NCT02937597

Brief Summary

Objective: To determine the effectiveness of proficiency based inter-professional communication training in an online environment on medical student's use of the ISBAR (Identify, Situation, Background, Assessment, Recommendation) communication escalation protocol in the deteriorating patient Setting: The study will be conducted in University College Cork, Ireland. Participants: 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 for training before undertaking a performance assessment of an ISBAR communication relevant to a deteriorating patient in a low fidelity simulation environment: HSE group (the national e-learning programme only); S group (national e- learning plus access to online scenarios and facilitator when requested) and PBP group (national e-learning plus access to online scenarios training course with in-built proficiency-based progression, and facilitator when requested). 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
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

October 16, 2016

Last Update Submit

May 1, 2018

Conditions

Communication

Keywords

proficiency based progressionfeedbackcomputer based assessmentnon technical skillsdeteriorating patientISBAR

Outcome Measures

Primary Outcomes (1)

  • Proportion of those reaching the benchmark on the assessment case

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

    12 months

Secondary Outcomes (2)

  • recording of data in learning management system for various course attempts

    12 months

  • Number of completed steps

    12 months

Other Outcomes (3)

  • Number of total errors

    12 months

  • Number of errors/critical errors

    12 months

  • Number of attempts required to reach proficiency on each of the 4 cases in ePBP

    12 months

Study Arms (3)

National e-learning programme only (HSE)

ACTIVE COMPARATOR

Active Comparator: National e-learning programme only (HSE) National e-learning programme only Recent successful completion of the National e-learning programme by certificate will be displayed. Students then undergo performance assessment via low fidelity simulation and complete a questionnaire.

Behavioral: HSE

eS: eScenarios

ACTIVE COMPARATOR

Recent successful completion of the National e-learning e-learning programme by certificate will be displayed. Students will proceed to an online learning course with 4 scenarios to work through but no requirement to meet a proficiency benchmark. Following training students undergo performance assessment via low fidelity simulation and complete a questionnaire.

Behavioral: eS: eScenarios

ePBP: eProficiency Based Progression

EXPERIMENTAL

Recent successful completion of the National e-learning programme by certificate will be displayed. Students will proceed to a PBP e-learning course using the same series of cases as S. PBP students will be scored according to predefined metrics and will be required to reach proficiency benchmarks for the cases within the e-learning course to allow progression through the cases. Following training students undergo performance assessment via low fidelity simulation and complete a questionnaire.

Behavioral: ePBP: eProficiency Based Progression

Interventions

ePBP: eProficiency Based ProgressionBEHAVIORAL

National e-learning programme plus Proficiency-based progression through 4 scenarios in an online learning course and facilitator when requested

ePBP: eProficiency Based Progression
eS: eScenariosBEHAVIORAL

National e-learning programme plus access to 4 scenarios in an online learning course and facilitator when requested

eS: eScenarios
HSEBEHAVIORAL

National HSE e-learning programme only

National e-learning programme only (HSE)

Eligibility Criteria

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

You may qualify if:

  • final year medical students in UCC

You may not qualify if:

  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Cork

Cork, 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

  • McCarthy N, Neville K, Pope A, Barry L, Livingstone V. Effectiveness of a proficiency-based progression e-learning approach to training in communication in the context of clinically deteriorating patients: a multi-arm randomised controlled trial. BMJ Open. 2023 Aug 3;13(8):e072488. doi: 10.1136/bmjopen-2023-072488.

    PMID: 37536965DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anthony Gallagher, PhD

    Director Technology Enhanced Learning ASSERT, UCC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Medical Education

Study Record Dates

First Submitted

October 16, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)