NCT02886754

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

2 days

First QC Date

August 27, 2016

Last Update Submit

July 24, 2017

Conditions

Keywords

Clinical CommunicationISBARSimulationPerformanceNon technical skillsProficiency

Outcome Measures

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

    6 months

Secondary Outcomes (1)

  • Number of completed steps

    6 months

Other Outcomes (2)

  • Number of total errors

    6 months

  • Number of errors/critical errors

    6 months

Study Arms (3)

National e-learning programme only (HSE)

ACTIVE COMPARATOR

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

Simulation (S)

ACTIVE COMPARATOR

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 onlyBehavioral: Standard simulation

Proficiency-Based Progression (PBP)

EXPERIMENTAL

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 progressionBehavioral: National e-learning programme only

Interventions

Use of validated metrics and performance benchmarks to simulation training

Also known as: PBP
Proficiency-Based Progression (PBP)

National e-learning programme (COMPASS)

Also known as: HSE
National e-learning programme only (HSE)Proficiency-Based Progression (PBP)Simulation (S)

Paper based simulation cases

Also known as: Simulation S
Simulation (S)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Third year undergraduate nursing students
  • Fifth year medical students

You may not qualify if:

  • Lack of consent
  • Failure to successfully complete the National e-learning NEWS programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Cork

Cork, T12EH31, Ireland

Location

Related Publications (4)

  • 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.

    PMID: 23426342BACKGROUND
  • 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.

    PMID: 26341047BACKGROUND
  • 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.

    PMID: 18926460BACKGROUND
  • 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 Officials

  • Anthony Gallagher, PhD, DSc

    University College Cork, College Rd, Cork Ireland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors were unaware of which intervention group subjects were allocated
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study design is a parallel group, double-blind, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specilaist in Intensive Care and Director of Education, ASSERT, Principal Invesitgator

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 1, 2016

Study Start

September 14, 2016

Primary Completion

September 16, 2016

Study Completion

September 16, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations