Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000342617
Ethics application status
Approved
Date submitted
19/03/2023
Date registered
31/03/2023
Date last updated
7/07/2023
Date data sharing statement initially provided
31/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of a Positive Participatory Organisational Intervention on Burnout in New Zealand Emergency Department Staff – Multisite Study
Scientific title
Investigating the impact of a Positive Participatory Organisational Intervention on Burnout in New Zealand Emergency Department Staff – Multisite Study
Secondary ID [1] 308550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 328409 0
Workplace Wellbeing 328410 0
Condition category
Condition code
Emergency medicine 325430 325430 0 0
Other emergency care
Mental Health 326402 326402 0 0
Other mental health disorders
Public Health 326403 326403 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multicomponent intervention targeting individual, group and system levels. Our individual-level intervention will consist of a positive psychological intervention. Individual HCWs will choose from 3 positive psychological interventions and participate in those most appropriate for them. Members of the Local Champions Group (LCG) will decide, from 2 possibilities, which group-level intervention their department will use. All ED staff will be able to use the system-level Quality Improvement Learning System (QILS).

Individual intervention will be one of the following positive psychological interventions: Mindfulness-based, Three Good Things, Cognitive Behavioural Therapy (CBT)-based. Mindfulness-based intervention will include standard grounding, centering, observing and breathing practices. Three Good Things intervention will consist of reminders and encouragement to consider and document reflections relating to "good things" that have happened/are happening at work, home, family, etc. Cognitive-Based Therapy intervention will consist of a standard step-wise observation of thinking, consideration of cognitive distortions, then re-framing of thoughts.

Individuals will choose which of these they participate in. They are able to participate in none, one, two, or all three over time. These interventions will be delivered online via a web-portal designed specifically for this study. These will be available throughout the duration of the intervention period. While the content and duration of each will vary, none of these individual-level interventions will take longer than 100 minutes in total. Each intervention will be completed in brief periods, less than 10 minutes, over a duration of 1 month.

Web-portal analytics will be used to determine adherence to individual interventions.

Group level interventions will be one of Learning from Excellence, or Clinical Event Debriefing. The Learning from Excellence intervention is a department-wide approach to feedback to colleagues in which a strengths-based view is used. This is consistent with a "Safety-2" mindset. To ensure relevance and acceptability, each department will apply their own particular approach to these interventions. The Learning for Excellence intervention will require a process that makes it simple for staff to lodge and receive brief, relevant, timely feedback. For example, the LCG of a given department may adopt a brief electronic questionnaire, accessed by a QR code that is widely available throughout the department, into which staff can lodge feedback about a member of staff or a group of staff. A dedicated team will be required to review and forward that feedback. For example, a representative from each staff group will meet weekly to asses the feedback and forward that via the electronic means most appropriate to a given staff member. In addition, a summary of feedback will be publicised each week to the entire group at an appropriate site or sites, e.g. the homepage on the department intranet, and a poster on the Wellbeing noticeboard in the tea room.

The Clinical Event Debriefing intervention is intended to ensure that staff involved in important clinical events are routinely able to participate in a "hot debrief" which are brief, structured, timely, relevant reflections upon those clinical events. These are designed to take up to 10 minutes, and take place within the clinical workspace or adjacent (e.g. a training room) as soon as possible after an important clinical event. They will always be done during of immediately after a given shift. If further actions are required after the CED, for example, a larger team debrief, these can be organised for a later date.

In partnership with the Primary Investigator and based upon a consideration of the needs of their ED, the LCG will decide which of these interventions will be implemented in their ED. All ED staff will be exposed to the group level intervention while maintaining an ability to opt out of engaging with these. For example, should a LCG decide to implement the Clinical Event Debriefing intervention, participation in a given debrief will always remain optional for all ED staff. Similarly, while all ED staff will have exposure to Learning From Excellence, no staff are obliged to actively contribute, rather all contributions must be voluntary. The implementation of the group level intervention will vary at each ED and will work slightly differently, the intention is that these become "business as usual", so that these become part of the daily practice and culture of each ED. Monitoring of adherence will be determined by the LCG, and may include via use of a hot debrief form, or contributions to a Learning from Excellence forum, for example.

System level intervention will be QILS: Quality Improvement Learning System. This will be a robust system for identifying areas for improvement at the department level and implementing these using robust QI methods. Important features include simple, timely access to all staff, timely and careful consideration by a QILS team, transparent prioritisation of improvement projects, potential for involvement of all staff in solution generation and work, and robust feedback.

Intervention code [1] 324997 0
Treatment: Other
Intervention code [2] 324998 0
Behaviour
Comparator / control treatment
Before and After trial.

Data will be collected on staff wellbeing for 4weeks prior to the implementation period
Control group
Active

Outcomes
Primary outcome [1] 333289 0
Burnout - mean change Workplace domain of Copenhagen Burnout Inventory (CBI)
Timepoint [1] 333289 0
12 months post-intervention implementation
Secondary outcome [1] 416494 0
mean change in CBI (personal and patient-related domains)
Timepoint [1] 416494 0
12 months post-intervention implementation
Secondary outcome [2] 416495 0
Utrecht Work Engagement Scale (UWES) 9-item short form
Timepoint [2] 416495 0
12 months post-intervention implementation
Secondary outcome [3] 416496 0
Psychological Empowerment in the Workplace Psychological Empowerment in the Workplace: Dimensions, Measurement, and Validation. G. M. Spreitzer. Academy of Management Journal 1995 Vol. 38 Issue 5 Pages 1442-1465
Timepoint [3] 416496 0
12 months post-intervention implementation
Secondary outcome [4] 416497 0
mean change in WHO-5 Wellbeing Index
Timepoint [4] 416497 0
12 months post-intervention implementation
Secondary outcome [5] 419978 0
Number of issues raised via QILS, by staff and by patients, whanau and carers, and number of QILS solutions. All QILS suggestions will autopopulate a spreadsheet, e.g. an excel spreadsheet. A record of QILS issues raised, and what action was taken, as well as the duration from start to finish, will be recorded in this spreadsheet. These anonymised data will be then easily be summarised and presented monthly.
Timepoint [5] 419978 0
Monthly for 12 months post-implementation of the intervention
Secondary outcome [6] 419979 0
Departmental demographics, including o patient census, o triage proportions, o triage time compliance, o admission rate, o intensive care unit (ICU) admission rate, o patient did not wait rates, and o ED length of stay (LOS) over intervention year.
Timepoint [6] 419979 0
Monthly for 12 months post-implementation of the intervention
Secondary outcome [7] 419980 0
Seasonally adjusted daily staff absence, vacancies, monthly resignations, and Bradford Scale Score.
Timepoint [7] 419980 0
Monthly for 12 months post-implementation of the intervention
Secondary outcome [8] 419981 0
Compliance with the 6 targets of Te Tumu Whakarae for Maori workforce development
Timepoint [8] 419981 0
12 months post-implementation of the intervention

Eligibility
Key inclusion criteria
A member of ED staff at a participating Emergency Department.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not a member of ED staff at a participating emergency department

Study design
Purpose of the study
Treatment
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
Other
Other design features
Multiple site before- and after.
The duration of the pre-implementation will vary depending on the department. Sites will be recruited in waves. The first wave is March 2023. A subsequent wave of sites will be recruited for March 2024. Depending upon logistic considerations a wave of sites may be recruited between these dates, for October 2023.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: Power
Differences of greater than or equal to 5 on the CBI work-related burnout scale are considered clinically significant. A sample size of 900 participants over 8 EDs will have 90% power to detect a change of greater than or equal to 5 (2-tail a=0.05).

The primary and secondary outcomes will be compared pre and post intervention using a general linear mixed model with site as a random factor. Additional analyses of the primary outcome will be undertaken based on workforce group (nurse vs. other), and ethnicity (Maori vs. non-Maori), to test for differential effects of the intervention among these subgroups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
3/04/2023
Date of last participant enrolment
Anticipated
27/05/2024
Actual
Date of last data collection
Anticipated
26/05/2025
Actual
Sample size
Target
900
Accrual to date
308
Final
Recruitment outside Australia
Country [1] 25167 0
New Zealand
State/province [1] 25167 0

Funding & Sponsors
Funding source category [1] 312798 0
Government body
Name [1] 312798 0
Health Research Council NZ
Country [1] 312798 0
New Zealand
Funding source category [2] 312800 0
Hospital
Name [2] 312800 0
Auckland City Hospital A+ Trust
Country [2] 312800 0
New Zealand
Primary sponsor type
Individual
Name
Dr Mike Nicholls
Address
Adult Emergency Department
Auckland City Hospital Te Toka Tumai
Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 315192 0
None
Name [1] 315192 0
Address [1] 315192 0
Country [1] 315192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312085 0
Northern B Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 312085 0
Ethics committee country [1] 312085 0
New Zealand
Date submitted for ethics approval [1] 312085 0
08/12/2022
Approval date [1] 312085 0
09/03/2023
Ethics approval number [1] 312085 0
2023 EXP 15332

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

Contacts
Principal investigator
Name 123418 0
Dr Mike Nicholls
Address 123418 0
Adult Emergency Dept Auckland City Hospital Park Rd Grafton Auckland 1023
Country 123418 0
New Zealand
Phone 123418 0
+64 212066245
Fax 123418 0
Email 123418 0
[email protected]
Contact person for public queries
Name 123419 0
Mike Nicholls
Address 123419 0
Adult Emergency Dept Auckland City Hospital Park Rd Grafton Auckland 1023
Country 123419 0
New Zealand
Phone 123419 0
+64 212066245
Fax 123419 0
Email 123419 0
[email protected]
Contact person for scientific queries
Name 123420 0
Mike Nicholls
Address 123420 0
Adult Emergency Dept Auckland City Hospital Park Rd Grafton Auckland 1023
Country 123420 0
New Zealand
Phone 123420 0
+64 212066245
Fax 123420 0
Email 123420 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal, and case-by-case basis at the discretion of Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?
• after de-identification, individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• For IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, end date 10 years post data collection

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18684Study protocol    Study-related document.pdf
18685Ethical approval    Study-related document.pdf



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.