Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05514093

Collaborator

Public Health Agency of Canada (PHAC) (Other)

50,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issue Mental Stress Post-traumatic Stress Disorder Moral Injury	Device: Beyond Silence app

Detailed Description

This project is 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 rely on their services. This project will provide an opportunity to study the implementation and impact of Beyond Silence, a new e-mental health approach to early intervention and peer support that is customized for healthcare workers.

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

Implementation

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

Impact:

Does use of the app increase mental health literacy among healthcare workers?
Does the app increase outreach to peer support?
Does outreach to peer support in the app reduce level of distress?

This will be a prospective cohort implementation study, studying implementation and impact of the app over a 3-month period in participating healthcare organizations. The Consolidated Framework for Implementation Research (CFIR) will inform exploration of how the app is adopted and the individual and organizational forces that shape adoption. Pre/post impact data will be collected over a 3-month 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 will occur on three levels: (1) organization (2) peer support providers (3) frontline healthcare workers. Eight to ten healthcare organizations across Canada will be recruited into the study, with at least one organizational champion who will liaise with the research team. Champions will be interviewed to understand the workplace context and create a communication plan. Each organization will also nominate at least 4-5 peer support providers who will be trained to provide service through the app. Frontline workers will be invited to complete a baseline survey, then invited to download the app using an organizational code. Implementation will take place over a 3-month period; utilization patterns will be 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 will be invited to complete a follow-up survey to gather their input and to track change 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 will utilize a multi-pronged approach to data collection via the following:

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
App user impact - impact on app users will be tracked through baseline and 3-month 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 behaviors, and perceived psychological safety.
Peer support provider focus group interviews conducted after the three-month implementation period to explore providers' experiences facilitating peer support via the app
Organizational champion interviews conducted after the three-month 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, self-report of help-seeking/outreach. The model will include 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 will also 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 will be transcribed with the transcripts then reviewed and used for thematic analysis. Lastly, a cost-benefit analysis will be conducted to examine app implementation costs.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
App users As this is a single cohort study, there is only one group consisting of the Beyond Silence app users.	Device: Beyond Silence app The Beyond Silence app is designed to be a "mental health coach in your pocket" for healthcare workers. It provides opportunities to build mental health literacy and reduce barriers to seeking support, including access to peer support either within or outside the organization. Other Names: Beyond Silence

Arm

Intervention/Treatment

App users

As this is a single cohort study, there is only one group consisting of the Beyond Silence app users.

Device: Beyond Silence app

The Beyond Silence app is designed to be a "mental health coach in your pocket" for healthcare workers. It provides opportunities to build mental health literacy and reduce barriers to seeking support, including access to peer support either within or outside the organization.

Other Names:

Beyond Silence

Outcome Measures

Primary Outcome Measures

Change from baseline mental health literacy at 3 months [Baseline, 3 months]
The primary outcome is changes in mental health knowledge scores from baseline to 3 months among app users. Mental health literacy regarding how to identify and address mental health issues in the workplace will be rated on a 7-point scale of perceived knowledge.

Secondary Outcome Measures

Change from baseline depression at 3 months [Baseline, 3 months]
Depression will be assessed via the Patient Health Questionnaire-2 (PHQ-2), a brief and valid two item screening tool for the core symptoms depression
Change from baseline anxiety at 3 months [Baseline, 3 months]
Symptoms of anxiety will be measured using the Generalized Anxiety Disorder Assessment-7 (GAD-7), which consists of seven questions answered via a 4-point Likert scale
Change from baseline post-traumatic stress disorder at 3 months [Baseline, 3 months]
To assess PTSD, the PTSD Checklist for Diagnostic and Statistics Manual 5 (PCL-5) will be used, a 20-item standardized self-report measure that assesses the DSM-5 symptoms of PTSD over the past month
Change from baseline burn-out at 3 months [Baseline, 3 months]
To assess mental distress related to burnout, the Maslach Burnout Inventory-2 (MBI-2) will be used. This validated burn-out screening tool consists of two questions answered via a 7-point Likert scale.
Change from baseline perceived psychological health and safety at 3 months [Baseline, 3 months]
Perceived psychological health and safety in the workplace will be assessed via excerpts from StressAssess, a tool based on the Copenhagen validated Canadian survey. We are utilizing 13 questions from this survey, which are answered via variable Likert scale responses.
Change from baseline help outreach behavior at 3 months [Baseline, 3 months]
Participants will be asked whether they have sought help for themselves or a colleague in the past 3 months. If yes, they will be asked to identify the type of help sought.
Peer support [3-month implementation period]
Following use of peer support services, app users will be invited to fill out an in-app survey immediately following the peer support interaction, asking service recipients to rate how they felt before and after the interaction (10-point Likert scale) and to comment on their experience.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)