Clinical CommunicationNCT02886754
Proficiency-Based Progression Training for Clinical Communication
A study testing Proficiency-based progression, National e-learning programme only and Standard simulation in people with Clinical Communication and ISBAR, run by University College Cork at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Communication, ISBAR, Simulation
- What is being tested?
- Proficiency-based progression, National e-learning programme only and Standard simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIreland
- Study dates
- 14 Sep 2016to 16 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Third year undergraduate nursing students
- Fifth year medical students
Who cannot join
- Lack of consent
- Failure to successfully complete the National e-learning NEWS programme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- 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.
- Conditions
- Clinical Communication, ISBAR, Simulation, Proficiency-Based Progression, Non Technical Skills, Performance
- Being tested
- Proficiency-based progression, National e-learning programme only, Standard simulation
- Keywords
- Clinical Communication, ISBAR, Simulation, Performance, Non technical skills, Proficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proficiency-based progressionBehavioural
Also called PBP
Use of validated metrics and performance benchmarks to simulation training
National e-learning programme onlyBehavioural
Also called HSE
National e-learning programme (COMPASS)
Standard simulationBehavioural
Also called Simulation S
Paper based simulation cases
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: National e-learning programme only; Behavioral: 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. Receives: Behavioral: Proficiency-based progression; Behavioral: National e-learning programme only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Number of completed steps
Number of successfully completed steps as predefined by the metrics for the assessment case
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start14 Sep 2016
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clinical CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a parallel group, double-blind, randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Breen, University College Cork
- Investigators
- Anthony Gallagher, PhD, DSc, Study director, University College Cork, College Rd, Cork Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886754
- Sponsor's protocol ID
- ISBAR
- Status last verified
- Jul 2017
- First submitted
- 27 Aug 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 23426342Angelo 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 26341047Van 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 18926460Breen 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance
- ClinicalTrials.gov ID
- NCT02886754
- Acronym / sponsor ID
- ISBAR
- Conditions
- Clinical Communication, ISBAR, Simulation, Proficiency-Based Progression, Non Technical Skills, Performance
- Keywords
- Clinical Communication, ISBAR, Simulation, Performance, Non technical skills, Proficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study design is a parallel group, double-blind, randomized trial
| Arm | Type | Receives |
|---|---|---|
| National e-learning programme only (HSE) | Active comparator | Behavioral: National e-learning programme onlyNational 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. |
| Simulation (S) | Active comparator | Behavioral: National e-learning programme only, Behavioral: Standard simulationSimulation 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. |
| Proficiency-Based Progression (PBP) | Experimental | Behavioral: Proficiency-based progression, Behavioral: National e-learning programme onlyRecent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Third year undergraduate nursing students
- Fifth year medical students
Key exclusion criteria (2 listed)
- Lack of consent
- Failure to successfully complete the National e-learning NEWS programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proficiency-based progressionAlso: PBPUse of validated metrics and performance benchmarks to simulation training | Behavioural | Proficiency-Based Progression (PBP) |
| National e-learning programme onlyAlso: HSENational e-learning programme (COMPASS) | Behavioural | National e-learning programme only (HSE), Proficiency-Based Progression (PBP), Simulation (S) |
| Standard simulationAlso: Simulation SPaper based simulation cases | Behavioural | Simulation (S) |
Primary outcome
Proportion of those reaching the benchmark on the assessment case
Time frame: 6 months
Independent review by two blinded assessors of recorded ISBAR phone call conducted in the high fidelity simulation setting
1 secondary outcome
Number of completed steps
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 23426342Gallagher 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.
- Background: PubMed 26341047Angelo 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.
- Background: PubMed 18926460Van 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.
- Derived from this study: PubMed 31289064Breen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Gallagher, PhD, DSc study director
University College Cork, College Rd, Cork Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proficiency-based progression, National e-learning programme only and Standard simulation in people with Clinical Communication and ISBAR, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of those reaching the benchmark on the assessment case (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886754, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.