Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05514093 |
| Other study ID # |
14740 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
October 2023 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
