Clinical trial NCT05255419: "OnCall": Implementation Study of M-Health for Canadian Public Safety Personnel
Official title: "OnCall": Implementing a Mobile Health Approach to Post-traumatic Stress Injury (PTSI) Prevention and Peer Support for Canadian Public Safety Personnel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Issue
Mental Stress
Post Traumatic Stress Disorder
Keywords: peer support
mobile health
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Movember Foundation
First posted: 2022-02-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals employed by participating Public Safety Organizations (corrections, EMS, police, emergency communications, fire)

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Public Safety providers (police, fire, paramedics, corrections, emergency communications)
* Employed (full or part-time) by the participating organizations
* Agree to download the OnCall app on their mobile phone (Android or Apple)

Exclusion Criteria:

* Not able to access app on their mobile health device

Primary outcomes:
measure: Accessing peer support via phone or text via the OnCall app (frequency count)
timeFrame: Monthly intervals from 1 to 6 months
Secondary outcomes:
measure: Change in Mental health literacy (7-point Likert scale rating)
timeFrame: baseline, 3 months, 6 months
measure: Change in level of distress (Visual analogue scale)
timeFrame: Immediately following a peer support call or text exchange via the app
measure: Changes in symptoms of anxiety (GAD-2 screening tool)
timeFrame: baseline, 3 months, 6 months
measure: Change in symptoms of depression (PHQ-2 screening tool)
timeFrame: baseline, 3 months, 6 months
measure: Change in symptoms of trauma (PTSD Checklist - PCL-5)
timeFrame: baseline, 3 months, 6 months
measure: Change in functioning at work (Lam Employment Absence and Productivity Scale -LEAPS)
timeFrame: baseline, 3 months, 6 months
measure: Satisfaction with app (via adapted Mobile Application Rating Scale)
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Sandra E Moll, PhD
role: PRINCIPAL_INVESTIGATOR
References: