Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03804918 |
| Other study ID # |
18SM4947 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 25, 2019 |
| Est. completion date |
August 30, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
