EducationNCT03804918
Mobile Learning to Improve Clinician's Ability to Break Bad News
A study testing VitalTips mobile application in people with Education, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
Design: A pre-post mixed methods pilot study. All participants granted access to a breaking bad news mobile learning resource (VitalTips). Baseline and post-intervention questionnaires, pre- and post-intervention simulated patient encounters, and post-intervention semi-structured interviews. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- VitalTips mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 25 Feb 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working and training within NHS England and a private healthcare hospital.
- Junior doctor, pre-certificate of completion of training (of any specialty).
- Junior nurse band 5 to 6 (or equivalent) from any specialty.
- Over the age of 18.
- Able to communicate and write in English.
- Willing to engage with mobile learning resources as an additional task to their clinical role, ensuring their learning does not take time out of their clinical commitments.
Who cannot join
- Medical and nursing students.
- Clinicians who have completed their training programmes i.e. medical or nursing consultants, matrons.
- Retired clinicians.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barts Health NHS Trust
London, E1 2EF
Bupa Cromwell Hospital
London, SW5 0TU
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study
Design:
A pre-post mixed methods pilot study. All participants granted access to a breaking bad news mobile learning resource (VitalTips).
Baseline and post-intervention questionnaires, pre- and post-intervention simulated patient encounters, and post-intervention semi-structured interviews.
Objective:
To assess if a selected breaking bad news mobile learning resource can improve the ability of clinicians to break bad news.
Population/Eligibility:
15-20 junior doctors and nurses working within two NHS hospitals trusts and one private hospital in England.
Duration:
25th February 2019 to 8th July 2019.
Read the detailed description
Purpose:
Digital and mobile learning is at the forefront of healthcare education. Though there is evidence for the use of digital learning for practical skills acquisition, there is little evidence of the use of digital learning for breaking bad news training. This pre-post mixed methods pilot study aimed to address this gap in knowledge by assessing how a mobile learning resource may impact the ability of clinicians to break bad news.
Hypothesis:
The addition of a breaking bad news mobile learning resource to clinical practice improves the confidence and ability of junior doctors and nurses to break bad news.
Study objective:
To assess if a breaking bad news mobile learning resource can improve the confidence and ability of clinicians to break bad news.
Methodology:
Potential participants were sent an invitation and participant information sheet (PIS) via e-mail. Potential participants were given up to two weeks to decide if they wanted to participate, with a reminder sent after one week. Each potential participant was referenced by a participant ID number for confidentiality purposes.
Once potential participants read the PIS and given consent, they were asked to complete a baseline questionnaire to understand their demographics, their previous exposure to breaking bad news (through formal or informal training) and their engagement with digital resources.
Following this, participants were asked to complete a baseline simulated patient encounter (SPE) with a simulated patient (SP) (role-played by an actor) to assess their baseline ability to break bad news. Participants were given a task sheet with a brief history of the SP and what news they needed to deliver. The details and history of the SP was documented on a character sheet for the actor's reference. Each participant was given 15 minutes to complete the SPE which was video-recorded. The SPEs were evaluated against the validated Breaking bad news Assessment Schedule (BAS) mark sheet completed by the chief investigator, actor and an independent assessor (by watching the video footage).
Access to the mobile learning resource was granted following the baseline SPE. The mobile learning resource was the freely available VitalTips mobile application, provided by VitalTalks. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time did not impact on their clinical and academic commitments.
Four to six weeks later, participants were asked to complete a second videoed SPE, which was marked as described above. The participants were asked to complete a post-intervention questionnaire to gauge the impact on their clinical practice and their engagement with the mobile resources.
The questionnaires utilised a five-point Likert scale ranking of the user's confidence and agreeability with statements. The questionnaires are novel to this study and were developed using the principles of Kirkpatrick's Model of Learning Evaluation, the Theory of Planned Behaviour and the Technology Acceptance Model, whilst also drawing on the most important curricula competencies derived from the content analysis of a sample of medical and nursing curricula followed by an expert consensus.
Soon after the completion of the post-intervention questionnaire, the participants were asked to participate in a 15-30 minutes semi-structured interview with the chief investigator. The participant was asked about their general impressions of the mobile learning resource, their use of the resource in and outside of the clinical environment, their perception of their ability to break bad news before and after the intervention, their perception of their performance in the SPE and any impact on their practice.
Data handling and confidentiality:
Following consent, participants were referenced by their participant ID number (e.g. MLR001). Their e-mail address was recorded next to their participant ID number, gender, role (i.e. doctor or nurse) and training grade, on an Excel spreadsheet for the purpose of contacting participants as the study progressed. Once their commitment to the study had ended, the e-mail addresses were deleted.
Video recordings from the SPEs were transferred from the recording device to a password protected USB stick referenced by the participant ID followed by SPE1 (baseline) or SPE2 (post-intervention), e.g. MLR001_SPE1. Once the independent reviewer had viewed the video and marked the participant, the video file was destroyed.
Audio files from the interviews was transferred from the recording device onto a password protected computer using a USB stick. Once the transfer was completed, the files were deleted from the USB stick. The transferred files were stored on the password protected computer till the returned transcriptions were checked by the chief investigator. Once the files had been checked, the recordings were deleted.
- Conditions
- Education
- Being tested
- VitalTips mobile application
- Keywords
- Healthcare education, Breaking bad news, Digital learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalTips mobile applicationOther
VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group: All participants | Experimental | Given access to a selected breaking bad news mobile learning resource (VitalTips application). Receives: Other: VitalTips mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.
Measured: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.
Measured: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start25 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A pre-post mixed methods pilot educational study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gehan B Soosaipillai, BM BSc, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804918
- Sponsor's protocol ID
- 18SM4947
- Status last verified
- Oct 2020
- First submitted
- 7 Jan 2019
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD was only be available on a password protected computer with sole access to the chief investigator. Only anonymised data was sent to the academic supervisor and other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study
- ClinicalTrials.gov ID
- NCT03804918
- Acronym / sponsor ID
- 18SM4947
- Conditions
- Education
- Keywords
- Healthcare education, Breaking bad news, Digital learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Design:
A pre-post mixed methods pilot study. All participants granted access to a breaking bad news mobile learning resource (VitalTips).
Baseline and post-intervention questionnaires, pre- and post-intervention simulated patient encounters, and post-intervention semi-structured interviews.
Objective:
To assess if a selected breaking bad news mobile learning resource can improve the ability of clinicians to break bad news.
Population/Eligibility:
15-20 junior doctors and nurses working within two NHS hospitals trusts and one private hospital in England.
Duration:
25th February 2019 to 8th July 2019.
Detailed description
Purpose:
Digital and mobile learning is at the forefront of healthcare education. Though there is evidence for the use of digital learning for practical skills acquisition, there is little evidence of the use of digital learning for breaking bad news training. This pre-post mixed methods pilot study aimed to address this gap in knowledge by assessing how a mobile learning resource may impact the ability of clinicians to break bad news.
Hypothesis:
The addition of a breaking bad news mobile learning resource to clinical practice improves the confidence and ability of junior doctors and nurses to break bad news.
Study objective:
To assess if a breaking bad news mobile learning resource can improve the confidence and ability of clinicians to break bad news.
Methodology:
Potential participants were sent an invitation and participant information sheet (PIS) via e-mail. Potential participants were given up to two weeks to decide if they wanted to participate, with a reminder sent after one week. Each potential participant was referenced by a participant ID number for confidentiality purposes.
Once potential participants read the PIS and given consent, they were asked to complete a baseline questionnaire to understand their demographics, their previous exposure to breaking bad news (through formal or informal training) and their engagement with digital resources.
Following this, participants were asked to complete a baseline simulated patient encounter (SPE) with a simulated patient (SP) (role-played by an actor) to assess their baseline ability to break bad news. Participants were given a task sheet with a brief history of the SP and what news they needed to deliver. The details and history of the SP was documented on a character sheet for the actor's reference. Each participant was given 15 minutes to complete the SPE which was video-recorded. The SPEs were evaluated against the validated Breaking bad news Assessment Schedule (BAS) mark sheet completed by the chief investigator, actor and an independent assessor (by watching the video footage).
Access to the mobile learning resource was granted following the baseline SPE. The mobile learning resource was the freely available VitalTips mobile application, provided by VitalTalks. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time did not impact on their clinical and academic commitments.
Four to six weeks later, participants were asked to complete a second videoed SPE, which was marked as described above. The participants were asked to complete a post-intervention questionnaire to gauge the impact on their clinical practice and their engagement with the mobile resources.
The questionnaires utilised a five-point Likert scale ranking of the user's confidence and agreeability with statements. The questionnaires are novel to this study and were developed using the principles of Kirkpatrick's Model of Learning Evaluation, the Theory of Planned Behaviour and the Technology Acceptance Model, whilst also drawing on the most important curricula competencies derived from the content analysis of a sample of medical and nursing curricula followed by an expert consensus.
Soon after the completion of the post-intervention questionnaire, the participants were asked to participate in a 15-30 minutes semi-structured interview with the chief investigator. The participant was asked about their general impressions of the mobile learning resource, their use of the resource in and outside of the clinical environment, their perception of their ability to break bad news before and after the intervention, their perception of their performance in the SPE and any impact on their practice.
Data handling and confidentiality:
Following consent, participants were referenced by their participant ID number (e.g. MLR001). Their e-mail address was recorded next to their participant ID number, gender, role (i.e. doctor or nurse) and training grade, on an Excel spreadsheet for the purpose of contacting participants as the study progressed. Once their commitment to the study had ended, the e-mail addresses were deleted.
Video recordings from the SPEs were transferred from the recording device to a password protected USB stick referenced by the participant ID followed by SPE1 (baseline) or SPE2 (post-intervention), e.g. MLR001_SPE1. Once the independent reviewer had viewed the video and marked the participant, the video file was destroyed.
Audio files from the interviews was transferred from the recording device onto a password protected computer using a USB stick. Once the transfer was completed, the files were deleted from the USB stick. The transferred files were stored on the password protected computer till the returned transcriptions were checked by the chief investigator. Once the files had been checked, the recordings were deleted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pre-post mixed methods pilot educational study
| Arm | Type | Receives |
|---|---|---|
| Interventional group: All participants | Experimental | Other: VitalTips mobile applicationGiven access to a selected breaking bad news mobile learning resource (VitalTips application). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Working and training within NHS England and a private healthcare hospital.
- Junior doctor, pre-certificate of completion of training (of any specialty).
- Junior nurse band 5 to 6 (or equivalent) from any specialty.
- Over the age of 18.
- Able to communicate and write in English.
Key exclusion criteria (3 listed)
- Medical and nursing students.
- Clinicians who have completed their training programmes i.e. medical or nursing consultants, matrons.
- Retired clinicians.
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 |
|---|---|---|
| VitalTips mobile applicationVitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments. | Other | Interventional group: All participants |
Primary outcome
Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Time frame: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.
Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Time frame: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD was only be available on a password protected computer with sole access to the chief investigator. Only anonymised data was sent to the academic supervisor and other researchers.
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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.
Gehan B Soosaipillai, BM BSc principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitalTips mobile application in people with Education, run by Imperial College London at 3 sites in United Kingdom.
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 6 inclusion and 3 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention. (time frame: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.