CommunicationeISBARNCT02937597
E-learning Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance (eISBAR)
A study testing ePBP: eProficiency Based Progression, eS: eScenarios and HSE in people with Communication, run by University College Cork at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication
- What is being tested?
- ePBP: eProficiency Based Progression, eS: eScenarios and HSE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2016to Apr 2018
- 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
- final year medical students in UCC
Who cannot join
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an E-learning Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance
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
Read more
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.
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. It has also not yet been validated through the medium of virtual learning. 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 an e-learning training course 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 e-learning course with scenarios or proficiency-based progression (PBP) e-learning course with scenarios.
Participants will be prospectively randomized to one of three training groups. Following a pre-test observation through low-fidelity simulation, they will then undergo their respective training courses before undertaking a post-test performance assessment of an ISBAR communication relevant to a deteriorating patient in a low fidelity simulation environment:
- Online learning only (HSE) -the national e-learning programme only
- Scenarios (S) -national online learning plus online scenario course training
- Proficiency based progression (PBP) -national online learning plus proficiency-based progression online scenario course training.
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 supply 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 experts for a series of paper-based simulation cases and a standardised high fidelity simulation case used as the assessment case. This case will be used in this study in a low fidelity environment. The proficiency benchmark for each case has been set based on the performance of experienced medical personnel on each case as a series of steps, errors and critical errors.
Outcome assessment will be scored by reviewing auditory recordings of ISBAR performance by each participant on the standardised case in the low fidelity simulated environment.
- Conditions
- Communication
- Being tested
- ePBP: eProficiency Based Progression, eS: eScenarios, HSE
- Keywords
- proficiency based progression, feedback, computer based assessment, non technical skills, deteriorating patient, ISBAR
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePBP: eProficiency Based ProgressionBehavioural
National e-learning programme plus Proficiency-based progression through 4 scenarios in an online learning course and facilitator when requested
eS: eScenariosBehavioural
National e-learning programme plus access to 4 scenarios in an online learning course and facilitator when requested
HSEBehavioural
National HSE e-learning programme only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: ePBP: eProficiency Based Progression |
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 audio recorded ISBAR phone call conducted in the low fidelity simulation setting
Measured: 12 months
Secondary outcomes (2)
recording of data in learning management system for various course attempts
recording of data in learning management system for various course attempts
Measured: 12 months
Number of completed steps
Number of successfully completed steps as predefined by the metrics for the assessment case
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2018
- Study completionApr 2018
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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora McCarthy, University College Cork
- Investigators
- Anthony Gallagher, PhD, Study director, Director Technology Enhanced Learning ASSERT, UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937597
- Sponsor's protocol ID
- eISBAR
- Acronym
- eISBAR
- Status last verified
- May 2018
- First submitted
- 16 Oct 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 18926460McCarthy 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.
PubMed 37536965
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an E-learning Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance
- ClinicalTrials.gov ID
- NCT02937597
- Acronym / sponsor ID
- eISBAR / eISBAR
- Conditions
- Communication
- Keywords
- proficiency based progression, feedback, computer based assessment, non technical skills, deteriorating patient, ISBAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Oct 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.
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.
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. It has also not yet been validated through the medium of virtual learning. 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 an e-learning training course 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 e-learning course with scenarios or proficiency-based progression (PBP) e-learning course with scenarios.
Participants will be prospectively randomized to one of three training groups. Following a pre-test observation through low-fidelity simulation, they will then undergo their respective training courses before undertaking a post-test performance assessment of an ISBAR communication relevant to a deteriorating patient in a low fidelity simulation environment:
- Online learning only (HSE) -the national e-learning programme only
- Scenarios (S) -national online learning plus online scenario course training
- Proficiency based progression (PBP) -national online learning plus proficiency-based progression online scenario course training.
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 supply 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 experts for a series of paper-based simulation cases and a standardised high fidelity simulation case used as the assessment case. This case will be used in this study in a low fidelity environment. The proficiency benchmark for each case has been set based on the performance of experienced medical personnel on each case as a series of steps, errors and critical errors.
Outcome assessment will be scored by reviewing auditory recordings of ISBAR performance by each participant on the standardised case in the low fidelity simulated environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| National e-learning programme only (HSE) | Active comparator | Behavioral: HSEActive 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. |
| eS: eScenarios | Active comparator | Behavioral: eS: eScenariosRecent 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. |
| ePBP: eProficiency Based Progression | Experimental | Behavioral: ePBP: eProficiency Based ProgressionRecent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- final year medical students in UCC
Key exclusion criteria (1 listed)
- lack of consent
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 |
|---|---|---|
| ePBP: eProficiency Based ProgressionNational e-learning programme plus Proficiency-based progression through 4 scenarios in an online learning course and facilitator when requested | Behavioural | ePBP: eProficiency Based Progression |
| eS: eScenariosNational e-learning programme plus access to 4 scenarios in an online learning course and facilitator when requested | Behavioural | eS: eScenarios |
| HSENational HSE e-learning programme only | Behavioural | National e-learning programme only (HSE) |
Primary outcome
Proportion of those reaching the benchmark on the assessment case
Time frame: 12 months
Independent review by two blinded assessors of audio recorded ISBAR phone call conducted in the low fidelity simulation setting
2 secondary outcomes
recording of data in learning management system for various course attempts
Time frame: 12 months
Number of completed steps
Time frame: 12 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 2 May 2018.
- 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 37536965McCarthy 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.
- Individual participant dataSharing planned: No
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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 study director
Director Technology Enhanced Learning ASSERT, UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePBP: eProficiency Based Progression, eS: eScenarios and HSE in people with Communication, 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 1 inclusion and 1 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 2 May 2018. 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: 12 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 NCT02937597, 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 2 May 2018.