Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001658808
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
1/12/2021
Date last updated
1/12/2021
Date data sharing statement initially provided
1/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing the quality of patient care and healthcare staff well-being through an empathy immersion educational programme in New Zealand: EmpEd study
Scientific title
Enhancing the quality of patient care and healthcare staff well-being through an empathy immersion educational programme In New Zealand: EmpEd study
Secondary ID [1] 305400 0
Victoria University of Wellington Grant Number: 223854
Universal Trial Number (UTN)
Trial acronym
EmpEd
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological wellbeing 323758 0
Stress 323759 0
Condition category
Condition code
Mental Health 321281 321281 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention ward will be identified by the chief nursing officer. Every worker in the ward will be invited to participate in the study. Participation means that healthcare workers in the intervention ward will receive the EmpEd immersion programme. Patients and support persons will receive care from healthcare participants and interact with the healthcare them as usual. All participants will fill out a survey at three-time points.

The EmpEd immersion programme has 2 components.

Empathy Passport: We will provide participants with an empathy passport (hard copy) to complete in their own time. The passport is a physical workbook designed specifically for this study by Registered Nurses, Mind Coach Practitioner and psychology scholar. Participants are expected to work through the activities each week. Reminders of the activities will be provided via email messages and the designated empathy research space on the ward. The passport contains evidence-based activities aimed at improving empathy. These actives are grouped into watching, listening, reading, reflecting and specific empathy tasks such as finding of about people in their team. Activity duration ranged from 1min to 34min. If participants choose 3-4 activities lasting 1-34min they could spend a total of 2hrs per week on the passport activities. Each week the activities will focus on different aspects of empathy:

Week 1: Self Compassion-Caring for self

Week 2: The people you work with- Getting to know those around you.

Week 3: The people who access healthcare- Getting to know patients, family and whanau

Week 4: Difference-Getting to know your values and the values of others

Week 5: Kindness- Ways to show kindness toward self and others

Week 6: Choosing Empathy- Building awareness of your feelings and thoughts about your ability to understand and share in the feelings of others

Week 7: Listening and noticing- Enhancing communication

Week 8: Self Compassion Revisited- Caring for self

Ward based researcher facilitated activities: We will engage with participants in short activities during work time selected from an evidence-based toolkit, designed specifically for this study, that reinforces the weekly empathy passport activities described above. These include 5min meditation sessions, a twice-daily hydration station where the research team make tea and administer it to the ward staff. The focus of the week will be displayed on a ward notice board and in a dedicated area identified as a staff 'quiet space' referred to as the 'Empathy Station'. The station will have a range of resources such as books, swiss ball, interactive posters for staff to write on and display posters with positive messages and prompts about empathy. Engagement is completely optional and at the discretion of each individual participant; no more than 30 minutes each week.

Adherence to the intervention activities will be monitored during the daily 'hydration round' when there will be an opportunity to meet with participants.
Intervention code [1] 321806 0
Behaviour
Comparator / control treatment
The control ward will be identified by the chief nursing officer. Every worker on the ward will be invited to participate in the study. Participation means that the control ward/group will operate as usual during the research study. Patients and support persons will receive care from healthcare participants and interact with the healthcare them as usual. All participants will fill out a survey at three-time points.

Control group
Active

Outcomes
Primary outcome [1] 329058 0
To determine the impact of an EmpEd on the measured empathy levels of the healthcare staff and ward culture.

We will use the Interpersonal and Social Empathy Index to measure changes in macro perspective-taking, cognitive empathy, self-other awareness, and effective response.
Timepoint [1] 329058 0
Baseline, 8 weeks (primary endpoint) and 24 weeks post-intervention commencement.
Primary outcome [2] 329322 0
To determine the impact of an EmpEd on the measured empathy levels of the healthcare staff and ward culture.

Employee Organisation Satisfaction Scale will measure the emotional culture of the clinical unit in terms of employee satisfaction.

Timepoint [2] 329322 0
Baseline, 8 weeks (primary endpoint) and 24 weeks post-intervention commencement.
Primary outcome [3] 329323 0
To determine the impact of an EmpEd on the measured empathy levels of the healthcare staff and ward culture.

The ProQOL: professional quality of life scale will be used to measure compassion satisfaction, burnout and compassion fatigue /secondary trauma.
Timepoint [3] 329323 0
Baseline, 8 weeks (primary endpoint) and 24 weeks post-intervention commencement.
Secondary outcome [1] 401306 0
To determine the impact of an EmpEd programme on the experience of patients.

The Consultation and Relational Empathy (CARE) will be used to measure empathy in the context of the therapeutic relationship during a one-on-one consultation between a clinician and a patient.

Timepoint [1] 401306 0
Baseline, 8 weeks and 24 weeks post-intervention commencement.
Secondary outcome [2] 401307 0
To determine the impact of an EmpEd programme on the experience of family/whanau

The Adapted Australian Hospital Patient Experience Question Set will be used to measure patient and family/whanau experience.
Timepoint [2] 401307 0
Baseline, 8 weeks and 24 weeks post-intervention commencement.
Secondary outcome [3] 401308 0
To evaluate the quality and delivery of the EmpEd programme and in an exploratory fashion to assess potential factors associated with a drop of empathy levels three months after the completion EmpEd Programme

Qualitative Focus groups to explore participants experiences of the whole intervention programme.

Timepoint [3] 401308 0
Three months after the completion of the EmpEd Programme
Secondary outcome [4] 402139 0
To evaluate the quality and delivery of the EmpEd programme and in an exploratory fashion to assess potential factors associated with a drop of empathy levels three months after completion of the EmpEd Programme

Qualitative feedback box: provides weekly assessment of the programme performance
Timepoint [4] 402139 0
Three months after completion of the EmpEd Programme

Eligibility
Key inclusion criteria
Healthcare team participants inclusion criteria:
• All healthcare staff employed to work in the clinical sites. This includes registered and non-registered staff, such as pharmacists, physiotherapists, occupational therapists, social workers, nurses, doctors, health care assistants, ward clerks, and domestic services staff.
• Give informed consent

Patient participant inclusion criteria:
• Capacity to give informed consent
• Ready for discharge, this is to allow patients to reflect on their experiences and interactions in a non-acute phase of their illness.
• Ability to understand, read and write English.
• Ability to provide consent by completion of the survey.

Family/whanau participant inclusion criteria:
• Capacity to give informed consent
• Have been actively supporting the patient during their admission (i.e., visited patient at least once per week)
• Ability to understand, read and write English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthcare team participants exclusion criteria:
• Working across both the intervention and control wards
• Agency staff working across multiple wards
• Medical students
• Nursing students
• Allied health students

Patient participant exclusion criteria:
• Unable to give informed consent
• Not predicted to be discharged from the ward between the data collection periods
• Under the age of 18 years

Family/whanau participant exclusion criteria:
• Has not been involved in regular support of the patient (i.e. visited less than once a week)
• Unable to give informed consent
• Under the age of 18 years

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive Statistics
Demographic and baseline characteristics will be summarised. In general, for the continuous demographic variables results will be summarised using number of observations, mean, standard deviation, and minimum and maximum values, and for categorical (nominal) variables, the number and percentage of participants will be used. Baseline data will include, total number of participants, mean age (+/- SD and range), gender, ethnicity, level of education, staff’s position on ward, staff’s weekly working hours, years of registration (as applicable), length of hospitalisation for patients, frequency of interaction with the healthcare team for patients and their family/whanau, frequency of visiting patient for family/whanau.

Inferential Statistics
To test our hypotheses, first, between group comparisons of mean scores of the continues scales that assessed level of empathy and level of satisfaction will be conducted using data at each time point from the intervention and the control groups. Three sets of analyses will compare healthcare teams across the intervention group and the control group (1), patients across the intervention group and the control group (2) and visiting family/whanau across the intervention group and the control group (3). Second, within group comparisons of mean scores of the continuous scales will be conducted using data from the three time points.
All statistical analyses will be performed using SPSS and R Statistical softwares.


Power calculations have been done in G*Power Version 3.1.9.4 for Windows for the following survey tools: The Employee Organizational Satisfaction Scale, Interpersonal and Social Empathy Index and the Professional Quality of Life Scale. Each questionnaire will be administered to the two groups (control and intervention) at three-time points, meaning we have nine comparisons to make.
• Compare the groups at each time point
• Within each group, compare outcomes across the three-time points (T1 vs T2, T1 vs T3, and T2 vs T3)
To get a conservative estimate of the required sample size, we estimate that the smallest effect size we need to detect is d = 0.8 and propose to use a Wilcoxon–Mann–Whitney test to detect a difference between the treatment groups as data will not be normally distributed. Applying the Bonferroni correction, the significance level for each test is adjusted to a = 0.05/9 = 0.0056. We estimate that including approximately 55 staff in each treatment group (110 total) will result in at least 80% power to detect a difference in the questionnaire outcomes due to the intervention.

Power calculations have been done in G*Power Version 3.1.9.4 for Windows for the following survey tools: The Consultation and Relational Empathy Measure and the Australian hospital patient experience questionnaire. Initial power calculations suggested that a sample size of 50 per group per time point in each ward (300 participants) would result in a confidence interval limit of ± 0.139 or 13.9% on a result of 0.5 or 50%. However, we expect that it would be difficult to achieve a sample size of >25, therefore, this part of the study will be exploratory.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/05/2021
Date of last participant enrolment
Anticipated
3/12/2021
Actual
Date of last data collection
Anticipated
7/04/2022
Actual
Sample size
Target
410
Accrual to date
248
Final
Recruitment outside Australia
Country [1] 24145 0
New Zealand
State/province [1] 24145 0

Funding & Sponsors
Funding source category [1] 309763 0
University
Name [1] 309763 0
Victoria University of Wellington
Country [1] 309763 0
New Zealand
Primary sponsor type
University
Name
Victoria University Of Wellington
Address
Faculty of Health
Kelburn,
PO Box 600, Wellington 6012
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311029 0
None
Name [1] 311029 0
Address [1] 311029 0
Country [1] 311029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309520 0
Victoria University of Wellington
Ethics committee address [1] 309520 0
Ethics committee country [1] 309520 0
New Zealand
Date submitted for ethics approval [1] 309520 0
11/02/2021
Approval date [1] 309520 0
18/03/2021
Ethics approval number [1] 309520 0
29251

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

Contacts
Principal investigator
Name 114438 0
Dr Helen Rook
Address 114438 0
Wellington Faculty of Health, Victoria University of Wellington
PO Box 600, Wellington 6140, New Zealand
Country 114438 0
New Zealand
Phone 114438 0
+64 44636145
Fax 114438 0
Email 114438 0
Helen.rook@vuw.ac.nz
Contact person for public queries
Name 114439 0
Helen Rook
Address 114439 0
Wellington Faculty of Health, Victoria University of Wellington
PO Box 600, Wellington 6140, New Zealand
Country 114439 0
New Zealand
Phone 114439 0
+64 44636145
Fax 114439 0
Email 114439 0
Helen.rook@vuw.ac.nz
Contact person for scientific queries
Name 114440 0
Helen Rook
Address 114440 0
Wellington Faculty of Health, Victoria University of Wellington
PO Box 600, Wellington 6140, New Zealand
Country 114440 0
New Zealand
Phone 114440 0
+64 44636145
Fax 114440 0
Email 114440 0
Helen.rook@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be aggregated


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
5127ProtocolNohttps://doi.org/10.3390/mps4040089 Hales C, Deak CK, Popoola T, Harris DL, Rook H. Im... [More Details]

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