Clinical trial NCT03804918: Mobile Learning to Improve Clinician's Ability to Break Bad News
Official title: Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: Healthcare education
Breaking bad news
Digital learning
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post mixed methods pilot educational study
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
timeFrame: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
measure: Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
timeFrame: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Bupa Cromwell Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Gehan B Soosaipillai, BM BSc
role: PRINCIPAL_INVESTIGATOR
References: