customized scoring system will be employed to grade the observed errors noted in the anesthesia record.

    Measured: A total of thirty separate anesthesia records will be inidividually assessed and compared to the data prospectively collected during each corresponding anesthetic (lasting an average of 5 hours in the OR and 45 min in the EP lab.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2010 (estimated)
  4. Study completionAug 2011 (estimated)

Why it stopped: Never started

Resources

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
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179932
Sponsor's protocol ID
Charting Pilot
Status last verified
Apr 2022
First submitted
26 Jul 2010
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
No

Publications

  • Chamisa I, Zulu BM. Setting the records straight--a prospective audit of the quality of case notes in a surgical department. S Afr J Surg. 2007 Aug;45(3):92, 94-5.

    PubMed 17892187
  • Ho MY, Anderson AR, Nijjar A, Thomas C, Goenka A, Hossain J, Curley PJ. Use of the CRABEL Score for improving surgical case-note quality. Ann R Coll Surg Engl. 2005 Nov;87(6):454-7. doi: 10.1308/003588405X60687.

    PubMed 16263017
  • Devitt JH, Rapanos T, Kurrek M, Cohen MM, Shaw M. The anesthetic record: accuracy and completeness. Can J Anaesth. 1999 Feb;46(2):122-8. doi: 10.1007/BF03012545.

    PubMed 10083991
  • Byrne AJ, Sellen AJ, Jones JG. Errors on anaesthetic record charts as a measure of anaesthetic performance during simulated critical incidents. Br J Anaesth. 1998 Jan;80(1):58-62. doi: 10.1093/bja/80.1.58.

    PubMed 9505779
  • Byrne AJ, Jones JG. Inaccurate reporting of simulated critical anaesthetic incidents. Br J Anaesth. 1997 Jun;78(6):637-41. doi: 10.1093/bja/78.6.637.

    PubMed 9215012

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by University Hospitals Cleveland Medical Center 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?

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: withdrawn, as of the sponsor's last update on 18 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Frequency/severity of anesthesia charting fidelity weaknesses in cardiac care based clinical environments as assessed by an error scoring system. (time frame: A total of thirty separate anesthesia records will be inidividually assessed and compared to the data prospectively collected during each corresponding anesthetic (lasting an average of 5 hours in the OR and 45 min in the EP lab.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01179932, which also lists 5 linked publications.

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 18 Apr 2022.

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