- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02886754
Proficiency-Based Progression Training for Clinical Communication
The Effect of a Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance
Importance: Clinical communication is an important source of medical error and preventable adverse events.
Objective: To determine the effectiveness of proficiency-based progression (PBP) simulation training for ISBAR (Identify, Situation, Background, Assessment, Recommendation) communication in the deteriorating patient.
Setting: The study will be conducted in University College Cork, Ireland. Participants: Third year undergraduate nursing and fifth year medical students, who are scheduled to undertake ISBAR training as part of the National Early Warning Score (NEWS) programme.
Intervention: Participants will be prospectively randomized to one of three groups before undertaking a performance assessment of an ISBAR communication relevant to a deteriorating patient in a high fidelity simulation laboratory: HSE group (the national e-learning programme only); S group (national e- learning plus simulation training) and PBP group (national e-learning plus proficiency-based progression simulation).
Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication in the context of an acutely deteriorating patient.
Study Overview
Status
Conditions
Detailed Description
The first successful simulation validation study used a proficiency-based progression methodology. Since then the approach has been successfully deployed to produce superior technical skills but has not yet been validated for non-technical (communication) skills. The ISBAR (Identify, Situation, Background, Assessment and Recommendation) has been selected as the standardised tool for clinical communication in relation to an acutely deteriorating patient in many healthcare organisations worldwide, including Ireland.
The aim of this study is to explore whether proficiency-based progression (PBP) could be applied to simulation-based training for ISBAR performance to produce a superior skill set.
The study will compare performance outcomes of students, who receive the national e-learning programme only with those who receive it in combination with either standard simulation or proficiency-based progression (PBP) simulation.
Participants will be prospectively randomized to one of three training groups within their professional cohort (medicine or nursing) before undertaking a performance assessment of an ISBAR communication relevant to a deteriorating patient in a high fidelity simulation laboratory:
- Online learning only (HSE) -the national e-learning programme only
- Standard simulation (S) -online learning plus simulation training
- Proficiency based progression (PBP) -online learning plus proficiency-based progression simulation.
Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication in the context of an acutely deteriorating patient.
All participants will be required to demonstrate a certificate of successful completion on the national e-learning programme within the previous 4 weeks as well as supplying baseline demographic information before undertaking the training.
Performance metrics have previously been identified, operationally defined and agreed upon at a modified Delphi panel meeting consisting of medical and nursing experts for a series of paper-based simulation cases and a standardised high fidelity simulation case used as the assessment case. The proficiency benchmark for each case has been set based on the performance of experienced nursing and medical personnel on each case as a series of steps, errors and critical errors.
Outcome assessment will be scored by reviewing recordings of ISBAR performance by each participant on the standardised case in the high fidelity laboratory.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cork, Ireland, T12EH31
- University College Cork
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Third year undergraduate nursing students
Fifth year medical students
Exclusion Criteria:
Lack of consent
Failure to successfully complete the National e-learning NEWS programme
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: National e-learning programme only (HSE)
National e-learning programme only Recent successful completion the National e-learning programme by certificate will be displayed.
Students then complete a student satisfaction survey and proceed directly for performance assessment to the high-fidelity simulation suite.
|
National e-learning programme (COMPASS)
Other Names:
|
|
Active Comparator: Simulation (S)
Simulation Recent successful completion of the National e-learning e-learning programme by certificate will be displayed.
Students will proceed to standard simulation using the same series of paper cases as PBP which prompt simulated phone calls but no requirement to meet a proficiency benchmark.
4 hours will be allotted to this training.
Following training participants will complete the student satisfaction survey and will then proceed directly for performance assessment to the high-fidelity simulation suite.
|
National e-learning programme (COMPASS)
Other Names:
Paper based simulation cases
Other Names:
|
|
Experimental: Proficiency-Based Progression (PBP)
Recent successful completion of the National e-learning programme by certificate will be displayed.
Students will proceed to PBP simulation using the same series of paper cases as S which prompt simulated phone calls.
PBP students will be scored according to predefined metrics and will be required to reach proficiency benchmarks.
Following training participants will complete the student satisfaction survey and proceed directly for performance assessment to the high-fidelity simulation suite.
|
National e-learning programme (COMPASS)
Other Names:
Use of validated metrics and performance benchmarks to simulation training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of those reaching the benchmark on the assessment case
Time Frame: 6 months
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Independent review by two blinded assessors of recorded ISBAR phone call conducted in the high fidelity simulation setting
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of completed steps
Time Frame: 6 months
|
Number of successfully completed steps as predefined by the metrics for the assessment case
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of total errors
Time Frame: 6 months
|
Number of total errors as predefined by the metrics for the assessment case
|
6 months
|
|
Number of errors/critical errors
Time Frame: 6 months
|
Number of errors/critical errors as predefined by the metrics for the assessment case
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anthony Gallagher, PhD, DSc, University College Cork, College Rd, Cork Ireland
Publications and helpful links
General Publications
- Gallagher AG, Seymour NE, Jordan-Black JA, Bunting BP, McGlade K, Satava RM. Prospective, randomized assessment of transfer of training (ToT) and transfer effectiveness ratio (TER) of virtual reality simulation training for laparoscopic skill acquisition. Ann Surg. 2013 Jun;257(6):1025-31. doi: 10.1097/SLA.0b013e318284f658.
- Angelo RL, Ryu RK, Pedowitz RA, Beach W, Burns J, Dodds J, Field L, Getelman M, Hobgood R, McIntyre L, Gallagher AG. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015 Oct;31(10):1854-71. doi: 10.1016/j.arthro.2015.07.001. Epub 2015 Sep 2.
- Van Sickle KR, Ritter EM, Baghai M, Goldenberg AE, Huang IP, Gallagher AG, Smith CD. Prospective, randomized, double-blind trial of curriculum-based training for intracorporeal suturing and knot tying. J Am Coll Surg. 2008 Oct;207(4):560-8. doi: 10.1016/j.jamcollsurg.2008.05.007. Epub 2008 Jul 14.
- Breen D, O'Brien S, McCarthy N, Gallagher A, Walshe N. Effect of a proficiency-based progression simulation programme on clinical communication for the deteriorating patient: a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025992. doi: 10.1136/bmjopen-2018-025992.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISBAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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