Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000773538p
Ethics application status
Submitted, not yet approved
Date submitted
12/06/2024
Date registered
25/06/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Endometriosis at Work program
Scientific title
Endometriosis at Work: An evaluative intervention study to support employees to manage their endometriosis at work
Secondary ID [1] 312296 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 334087 0
Health related quality of life 334089 0
Condition category
Condition code
Public Health 330767 330767 0 0
Health promotion/education
Reproductive Health and Childbirth 330829 330829 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is implementing endometriosis guidelines at a national Australian workplace (600+ employees). The endometriosis guidelines involves two phases. Phase 1 is the adoption of endometriosis policy into existing HR systems (1 month). Phase 2 is comprised of a mandatory online course (approximately 1 – 2 hours) delivered via learning management system (LMS) and open to self-complete a 4-week period. Outcomes will be measured at baseline, 3, 6 and 12-months post LMS rollout.

Phase 1:
The endometriosis policy was codesigned by the research team, employed Australians with a diagnosis of endometriosis and individuals employed as managers, supervisors, senior leaders and human resources (HR). The policy consists of accommodations under education/awareness training of endometriosis, access to suitable working environments for those with endometriosis (such as access to adequate toilets, quiet break rooms, access to cold drinking water, etc), flexible working arrangements (such as, flexible start and endo times, flexibility around breaks, and ability to work-from-home if required). Lastly, the policy recommends the inclusion of surgery leave, which consists of a minimum of 5 days per calendar year (pro-rata, non-cumulative). Over the course of one month, the research team will work with the workplace’s HR to integrate the endometriosis policy into the existing HR system. This will be done by presenting the HR team with the co-designed endometriosis policy, and the HR team getting the appropriate senior leadership sign-offs to formally introduce the policy into their workplace. This timeframe also gives enough time for the HR team to input endometriosis leave and flexible working options into their online HR systems, so employees can log-in to their online HR system and request leave or notify of flexible working schedule under this HR system. E.g. an employee can log-in and request surgery leave under the endometriosis policy in their online HR system.

Phase 2:
Following completion of the baseline questionnaire, participants will engage with an online education course via online platform (learning management system or LMS). The LMS consists of five modules: (1) Welcome; (2) About Endo and EndoAware; (3) Supportive Workplaces; (4) Managers and Supervisors; (5) EndoChampions; to educate workplaces in best-practice to support employees with endometriosis. The education and downloadable resources within each module is based on thoroughly researched evidence-based practices from Western Sydney University.

Below is a summary of content in each training module
(1)Welcome: (2-3 minutes to complete)
Comprised of one 2 minute video introducing the program, its purpose, the research informing the program. As well as a quick run through of the course work, which is comprised of videos, photos, educational text, interactive activities,such as quizzes, and downloadable resources. All courses and quizzes must be completed, and you must pass each quiz by a score of 75% in order to gain a certificate of completion for each module and get signed-off as completing the course.

(2) About Endo and EndoAware: (approx. 25 mins)
Comprised of videos, photos, educational text and interactive ac interactive activities,such as quizzes, and downloadable resources. This section will cover the following topics: What is endometriosis, breaking down the definition of endometriosis, its prevalence in society, and the common symptoms experienced by individuals; Next, we'll move on to explore how Endometriosis impacts a person's work and career. Here, we'll provide an overview of the challenges individuals with endometriosis may face in the workplace and discuss how initiatives like EndoAware can make a difference. Finally, we'll wrap up Module 2 with a quiz to reinforce your understanding of the material covered.

(3) Supportive Workplaces: (approx. 35 minutes)
Comprised of videos, photos, educational text and interactive ac interactive activities,such as quizzes, and downloadable resources. This section is Module 3: Supporting People with Endometriosis at Work. In this module, we're going to explore how we can create a more inclusive and supportive workplace for individuals dealing with endometriosis. First, we'll start with 3.1: Addressing Discrimination. Here, we'll discuss the types of discrimination that people with endometriosis might face in the workplace and how we can actively work to prevent and address these issues. Next, in 3.2: Challenging Our Assumptions of the ‘Perfect Employee’, we'll examine the often unrealistic standards we hold and how these assumptions can negatively impact those with chronic illnesses like endometriosis. We’ll learn why it’s important to redefine what makes a valuable and effective employee. Moving on to 3.3: Rethinking Flexibility and Support in the Workplace, this section will focus on new ways to think about flexibility and support. Specifically, we'll outline the key features and benefits of the Endo Aware program and endometriosis policy. In 3.4: What Is a Supportive Workplace, we’ll cover the characteristics of a truly supportive workplace and how to foster an environment where all employees, especially those with endometriosis, can thrive. Finally, we’ll wrap up with the Module 3 Quiz to test your understanding and reinforce the key points from this module. Following that, we will provide a step-by-step guide on how employees and managers can utilize this policy effectively.

(4) Managers and Supervisors: (approx. 25 mins)
Comprised of videos, photos, educational text and interactive ac interactive activities, such as quizzes, and downloadable resources. Module 4 is Managerial and Senior Leadership Support. This module focuses on how managers and supervisors should and can support staff dealing with endometriosis. We'll begin with 4.1: Why Senior Leadership Buy-In Is So Important. In this section, we'll discuss the critical role that senior leadership plays in fostering a supportive environment and consistent policy implementation. We'll cover why your commitment and understanding are essential for the success of any supportive policy. Next, in 4.2: What to Do When a Member of Your Staff Talks to You About Their Endometriosis, we'll provide practical guidance on how to respond effectively and empathetically. You'll learn the steps to take to ensure your staff member feels heard and supported, and how to implement the appropriate accommodations. Then, we’ll move on to 4.3: Review: Key Factors to Ensuring Your Staff Feel Supported. This section will recap the essential elements that contribute to a supportive workplace environment, emphasizing the practices and attitudes that help your team thrive. Finally, we'll wrap up with the Module 4 Quiz. This quiz will help reinforce the key points and ensure you’re prepared to apply what you've learned in real-world situations.


(5) EndoChampions: (approx. 40 mins)
Comprised of videos, photos, educational text and interactive ac interactive activities, such as quizzes, and downloadable resources. Module 5 is dedicated to the important role of being an EndoChampion in your workplace. We'll start with 5.1: Overview. This section will introduce you to the concept of an EndoChampion and outline the impact you can have in supporting colleagues with endometriosis. Next, in 5.2: Details of Your Role and Responsibility, we'll delve into what it means to be an EndoChampion. You'll learn about the specific duties and expectations associated with this role, and how you can effectively advocate for and support your colleagues. Moving on to 5.3: Get Ready for Your EndoChampion Role, we'll prepare you for the journey ahead. This section will provide practical tips and strategies to help you hit the ground running as an EndoChampion. Then, we'll cover the 5.4: EndoChampion Activity Checklist. This checklist will be a handy tool to ensure you're meeting all the necessary requirements and making the most out of your role. In 5.5: What to Do When an Employee Discloses They Have Endometriosis, we'll guide you through the appropriate steps to take when an employee opens up about their condition. You'll learn how to handle these disclosures with sensitivity and confidentiality. Along with facilitating their one-on-one EndoAware plan. Next, we'll discuss 5.6: Tips for Facilitating Difficult Conversations. This section will equip you with the skills to navigate and support challenging discussions, ensuring they are productive and compassionate. Finally, in 5.7: Additional Resources for EndoChampions, we'll provide you with further reading, tools, and support networks that can enhance your ability to serve as an effective EndoChampion. And to wrap it all up, there will be the Module 5 Quiz. This quiz will help reinforce what you've learned and ensure you're ready to apply these insights in your role

The approximate time it should take to complete the 5 modules is approximately 2 – 2.5 hours.

The educational videos in each module are designed to incorporate a collection of stories gathered from a series of focus groups lead by researchers at Western Sydney University which took place 2022 – 2023. These groups comprised individuals diagnosed with endometriosis who are working in Australia, as well as partners, friends, employers, supervisors, and managers with experience supporting someone with endometriosis. While each story is based on real experiences, they have been combined into a single narrative for educational purposes.

The LMS is mandatory for all staff to complete. Staff will be given a link to access course online, and will have four weeks to complete the online course at their own pace. Online module completion rates will be recorded through the online LMS system to monitor adherence to the intervention.
Intervention code [1] 328811 0
Treatment: Other
Intervention code [2] 328812 0
Behaviour
Comparator / control treatment
The control group consists of people who do not have a diagnosis of endometriosis and employed at target workplace. Through purposeful sampling across the workplace, Researchers will acquire 30 employees matching respondents who have a confirmed diagnosis of endometriosis (Group 1) for age and gender.
Control group
Active

Outcomes
Primary outcome [1] 338524 0
Endometriosis health profile in employees diagnosed with endometriosis.
Timepoint [1] 338524 0
Baseline and follow-up at 3 (primary timepoint), 6, 12-month post-LMS completion.
Primary outcome [2] 338525 0
Workplace performance in employees diagnosed with endometriosis.
Timepoint [2] 338525 0
Baseline and follow-up at 3 (primary timepoint), 6, 12-month post-LMS completion.
Primary outcome [3] 338597 0
Job Satisfaction which correlates to employee retention, absenteeism and presenteeism.
Timepoint [3] 338597 0
Baseline and follow-up at 3 (primary timepoint), 6, 12-month post-LMS completion.
Secondary outcome [1] 436275 0
Perceived changes in managerial support.
Timepoint [1] 436275 0
Baseline and follow-up at 3, 6, 12-month post-LMS completion.
Secondary outcome [2] 436276 0
Perceived changes in workplace culture
Timepoint [2] 436276 0
Baseline and follow-up at 3, 6, 12-month post-LMS completion.

Eligibility
Key inclusion criteria
Group 1: Employees with a diagnosis of endometriosis.
Diagnosis of Endometriosis from a medical professional
Currently living in Australia
Currently employed at target workplace (across Professional, Sales, and Clerical and administration staff)
Inclusive of all employment contracts (casual, ongoing, part-time, fulltime)
Must have worked at target workplace for a minimum of 3 months

Group 2: Control
No diagnosis of Endometriosis from a medical professional
Currently living in Australia
Currently employed at target workplace (across Professional, Sales, and Clerical and administration staff)
Inclusive of all employment contracts (casual, ongoing, part-time, fulltime)
Must have worked at target workplace for a minimum of 3 months
Employees with a chronic health condition other than endometriosis may still participate, however their responses will be stratified (and therefore controlled for) during analysis.

Group 3: Managers/Supervisors
Managers, line managers, supervisors with insight into organisational processes, trends, and staff needs; diverse employment sector representation.
Managers/Supervisors with a diagnosis of endometriosis may still participate, however their responses will be stratified (and therefore controlled for) during analysis.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1: Employees with a diagnosis of endometriosis.
Staff who have worked at SCA less than 3 months.

Group 2: Control
Staff who have worked at SCA less than 3 months.

Group 3: Managers/Supervisors
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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316685 0
University
Name [1] 316685 0
Western Sydney University
Country [1] 316685 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 318876 0
None
Name [1] 318876 0
Address [1] 318876 0
Country [1] 318876 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315462 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 315462 0
Ethics committee country [1] 315462 0
Australia
Date submitted for ethics approval [1] 315462 0
04/05/2024
Approval date [1] 315462 0
Ethics approval number [1] 315462 0

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

Contacts
Principal investigator
Name 134778 0
Miss Danielle Howe
Address 134778 0
NICM Health Research Institute, Western Sydney University, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134778 0
Australia
Phone 134778 0
+61 2 9685 4749
Fax 134778 0
Email 134778 0
[email protected]
Contact person for public queries
Name 134779 0
Danielle Howe
Address 134779 0
NICM Health Research Institute, Western Sydney University, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134779 0
Australia
Phone 134779 0
+61 2 9685 4749
Fax 134779 0
Email 134779 0
[email protected]
Contact person for scientific queries
Name 134780 0
Danielle Howe
Address 134780 0
NICM Health Research Institute, Western Sydney University, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134780 0
Australia
Phone 134780 0
+61 2 9685 4749
Fax 134780 0
Email 134780 0
[email protected]

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


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.