Clinical trial NCT05514093: Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers
Official title: Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mental Health Issue
Mental Stress
Post-traumatic Stress Disorder
Moral Injury
Keywords: Mental health
Peer support
Mobile health
Healthcare workers
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2022-08-24
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of healthcare workers of all ages and genders (from frontline workers to middle and high-level management) in the participating organizations. Frontline healthcare workers include any staff providing direct patient services (e.g., personal support workers, healthcare aids, nursing. physician, allied health) as well as non-clinical staff (e.g. management, administration).

Brief summary: The purpose of this project is to scale implementation and evaluation of an m-health app designed to promote early intervention and mental health support for frontline healthcare workers to reduce their risk of post-traumatic stress disorder (PTSD) and/or the mental health impact of the COVID-19 pandemic. Beyond Silence has received an additional year of funding to scale implementation across 4-6 additional healthcare organizations.

Detailed description: This project was designed to respond to the urgent and critical need for accessible mental health services and supports for front-line healthcare workers. Innovative solutions are needed to ensure the psychological health and safety of frontline workers and to ensure quality care for the millions of Canadians who relied on their services. This project provides an opportunity to study the implementation and impact of Beyond Silence, a new e-mental health approach to early intervention and peer support that was customized for healthcare workers.

The objectives of this study are to answer both implementation and impact questions:

Implementation:

1. What are the patterns of app use among healthcare workers over a 3-6 month period?
2. What factors influence how the app is utilized among workers in diverse healthcare organizations?

   Impact:
3. Does use of the app increase mental health literacy among healthcare workers?
4. Does the app increase outreach to peer support?
5. Does outreach to peer support in the app reduce the level of distress?

This is a prospective cohort implementation study, studying the implementation and impact of the app over a 3-6 month period in participating healthcare organizations. The Consolidated Framework for Implementation Research (CFIR) informs the exploration of how the app is adopted and the individual and organizational forces that shape adoption. Pre/post impact data are being collected over the implementation period to assess whether the app leads to improved mental health knowledge among workers who use the app (primary outcome), and to increased access to peer support (secondary outcome).

Recruitment for this study is occuring on three levels: (1) organization (2) peer support providers (3) frontline healthcare workers. Eight to ten healthcare organizations across Canada have been recruited into the study, with at least one organizational champion who liaises with the research team. Champions are interviewed to understand the workplace context and create a communication plan. Each organization also nominates at least 4-5 peer support providers who are trained to provide service through the app. Frontline workers are invited to complete a baseline survey, then invited to download the app using an organizational code. Implementation takes place over a 3-6 month period; utilization patterns are tracked over time (aggregate data only). At the end of the trial, champions will be interviewed again to gather their feedback, and peer support providers will be invited to a focus group discussion to reflect on the implementation process. All employees are invited to complete a follow-up survey to gather their input and to track changes in mental health knowledge, mental distress, and help outreach. Implementation and impact data will be analyzed to identify trends within and across organizations.

The investigators are utilizing a multi-pronged approach to data collection via the following:

1. App utilization data including adoption rates across each organization, as well as aggregate data on how often the app was used, average duration of use, the number of times different features were accessed, and how often users accessed links to the different types of peer support.
2. App user impact - impact on app users is tracked through baseline and follow-up surveys to see if there are any statistically significant changes in mental health literacy, symptoms of mental distress (anxiety, depression, PTSD), burn-out, help outreach behaviours, and perceived psychological safety.
3. Peer support provider focus group interviews will be conducted after the implementation period to explore providers' experiences facilitating peer support via the app.
4. Organizational champion interviews will be conducted after the implementation period to explore organizational contextual factors.

Analysis of the collected survey data will examine change scores across the dataset as well as trends, with results disaggregated by gender, caregiver status, work role, organization, job tenure. Linear mixed models will be used to track changes over time in mental health knowledge (primary outcome), distress levels, and self-report of help-seeking/outreach. The model includes a fixed effect for time and random effects for organization types and participants. Age, gender, and caregiver status will be included in the models as covariates. The investigators also will explore potential predictors of outcomes using linear regression models (e.g., app usage, age, gender, education, role in organization - clinical/non-clinical). Additionally, qualitative content analysis will be used to examine focus group and interview data. All focus group and interview data are transcribed with the transcripts then reviewed and used for thematic analysis. Lastly, a cost-benefit analysis will be conducted to examine app implementation costs.

Eligibility criteria: Inclusion Criteria:

* Employees (full-time or part-time) at participating healthcare organizations
* Agree to download the Beyond Silence app to their mobile phone (Apple or Android)

Exclusion Criteria:

* Not able to access app on their smart device

Primary outcomes:
measure: Change from baseline mental health literacy after implementation
timeFrame: Baseline, 3-6 months
Secondary outcomes:
measure: Change from baseline depression after implementation
timeFrame: Baseline, 3-6 months
measure: Change from baseline anxiety after implementation
timeFrame: Baseline, 3-6 months
measure: Change from baseline post-traumatic stress disorder after implementation
timeFrame: Baseline, 3-6 months
measure: Change from baseline burn-out after implementation
timeFrame: Baseline, 3-6 months
measure: Change from baseline perceived psychological health and safety after implementation
timeFrame: Baseline, 3-6 months
measure: Change from baseline help outreach behavior after implementation
timeFrame: Baseline, 3-6 months
measure: Peer support
timeFrame: 3-to-6-month implementation period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: