Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001575123
Ethics application status
Approved
Date submitted
31/10/2019
Date registered
14/11/2019
Date last updated
21/06/2021
Date data sharing statement initially provided
14/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Choose your own adventure: An evaluation of a training video on escalation of care conversations during the pre-Medical Emergency Team (MET) period.
Scientific title
Choose your own adventure: An evaluation of a training video on escalation of care conversations for clinical deterioration not breaching the Medical Emergency Team (MET) criteria.
Secondary ID [1] 298974 0
None
Universal Trial Number (UTN)
U1111-1238-3388
Trial acronym
na
Linked study record
na

Health condition
Health condition(s) or problem(s) studied:
Clinical deterioration 313964 0
Clinical Decision Making 313965 0
Condition category
Condition code
Public Health 312365 312365 0 0
Health service research
Public Health 312366 312366 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a short interactive training video completed as a one-off training session, lasting approximately 10 minutes. The training is designed to improve escalation of care conversations between clinicians by exposing each participant to a series of pre-Medical Emergency Team (MET) conversations and scenarios that enable them to practice identifying specific pre-MET communication skills and navigate common challenges. The training takes the form of a choose-your-own adventure video to engage and immerse the viewer and to enable computer-generated feedback on their learning via different outcomes and lessons associated with the choices made at each decision point. The scenarios were developed specifically for this study, with input from key stakeholders, including from four public hospitals in Victoria (Eastern Health, Austin Health, The Alfred, and Royal Melbourne hospitals). The video will take every participant through five core scenarios related to the escalation of care process, designed to elicit a key communication principle central to appropriate escalation of care (in the same order). The themes of these five scenarios are: i) effective communication of critical information between team members, ii) obtaining the right information before escalating care, iii) ensuring communication is clear, concise, and structured, iv) speaking up and discussing clinical concerns as the arise, and v) respectful, closed-loop communication. A participant questionnaire will be used to monitor adherence to the intervention, and up to two email reminders to complete the training will be sent to participants over a one-week period.
Intervention code [1] 315241 0
Behaviour
Intervention code [2] 316008 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321306 0
Potential barriers to escalating care, using the ‘Factors influencing escalation of care by junior medical officers’ survey (Rotella et al., 2014).
Timepoint [1] 321306 0
Baseline and 2-4 weeks (primary timepoint) after intervention delivery.
Primary outcome [2] 321307 0
Confidence in escalating care, using five items developed specifically for this study.
Timepoint [2] 321307 0
Baseline and 2-4 weeks (primary timepoint) after intervention delivery.
Secondary outcome [1] 374580 0
Mean number of reported escalation of care conversations per day, gathered using experience sampling.
Timepoint [1] 374580 0
Once per day prior to (baseline) and once per day for 2-4 weeks after (primary timepoint) intervention delivery.
Secondary outcome [2] 374581 0
Mean number of communication challenges identified during escalation of care conversations per day, using a list of 10 communication challenges designed specifically for this study, gathered using experience sampling.
Timepoint [2] 374581 0
Once per day prior to (baseline) and once per day for 2-4 weeks after (primary timepoint) intervention delivery.
Secondary outcome [3] 374597 0
Mean number of MET calls made per day from the trial sites, assessed via Decision Support reports.
Timepoint [3] 374597 0
Each day prior to (baseline) and each day for 2-4 weeks after (primary timepoint) intervention delivery.

Eligibility
Key inclusion criteria
Clinicians of all age groups who work at the recruitment sites during the trial period and are potentially involved in escalation of care conversations through their work are eligible to participate, including nursing staff, doctors, and allied health professionals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No further exclusion criteria were required following recruitment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size will be determined on a pragmatic basis, and will include eligible clinicians who participate during the 1-2 month trial period. This is estimated to be a total sample size of 60 participants across two recruitment sites, which would allow us to detect a mean difference of 0.3 from pre- to post-intervention with 80% power. This assumes an intracluster correlation of .1, a correlation between pre- and post-intervention responses of r = .3, and a two-sided significance level of p < 0.05.

The effects of the intervention on quantitative outcomes will be examined using the generalised estimating equations procedure. For all other quantitative outcomes, descriptive statistics will be reported. For qualitative outcomes, thematic analysis will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2019
Actual
20/11/2019
Date of last participant enrolment
Anticipated
27/11/2019
Actual
27/11/2019
Date of last data collection
Anticipated
23/12/2019
Actual
30/12/2019
Sample size
Target
60
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14468 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 14469 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 14731 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27483 0
3128 - Box Hill
Recruitment postcode(s) [2] 27484 0
3135 - Ringwood East
Recruitment postcode(s) [3] 27773 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303511 0
Government body
Name [1] 303511 0
Victorian Managed Insurance Authority
Country [1] 303511 0
Australia
Primary sponsor type
University
Name
Monash University
Address
8 Scenic Blvd, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 303566 0
Hospital
Name [1] 303566 0
Box Hill Hospital
Address [1] 303566 0
8 Arnold St, Box Hill, Victoria, 3128
Country [1] 303566 0
Australia
Secondary sponsor category [2] 303568 0
Hospital
Name [2] 303568 0
Maroondah Hospital
Address [2] 303568 0
Davey Drive, East Ringwood, Victoria, 3135
Country [2] 303568 0
Australia
Secondary sponsor category [3] 303861 0
Hospital
Name [3] 303861 0
Austin Health
Address [3] 303861 0
145 Studley Road, Heidelberg, Victoria, 3084
Country [3] 303861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304036 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 304036 0
Ethics committee country [1] 304036 0
Australia
Date submitted for ethics approval [1] 304036 0
01/07/2019
Approval date [1] 304036 0
06/08/2019
Ethics approval number [1] 304036 0
LR19/061
Ethics committee name [2] 304038 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 304038 0
Ethics committee country [2] 304038 0
Australia
Date submitted for ethics approval [2] 304038 0
07/08/2019
Approval date [2] 304038 0
08/08/2019
Ethics approval number [2] 304038 0
21478
Ethics committee name [3] 304627 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 304627 0
Ethics committee country [3] 304627 0
Australia
Date submitted for ethics approval [3] 304627 0
09/07/2019
Approval date [3] 304627 0
26/09/2019
Ethics approval number [3] 304627 0
HREC/54329/Austin-2019
Ethics committee name [4] 304628 0
Monash University Human Research Ethics Committee
Ethics committee address [4] 304628 0
Ethics committee country [4] 304628 0
Australia
Date submitted for ethics approval [4] 304628 0
26/09/2019
Approval date [4] 304628 0
07/10/2019
Ethics approval number [4] 304628 0
22125

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95618 0
Dr Dr Breanna Wright
Address 95618 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 95618 0
Australia
Phone 95618 0
+61 4 2231 6401
Fax 95618 0
Email 95618 0
[email protected]
Contact person for public queries
Name 95619 0
Dr Breanna Wright
Address 95619 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 95619 0
Australia
Phone 95619 0
+61 4 2231 6401
Fax 95619 0
Email 95619 0
[email protected]
Contact person for scientific queries
Name 95620 0
Bernice Plant
Address 95620 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 95620 0
Australia
Phone 95620 0
+613 9905 9656
Fax 95620 0
Email 95620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified survey data underlying the published results will be shared only. De-identified MET-call data may be made available subject to hospital approval.
When will data be available (start and end dates)?
Immediately following publication, for a minimum of 7 years following publication.
Available to whom?
Survey data will be available to anyone via Open Science Framework (https://osf.io/). MET-call data will be available subject to hospital approval.
Available for what types of analyses?
De-identified survey data will be available for research purposes only (e.g., to replicate key findings or for meta-analyses).
How or where can data be obtained?
Survey data will be available via Open Science Framework (https://osf.io/).
Applications for MET-call data can be made by contacting the Principal Investigator (Dr Breanna Wright, [email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.