Development and Assessment of a Simulation Model of Focused and Ongoing Professional Practice Evaluations (OPPE16)

July 26, 2017 updated by: Rush University Medical Center

Since 2007, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has required evaluation of practicing attending physicians by management to ensure that procedural skills and medical care are meeting the accepted standards of care as assessed by each individual institution. This assessment is known as the ongoing professional practice evaluation (OPPE). There are several methods by which this can be accomplished, including through chart review of clinician practice and by verbally assessing knowledge of the steps required to do a particular procedure. However, for infrequently performed or complicated procedures, these methods may not allow objective evaluation on a regular basis. Simulation using task trainers or manikin models offers an alternative method of objective evaluation in a standardized setting.

The goal of this study is to develop two simulated scenarios to assess physician skill in relatively uncommon procedures and compare the data obtained against the verbal assessment and chart review model previously used at our institution. Two raters will assess each practitioner's verbal and simulated procedures. They will also assess globally their confidence that the physician is capable of performing the procedure safely and correctly based on the verbal or simulated trial.

The investigators anticipate that using a simulated experience for assessment will increase the ability of raters to assess proficiency for the purposes of an OPPE, specifically by increasing the number of critical procedural components that can be objectively evaluated. The investigators hypothesize that there will not be a strong relationship between the scores obtained on the verbal assessment and the scores obtained on the task trainer assessment. The investigators anticipate that there will be a portion of study participants that do not meet a minimum passing standard and may require additional deliberate practice and further testing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Physician training has developed over recent years to include simulation-based learning as a method of both formative and summative assessment. Simulation based medical education (SBME) with deliberate practice has been shown to be superior to traditional clinical education with respect to procedural skills in physicians in training (McGaghie,W.C. 2011), and a similar concept with Mastery Learning has shown to increase resident skill in lumbar puncture placement. In addition, it has been shown that Simulation Based Mastery Learning (SBML) in central line placement reduces hospital wide rates of central line associated bacterial infections.

When used in continuing medical education (CME), simulation has been shown to be feasible, and to increase clinician confidence in patient management. A recent study of nephrology fellows and attendings in practice showed that both groups scored similarly on a pre-test examination, and that all fellows who completed mastery learning subsequently passed the checklist assessment at the competency level and rated the training session highly.

In other work, simulation has been used for ongoing professional practice assessments (OPPE), for example in psychiatry using online simulated patients and assessments as a way of identifying a smaller number of attendings requiring focused assessment in person). Using electronically collected clinical data, anesthesia cases were reviewed for deviation from the standard of care on several key pieces of documentation common to many anesthesia procedures. This method of direct chart assessment for OPPE may be possible in anesthesia, a field where many cases have similarities in procedure, but would not work for a field such as Emergency Medicine, where the type and acuity of patient encounters varies greatly from day to day.

The ability of Simulation to present a standardized, specific procedural need offers an opportunity to assess Attending Emergency Physicians on a variety of critical procedures in a concise way. The investigators' research aims to present one possible approach to this assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All faculty practicing in an urban emergency department were eligible for enrollment

Description

Inclusion Criteria:

  • Emergency Medicine physician

Exclusion Criteria:

  • Not Emergency Medicine physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
2016 OPPE
All faculty participating in yearly ongoing professional Practice evaluation were eligible for enrollment
Other: Verbal versus procedural assessment
Faculty were assessed on both verbal and simulated performance of procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance on Procedural Checklist
Time Frame: Immediate
A 29-item procedural checklist for Central Line and a 21-item procedural checklist for Lumbar puncture will be used to assess performance by clinicians on Central Venous Catheter insertion and Lumbar Puncture performance.
Immediate

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptance of simulated training and assessment format
Time Frame: Immediate
A survey tool will be used to query participants on their preferred way of both practicing and being assessed on procedural skill. It will also assess whether participants feel inclined to complete a future simulated procedural training session.
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara M Hock, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15100805-IRB01-AM01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If requested, data may be shared. Limited generalizability of data may limit its usefulness to other investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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