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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02886754
Other study ID # ISBAR
Secondary ID
Status Completed
Phase N/A
First received August 27, 2016
Last updated July 24, 2017
Start date September 14, 2016
Est. completion date September 16, 2016

Study information

Verified date July 2017
Source University College Cork
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 16, 2016
Est. primary completion date September 16, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Proficiency-based progression
Use of validated metrics and performance benchmarks to simulation training
National e-learning programme only
National e-learning programme (COMPASS)
Standard simulation
Paper based simulation cases

Locations

Country Name City State
Ireland University College Cork Cork

Sponsors (1)

Lead Sponsor Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of total errors Number of total errors as predefined by the metrics for the assessment case 6 months
Other Number of errors/critical errors Number of errors/critical errors as predefined by the metrics for the assessment case 6 months
Primary 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 Number of completed steps Number of successfully completed steps as predefined by the metrics for the assessment case 6 months
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