ClinicalTrials.gg
CompletedNCT02886754Updated Jul 25, 2017

Proficiency-Based Progression Training for Clinical Communication

An interventional study of Proficiency-based progression and National e-learning programme only in Clinical Communication, ISBAR and Simulation, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-25.

Sponsored by University College Cork · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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:

  1. Online learning only (HSE) -the national e-learning programme only
  2. Standard simulation (S) -online learning plus simulation training
  3. 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.

02

Conditions studied

  • Clinical Communication
  • ISBAR
  • Simulation
  • Proficiency-Based Progression
  • Non Technical Skills
  • Performance
  • Deteriorating Patient

Keywords

  • Clinical Communication
  • ISBAR
  • Simulation
  • Performance
  • Non technical skills
  • Proficiency
03

In context

Lead sponsor

University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Third year undergraduate nursing students

Fifth year medical students

Exclusion criteria

Exclusion Criteria:

Lack of consent

Failure to successfully complete the National e-learning NEWS programme

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
77 participants (actual)

Study arms

  • 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.

    Behavioral: National e-learning programme only

  • 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.

    Behavioral: National e-learning programme only · Behavioral: Standard simulation

  • 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.

    Behavioral: Proficiency-based progression · Behavioral: National e-learning programme only

Interventions

  • BehavioralProficiency-based progression

    Use of validated metrics and performance benchmarks to simulation training

    Also known as: PBP

  • BehavioralNational e-learning programme only

    National e-learning programme (COMPASS)

    Also known as: HSE

  • BehavioralStandard simulation

    Paper based simulation cases

    Also known as: Simulation S

06

What researchers measure

Primary outcomes

  1. Proportion of those reaching the benchmark on the assessment case

    Independent review by two blinded assessors of recorded ISBAR phone call conducted in the high fidelity simulation setting

    Time frame: 6 months

Secondary outcomes

  1. Number of completed steps

    Number of successfully completed steps as predefined by the metrics for the assessment case

    Time frame: 6 months

Other outcomes

  1. Number of total errors

    Number of total errors as predefined by the metrics for the assessment case

    Time frame: 6 months

  2. Number of errors/critical errors

    Number of errors/critical errors as predefined by the metrics for the assessment case

    Time frame: 6 months

07

Study locations

1 site
  • University College Cork
    Cork, T12EH31, Ireland
08

References and documents

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. PubMed 23426342 ↗
  • 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. PubMed 26341047 ↗
  • 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. PubMed 18926460 ↗
  • 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. PubMed 31289064 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2016 to primary completion in Sep 2016, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2016
First posted
Sep 1, 2016
StartActual
Sep 14, 2016
Primary completionActual
Sep 16, 2016
CompletionActual
Sep 16, 2016
Last update
Jul 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02886754
Responsible party
Dorothy Breen (Specilaist in Intensive Care and Director of Education, ASSERT, Principal Invesitgator, University College Cork) — Principal investigator
First posted
Sep 1, 2016
Start date
Sep 14, 2016
Primary completion
Sep 16, 2016
Completion
Sep 16, 2016
Last update
Jul 25, 2017

Study contacts

Anthony Gallagher, PhD, DSc
study director · University College Cork, College Rd, Cork Ireland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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