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Trial registered on ANZCTR


Registration number
ACTRN12621001473853
Ethics application status
Approved
Date submitted
13/09/2021
Date registered
28/10/2021
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Connecting Health Care Teams via Schwartz Rounds
Scientific title
Schwartz Rounds in an Australian setting: Evaluation of a team and system level wellness intervention on the prevalence of burnout
Secondary ID [1] 305291 0
Nill known
Universal Trial Number (UTN)
U1111-1269-4123
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 323600 0
Condition category
Condition code
Mental Health 321143 321143 0 0
Other mental health disorders
Public Health 321145 321145 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schwartz Rounds provide a safe space wherein both clinical and non-clinical health care staff can connect with each other and share their experiences about the social and emotional aspects of patient care and broader related issues.Schwartz Rounds are structured group meetings led by a nominated facilitator. They involve 2-3 panel members who briefly share their stories about challenges of healthcare for about 5 minutes each, followed by the facilitataed, reflective discussion with the audience.

Schwartz Rounds last for approximately 1 hour and are conducted monthly. In this pilot trial, Schwartz Rounds will be deliverd to two different departments, intensive care unit (ICU) and gastroenterology department. Each department will receive three Schwartz Rounds, a month apart.

The Rounds will be conducted with a group of 8-20 participants, in large hospital meeting rooms, suitable for this purpose.

Adherence to the intervention i.e. intervention fidelity, will be monitored through session attendance checklists, and fidelity checklists completed immediately post Rounds.

Focus groups will be held after the completion of the Rounds, to give participants the opportunity to provide detailed feedback on the Rounds. They will be conducted approximately two months after the third Round for each group. They will have between 5-10 participants, in keeping with the reccomended numbers for this type of research. Participants for the focus groups will be invited at the initial recruitment for the study, they will be informed that focus group participation is not mandatory but based on them opting in to participate in the focus groups. Once the first 10 participants are enrolled for the focus groups, further recruitment for the focus groups will stop.
Focus groups will be facilitated by an external member of the research team (psychologist at Griffith University) with prior experience in facilitating groups and adequate knowledge of the topic and the purpose of the group. Conversation openers developed by the research team will be used. Qualitative data from the focus groups transcripts will be analysed thematically by two researchers independently to ensure validity.
Intervention code [1] 321700 0
Behaviour
Intervention code [2] 321853 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328931 0
Maslach burnout inventory (MBI; Maslach, Jackson, Leiter, Schaufeli, & Schwab, 1986)
Timepoint [1] 328931 0
Baseline, two months post baseline (after three Rounds) and five months post baseline (three months after three Rounds).
Primary outcome [2] 329126 0
Feasibility

Feasibility will be assessed as a composite of the Schwartz Rounds attendance (at least 2 out of 3 Rounds attendance will be required), participant feedback provided via post-round evaluation surveys and focus-groups, and intervention fidelity. (assessed through the post-rounds fidelity checklist). Post-rounds evaluation surveys were desined by the Schwartz Centre and they have not been validated.
Timepoint [2] 329126 0
Baseline, two months post baseline (after three Rounds) and five months post baseline (three months after three Rounds).
Secondary outcome [1] 400891 0
the Schwartz Centre Compassionate Care Scale – provider version (Lown, Muncer, & Chadwick, 2015).
Timepoint [1] 400891 0
Baseline, two months post baseline (after three Rounds) and five monthhs post baseline (three months after three Rounds).
Secondary outcome [2] 400892 0
Culture of Care Barometer – v2 (CoCB-v2; Rafferty, Philippou, Fitzpatrick, & Ball, 2017).
Timepoint [2] 400892 0
Baseline, two months post baseline (after three Rounds) and five monthhs post baseline (three months after three Rounds)

Eligibility
Key inclusion criteria
All staff employed at Mater Hospital Brisbane. who are interested in participating.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
NA-Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Qualitative and quantitative data will be collected by the research team through the self-report questionnaires, rounds attendance sheets, post-round feedback forms, and focus groups transcripts. Data will be deidentified and each participant will be given a number or pseudonym. All deidentified and identifiable data will be stored electronically on REDCap and Griffith University Research Space, where only the research team will have access to the data. All hard copy documents will be stored in a locked cabinet at Griffith University where only those that require direct access will be able to access it. Electronic information will be kept on encrypted devices. All data will be stored for five years and then destroyed in compliance with Griffith University and Mater Health policies. Upon study completion, deidentified data will be kept on the Griffith University repository after the final ethics report has been submitted.

Qualitative data from the open comment section of the standard post-round evaluation form and focus groups transcripts will be thematically analysed by two members of the research team. Quantitative data will be analysed using IBMs Statistical Package for the Social Sciences (SPSS). Descriptive statistics, t-tests, chi-square tests (or other suitable non-parametric tests), and analysis of variance (ANOVA) will be used to compare survey data across time points and groups. Post-hoc analyses will be conducted to compare differences between specific time points.

Participants will be recruited via a convenience sample. The required sample size was calculated using a power calculation for a repeated measures ANOVA (one group measured across three time points) study using G*Power with effect size = 0.25 (f), alpha level = 0.05, power = 0.80, and correlation among repeated measures = 0.5. Therefore, it is calculated that a total sample size of n = 24 will be required for the study to be adequately powered to detect a significant difference between the time points. Approximately 10-15 participants will be selected from interested staff, to participate in two focus groups. This number of participants will ensure that 5-8 participants will take part in each focus group, in keeping with the recommended size for focus groups, and to ensure an even spread between professions, consistent with previous research reccomendations.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
8/06/2020
Date of last participant enrolment
Anticipated
Actual
6/10/2021
Date of last data collection
Anticipated
10/12/2021
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20513 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 35290 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309662 0
University
Name [1] 309662 0
Griffith University
Country [1] 309662 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Dr
Southport QLD
4222
Country
Australia
Secondary sponsor category [1] 310686 0
None
Name [1] 310686 0
Address [1] 310686 0
Country [1] 310686 0
Other collaborator category [1] 281984 0
Hospital
Name [1] 281984 0
Mater Hospital
Address [1] 281984 0
Raymond Terrace, South Brisbane 4101 Queensland
Country [1] 281984 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309429 0
Mater Hospital Ethics Committee
Ethics committee address [1] 309429 0
Ethics committee country [1] 309429 0
Australia
Date submitted for ethics approval [1] 309429 0
30/12/2020
Approval date [1] 309429 0
30/01/2021
Ethics approval number [1] 309429 0
HREC/MML/71868
Ethics committee name [2] 309436 0
Griffith University HREC
Ethics committee address [2] 309436 0
Ethics committee country [2] 309436 0
Australia
Date submitted for ethics approval [2] 309436 0
24/02/2021
Approval date [2] 309436 0
22/04/2021
Ethics approval number [2] 309436 0
2021/025.

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

Contacts
Principal investigator
Name 114134 0
Dr Jonathan Munro
Address 114134 0
Griffith University, Parklands Dr
Southport QLD
4222
Country 114134 0
Australia
Phone 114134 0
+61 7 3735 5488
Fax 114134 0
+61 7 5552 8854
Email 114134 0
[email protected]
Contact person for public queries
Name 114135 0
Tatjana Ewais
Address 114135 0
Mater Young Adult Health Centre

Level 4, Salmon Building

Raymond Terrace South Brisbane 4101 QLD
Country 114135 0
Australia
Phone 114135 0
+61 7 31635800
Fax 114135 0
+61 7 3163 8445
Email 114135 0
[email protected]
Contact person for scientific queries
Name 114136 0
Tatjana Ewais
Address 114136 0
Mater Young Adult Health Centre

Level 4, Salmon Building

Raymond Terrace South Brisbane 4101 QLD
Country 114136 0
Australia
Phone 114136 0
+61 7 3163 5800
Fax 114136 0
+61 7 3163 8445
Email 114136 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?
Deintified data, in the Giffith University repository-available on request
When will data be available (start and end dates)?
Immediately folllwing publication, for five years.
Available to whom?
Case by case basis at the discretion of the primary sponsor.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approval by principal investigator,email [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.