AnesthesiaNCT01179932
Anesthesia Charting Fidelity Study
An observational study of Anesthesia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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.
- Inclusion criteria:
- Male or female patients ≥ 18 years of age
- 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
- Defibrillation threshold testing using non-invasive programmed stimulation of an implantable cardiovertor defibrillator (ICD)
- Transesophageal echocardiography guided electrical cardioversion of patients with supraventricular arrhythmias
- 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
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
- 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.
- 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
- 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
- Electrophysiology laboratory: select electrophysiology laboratory based procedures that employ a paper anesthesia chart
- Secondary and Exploratory Objectives:
- Identify environmental variables that contribute significantly to medical record errors.
- Identify clinical role of individual responsible for charting
- Investigate time of day/patterns that charting errors occur
- Relationship of clinical acuity and event occurrences
- Role of equipment malfunction and event frequency
- Role of social distracters and event frequency
- Role of monitor infidelity and event frequency
- Role of delayed charting of event and frequency of errors
- 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
- Examine the relationship between the assessed environments and the frequency of medical charting errors
- 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:
- 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.
- Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from actual time of event/observation.
- Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation from actual time of event/observation.
- Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation from actual time of event/observation.
- Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from actual time of event/observation.
- The degree of charting fidelity error observed with respect to hemodynamic parameters will be classified as follows:
- Class Ih: accurate hemodynamic data with less than 3% deviation from the representative value recorded by the scribe.
- Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the representative value recorded by the scribe.
- Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the representative value recorded by the scribe.
- Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the representative value recorded by the scribe.
- 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.
- 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.
- The degree of charting fidelity error observed with respect to drug dosing will be assessed as a dichotomous variable, Yes or No.
- The degree of charting fidelity error as related to procedural details will be assessed as a dichotomous variable, Yes or No.
- 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 group | Role | What they receive |
|---|---|---|
| Anesthesia Record | The 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.
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.
- First posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Edwin G Avery, MD, Principal investigator, UH Case Medical Center
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 17892187Ho 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 16263017Devitt 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 10083991Byrne 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 9505779Byrne 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Anesthesia Charting Fidelity Quality Assessment Pilot Study
- ClinicalTrials.gov ID
- NCT01179932
- Acronym / sponsor ID
- Charting Pilot
- Conditions
- Anesthesia
- Keywords
- Pilot, Charting, Anesthesia Record, Cardiac surgical operating room, Cardiac surgical intensive care unit, Electrophysiology lab
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 11 Aug 2010 (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.
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.
Detailed description
- 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.
- 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
- 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
- Electrophysiology laboratory: select electrophysiology laboratory based procedures that employ a paper anesthesia chart
- Secondary and Exploratory Objectives:
- Identify environmental variables that contribute significantly to medical record errors.
- Identify clinical role of individual responsible for charting
- Investigate time of day/patterns that charting errors occur
- Relationship of clinical acuity and event occurrences
- Role of equipment malfunction and event frequency
- Role of social distracters and event frequency
- Role of monitor infidelity and event frequency
- Role of delayed charting of event and frequency of errors
- 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
- Examine the relationship between the assessed environments and the frequency of medical charting errors
- 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:
- 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.
- Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from actual time of event/observation.
- Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation from actual time of event/observation.
- Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation from actual time of event/observation.
- Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from actual time of event/observation.
- The degree of charting fidelity error observed with respect to hemodynamic parameters will be classified as follows:
- Class Ih: accurate hemodynamic data with less than 3% deviation from the representative value recorded by the scribe.
- Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the representative value recorded by the scribe.
- Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the representative value recorded by the scribe.
- Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the representative value recorded by the scribe.
- 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.
- 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.
- The degree of charting fidelity error observed with respect to drug dosing will be assessed as a dichotomous variable, Yes or No.
- The degree of charting fidelity error as related to procedural details will be assessed as a dichotomous variable, Yes or No.
- Full statistical analysis making all possible comparisons of collected data will be performed with the assistance of a trained statistician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia Record | – | Other: No Intervention UsedThe nursing and anesthesia records will be examined for accuracy and completeness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
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 |
|---|---|---|
| No Intervention UsedOur study is observational; therefore, there is no type of intervention being used. | Other | Anesthesia Record |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Results publication: PubMed 17892187Chamisa 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.
- Results publication: PubMed 16263017Ho 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.
- Results publication: PubMed 10083991Devitt 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.
- Results publication: PubMed 9505779Byrne 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.
- Results publication: PubMed 9215012Byrne 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.
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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.
Edwin G Avery, MD principal investigator
UH Case Medical Center
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 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.