Trial Outcomes & Findings for Mobile Learning to Improve Clinician's Ability to Break Bad News (NCT NCT03804918)
NCT ID: NCT03804918
Last Updated: 2020-11-03
Results Overview
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.
COMPLETED
NA
17 participants
Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
2020-11-03
Participant Flow
Participant milestones
| Measure |
Interventional Group: All Participants
Given access to a selected breaking bad news mobile learning resource (VitalTips application).
VitalTips mobile 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 this time does not impact on their clinical and academic commitments.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Interventional Group: All Participants
Given access to a selected breaking bad news mobile learning resource (VitalTips application).
VitalTips mobile 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 this time does not impact on their clinical and academic commitments.
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Overall Study
Participant did not use the app
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Interventional Group: All Participants
n=16 Participants
Given access to a selected breaking bad news mobile learning resource (VitalTips application).
VitalTips mobile 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 this time does not impact on their clinical and academic commitments.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=16 Participants
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Age, Categorical
Between 18 and 65 years
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16 Participants
n=16 Participants
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Age, Categorical
>=65 years
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0 Participants
n=16 Participants
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Sex: Female, Male
Female
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9 Participants
n=16 Participants
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Sex: Female, Male
Male
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7 Participants
n=16 Participants
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Region of Enrollment
United Kingdom
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16 participants
n=16 Participants
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Specialty
Intensive care
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1 Participants
n=16 Participants
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Specialty
Medicine
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5 Participants
n=16 Participants
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Specialty
Oncology
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7 Participants
n=16 Participants
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Specialty
Paediatrics
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1 Participants
n=16 Participants
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Specialty
Surgery
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2 Participants
n=16 Participants
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PRIMARY outcome
Timeframe: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)Population: All participants (n=16) completed both the pre- and post-intervention questionnaires and there was no missing data.
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.
Outcome measures
| Measure |
Interventional Group: All Participants
n=16 Participants
Given access to a selected breaking bad news mobile learning resource (VitalTips application).
VitalTips mobile 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 this time does not impact on their clinical and academic commitments.
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|---|---|
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Extremely confident
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0 Participants
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Very confident
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3 Participants
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Extremely confident
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0 Participants
|
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Not very confident at all
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1 Participants
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Not very confident at all
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0 Participants
|
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Not very confident
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1 Participants
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Not very confident
|
0 Participants
|
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Somewhat confident
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12 Participants
|
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Somewhat confident
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13 Participants
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Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Very confident
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2 Participants
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PRIMARY outcome
Timeframe: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)Population: All participants (n=16) completed both the pre- and post-intervention SPEs and there was no missing data.
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.
Outcome measures
| Measure |
Interventional Group: All Participants
n=16 Participants
Given access to a selected breaking bad news mobile learning resource (VitalTips application).
VitalTips mobile 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 this time does not impact on their clinical and academic commitments.
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|---|---|
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Setting the scene
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10.15 score on the BAS scale
Standard Deviation 2.54
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Setting the scene
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12.25 score on the BAS scale
Standard Deviation 1.51
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Breaking the news
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13.31 score on the BAS scale
Standard Deviation 5.06
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Breaking the news
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20.85 score on the BAS scale
Standard Deviation 2.66
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Eliciting concerns
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7.71 score on the BAS scale
Standard Deviation 2.54
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Eliciting concerns
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10.77 score on the BAS scale
Standard Deviation 1.8
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Information giving
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13.23 score on the BAS scale
Standard Deviation 2.92
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Information giving
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17.46 score on the BAS scale
Standard Deviation 1.33
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: General considerations
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26.54 score on the BAS scale
Standard Deviation 6.08
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: General considerations
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33.58 score on the BAS scale
Standard Deviation 3.72
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Pre-intervention: Overall
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71.15 score on the BAS scale
Standard Deviation 17.19
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Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
Post-intervention: Overall
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94.92 score on the BAS scale
Standard Deviation 9.58
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Adverse Events
Interventional Group: All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place