- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03804918
Mobile Learning to Improve Clinician's Ability to Break Bad News
Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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London, Regno Unito, W2 1NY
- Imperial College Healthcare NHS Trust
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London, Regno Unito, E1 2EF
- Barts Health NHS Trust
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London, Regno Unito, SW5 0TU
- Bupa Cromwell Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Interventional group: All participants
Given access to a selected breaking bad news mobile learning resource (VitalTips 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Lasso di tempo: 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.
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Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
|
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Lasso di tempo: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
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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.
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Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gehan B Soosaipillai, BM BSc, Imperial College London
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 18SM4947
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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