Mobile learning resources as a tool for improving clinician’s ability to break bad news - A pre-post mixed methods pilot study - Version 2.1 - 18th March 2019

Sep 12, 2026

A pre-post mixed methods pilot study protocol evaluates whether a breaking bad news mobile learning resource (VitalTips) improves clinicians’ ability to conduct difficult conversations. Junior doctors and nurses (15–20) from two NHS hospital trusts and one private hospital in England will receive access to the resource. Outcomes include baseline and post-intervention questionnaires, pre- and post-intervention simulated patient encounters, and post-intervention semi-structured interviews, with data handling aligned to relevant governance and protection requirements.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages48

Reading Time17 min

AccessFree to download

1. INTRODUCTION

1.1 BACKGROUND

1.2 RATIONALE

1.3 HYPOTHESIS

2. STUDY OBJECTIVE

3. STUDY DESIGN

3.1 METHODOLOGY & DESIGN

3.2 STUDY SETTING

3.3 PARTICIPANTS

3.4 SAMPLE SELECTION, PERMISSION & INVITATION

3.5 MEASURES

3.6 DATA HANDLING & CONFIDENTIALITY

3.7 RISKS

4. PARTICIPANT ENTRY

4.1 PRE-REGISTRATION EVALUATION

4.2 INCLUSION CRITERIA

4.3 EXCLUSION CRITERIA

4.4 WITHDRAWAL CRITERIA

5. ADVERSE EFFECTS

5.1 DEFINITIONS

5.2 REPORTING PROCEDURES

6. ASSESSMENT & FOLLOW-UP

7. STATISTICS & DATA ANALYSIS

7.1 SAMPLE SIZE

7.2 DATA ANALYSIS

7.3 DATA PROTECTION

8. REGULATORY ISSUES

8.1 ETHICS APPROVAL

8.2 CONSENT

8.3 CONFIDENTIALITY

8.4 INDEMNITY

8.5 SPONSOR

8.6 FUNDING

8.7 AUDITS

9. STUDY MANAGEMENT

10. PUBLICATION POLICY

11. REFERENCES

APPENDICES

Mobile learning resources as a tool for improving clinician’s ability to break bad news: A pre-post mixed methods pilot study Version 2.1, 18th March 2019 Sponsors: Imperial College London Funders: Imperial College London Study Coordination Centre: Imperial College London IRAS Project ID: 258886 Chief Investigator & Study Management: Dr Gehan Soosaipillai Co-investigators: Dr Stephanie Archer and Mr Hutan Ashrafian For general queries, supply of study documentation, and collection of data, please contact: Chief investigator: Dr Gehan Soosaipillai Address: Academic Surgical Unit, 10th Floor, QEQM, St Mary’s Hospital, London, W2 1NY Tel: 07958 683379 [E-mail: gsoosaip@ic.ac.uk](E-mail: gsoosaip@ic.ac.uk) Study protocol version 2.1 18/03/2019 1 CLINICAL QUERIES Clinical queries should be directed to Dr Gehan Soosaipillai who will direct the query to the appropriate person. SPONSOR Imperial College London acts as the main research Sponsor for the Chief Investigator (CI) . For further information regarding the sponsorship conditions, please contact: Ruth Nicholson, Research Governance Manager Room 221, Level 2, Medical School Building Norfolk Place, London W2 1PG Tel: 020759 41862 E-mail: [r.nicholson@imperial.ac.uk](r.nicholson@imperial.ac.uk) FUNDER The CI is funded through a Clinical Research Fellowship at Imperial College London and is not receiving any monetary compensation for the work. This protocol describes a pre-post mixed methods pilot study assessing the impact of a mobile learning resource on the ability of clinicians to break bad news. Every care was taken in its drafting, but corrections or amendments may be necessary. This protocol will be circulated to investigators in the study. Problems relating to this study should be referred, in the first instance, to the CI. This study will adhere to the principles outlined in the NHS Research Governance Framework for Health and Social Care (2nd edition) . It will be conducted in compliance with the protocol, the Data Protection Act and other regulatory requirements as appropriate. Study protocol version 2.1 18/03/2019 2 Title Mobile learning resources as a tool for improving clinician’s ability to break bad news: A pre-post mixed methods pilot study. Design 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 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 January 2019 to August 2019. Study protocol version 2.1 18/03/2019 3 1. INTRODUCTION 6 1.1 BACKGROUND 6 1.2 RATIONALE 6 1.3 HYPOTHESIS 6 2. STUDY OBJECTIVE 6 3. STUDY DESIGN 7 3.1 METHODOLOGY & DESIGN 7 3.2 STUDY SETTING 7 3.3 PARTICIPANTS 8 3.4 SAMPLE SELECTION, PERMISSION & INVITATION 8 3.4 CONSENT 9 3.5 MEASURES 9 3.6 DATA HANDLING & CONFIDENTIALITY 10 3.7 RISKS 11 4. PARTICIPANT ENTRY 11 4.1 PRE-REGISTRATION EVALUATION 11 4.2 INCLUSION CRITERIA 11 4.3 EXCLUSION CRITERIA 11 4.4 WITHDRAWAL CRITERIA 11 5. ADVERSE EFFECTS 12 5.1 DEFINITIONS 12 5.2 REPORTING PROCEDURES 12 6. ASSESSMENT & FOLLOW-UP 12 7. STATISTICS & DATA ANALYSIS 13 7.1 SAMPLE SIZE 13 7.2 DATA ANALYSIS 13 7.3 DATA PROTECTION 14 8. REGULATORY ISSUES 14 8.1 ETHICS APPROVAL 14 8.2 CONSENT 14 8.3 CONFIDENTIALITY 14 8.4 INDEMNITY 14 8.5 SPONSOR 14 8.6 FUNDING 14 8.7 AUDITS 15 9. STUDY MANAGEMENT 15 10. PUBLICATION POLICY 15 11. REFERENCES 16 APPENDICES 19 Appendix 1A Invitation email 19 Appendix 1B Reminder invitation email 20 Appendix 2 Participant information sheet 21 Study protocol version 2.1 18/03/20

FAQs

What is the study assessing about clinicians’ performance?

The study assesses whether a breaking bad news mobile learning resource (VitalTips) can improve clinicians’ ability to break bad news. It uses questionnaires, simulated patient encounters, and semi-structured interviews.

Who can participate and how many participants are planned?

The study plans to recruit 15–20 junior doctors and nurses working within two NHS hospital trusts and one private hospital in England. Eligibility is defined within pre-registration evaluation, inclusion, exclusion, and withdrawal criteria.

What is the study duration and timeline?

The protocol specifies a duration from January 2019 to August 2019. Baseline and post-intervention measures and follow-up activities are carried out across the pre-post design.

Sep 12, 2026

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