NCT03804918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

January 7, 2019

Results QC Date

July 31, 2020

Last Update Submit

October 13, 2020

Conditions

Keywords

Healthcare educationBreaking bad newsDigital learning

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)

Study Arms (1)

Interventional group: All participants

EXPERIMENTAL

Given access to a selected breaking bad news mobile learning resource (VitalTips application).

Other: VitalTips mobile application

Interventions

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.

Interventional group: All participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Medical and nursing students.
  • Clinicians who have completed their training programmes i.e. medical or nursing consultants, matrons.
  • Retired clinicians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barts Health NHS Trust

London, E1 2EF, United Kingdom

Location

Bupa Cromwell Hospital

London, SW5 0TU, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Limitations and 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.

Results Point of Contact

Title
Dr Gehan Soosaipillai
Organization
Imperial College London

Study Officials

  • Gehan B Soosaipillai, BM BSc

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A pre-post mixed methods pilot educational study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 15, 2019

Study Start

February 25, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

November 3, 2020

Results First Posted

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

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.

Locations