Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05255419 |
| Other study ID # |
13990 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2022 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
June 2022 |
| Source |
McMaster University |
| Contact |
Sandra E Moll, PhD |
| Phone |
19054672155 |
| Email |
molls[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
First Responders, or Public Safety Personnel (PSP), play a key role in protecting the health
and safety of Canadians, yet this important work can take a toll on their mental health,
leading to an elevated risk of post-traumatic stress injury (PTSI). Mobile health approaches
are a promising tool to facilitate access to confidential on-demand mental health support
both when and where it is needed. There are gaps, however, in evidence to support the use of
m-health apps, particularly in relation to implementation in the PSP community.
The overall purpose of this prospective cohort implementation study is to explore how OnCall,
a new mobile health peer-to-peer support application for Public Safety Personnel (PSP)
affects peer support help-outreach in the workplace. Implementation and impact will be
tracked over 6-month period in a purposive sample of 6-8 different PSP organizations across
Canada. Study findings will inform recommendations for optimizing implementation of the
m-health platform with employees in other PSP organisations.
Description:
Public Safety Personnel (PSP), including, but not limited to correctional workers, emergency
communications, firefighters, paramedics, and police officers have an elevated risk of
post-traumatic stress injury (PTSI) due to the challenging nature of their work.
Unfortunately, they also face barriers to seeking support due to stigma combined with
gendered beliefs regarding perception of weakness, pressure to control emotions and
reluctance to seek help, as well as lack of access to timely, high-quality care, particularly
for those who work in rural or remote areas. Peer support is highly valued, however peer
support services are often fragmented with inconsistencies in training and varied models of
service delivery, and there are almost no systematic evaluations to inform continuous
improvements. Mobile health technology (m-health apps) can be an effective and efficient
approach to reaching large numbers of PSP, regardless of location, and an accessible conduit
to peer (and professional) support. This research study will explore the implementation and
impact of a new m-health platform (OnCall and OnCallSupport) that is customized for public
safety personnel.
There are two sets of research questions guiding this project. The first set relates to
implementation; How do frontline PSP utilize the OnCall support app? How do these patterns of
use change over time? What organizational and social forces shape patterns of app use? The
Consolidated Framework for Implementation Research (CFIR) will be used to guide data
collection and analysis of the app implementation. The second set of questions relate to
impact of the app on service users. Does use of the app increase outreach to peer support?
Does peer support provided in the app reduce levels of mental distress? Does use of the app
affect mental health literacy, symptoms of anxiety, depression and post-traumatic stress
disorder (PTSD), and/or work performance?
Implementation of the app will be studied over a 6 month period with employees in 6-8 PSP
organizations. Organizations will be purposively selected to explore differences in size,
geographical location, and type of service. All participating organizations must have an
established peer support program, with established training and ongoing support for the peer
providers. The organizations must also identify 1-2 organizational champions who will liaise
with the research team, organizational leaders and frontline employees. Peer providers within
the organization will be oriented to the OnCallSupport app, and asked to provide support via
this m-health platform. All employees in each organization will then be invited to download
the OnCall app via tokens provided by the research team. No personal data is collected in the
app, and connections with the peer providers are completely private. Employees will also be
invited to complete baseline, 3 month and 6 month follow-up surveys to track changes in
help-outreach, mental health literacy, symptoms of anxiety, depression and PTSD, as well as
work performance. Employees are able to use the app without participating in the online
surveys.
Data collection will include: a) interviews with champions in each organization at the start
and end of the 6-month trial, b) surveys with app users at baseline, 3-month and 6-months, c)
review of anonymous, aggregate app utilization data, over the trial period and d) focus group
discussions with peer support providers at 1 month and 6 months.
Analysis of the implementation data (interview transcripts with organizational champions,
focus group transcripts with peer support providers, and software analytics re: patterns of
app use) will be informed by the CFIR framework to identify how the outer setting, inner
setting, the intervention, participants and process of implementation affect how employees
respond to the app.
Analysis of the impact data will include evaluation of whether there is a significant change
over time in each of the outcomes (help-outreach, mental health literacy, symptoms of
anxiety, depression, PTSD, work performance). Pre/post data from the baseline, 3- and 6-month
follow-up surveys will be compared to track changes in dimensions of mental health literacy,
levels of mental distress(standardized assessments of anxiety, depression, PTSD), and
frequency of outreach behaviors in seeking mental health support. Data will be compared
across organizations to highlight links between implementation and outcomes. Multiple
hierarchical linear regression analyses will be conducted to examine differences in
effectiveness based on gender, service, job tenure. Demographic variables will be used as
primary step independent variables, with each primary outcome variable set as the dependent
variable for a dedicated regression. The investigators will include a sex and gender-based
analysis (SGBA) since biological sex and socially constructed gender can affect stress
responses, mental health, and help outreach. Gender is particularly important with respect to
peer support needs, engagement with technology, and mental health outcomes. In keeping with
Sex and Gender Equity in Research (SAGER) guidelines, gender will be considered throughout
the design and analysis. In both quantitative and qualitative analyses, gender will be
considered as a potential mediator. For regression modelling, gender will be included as a
covariate, considering interactions between gender and other variables, and where possible
disaggregated modelling will be conducted for men and women to determine if differences
exist.
Analysis from all data sources will be used to generate recommendations for optimizing
implementation and impact at an individual and organization level.
