Mobile Learning to Improve Clinician's Ability to Break Bad News

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03804918
• Collaborator: (none)
• Enrollment: 17
• Locations: 3
• Arm: 1
• Actual Duration (Months): 6.1
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Education	Other: VitalTips mobile application	N/A

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

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A pre-post mixed methods pilot educational studyA pre-post mixed methods pilot educational study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study
• Actual Study Start Date: Feb 25, 2019
• Actual Primary Completion Date: Aug 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional group: All participants Given access to a selected breaking bad news mobile learning resource (VitalTips application).	Other: VitalTips mobile application; 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.

Outcome Measures

Primary Outcome Measures

1. Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention. [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.

2. Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Medical and nursing students.

• Clinicians who have completed their training programmes i.e. medical or nursing consultants, matrons.

• Retired clinicians.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barts Health NHS Trust	London		United Kingdom	E1 2EF
2	Bupa Cromwell Hospital	London		United Kingdom	SW5 0TU
3	Imperial College Healthcare NHS Trust	London		United Kingdom	W2 1NY

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Gehan B Soosaipillai, BM BSc, Imperial College London

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 18, 2019

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03804918
• Other Study ID Numbers: 18SM4947
• First Posted: Jan 15, 2019
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Healthcare education; Breaking bad news; Digital learning

Study Results

Participant Flow

Arm/Group Title	Interventional Group: All Participants
Arm/Group Description	Given access to a selected breaking bad news mobile learning resource (VitalTips application). VitalTips mobile application: 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 this time does not impact on their clinical and academic commitments.
Period Title: Overall Study
STARTED	17
COMPLETED	16
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Interventional Group: All Participants
Arm/Group Description	Given access to a selected breaking bad news mobile learning resource (VitalTips application). VitalTips mobile application: 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 this time does not impact on their clinical and academic commitments.
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	9 56.3%
Male	7 43.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	16 100%
Specialty (Count of Participants)
Intensive care	1 6.3%
Medicine	5 31.3%
Oncology	7 43.8%
Paediatrics	1 6.3%
Surgery	2 12.5%

Outcome Measures

1. Primary Outcome

Title	Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Description	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.
Time Frame	Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)

Outcome Measure Data

Analysis Population Description

All participants (n=16) completed both the pre- and post-intervention questionnaires and there was no missing data.

Arm/Group Title	Interventional Group: All Participants
Arm/Group Description	Given access to a selected breaking bad news mobile learning resource (VitalTips application). VitalTips mobile application: 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 this time does not impact on their clinical and academic commitments.
Measure Participants	16
Pre-intervention: Not very confident at all	1 6.3%
Post-intervention: Not very confident at all	0 0%
Pre-intervention: Not very confident	1 6.3%
Post-intervention: Not very confident	0 0%
Pre-intervention: Somewhat confident	12 75%
Post-intervention: Somewhat confident	13 81.3%
Pre-intervention: Very confident	2 12.5%
Post-intervention: Very confident	3 18.8%
Pre-intervention: Extremely confident	0 0%
Post-intervention: Extremely confident	0 0%

2. Primary Outcome

Title	Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Description	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.
Time Frame	Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)

Outcome Measure Data

Analysis Population Description

All participants (n=16) completed both the pre- and post-intervention SPEs and there was no missing data.

Arm/Group Title	Interventional Group: All Participants
Arm/Group Description	Given access to a selected breaking bad news mobile learning resource (VitalTips application). VitalTips mobile application: 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 this time does not impact on their clinical and academic commitments.
Measure Participants	16
Pre-intervention: Setting the scene	10.15 (2.54)
Post-intervention: Setting the scene	12.25 (1.51)
Pre-intervention: Breaking the news	13.31 (5.06)
Post-intervention: Breaking the news	20.85 (2.66)
Pre-intervention: Eliciting concerns	7.71 (2.54)
Post-intervention: Eliciting concerns	10.77 (1.8)
Pre-intervention: Information giving	13.23 (2.92)
Post-intervention: Information giving	17.46 (1.33)
Pre-intervention: General considerations	26.54 (6.08)
Post-intervention: General considerations	33.58 (3.72)
Pre-intervention: Overall	71.15 (17.19)
Post-intervention: Overall	94.92 (9.58)

Adverse Events

Time Frame	AE data was not collected due to it being an observational study and no AE's were anticipated.
Adverse Event Reporting Description	No AE's were expected and AE's were not monitored for this reason.
Arm/Group Title	Interventional Group: All Participants
Arm/Group Description	Given access to a selected breaking bad news mobile learning resource (VitalTips application). VitalTips mobile application: 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 this time does not impact on their clinical and academic commitments.
All Cause Mortality
	Interventional Group: All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Interventional Group: All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Interventional Group: All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Sample numbers were small, which affects the interpretation of the quantitative measures (BAS mark sheet). Participants learned both from the app and the SPEs. Any change in the skill set must also take into consideration the learning from the SPEs.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.