AnesthesiaNCT02161497
Clinical History Taking Versus the Addition of an Electronic File Consultation in Pediatric Pre-operative Assessments
An observational study of Anesthesia, run by Meir Medical Center at 1 site in Israel.
Trial summary
The investigators are studying the difference between the history taken from parents prior to their child's anesthesia to information gleaned routinely from a patient information system called Ofek. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parents of children being interviewed at pre anesthesia assessment
Who may be able to join
- Children presenting with parent/s for pre-operative assessment
- Ages newborn to 16 years
- Elective and emergency surgery
Who cannot join
- Premature infants still hospitalized in the Neonatal intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical History Taking Versus the Addition of an Electronic Patient File Consultation in Pediatric Pre-operative Assessments
The investigators are studying the difference between the history taken from parents prior to their child's anesthesia to information gleaned routinely from a patient information system called Ofek.
Read the detailed description
Introduction One of the cornerstones of pre-operative assessment is an accurate clinical history. In pediatric anesthetic practice, the history is typically obtained from an accompanying parent. A letter from the patient's primary care physician may accompany the child for elective cases, but typically contains general information and may omit recent illnesses. In addition, parents may underplay or deny respiratory problems such as upper or lower respiratory tract infections, asthma, cough or snoring as the norm for a particular child and not understand their importance in pre-operative assessment.
The Clalit Health Services HMO is Israel's largest health insurer and has a comprehensive online patient database for healthcare workers to use for patient care. The Ofek patient electronic record system allows the physician to view patient community and hospital records, including special investigations and drug prescription and purchases, updated in real time. Recently, the system was upgraded to view patient records from all of the four Israeli HMOs. This has enabled the treating physicians' electronic record access to any patient that may present.
The investigators see this development as a major advantage. Moreover, in the pediatric pre-anesthetic assessment setting, the clinical history may be verified by the Ofek system.
Aim To compare the details obtained at pre-anesthetic clinical history given by parents of children undergoing surgery to those obtained using the Ofek electronic patient record system. In addition, we would like to inquire into the reasons that discrepancies may exist between clinical histories and the electronic patient record and the clinical impact of those differences on clinical decision making.
Methods Two hundred children and parent/s will undergo pre-anesthetic clinical history taking. Each parent and child will be screened pre-operatively by a senior anesthesiology resident using the Meir Medical Center Anesthesia pre-operative pediatric assessment form. Thereafter, the resident will open the electronic patient file using the Ofek system and additional information, if present will be noted. Parents will be asked, where relevant, for the reason additional information gleaned via Ofek was omitted during the direct questioning. If the clinical history and/or Ofek resulted in changes in patient management, this will be noted as well.
Data to be collected will include the number of discrepancies between clinical history and information obtained using Ofek and the reasons for those differences will be noted. In addition, the source of all information whether obtained via clinical history or Ofek will be noted. If information obtained by either of the abovementioned means results in changes in clinical management, these will be noted as well. The data collected from parents and Ofek is done so without any connection to the study.
Statistical analysis Comparisons between nominal variables will be analyzed by Chi-Square and derivatives of it (McNemar, Kappa). Continuous parameters - by paired tests -parametric and non-parametric,each as appropriate. Reliability between "Ofek" and clinical history will be measured by Intra-Class Coefficients and coefficient of variations (CoV). All statistical procedures, each as needed.
- Conditions
- Anesthesia
- Keywords
- Medical History Taking, Electronic Health Records, Pediatrics, Parents
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of discrepancies found between clinical history and information received from OFEK system, the reasons for those discrepancies and how they influenced peri-operative clinical decision making.
Measured: Immediate
Secondary outcomes (4)
Average time spent using OFEK system per patient.
Measured: Immediate
Average time spent taking clinical history per patient.
Measured: Immediate
Number of discrepancies found between clinical history and information received from OFEK system that do not influence peri-operative clinical decision making.
Measured: Immediate
Reasons for each discrepancy.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJul 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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Hoppenstein, MBBCh, Principal investigator, Meir Medical Center Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161497
- Sponsor's protocol ID
- 0313-13-MMC
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical History Taking Versus the Addition of an Electronic Patient File Consultation in Pediatric Pre-operative Assessments
- ClinicalTrials.gov ID
- NCT02161497
- Acronym / sponsor ID
- 0313-13-MMC
- Conditions
- Anesthesia
- Keywords
- Medical History Taking, Electronic Health Records, Pediatrics, Parents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jun 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.
The investigators are studying the difference between the history taken from parents prior to their child's anesthesia to information gleaned routinely from a patient information system called Ofek.
Detailed description
Introduction One of the cornerstones of pre-operative assessment is an accurate clinical history. In pediatric anesthetic practice, the history is typically obtained from an accompanying parent. A letter from the patient's primary care physician may accompany the child for elective cases, but typically contains general information and may omit recent illnesses. In addition, parents may underplay or deny respiratory problems such as upper or lower respiratory tract infections, asthma, cough or snoring as the norm for a particular child and not understand their importance in pre-operative assessment.
The Clalit Health Services HMO is Israel's largest health insurer and has a comprehensive online patient database for healthcare workers to use for patient care. The Ofek patient electronic record system allows the physician to view patient community and hospital records, including special investigations and drug prescription and purchases, updated in real time. Recently, the system was upgraded to view patient records from all of the four Israeli HMOs. This has enabled the treating physicians' electronic record access to any patient that may present.
The investigators see this development as a major advantage. Moreover, in the pediatric pre-anesthetic assessment setting, the clinical history may be verified by the Ofek system.
Aim To compare the details obtained at pre-anesthetic clinical history given by parents of children undergoing surgery to those obtained using the Ofek electronic patient record system. In addition, we would like to inquire into the reasons that discrepancies may exist between clinical histories and the electronic patient record and the clinical impact of those differences on clinical decision making.
Methods Two hundred children and parent/s will undergo pre-anesthetic clinical history taking. Each parent and child will be screened pre-operatively by a senior anesthesiology resident using the Meir Medical Center Anesthesia pre-operative pediatric assessment form. Thereafter, the resident will open the electronic patient file using the Ofek system and additional information, if present will be noted. Parents will be asked, where relevant, for the reason additional information gleaned via Ofek was omitted during the direct questioning. If the clinical history and/or Ofek resulted in changes in patient management, this will be noted as well.
Data to be collected will include the number of discrepancies between clinical history and information obtained using Ofek and the reasons for those differences will be noted. In addition, the source of all information whether obtained via clinical history or Ofek will be noted. If information obtained by either of the abovementioned means results in changes in clinical management, these will be noted as well. The data collected from parents and Ofek is done so without any connection to the study.
Statistical analysis Comparisons between nominal variables will be analyzed by Chi-Square and derivatives of it (McNemar, Kappa). Continuous parameters - by paired tests -parametric and non-parametric,each as appropriate. Reliability between "Ofek" and clinical history will be measured by Intra-Class Coefficients and coefficient of variations (CoV). All statistical procedures, each as needed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parents of children being interviewed at pre anesthesia assessment
Key inclusion criteria (3 listed)
- Children presenting with parent/s for pre-operative assessment
- Ages newborn to 16 years
- Elective and emergency surgery
Key exclusion criteria (1 listed)
- Premature infants still hospitalized in the Neonatal intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of discrepancies found between clinical history and information received from OFEK system, the reasons for those discrepancies and how they influenced peri-operative clinical decision making.
Time frame: Immediate
4 secondary outcomes
Average time spent using OFEK system per patient.
Time frame: Immediate
Average time spent taking clinical history per patient.
Time frame: Immediate
Number of discrepancies found between clinical history and information received from OFEK system that do not influence peri-operative clinical decision making.
Time frame: Immediate
Reasons for each discrepancy.
Time frame: Immediate
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 28 Apr 2015.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
David R Hoppenstein, MBBCh principal investigator
Meir Medical Center Tel Aviv University
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 Meir Medical Center at 1 site in Israel.
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 3 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 28 Apr 2015. 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 Israel. 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?
Number of discrepancies found between clinical history and information received from OFEK system, the reasons for those discrepancies and how they influenced peri-operative clinical decision making. (time frame: Immediate). 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 28 Apr 2015.