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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Meir Medical Center

    Kfar Saba

Other trials in Israel

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.

  1. 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)
  1. Average time spent using OFEK system per patient.

    Measured: Immediate

  2. Average time spent taking clinical history per patient.

    Measured: Immediate

  3. Number of discrepancies found between clinical history and information received from OFEK system that do not influence peri-operative clinical decision making.

    Measured: Immediate

  4. 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.

  1. First posted11 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

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
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
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

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.

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Clinical Trial NCT02161497 | AzTrials