NCT03229226

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 17, 2017

Last Update Submit

July 26, 2017

Conditions

Keywords

SimulationTask Trainer

Outcome Measures

Primary Outcomes (1)

  • Performance on Procedural Checklist

    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 Outcomes (1)

  • Acceptance of simulated training and assessment format

    Immediate

Study Arms (1)

2016 OPPE

All faculty participating in yearly ongoing professional Practice evaluation were eligible for enrollment

Other: Verbal versus procedural assessment

Interventions

Faculty were assessed on both verbal and simulated performance of procedures.

2016 OPPE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Emergency Medicine physician

You may not qualify if:

  • Not Emergency Medicine physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • OPPE and FPPE: Tools to help make privileging decisions 2013. Wise RA. (Accessed Jul 19, 2017, at http://www.jointcommission.org/jc_physician_blog/oppe_fppe_tools_privileging_decisions/).

    BACKGROUND
  • McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.

    PMID: 21512370BACKGROUND
  • Barsuk JH, Cohen ER, Caprio T, McGaghie WC, Simuni T, Wayne DB. Simulation-based education with mastery learning improves residents' lumbar puncture skills. Neurology. 2012 Jul 10;79(2):132-7. doi: 10.1212/WNL.0b013e31825dd39d. Epub 2012 Jun 6.

    PMID: 22675080BACKGROUND
  • Barsuk JH, McGaghie WC, Cohen ER, O'Leary KJ, Wayne DB. Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med. 2009 Oct;37(10):2697-701.

    PMID: 19885989BACKGROUND
  • Barsuk JH, Cohen ER, Potts S, Demo H, Gupta S, Feinglass J, McGaghie WC, Wayne DB. Dissemination of a simulation-based mastery learning intervention reduces central line-associated bloodstream infections. BMJ Qual Saf. 2014 Sep;23(9):749-56. doi: 10.1136/bmjqs-2013-002665. Epub 2014 Mar 14.

    PMID: 24632995BACKGROUND
  • Kerr B, Hawkins TL, Herman R, Barnes S, Kaufmann S, Fraser K, Ma IW. Feasibility of scenario-based simulation training versus traditional workshops in continuing medical education: a randomized controlled trial. Med Educ Online. 2013 Jul 18;18:21312. doi: 10.3402/meo.v18i0.21312.

    PMID: 23870304BACKGROUND
  • McQuillan RF, Clark E, Zahirieh A, Cohen ER, Paparello JJ, Wayne DB, Barsuk JH. Performance of Temporary Hemodialysis Catheter Insertion by Nephrology Fellows and Attending Nephrologists. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1767-72. doi: 10.2215/CJN.01720215. Epub 2015 Sep 25.

    PMID: 26408550BACKGROUND
  • Barsuk JH, Cohen ER, Nguyen D, Mitra D, O'Hara K, Okuda Y, Feinglass J, Cameron KA, McGaghie WC, Wayne DB. Attending Physician Adherence to a 29-Component Central Venous Catheter Bundle Checklist During Simulated Procedures. Crit Care Med. 2016 Oct;44(10):1871-81. doi: 10.1097/CCM.0000000000001831.

    PMID: 27336437BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sara M Hock, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 25, 2017

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 28, 2017

Record last verified: 2017-07