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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05429619
Other study ID # 14731
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date April 2024

Study information

Verified date April 2024
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective cohort study design will be implemented across four sectors and multiple organizations sites to evaluate implementation and impact of the apps. Pre/post impact data will be collected over a six-month implementation period to assess whether the apps lead to increased Public Safety Personnel outreach to peer support (primary outcome), and to increased mental health literacy, and decreased mental distress (secondary outcomes). Recruitment will take place at three levels; 1) organizations (including knowledge users/organization champions), 2) peer support providers, and 3) public safety personnel employed within each participating organization. Sources of implementation and impact data for the six-month trial will include: 1) app utilization data, 2) knowledge user/organization champion interviews, 3) surveys with public safety personnel, 4) focus groups with peer support providers, and 5) implementation costs. Analysis will focus on both implementation and effectiveness to address the research questions related to the impact of the apps, as well as how the process and context of implementation shapes effectiveness.


Description:

PeerOnCall was developed to support frontline PSP and includes features such as anonymous calling or messaging to a choice of peer support providers, access to self-screening tools, a personal wellness toolbox, and "tips to cope" resources. PeerOnCall Support is designed for peer support providers to provide a secure, private platform for providing support to peers who reach out via text or telephone through the PeerOnCall app. This study will explicitly scale implementation and evaluation of these apps in the context of day-to-day work within a range of PSP organizations across four different service sectors (corrections, emergency communicators, fire services and paramedic services). The implementation period for the app is six-months. Prior to the end of the six-month implementation period, the sector lead will meet with each organization to review app utilization data and to discuss options for continued usage of the app within the organization. The Consolidated Framework for Implementation Research (CFIR) will inform exploration, not only of whether the apps 'work', but also about how the apps are adopted, and the individual and organizational forces that shape adoption. The study will deploy the apps to a purposive sample of approximately 24 organizations across four sectors: 1) correctional workers; 2) emergency communicators (e.g., 911 call takers, dispatchers); 3) fire services; and 4) paramedic services. All participating organizations must have an established internal peer support service (with procedures for vetting, training, and ongoing support of the peer support providers), an organization champion who will liaise between the research team and employees, and support from leadership to participate in the study. The process of recruitment will be facilitated by sector leads and knowledge users who have extensive networks within the sectors. The number of organizations recruited across each sector will be different, recognizing differences in how services are provided, and the need for understanding breadth versus depth of implementation in key stakeholder groups. Within each sector, key knowledge users (at the sector level) and organization champions (at the organization level) will be recruited. The sector-level knowledge users will provide insights into general considerations for implementation and evaluation. In the participating organizations, one or two "champions" will be recruited who will be responsible for organization onboarding, including customizing content, securing participation of in-house peer support providers, and sharing information with co-workers via formal and informal communication channels. Peer support providers within each organization will be recruited to provide services through the app. All trained peer providers within each organization will be invited to participate. Information meetings will be held in each organization for the peer supporters regarding the PeerOnCall Support app. The orientation will ensure that the peer supporteres are aware of how to use the app and the protocols for responding to PSP who reach out for support, including those who may be in crisis. All eligible employees within each organization will be invited to participate in the research via established communication channels within the organization (e.g., recruitment posters distributed via email, social media etc.), and information meetings held in the organization in the month prior to distributing access to the PeerOnCall app. After orientation within the organization, employees will be provided with an organization code to access the PeerOnCall app once it has been downloaded from the Google Play or Apple store. Employees can choose whether to download the app and they are able to use the app without engaging in the baseline and follow-up surveys. To ensure adequate power for evaluating impact of the app, sample size estimates were based on the primary outcome of interest: the frequency of outreach to peer support through the app (count of the number of times contact was initiated by PeerOnCall users via phone and/or text). The sample size was calculated using a one-sided Poisson test since the frequency of outreach via the app can only increase from no outreach at baseline. Assuming 90% power, a significance level of 0.025 for a one-sided test, a hypothesized rate of 0.2 (20% increase in rates of outreach) and alternative hypothesis rate of 0.1 (thus a difference of 0.1), 161 participants will be required. Considering an estimated 20% drop out rate, 202 participants will be needed. Aggregate data collected will include participant adoptions rates across each organization (e.g., the number of times the app was downloaded) as well as aggregate data on how often the app was used, average durations of use, the number of times different features were accessed, and the number and duration of contacts with peer supporters. Knowledge user/Organization Champion Interviews will be conducted at baseline, three-months and six-months after app implementation begins at each participating organization to explore the context for implementation. Interview questions will be congruent with the Consolidated Framework for Implementation Research. These data will be used to identify facilitators and barriers to app use and inform interpretation of the adoption rates and outcome data both within and across participating organizations. To track immediate feedback about the peer support service, a 'pop-up' feedback survey is presented to users within the application following each peer support encounter asking for a rating of their level of distress before and after the interaction using a 10-point Visual Analogue Scale. There is also an option to provide comments about the encounter. Data from the feedback surveys will help understand the immediate impact of peer support on level of distress. To evaluate user impact over time, employees in each organization will be invited to complete baseline, three-month, and six-month follow-up surveys via a link to complete a survey. Focus groups will be scheduled at three-months and six months after the implementation period with PeerOnCall Support peer support providers to explore their experiences with providing peer support through the app. Three sets of focus groups will be conducted within each sector with six to eight participants in each group. Data regarding implementation costs within each organization will include: the organization champion's time invested on onboarding and communication, administrative time for uploading users and responding to requests, and metrics regarding peer support service provision. The cost of server hosting, troubleshooting, and regular upgrades to the apps will also be tracked across sites. Implementation within each organization will be tracked via descriptive data regarding adoption rates (proportion of employees who download & use the app), and usage rates over time, including the number of times users reach out for peer support via phone/text, and the number of repeated calls. To evaluate effectiveness, analysis of the pre/post survey data will examine the change in scores across the dataset in dimensions of mental health literacy, levels of mental distress (standardized assessments of anxiety, depression, and Post Traumatic Stress Disorder), and frequency of outreach behaviors in seeking mental health support. Multiple hierarchical linear regression analyses will be conducted to examine differences in effectiveness based on gender, service, and job tenure. Effectiveness of the peer support service will also be evaluated by comparing change scores in level of distress before and after each peer support encounter via the in-app surveys. Identification of barriers and facilitators to adoption of the technology and peer support service will occur through qualitative content analysis of the interview transcripts with the organizational champions and focus groups with the peer supporters. The CFIR framework will guide the analysis process considering organization internal and external forces, as well as how communication strategies influence implementation, and consistency in providing the peer support service. All the data from the evaluation process will be reviewed to generate recommendations for optimizing uptake and impact of the app across different types of organizations.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 950
Est. completion date April 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Public Safety Personnel working in fire services, paramedic services, emergency communications and correctional services - Employed (full or part-time) by the participating organizations - Agree to download the PeerOnCall app on their mobile phone (Android or Apple) Exclusion Criteria: - Not able to access the app on their mobile health device

Study Design


Intervention

Other:
PeerOnCall
A mobile health peer-to-peer support platform that consists of two inter-connected apps: PeerOnCall and PeerOnCall Support. The apps were co-designed by and for the public safety community in Canada, with customized content for correctional workers, emergency communicators, firefighters, paramedics and police.

Locations

Country Name City State
Canada Western University London Ontario
Canada Memorial University of Newfoundland Saint John's Newfoundland and Labrador
Canada Wilfrid Laurier University Waterloo Ontario

Sponsors (8)

Lead Sponsor Collaborator
McMaster University Canadian Institute for Public Safety Research and Treatment, Fisheries and Marine Institute of Memorial University of Newfoundland, Memorial University of Newfoundland, Public Health Agency of Canada (PHAC), University of Regina, Western University, Wilfrid Laurier University

Country where clinical trial is conducted

Canada, 

References & Publications (35)

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Anderson GS, Di Nota PM, Groll D, Carleton RN. Peer Support and Crisis-Focused Psychological Interventions Designed to Mitigate Post-Traumatic Stress Injuries among Public Safety and Frontline Healthcare Personnel: A Systematic Review. Int J Environ Res Public Health. 2020 Oct 20;17(20):7645. doi: 10.3390/ijerph17207645. — View Citation

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Carleton RN, Afifi TO, Taillieu T, Turner S, Mason JE, Ricciardelli R, McCreary DR, Vaughan AD, Anderson GS, Krakauer RL, Donnelly EA, Camp RD 2nd, Groll D, Cramm HA, MacPhee RS, Griffiths CT. Assessing the Relative Impact of Diverse Stressors among Public Safety Personnel. Int J Environ Res Public Health. 2020 Feb 14;17(4):1234. doi: 10.3390/ijerph17041234. — View Citation

Carleton RN, Afifi TO, Turner S, Taillieu T, Duranceau S, LeBouthillier DM, Sareen J, Ricciardelli R, MacPhee RS, Groll D, Hozempa K, Brunet A, Weekes JR, Griffiths CT, Abrams KJ, Jones NA, Beshai S, Cramm HA, Dobson KS, Hatcher S, Keane TM, Stewart SH, Asmundson GJG. Mental Disorder Symptoms among Public Safety Personnel in Canada. Can J Psychiatry. 2018 Jan;63(1):54-64. doi: 10.1177/0706743717723825. Epub 2017 Aug 28. — View Citation

Carleton RN, Afifi TO, Turner S, Taillieu T, Vaughan AD, Anderson GS, Ricciardelli R, MacPhee RS, Cramm HA, Czarnuch S, Hozempa K, Camp RD. Mental health training, attitudes toward support, and screening positive for mental disorders. Cogn Behav Ther. 2020 Jan;49(1):55-73. doi: 10.1080/16506073.2019.1575900. Epub 2019 Feb 22. — View Citation

Carleton, R. N., Afifi, T.O., Turner, S., Taillieu, T., LeBouthiller, D.M., Duranceau, S., Sareen, J., Ricciardelli, R., MacPhee, Krakauer, R., Anderson, G. S., Cramm, H. A., Groll, D., & McCreary, D. R. (2019). Exposures to potentially traumatic events among public safety personnel in Canada. Canadian Journal of Behavioural Science / Revue canadienne des sciences du comportement, 51(1), 37-52. Doi: 10.1037/cbs0000115

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Keith RE, Crosson JC, O'Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci. 2017 Feb 10;12(1):15. doi: 10.1186/s13012-017-0550-7. — View Citation

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Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Levis B, Sun Y, He C, Wu Y, Krishnan A, Bhandari PM, Neupane D, Imran M, Brehaut E, Negeri Z, Fischer FH, Benedetti A, Thombs BD; Depression Screening Data (DEPRESSD) PHQ Collaboration; Che L, Levis A, Riehm K, Saadat N, Azar M, Rice D, Boruff J, Kloda L, Cuijpers P, Gilbody S, Ioannidis J, McMillan D, Patten S, Shrier I, Ziegelstein R, Moore A, Akena D, Amtmann D, Arroll B, Ayalon L, Baradaran H, Beraldi A, Bernstein C, Bhana A, Bombardier C, Buji RI, Butterworth P, Carter G, Chagas M, Chan J, Chan LF, Chibanda D, Cholera R, Clover K, Conway A, Conwell Y, Daray F, de Man-van Ginkel J, Delgadillo J, Diez-Quevedo C, Fann J, Field S, Fisher J, Fung D, Garman E, Gelaye B, Gholizadeh L, Gibson L, Goodyear-Smith F, Green E, Greeno C, Hall B, Hampel P, Hantsoo L, Haroz E, Harter M, Hegerl U, Hides L, Hobfoll S, Honikman S, Hudson M, Hyphantis T, Inagaki M, Ismail K, Jeon HJ, Jette N, Khamseh M, Kiely K, Kohler S, Kohrt B, Kwan Y, Lamers F, Asuncion Lara M, Levin-Aspenson H, Lino V, Liu SI, Lotrakul M, Loureiro S, Lowe B, Luitel N, Lund C, Marrie RA, Marsh L, Marx B, McGuire A, Mohd Sidik S, Munhoz T, Muramatsu K, Nakku J, Navarrete L, Osorio F, Patel V, Pence B, Persoons P, Petersen I, Picardi A, Pugh S, Quinn T, Rancans E, Rathod S, Reuter K, Roch S, Rooney A, Rowe H, Santos I, Schram M, Shaaban J, Shinn E, Sidebottom A, Simning A, Spangenberg L, Stafford L, Sung S, Suzuki K, Swartz R, Tan PLL, Taylor-Rowan M, Tran T, Turner A, van der Feltz-Cornelis C, van Heyningen T, van Weert H, Wagner L, Li Wang J, White J, Winkley K, Wynter K, Yamada M, Zhi Zeng Q, Zhang Y. Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis. JAMA. 2020 Jun 9;323(22):2290-2300. doi: 10.1001/jama.2020.6504. — View Citation

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Moll S, Zanhour M, Patten SB, Stuart H, MacDermid J. Evaluating Mental Health Literacy in the Workplace: Development and Psychometric Properties of a Vignette-Based Tool. J Occup Rehabil. 2017 Dec;27(4):601-611. doi: 10.1007/s10926-017-9695-0. — View Citation

Moll SE, Patten S, Stuart H, MacDermid JC, Kirsh B. Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees. Can J Psychiatry. 2018 Dec;63(12):826-833. doi: 10.1177/0706743718766051. Epub 2018 Apr 19. — View Citation

Norman M, Ricciardelli R. Operational and organisational stressors in community correctional work: Insights from probation and parole officers in Ontario, Canada. Probat J. 2022 Mar;69(1):86-106. doi: 10.1177/0264550520984253. Epub 2021 Feb 3. — View Citation

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Ramkissoon A, Smith P, Oudyk J. Dissecting the effect of workplace exposures on workers' rating of psychological health and safety. Am J Ind Med. 2019 May;62(5):412-421. doi: 10.1002/ajim.22964. Epub 2019 Mar 27. — View Citation

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* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Digital literacy Rating of knowledge and comfort level in using apps. Ratings from low to high levels of digital literacy. Hypothesis is that lower digital literacy will predict lower app use. The baseline scale provides descriptive data about levels of digital literacy across the organization. The follow-up scale provides descriptive data about perceived digital literacy. Baseline, 3 months, 6 months
Other Frequency of app use Report of how often the app was used over the past 4 weeks, ranging from not at all to more than once a day. This data can be used to note dose/response (I.e., Higher app use might lead to greater impact) and to track app user over time. 3 months, 6 months
Other Timing of app use Descriptive data of when the app is used the most. Can be used to report trends within/across sectors and organizations. This can also be used to cross-check with/against app utilization metrics. 3 months, 6 months
Other Rating of app Users are asked to rate the value of 8 different features of the app on a 5-point Likert scale from very poor to excellent. Plus, an overall rating of the likelihood of continued use of the app on a 5-point Likert scale from definitely not to definitely. 3 months, 6 months
Primary Accessing peer support via phone or text via the PeerOnCall app (Frequency count) Number of times PeerOnCall users within an organization create a connection with peer support providers via the app platform (Software analytics) Monthly intervals from 1 to 6 months.
Secondary Change in Mental Health Literacy (6 items, 7-point Likert scale rating) Rating using a 7-point Likert scale of perceived improvement in dimensions of mental health literacy (Promote mental health, knowledge of how to identify and address mental health issues in self and others, how to identify relevant resources). Range 7-42 with higher scores indicating higher levels of perceived literacy. Baseline, 3 months, 6 months
Secondary Changes in symptoms of anxiety (GAD-7 screening tool) The Generalised Anxiety Disorder (GAD-7) scale is a 7-item tool to evaluate anxiety symptoms over the past two weeks (4-point Likert scale ratings). Scores ranges from 0-21 with a score of 10 or more indicative of potential generalized anxiety disorder. Baseline, 3 months, 6 months
Secondary Change in symptoms of depression (PHQ-9 screening tool) The Patient Health Questionnaire (PHQ-9) is a 9-item screening tool for depression. Scores range from 0-27, with a score of 10 or more indicative of major depression. Baseline, 3 months, 6 months
Secondary Change in symptoms of trauma (PTSD Checklist, PCL-5 short version) The short version of the Post-Traumatic Stress Disorder Checklist (PCL-5) is a four-item PTSD screening checklist exploring responses to a stressful experience in terms of symptoms over the past month. Scores range from 0-16 with higher scores indicating more severe impairment. Baseline, 3 months, 6 months
Secondary Change in help-seeking behaviour Rating of how likely to reach out for support related to four different types of support (In-person peer support, app-based peer support, professional support, and employee assistance program). Ratings on a 5-point scale from not at all likely to extremely likely. Baseline, 3 months, 6 months
Secondary Perceived value of the app Questions about perceived impact adapted from the Mobile Rating Application Rating Scale (MARS) asks users to rate (on a 5-point Likert scale) the perceived value of the app on 7 items (Awareness of the importance of addressing mental health, reaching out for help and impact on mental health, perceived support, and ability to cope at work). 3 months, 6 months
Secondary Change in perceived level of stress Rating of current level of stress on a 7-point Likert scale from very low to very high. Baseline, 3 months, 6 months
Secondary Change in perceptions of workplace psychological health and safety climate Rating of psychological health and safety climate in the workplace on a 7-point Likert scale from toxic to excellent. Baseline, 3 months, 6 months
Secondary Change in current mental health challenges Rating of current mental health challenges on a 100-point Visual Analogue scale from ill to healthy. Baseline, 3 months, 6 months
Secondary Impact on work Questions about the number of hours users were scheduled/expected to work and the number of hours of work users missed because of the way they were feeling over the past 2 weeks. Baseline, 3 months, 6 months
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