The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Phase: NA
Conditions: Intentional Self-Harm, Suicide
Sponsor: University of Ottawa

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Study Protocol 
 
Protocol Name: 
The BEACON Study: Protocol for a cluster randomized controlled trial of a 
service to deliver smartphone-assisted problem solving therapy compared to 
usual care in men who present with intentional self-harm to Emergency 
Departments in Ontario 
Clinical Trial Type: 
Non-Regulated Investigational Clinical Trial 
REB Reference Number 
Pending 
Funder 
Ontario SPOR Support Unit (OSSU) 
Sponsor 
Ottawa Hospital Research Institute (OHRI) 
Study Status 
Active, not yet recruiting 
Principal Investigator 
Dr. Simon Hatcher 
Co-Principal Investigator 
Dr. Marnin Heisel  
Members of Steering 
Committee 
1. Dr. Simon Hatcher 
2. Dr. Marnin Heisel 
3. Dr. Paul Links 
4. Dr. Chris Mushquash 
5. Dr. Sidney Kennedy 
6. Dr. Susan Finch 
7. Dr. Ayal Schaffer 
8. Dr. Mark Sinyor 
9. Dr. Monica Taljaard 
10. Dr. David Koczerginski 
Date of Trial Initiation 
(dd-mmm-yyyy) 
 
  

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PROTOCOL SIGNATURE PAGE 
 
The clinical study as detailed within this research protocol (Version 1, dated 24-Feb-2017 or any 
subsequent amendments will be conducted in accordance with the Tri-Council Policy Statement: 
Ethical Conduct for Research Involving Humans (TCPS 2) and Good Clinical Practice (GCP), an 
international ethical and scientific quality standard for designing, conducting, recording and reporting 
trials that involve the participation of human subjects. 
 
Principal Investigator Name: Dr. Simon Hatcher 
Co-Principal Investigator Name: Dr. Marnin Heisel 
 
Coordinating Site:            Ottawa Hospital Research Institute 
Contact details:  Tel No: (613) 798-5555, ext. 73011 
 
 
 
Email: shatcher@uottawa.ca  
 
 
 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
 
Site Co-Principal Investigator Name: 
 
Site Name: [XXXXXXXXXXXXXXXXXX] 
Contact details:  Tel No: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Email: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Fax: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 
Site Co-Principal Investigator Name: 
 
Site Name: [XXXXXXXXXXXXXXXXXX] 
Contact details:  Tel No: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Email: [XXXXXXXXXXXXXXXXXX] 
 
 
 
Fax: [XXXXXXXXXXXXXXXXXX 
 
Signature 
 
Date 
(dd-mmm-yyyy) 
 

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World Health Organization Trial Registration Data Set Items 
 
DATA CATEGORY 
INFORMATION 
Primary registry and trial identifying number ClinicalTrials.gov 
Pending 
Date of registration in primary registry 
Pending 
Source(s) of monetary or material support 
Ontario SPOR Support Unit (OSSU) 
Primary sponsor 
Ottawa Hospital Research Institute 
Contact for public queries 
Dr. Simon Hatcher, MD 
Ottawa Hospital Research Institute, Ottawa, ON  
Tel: (613) 798-5555, ext. 73011 
Email: shatcher@uottawa.ca  
Contact for scientific queries 
Dr. Simon Hatcher, MD 
Ottawa Hospital Research Institute, Ottawa, ON  
Tel: (613) 798-5555, ext. 73011 
Email: shatcher@uottawa.ca 
Public title 
The BEACON Study 
Scientific title 
Protocol for a cluster RCT of a service to deliver 
smartphone assisted PST compared to usual care in 
men who present with intentional self-harm to 
Emergency Departments in Ontario: The 
BEACON Study 
Countries of recruitment 
Canada 
Health condition(s) or problem(s) studied 
Self-harm 
Intervention(s) 
Intervention: smartphone-assisted Problem-Solving 
Therapy (PST) 

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DATA CATEGORY 
INFORMATION 
 
Control: standard clinical care  
Key inclusion and exclusion criteria 
Ages eligible for study: ≥18 years 
Sexes eligible for study: Male 
Accepts healthy volunteers: No 
Inclusion criteria: adult patient (≥ 18 years); patient 
identifies as male, patient presents to Emergency 
Department for an index episode of intentional 
self-harm at an eligible Emergency Departments in 
Ontario, Canada.  
 
Exclusion criteria: patient presents to an eligible 
Emergency Department for a reason other than 
intentional self-harm.  
Study type 
Interventional 
Allocation: randomized, unbalanced 
Intervention model: parallel assignment 
Masking: none 
Primary purpose: prevention 
 
Date of first enrolment 
Pending 
Target sample size 
25 hospitals; anticipated total sample size of 
approximately 2,000 men  
Recruitment status 
Active, not yet recruiting 
Primary outcome(s) 
Composite measure of suicides and/or proportion 
of re-presentations to any Emergency Department 
in Ontario for intentional self-harm 
Key secondary outcomes 
Within one year of enrollment:  
 Number of suicides; 
 Proportion of self-harm re-presentations to any 

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DATA CATEGORY 
INFORMATION 
Emergency Department in Ontario; 
 Proportion of re-presentations for any reason to 
any Emergency Department in Ontario; 
 Proportion of hospital admissions for any 
reason to any hospital in Ontario; 
 Length of stay at any hospital in Ontario for 
any reason; 
 Proportion of hospital outpatient appointments 
for any reason at any hospital in Ontario; 
 Number of deaths (mortality rate), for reasons 
other than suicide and undetermined deaths; 
 Proportion of primary care visits, defined as 
any visit to a general practitioner; 
 Total health care costs for the treatment of self-
harm; 
 Physician costs for the treatment of self-harm; 
 Emergency Department costs for the treatment 
of self-harm; 
 Hospitalization costs for the treatment of self-
harm; 
 Other costs related to the treatment of self-
harm. 
 

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Table of Contents 
1. 
FUNDING.......................................................................................................................... 8 
2. 
ROLES AND RESPONSIBILITIES ................................................................................. 8 
2.1. Contributorship ............................................................................................................... 8 
2.1.1. 
Author’s Contributions ........................................................................................ 9 
2.1.2. 
Sponsor contact information ................................................................................ 9 
2.2. Committees ..................................................................................................................... 9 
2.2.1. 
Principal Investigator and co-Principal Investigator: .......................................... 9 
2.2.2. 
Steering Committee (refer to title page for membership) .................................... 9 
2.2.3. 
Trial Management Committee (TMC) ............................................................... 10 
2.2.4. 
Data and Safety Monitoring Committee (DSMC) ............................................. 10 
2.2.5. 
Lead Investigators .............................................................................................. 10 
3. 
INTRODUCTION ........................................................................................................... 11 
3.1. Background and Rationale ............................................................................................ 11 
3.1.1. 
Why is Intentional Self-Harm an Important Problem? ...................................... 11 
3.1.2. 
Summary of Relevant Studies of Blended Therapy in the Treatment of Self-
Harm 
13 
3.1.3. 
Assessment, Care and Discharge from the Emergency Department ................. 14 
3.2. Explanation for Choice of Comparators ....................................................................... 15 
3.3. Objectives and Hypotheses ........................................................................................... 15 
3.3.1. 
Primary Hypotheses and Objective .................................................................... 15 
3.3.2. 
Secondary Hypotheses and Objectives .............................................................. 16 
3.4. Trial Design .................................................................................................................. 16 
4. 
METHODS ...................................................................................................................... 16 
4.1. Participants, Interventions and Outcomes ..................................................................... 16 
4.1.1. 
Study Setting ...................................................................................................... 16 
4.1.2. 
Eligibility Criteria .............................................................................................. 16 
4.1.3. 
Interventions ...................................................................................................... 17 
4.1.4. 
Outcomes ........................................................................................................... 18 
4.1.6. 
Study Timeline ................................................................................................... 21 
4.2. Assignment of Interventions ......................................................................................... 21 
4.2.1. 
Allocation to Intervention .................................................................................. 21 
4.2.2. 
Blinding.............................................................................................................. 22 
4.3. Data Collection, Management and Analysis ................................................................. 22 

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4.3.1. 
Data Collection .................................................................................................. 22 
4.3.2. 
Data Management .............................................................................................. 23 
4.3.3. 
Statistical Methods ............................................................................................. 23 
4.4.2. 
Harms ................................................................................................................. 25 
4.4.3. 
Study Monitoring ............................................................................................... 25 
5. 
ETHICS AND DISSEMINATION.................................................................................. 26 
5.1. Research Ethics Approval ............................................................................................. 26 
5.2. Protocol Amendments ................................................................................................... 27 
5.3. Consent ......................................................................................................................... 27 
5.3.1. 
Waiver of Consent ............................................................................................. 27 
5.4. Ancillary Studies ........................................................................................................... 27 
5.5. Confidentiality .............................................................................................................. 27 
5.6. Declaration of Interests ................................................................................................. 28 
5.7. Access to Data............................................................................................................... 28 
5.8. Ancillary and Post-Trial Care ....................................................................................... 28 
5.9. Dissemination Policy .................................................................................................... 28 
5.9.1. 
Trial Results ....................................................................................................... 28 
5.9.2. 
Authorship.......................................................................................................... 30 
5.9.3. 
Reproducible Research ...................................................................................... 31 
6. 
APPENDCIES ................................................................................................................. 31 
6.1. Appendix A – Complete List of Study Sites ................................................................. 31 
6.2. Appendix B – ICD-10-CM Self-Harm Codes Included in Collection .......................... 32 
6.3. List of Substance Abuse ICD-10-CM Codes Included in Data Collection .................. 43 
7. 
REFERENCES ................................................................................................................ 47 
 
 
 

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THE BEACON STUDY: Protocol for a cluster randomized controlled trial of a service 
to deliver smartphone-assisted problem solving therapy compared to usual care in men 
who present with intentional self-harm to Emergency Departments in Ontario. 
 
 
1. FUNDING 
The Ontario SPOR Support Unit (OSSU) is funding the costs for the BEACON trial 
and recruitment of 25 Emergency Departments across Ontario. OSSU is a partnership 
between the Government of Ontario and the Canadian Institutes of Health Research (CIHR). 
Funding for this trial covers the cost of research staff salaries; capacity building; study-
related expenses; including the cost of the smartphone application, statistical analyses and 
knowledge translation; as well as meetings and organizational costs.  
2. ROLES AND RESPONSIBILITIES 
 
2.1. Contributorship 
 
The following individuals assisted with the development of this study protocol: Drs. 
Simon Hatcher1, Marnin Heisel2, Monica Taljaard1, Kednapa Thavorn3, Daniel Corsi4, Ayal 
Schaffer5, Sakina Rizvi6, Ian Colman7, Mark Sinyor8, Sidney Kennedy6, Christian 
Vaillancourt1, Venkatesh Thiruganasambandamoorthy1, John Lavis9, Paul Links10, 
Christopher Mushquash11, Peter Voros12; and Valerie Testa1, Sarah MacLean4, Megan 
Schellenberg13, Julie Kathleen Campbell14, Alicia Raimundo15 and Alaaddin Sidahmed15. 
 
                                                     
1 University of Ottawa; Ottawa Hospital Research Institute 
2 Western University; Lawson Health Research Institute 
3 University of Ottawa; Ottawa Hospital Research Institute; Institute for Clinical Evaluative Sciences 
4 Ottawa Hospital Research Institute 
5 University of Toronto; Sunnybrook Health Sciences Centre 
6 University of Toronto; St. Michael’s Hospital 
7 University of Ottawa 
8 University of Toronto; Sunnybrook Health Sciences Centre 
 
9 McMaster University 
10 Western University; St. Joseph’s Health Care London; London Health Sciences Centre 
11 Lakehead University; Dilico Anishinabek Family Care 
12 Thunder Bay Regional Health Sciences Centre 
13 Mental Health Commission of Canada 
14 Suicide Prevention Consultant; Centre prévention suicide Le Faubourg - Laurentides Quebec 
15 Service User Representative 
Explanatory note: This protocol describes an evaluation of the effectiveness of the provision of 
a smartphone-assisted face-to-face clinical intervention in men who present to the Emergency 
Departments in Ontario. Randomization has been conducted at the cluster level (i.e. at the level of 
the Emergency Department). However, the unit of analysis in this study is the individual patient. 
This is a health systems analysis of a complex intervention, individual patients will be identified 
and followed-up using routinely collected administrative health information obtained through the 
Institute for Clinical Evaluative Sciences (ICES). As such, while the unit of analysis is the 
individual patient, no patients will be actively recruited and enrolled in this study. A separate 
protocol describes the evaluation of the impact of the smartphone-assisted face-to-face clinical 
information on the well-being of individual male participants. We have chosen to present the 
protocols in this way to provide clarity around methodological and ethical issues for this trial.  

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2.1.1. Author’s Contributions 
Drs. Simon Hatcher and Marnin Heisel conceived of the study and are the grant 
holders. Dr. Monica Taljaard provided expertise in the design of cluster randomized 
controlled trials (RCTs) and conducted the randomization procedure. Dr. Daniel Corsi 
provided statistical expertise in designing the clinical trial and will be conducting the primary 
statistical analysis. Dr. Kednapa Thavorn designed a health economic evaluation and will 
supervise the health economic analysis. Valerie Testa and Sarah MacLean assisted with the 
drafting of the study protocol. All authors contributed to refinement of the study protocol and 
approved the final manuscript. 
 
2.1.2. Sponsor contact information 
This is an investigator-initiated clinical trial and is sponsored by the Ottawa Hospital 
Research Institute (OHRI): 
 
Trial Sponsor: Ottawa Hospital Research Institute (OHRI) 
Sponsor’s Reference: 20150765 
Contact name: Dr. Duncan Stewart 
Address: 501 Smyth Road, Ottawa, ON K1H 8L6 
Telephone: (613) 798-5555, ext.79017 
Email: djstewart@ohri.ca  
 
The sponsor (OHRI) had no role in the design of this study and will not have any role during 
its execution, analyses, interpretation of the data, or decision to submit results. 
 
2.2. Committees 
2.2.1. Principal Investigator and co-Principal Investigator: 
 Design and conduct of the BEACON Study;  
 Preparation of protocol and revisions;  
 Preparation of study documentation; 
 Organization of Steering Committee meetings; 
 Publication of study reports; and 
 Participation as members of Trial Management Committee (TMC). 
 
2.2.2. Steering Committee (refer to title page for membership) 
 Approval of the final protocol; 
 All co-Investigators at each intervention site will be steering committee 
members; 
 Recruitment of patients and liaising with Principal Investigator and co-
Principal Investigator; and 
 Reviewing progress of study and, if necessary, approval of changes to the 
protocol and/ to facilitate the smooth running of the study. 
 
 

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2.2.3. Trial Management Committee (TMC) 
 Includes: Principal Investigator, co-Principal Investigator, Clinical Research 
Program Manager and Research Coordinator; 
 Study planning; 
 Organization of Steering Committee meetings; 
 Organization of Data and Safety Monitoring Committee (DSMC) meetings; 
 Provide annual reporting to Research Ethics Board (REB); 
 Serious Adverse Event (SAE) reporting to DSMC and REB; 
 Responsible for Master Tracking Log; 
 Budget administration and contractual issues with individual centres; 
 Advice for lead investigators; 
 Coordination of study monitoring; 
 Assistance with REB applications; 
 Data verification; and 
 Randomization. 
 
2.2.4. Data and Safety Monitoring Committee (DSMC) 
 Comprised of four members from the following fields of expertise: 
statistics/biostatistics, epidemiology, methodology, psychiatry and the ethics 
of clinical trials; 
 Ensures the ongoing safety of study participants; 
 Reviews the conduct of the study, including protocol violations and 
deviations; 
 Reviews data on participant recruitment, accrual, and retention, as well as 
assessments of data quality, completeness, timeliness, data retention, data 
storage, data transmission and data access; 
 Reviews Adverse Events (AEs) and Serious Adverse Events (SAEs) reported 
between meeting dates; 
 Protects the confidentiality of the study data and the DSMC discussions; and 
 Makes recommendations to continue, modify, or terminate the study. 
 
 
2.2.5. Lead Investigators 
At each participating site, a site co-Investigator will be identified, to be responsible 
for identifying and recruiting participants, collecting data, and completing all study 
documentation, along with coordinating follow-up of study participants and adherence to 
study protocol. All site co-Investigators will be Steering Committee members. 
 
 
 
 
 
 

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3. INTRODUCTION 
3.1. Background and Rationale 
3.1.1. Why is Intentional Self-Harm an Important Problem? 
Definition of Self-Harm 
 
We define self-harm as intentional self-poisoning or self-injury, whether or not there 
is clear evidence that the act was intended to result in death. Previous terms used include 
“attempted suicide” and “deliberate self-harm”; however, patients’ motives for self-harm are 
highly variable, as a person may have more than one motive and motivation is difficult to 
assess and stated intent can fluctuate with time. In line with usual public policy in health and 
social care, we use the term ‘self-harm’ – avoiding the word ‘deliberate’ because many 
service users dislike its connotations and as it ignores/simplifies the issue of ambivalent and 
co-existing wishes to live and to die. We opted to use the term “self-harm” rather than Non-
Suicidal Self-Injury (NSSI), a term being increasingly used in the clinical literature [1], given 
that it is associated with risk for lethal and non-lethal self-harm and as some individuals 
engage in self-harm with suicidal intent at times, and without stated suicidal intent at other 
times.  The term “self-harm” also focuses on behaviour rather than on its motivation, which is 
often complex, multi-determined, and open to interpretation and recall bias and historical 
revision. 
 
Presenting to Hospitals with Self-Harm is Common 
 
In Ontario, the number of people who present to hospital Emergency Departments 
with self-harm is difficult to ascertain accurately due to chronic under-detection and variable 
inconsistency in the definition and recording of self-harm episodes. The Canadian Institute 
for Health Information (CIHI) estimates the 2014 Ontario provincial rate of self-harm to be 
61 per 100,000 population members, resulting in an estimate of approximately 8,250 
Emergency Department presentations a year, province-wide [2] . However, local data 
collected from Emergency Departments within the Champlain Local Health Integration 
Network indicate approximately 1,767 presentations per year, reflecting a rate of 123 per 
100,000 a year, or approximately double that estimated by CIHI for this region. Therefore, 
the provincial rate for Ontario may exceed 16,000 unique self-harm episodes per year. The 
under-detection of self-harm is further compounded by the recognition that official statistics 
do not capture those cases that did not involve a presentation to hospital or other healthcare 
services, and under-detection or misclassifications of presentations for self-harm. This issue 
has been identified as a significant problem by Statistics Canada [3].  
 
The most common form of self-harm seen in Emergency Departments, accounting for 
approximately 80% of all episodes, is the intentional consumption of an excess of a medicinal 
or toxic substance. Injuries, most commonly including self-cutting, account for the remaining 
15-20% of episodes. Two-thirds of patients presenting to Emergency Departments for the 
treatment of self-harm are under 35 years of age, with a mean age of approximately 30 [4-5]. 
Self-harm occurs more commonly in lower socioeconomic groups. In Ontario, hospitalization 
rates for those from the most affluent sectors of the community are 26% lower than the 
provincial average [6]. There is also evidence to suggest that the rate of self-harm is 
increasing in Ontario, especially in younger adults [6]. The number of deaths by suicide 

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among older men is increasing secondary to the aging of the vast baby-boom cohort, adding 
further impetus to the need to enhance mental healthcare for at-risk men [7]. 
 
Self-Harm is Related to Suicide, Premature Mortality and High Use of Services 
 
Self-harm has a strong association with suicide: 1.6% of people presenting to 
Emergency Departments with self-harm will die by suicide within one year (95% confidence 
interval 1.2 to 2.1%), with the incidence rate being almost double in men compared to 
women (2.7% vs 1.2%) [8]. Approximately four percent of individuals who have presented to 
the Emergency Department for the treatment of self-harm die by suicide within five years of 
their index presentation [8]. This risk is more than 50 times greater than the general 
population rate and is associated with a 40-year reduction in average life expectancy [8]. A 
recent population-based cohort study investigating administrative datasets in the province of 
Ontario discovered that: “all-cause mortality following a first episode of self-poisoning was 
1,107 per 100,000 person-years…[with] nearly half of all deaths being suicides, accidents or 
[of] undetermined intent”[9].  
 
Presentation to the Emergency Department with self-harm is a major identifiable risk 
factor for suicide, with at least one quarter of deaths by suicide being preceded by a hospital 
visit due to non-fatal self-harm in the previous year [10-11]. As such, it is likely that any 
reduction in the repetition of self-harm will be mirrored by a decline in subsequent deaths by 
suicide. The Canadian Association for Suicide Prevention (CASP) blueprint for a national 
suicide prevention strategy has also identified people who have attended hospital because of 
non-fatal self-harm as a high risk group to target in order to prevent suicide [12]. Mortality 
from non-suicidal causes is also high for those who self-harm, with significantly more than 
the expected numbers of deaths from natural causes and from accidents [13]. These 
premature deaths are greatly over-represented among young people and the potential years of 
life lost in the community are many. 
 
Individuals who self-harm are frequent users of health and social services [14]. 
Approximately 10% of those who present in an Emergency Department following self-harm 
will engage in repeat self-harm in the following month and up to 27% after six months [15]. 
Recurrent self-harm is associated with significant distress and many unresolved interpersonal 
problems [16]. 
 
Why Focus on Men? 
 
Whereas only four out of ten people who present to the Emergency Department with self-
harm are men, they represent nearly two-thirds of those who die by suicide after an index 
episode of self-harm and they are also far more likely than women to die of premature death 
from other causes [13]. In Ontario, from 2006-2008, 75% of those who died by suicide were 
men [17]. Men who self-harm are more likely to misuse alcohol compared to women; for 
instance, in one large study in the U.K., 45% of 7,893 men who presented with self-harm 
misused alcohol compared to 29% of women [18]. Further, men repeat self-harm at similar or 
higher rates than women; for example, a study conducted in Western Northern Ireland 
revealed an annual repetition rate of 19.3% in men compared to 16.8% in women [19].  The 
rates are even more pronounced in indigenous communities, with suicide rates of 126 per 
100,000 young men (15-24) compared to a rate of 24 per 100,000 in non-Indigenous men of 
the same age [20]. Previous trials have found that providing generic treatments to everyone is 

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not particularly effective [21]; effective interventions target health behaviours and values 
consistent with the target group. The intervention we will offer builds on previous work by 
trying to extend the range and intensity of a focused psychotherapy by supplementing it with 
a sophisticated smartphone application that has already demonstrated its effectiveness in men 
with substance abuse disorders [22]. We will be offering an intervention specifically designed 
for men who self-harm who, historically, are difficult to engage in psychotherapeutic 
treatment and who are more likely than women to have substance abuse problems [23]. 
 
Summary of Relevant Studies of Psychological Therapies After Self-Harm 
 
A 2012 U.S. review of literature on the screening and treatment of suicide risk 
indicated that trials among individuals who presented with self-harm to be limited by lack of 
power, although "trends suggested incremental benefits from some interventions (in 
particular, Problem-Solving Therapy (PST) for patients aged 15 or older)"[24]. The 2011 
National Institute for Health and Care Excellence (NICE) guideline on management of self-
harm, followed by a further NICE search and published update in 2014, found little that is 
likely to help with routine practice but concluded that there was sufficient evidence to 
recommend “a well conducted RCT” of psychosocial interventions [25-26]. The recently 
updated 2016 Cochrane review on interventions following self-harm found 55 trials involving 
17,699 participants, of which 18 trials investigated cognitive behaviour therapy (CBT) [21]. 
Here, CBT included problem solving therapy which is a cognitive therapy focused on current 
difficulties which aims to teach participants a cognitive skill, namely problem-solving, that 
can be applied across contexts and situations. The authors found there was a significant 
treatment effect for CBT compared to usual treatment at final follow-up, with fewer 
participants repeating self-harm (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55 to 
0.88; number of studies k = 17; N = 2,665; GRADE: low quality evidence), but with no 
reduction in the frequency of self-harm (mean difference (MD) -0.21, 95% CI -0.68 to 0.26; k 
= 6; N = 594; GRADE: low quality) [27]. The authors concluded that CBT, including PST, 
requires further investigation in order to clarify which patients benefit from these types of 
interventions. They further noted the need for more information about potential sex 
differences in the manner in which psychosocial interventions might work.  
 
The potential impact of this study is that it could improve patient and health system 
outcomes by decreasing repeat episodes of self-harm and deaths by suicide, presentations to 
Emergency Departments (as well as linked hospital admissions), and ultimately reduce 
healthcare costs.  
 
3.1.2. Summary of Relevant Studies of Blended Therapy in the Treatment of Self-Harm 
The electronic support of psychotherapy in the treatment of mental disorders has been 
called “blended care,” referring to the combination of online and face-to-face therapy in one 
treatment protocol [27]. Blended therapy potentially offers numerous benefits to both patients 
and health care providers, including increasing the intensity of mental health treatment 
without a reduction in the number of sessions [28], increasing patient agency by fostering 
increased self-management skills [29], as well as case management benefits for mental health 
professionals [30]. Studies have also shown that blended therapies have the potential to 
reduce the number of face-to-face therapy sessions required by patients, thereby reducing the 
total cost to the health care system [31]. These interventions may be especially beneficial for 
the financially and geographically disadvantaged, including those individuals whose financial 

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situation prohibits their seeking care during the work day, and those residing in rural and 
remote regions. 
 
The use of smartphone applications for the self-management and monitoring of 
mental health have been found to be acceptable by both research participants [32] and the 
wider community as long as appropriate privacy and security measures are taken [33]. There 
have been only a small number of studies that have investigated blended therapy but no 
studies that have examined blended therapy in secondary health care settings or in patients 
who are at high risk for suicide. Large trials in routine clinical settings are needed in order to 
assess the effectiveness of blended therapy interventions in those suffering from mental 
disorders. In recognition of this, the European Commission has funded a large study, the 
European Comparative Effectiveness Research on Internet-Based Depression Treatment 
project (E-COMPARED) in which the effectiveness of blended therapy for treating 
depression will be assessed in a RCT in eight European countries [31]. However, the E-
COMPARED study specifically excludes suicidal participants and those with co-morbid 
mental disorders, such as bipolar disorder or substance abuse.   
 
3.1.3. Assessment, Care and Discharge from the Emergency Department 
 
People attending Emergency Departments following self-harm receive variable levels 
of care in Ontario, and there is no standard protocol for therapy. Many are not assessed for 
psychological needs, and the little psychological therapy available is usually not covered by 
provincial healthcare plans, and is thus only accessible to individuals with greater financial 
resources, including employer-paid supplemental health benefits. Published work from other 
countries confirm that variation in the provision of care is the norm [34]. Local audit data 
from hospitals in Ottawa show that only four out of ten men who present with intentional 
self-harm are seen by a mental health professional, and few are offered an evidence-based 
treatment aimed at reducing their risk of suicide or repeated self-harm. Assessment of suicide 
risk is currently a Required Operating Practice for Canadian Hospital accreditation; however, 
individuals identified as being at-risk for suicide rarely receive recommended care.  
 
 
A cohort study of 7,355 Emergency Department presentations for self-harm in the 
U.S. found that less than half of those who presented with self-harm (47.5%) received any 
mental health assessment while in the Emergency Department [35]. The same study found 
that the lethality of self-harm was not associated with mental health assessment in the 
Emergency Department.  In a study of patients who presented to the Emergency Department 
with deliberate self-harm, Hickey, Hawton, Faag & Weitzel (2001) also found that those who 
were discharged from the Emergency Department without a psychiatric assessment were 
more likely to: be male, 20-34 years of age, have a previous history of self-harm, to 
demonstrate difficult behaviour while in hospital and to be intoxicated than patients who 
were assessed prior to discharge [36]. Follow-up after discharge from Emergency 
Departments for many disorders is often poor, with one study in Ontario finding that between 
15% and 31% of patients discharged from an Emergency Department with chronic heart 
failure, diabetes or chronic obstructive lung disease did not see any physician within 30 days 
of their Emergency Department contact [37]. Fewer than one in three primary care physicians 
in Canada report being told when their patients attend an Emergency Department [38].  
 
Following intentional self-harm, even fewer patients receive outpatient follow-up, 
with only half attending an appointment with a mental health professional within 30 days of 

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presentation to the Emergency Department for an episode of self-harm [35]. Here, too, 
policies vary by institution regarding the acceptable duration between discharge and an 
outpatient mental health visit. Even in RCTs, which typically involve rigorous specification 
in methods of approaching, recruiting, and determining eligibility of patients, the proportion 
of people who consent and then actually receive treatment is low, with one study reporting 
38% of people randomized to cognitive behaviour therapy attending no clinical sessions [37] 
and another trial finding 20% of people consenting to PST having received no sessions [40]. 
Methods to address the low rate of engagement include providing patients with a written 
discharge plan in the Emergency Department [27]; enabling Emergency Department 
physicians to make electronic bookings for follow-up; staff training; and feedback on the 
proportion of people receiving care after leaving the Emergency Department [41]. The U.S. 
Suicide Prevention Resource Center (SPRC) has produced a “consensus guide” for caring for 
adult patients at high-risk of suicide in the Emergency Departments which recommends a 
package of brief patient education; safety planning; lethal means counselling; rapid referral; 
and caring contacts, which include crisis line information [42]. They also recommend 
focused interventions targeting men in their middle years at elevated risk for suicide [43]. A 
Cochrane Systematic Review of interventions to improve outpatient referrals from primary 
care to secondary care concluded that local educational interventions and dissemination of 
guidelines with structured referral sheets were effective strategies [41]. These features are 
included as part of the BEACON Suicide Prevention Smartphone Application in this study. 
 
3.2. Explanation for Choice of Comparators 
 
An alternative to developing new interventions is to optimize standard clinical care. 
This usually consists of referral for psychiatric or psychological treatment as well as other 
health or non-health services. However, neither a systematic review nor a large multicentre 
study found a clear relationship between the nature and intensity of standard hospital care and 
subsequent fatal or non-fatal repetition of self-harm [44]. Specialist services offer intensive 
and lengthy treatment, such as dialectical behaviour therapy or mindfulness-based therapy for 
the minority of people who self-harm who are diagnosed with personality disorders. The 
evidence for the effectiveness of these therapies comes almost entirely from studies in 
women [21]. 
 
3.3. Objectives and Hypotheses 
3.3.1. Primary Hypotheses and Objective 
 
To determine whether the provision of a service that delivers smartphone-assisted 
PST specifically designed for men who present to the Emergency Department with self-harm, 
results in fewer suicides and/or contacts with Emergency Departments for self-harm, 
compared with usual care, in the year after the index episode. 
 
We anticipate that in sites implementing a service that delivers smartphone-assisted 
PST specifically designed for men, 12 months after the index episode, there will be: 
 
1. Fewer deaths by suicide; and/or  
2. Fewer contacts with the Emergency Departments in Ontario for the repetition of self-
harm. 
 

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3.3.2. Secondary Hypotheses and Objectives 
 
The key secondary objectives are to determine, compared to usual care, whether the 
provision of a service that delivers smartphone-assisted PST specifically designed for men 
who present to the Emergency Department with self-harm, results in:  
 
1. Lower suicide rates; 
2. Fewer contacts with any Emergency Departments in Ontario for the repetition of 
self-harm;  
3. Fewer contacts with any Emergency Department in Ontario for any reason;  
4. Fewer admissions to hospital for any reason;  
5. Fewer outpatient appointments for any reason at any hospital in Ontario; 
6. Lower mortality rates, not related to suicide;  
7. Lower use of primary care services (defined by contact with a family physician); 
and/or 
8. Decreased costs to the health care system, including physician, hospitalization, 
Emergency Department, and other costs. 
 
3.4. Trial Design 
 
 
  
 
This is a pragmatic, multicentre pre- and post-design cluster RCT comparing the offer 
of a service that delivers smartphone-assisted PST to usual care, in men who present to the 
Emergency Department with self-harm. We have chosen a cluster randomized design because 
we are testing the introduction of a service for suicidal men that addresses both the need to 
manage the transition from the Emergency Department to outpatient care and the provision of 
care specifically designed for men who have intentionally self-harmed.  
 
 
By randomizing entire sites with a waiver of informed consent for data collection with 
inclusion of all eligible men using routinely collected data, external validity of the study is 
maximized, in comparison to an individually randomized trial with a requirement to seek 
informed consent (refer to Section 5.3 Consent). 
4. METHODS 
4.1. Participants, Interventions and Outcomes 
4.1.1. Study Setting 
 
This multicenter cluster RCT will be conducted in 25 Emergency Departments in 
Ontario. The unit of randomization is selected Emergency Departments in each region (refer 
to Appendix A for a complete list of intervention and control sites). 
 
4.1.2. Eligibility Criteria 
Sites were deemed eligible if they averaged at least 50 self-harm presentations by men 
per year. and an absolute re-presentation rate of at least 6 over three years. This resulted in a 
list of 25 eligible Emergency Departments in Ontario. Eligible patients will be identified in 
Table 1. Patient Eligibility Criteria 

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ICES, using the following criteria: 
 
 
Intentional self-harm is defined as intentional self-poisoning or self-injury, whether or 
not there is evidence that the act was intended to result in death. This will be identified using 
ICD-10-CM codes T14.91, X71-X83 ICD-10 codes from health administrative databases 
held at ICES.   
 
4.1.3. Interventions 
Emergency Departments randomized to the study intervention will receive: 
 
1. Staff education incorporated into regular teaching rounds at least twice a year about 
the management of self-harm in the Emergency Department. This will include the 
dissemination of guidelines (APA, NICE, SPRC and CCSMH) [45] on how to ask 
questions about suicide, assessment of suicide risk, the creation of a management plan 
and how to refer patients to local mental health resources, including the study. 
 
2. Written materials developed by service users to be given to men who self-harm that 
outline local resources, distress centre helplines and follow-up arrangements. The 
materials will be available in French and English and we will be discussing with 
Aboriginal partners translation of some materials into Ojibwe or Oji Cree. 
 
3. The option to refer men who self-harm to a service that will deliver smartphone-
assisted PST specifically designed for men.  
 
Emergency Departments randomized to the control group will continue to provide treatment 
using established pathways. This typically constitutes assessment of clinical risk, the need for 
medical intervention to treat the effects of self-harm, and for inpatient or outpatient mental 
healthcare. All men who present to the Emergency Department with intentional self-harm 
will have access to the full range of mental health and other services that are usually available 
to individuals in the different regions. This includes inpatient admission and other crisis 
services. 
 
 
Inclusion Criteria 
1. 
Patient has presented with an index episode of intentional self-harm at an eligible 
Emergency Department in Ontario, Canada. 
2. 
Patient is biologically male. 
3. 
Patient is 18 years of age or older. 
4. 
Patient has a valid OHIP number. 
Exclusion Criteria 
1. 
Patient has presented to the Emergency Department for a reason other than intentional 
self-harm at an eligible Emergency Department in Ontario, Canada. 
2. 
Patient is biologically female. 
3. 
Patient is under 18 years of age. 
4. 
Patient does not have a valid OHIP number. 

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4.1.4. Outcomes 
 
The primary outcome measure will be a composite of the incidence of suicides and/or 
re-presentations to any Emergency Department in Ontario for self-harm in the year after the 
index episode of self-harm. The incidence of suicide and re-representation to Emergency 
Department will be measured using ICD-10-CM codes T360-T50992, T510-T6592, T71112- 
T71232, X71-X83 (refer to Appendix A for full list of codes and descriptors) [46].  
Individuals who died by suicide will be identified in ICES using the Vital Statistics - Death 
Database. A potential problem with the outcome measures in this trial is that the intervention 
may also change help-seeking behaviour. That is, men may seek out healthcare that they 
would not have in the past, which may lead to an increase in re-presentations to the 
Emergency Department for patients in the intervention group. In order to explore changes to 
health-related help-seeking, we will also collect data on primary care and hospital outpatient 
care not driven by emergencies through ICES. This will be measured in ICES, using the 
Ontario Health Insurance Plan (OHIP) Claims Database and National Ambulatory Care 
Reporting System Metadata (NACRS). We will also address this through a sub-study of 
smartphone-assisted PST. 
 
 
The secondary outcome measures will include total number of suicides; re-
presentations to any Emergency Department in Ontario for the repetition of self-harm; re-
presentations to any Emergency Department in Ontario for any reason; other health system 
use including use of primary care and hospital outpatient appointments; mortality not related 
to suicide; and, health system costs within one year which will inform an economic analysis. 
All outcomes will be identified and measured using routinely collected data housed at ICES. 
Men who present with intentional self-harm in the study Emergency Departments will be 
identified from ICES administrative health data.  
 
Table 2. Outcome Measures 
 
Justification 
Data Source 
Data Collection 
Period 
Primary Outcome Variable (composite outcome variable) 
Death by Suicide 
and/or re-
presentation to any 
Emergency 
Department in 
Ontario for Self-harm 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
ORGD, NACRS 
(ICES) 
Baseline; 12 months 
Secondary Outcomes 
Death by Suicide  
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
ORGD (ICES) 
Baseline; 12 months 
Re-presentation to 
any Emergency 
Department in 
Ontario for Self-harm 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
NACRS (ICES) 
Baseline; 12 months 

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PST service. 
Re-presentation to 
any Emergency 
Department for any 
reason 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
NACRS (ICES) 
Baseline; 12 months 
Admission to any 
hospital in Ontario 
for any reason 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
NACRS (ICES) 
Baseline; 12 months 
Hospital outpatient 
appointments in 
Ontario for any 
reason 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
OHIP (ICES) 
Baseline; 12 months 
Primary care 
appointments 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
OHIP (ICES) 
Baseline; 12 months 
Mortality for reasons 
other than suicide 
To assess the clinical 
impact of the 
provision of a 
smartphone-assisted 
PST service. 
ORGD (ICES) 
Baseline; 12 months 
Total Health Care 
Costs 
To assess the 
economic impact of 
the provision of a 
smartphone-assisted 
PST service. 
OHIP, DAD, 
NACRS, NRS, 
CCRS, OMHRS, 
ODB, ADP (ICES) 
Baseline; 12 months 
Physician Health 
Care Costs 
To assess the 
economic impact of 
the provision of a 
smartphone-assisted 
PST service. 
OHIP (ICES) 
Baseline; 12 months 
Emergency 
Department Health 
Care Costs 
To assess the 
economic impact of 
the provision of a 
smartphone-assisted 
PST service. 
NACRS (ICES) 
Baseline; 12 months 
Hospitalization 
Health Care Costs 
To assess the 
economic impact of 
the provision of a 
smartphone-assisted 
PST service. 
DAD (ICES) 
Baseline; 12 months 
Other Health Care 
Costs 
To assess the 
economic impact of 
the provision of a 
NRS, CCRS, 
OMHRS, ODB, ADP 
(ICES) 
Baseline; 12 months 

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smartphone-assisted 
PST service. 
Prognostic outcome measures 
Age 
To assess differences 
between subgroups. 
RPDB (ICES) 
Baseline 
Previous 
hospitalization for 
self-harm 
To assess differences 
between subgroups. 
NACRS (ICES) 
Baseline 
Previous 
hospitalization for 
substance use 
To assess differences 
between subgroups. 
NACRS (ICES)* 
Baseline 
* Appendix B for list of ICD-10-CM codes. 
Data Sources: ADP, Assistive Devices Program; CCRS, Continuing Care Reporting System; DAD, Discharge Abstract 
Database; NACRS, National Ambulatory Care Reporting System; NRS, National Rehabilitation Reporting System; ODB, 
Ontario Drug Benefit Claims; OHIP, Ontario Health Insurance Plan Claims Database; OMHRS, Ontario Mental Health 
Reporting System; RPBD, Registered Persons Database; ORGD, Vital Statistics – Death. 
 
4.1.5. Sample Size 
 
Power calculations for this trial were carried out within the logistical and practical 
constraints of the trial; in particular, a maximum of 25 sites are available for randomization, 
whereas the intervention can be implemented at only 10 sites. Consistent with previous 
clinical trials, we would consider a minimum relative reduction of 50% in the repetition 
rate to be both clinically important and achievable [47-49]. To conduct an accurate power 
calculation, we obtained data from ICES regarding the number of presentations with self-
harm by men and the re-presentation rate to every hospital in Ontario from 2012 to 2014. 
Using these data, we calculated an anticipated baseline repetition rate (primary outcome) 
after 12 months of 13%. We also calculated an intracluster correlation coefficient (ICC) of 
0.01 and an inter-period correlation of 0.008 (to account for over time correlations between 
pre- and post-intervention measures of the primary outcome). Given an average cluster size 
of 80 men and a coefficient of variation of cluster sizes (to account for imbalances in sizes) of 
30%, 10 intervention clusters and 15 control clusters (2000 men) achieve 90% power to 
detect the minimum important difference. With 80% power, the detectable difference is a 
relative reduction of 41%, i.e., from a control arm rate of 13% to an intervention arm rate of 
7.7% (an absolute reduction of 5.3%).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.1.6. Study Timeline 
 
 
4.2. Assignment of Interventions 
4.2.1. Allocation to Intervention 
 
To minimize the risk of imbalances between the study arms, allocation to the 
intervention or control arm was implemented using covariate constrained allocation [50]. 
Allocation was constrained based on: i) geographic areas, defined by whether the catchment 
area was predominantly urban or rural; ii) whether there was an onsite psychiatric service 
which assesses people in the Emergency Department; iii) size defined by the average number 
of presentations for self-harm for both men and women over a 3 year period; and iv) re-
presentation rate among men with intentional self-harm 12 months after the index episode. 
There was a total of over 3 million possible allocations of 10 intervention and 15 control 
sites, of which 7,131 of 100,000 randomly selected allocations met the pre-specified 
balancing constraints, namely a maximum difference of 3 between number of urban/rural 

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sites, a maximum difference of 3 in number of sites with onsite psychiatric service, a 
maximum difference in mean cluster size of 60, and a maximum difference in baseline re-
presentation rate of 3%. Among the 7,131 possible acceptable allocations, one allocation was 
selected at random using a computer-generated random number.  
 
4.2.2. Blinding 
 
Once randomization was complete, study sites allocated to the intervention arm were 
approached regarding their interest to participate in the study. Gatekeepers were not 
approached prior to randomization as the investigative team determined that informing 25 
sites and getting their agreement prior to randomization would result in significant delays to 
the study and that it was unlikely that hospitals would decline to participate in this study. 
Additionally, there were concerns regarding changes in institutional behaviour at the control 
sites as a result of knowing about the study. Should any intervention sites refuse to participate 
in the trial, they will be included in the final analyses as part of the intervention arm in order 
to respect the intent-to-treat (ITT) principle.  
 
 
Control sites will be unaware of their participation in the study as men who present 
with self-harm will be receiving their usual care and all outcome measures are routinely 
collected by ICES. 
 
4.3. Data Collection, Management and Analysis 
4.3.1. Data Collection 
Data Collection Methods 
 
Trial outcomes comprise routinely collected data which are housed at ICES. Access to 
all outcome data has been agreed upon with ICES.  
 
Retention 
Emergency Departments 
 
 
Once randomization of the study sites is completed, the Principal Investigator will 
contact members of the Department of Psychiatry and Department of Emergency Medicine at 
each intervention site to be site co-Investigators, to assume responsibility for all study-related 
activities at their respective site. They will act as study “champions” and, in conjunction with 
Research Assistants, will provide study support to Emergency Department staff members.  
 
 
Each study site will also receive training, as described in Section 4.1.3 Interventions, 
in the identification and management of self-harm as well as access to an electronic booking 
system for study referrals and Research Assistant(s) to coordinate all study-related activities.  
 
Participants 
 
 
This study will focus on the evaluation of a complex intervention based on routinely 
collected population-level health data. Given this, there will be no individual participant 

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recruitment for this study. All data collected through ICES will thus be included in the 
primary analysis irrespective of uptake of the smartphone-assisted PST.  
 
4.3.2. Data Management 
 
All electronic and hardcopies the study Case Report Forms will be stored at the 
Coordinating Study Site in areas with limited access. All electronic data will be stored on a 
secured server at The Ottawa Hospital. Once all data monitoring, validation and cleaning 
activities are complete, these records will be archived at a secure storage facility for a period 
of ten years, as required by ICH GCP guidelines. 
 
4.3.3. Statistical Methods 
Outcomes 
 
 
The unit of analysis will be the individual patient. To evaluate the effectiveness of the 
complex intervention at population-level (primary trial analysis), all outcomes will be 
obtained from ICES, regardless of whether men received or participated in the study therapy. 
Dichotomous primary and secondary outcomes will be described, by arm, using frequencies 
and percentages. The primary composite outcome as well as its individual components 
(completed suicides and re-presentations within 1 year) will be compared between the 
intervention and control sites using generalized linear mixed effects regression, accounting 
for the pre-and post-intervention measures using repeated cross-sectional analysis [51]. 
Differences between the arms will be expressed as absolute and relative differences in 
proportions, together with 95% confidence intervals. Models will account for clustering at the 
Emergency Department level and over time using random effects. Cluster level covariates for 
factors used in the allocation procedure, namely urban/rural, onsite psychiatric service, and 
size will be included in regression models. Additional analyses will adjust for individual 
prognostic variables including age, ethnicity, pre-specified comorbidities (such as previous 
hospitalizations for substance use), and repeat as compared with first-time presentations for 
self-harm.   
 
 
All binary secondary outcomes (representation to the ED for any reason, admission to 
hospital for any reason, and mortality for any reason) will be analyzed as described for the 
primary outcome. Length of hospital stay for any reason, number of hospital outpatient 
appointments, number of primary care appointments and cost data will be analyzed as 
described for the primary outcome, that is, using generalized linear mixed effects regression, 
but with either the Poisson or negative binomial distribution and using the log link function. 
Differences between the arms will be expressed as rate ratios together with 95% confidence 
intervals.  
 
 
Additional subgroup analyses will be carried out for the following subgroups: first 
time presentations of self-harm compared to repeat presentations; Francophone versus 
Anglophone; men with substance abuse disorders versus no substance abuse disorder; and 
rural versus urban residence. 
 
 
 

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Health Economic Evaluation 
 
 
We will conduct a cost-utility analysis from health system’s perspective to assess the 
value for money of the smartphone-assisted PST compared to standard clinical care. A 
decision analytic model will be used to synthesize data on resource use, clinical outcomes, 
and health utility values obtained from the trial and the published literature. Costs associated 
with the intervention will be summarized over the one-year period. Total costs of the 
intervention will include the cost of smartphone-assisted PST development, training, data 
plan, supplies/materials and costs associated with the health care use over the one-year 
period. We will use a micro-costing technique by identifying, measuring, and valuing 
resources used [52]. Health care resource use will be obtained from the health administrative 
databases housed at ICES which contain information on physician visits including primary 
care and specialists, inpatient hospital admissions, including mental health institutions, 
emergency and ambulatory care visits, home care and rehabilitation claims, use of laboratory 
services, and prescription drug claims for those with high drug costs compared to their 
income. The efficacy of the smartphone-assisted PST will be obtained from the concurrent 
trial while the health utility values associated with self-harm and smartphone-assisted PST 
will derived from the concurrent cohort study. A one-year time horizon will be adopted in a 
base case analysis, and a lifetime horizon will be used in a scenario analysis. As a secondary 
analysis, we will take the societal perspective and include productivity loss in a cost 
calculation. The loss of productivity data will be gathered from the published literature. 
 
 
An incremental cost per one additional quality-adjusted life year (QALY) gained will 
be estimated. Uncertainty in the analysis will be assessed using one-way and probabilistic 
sensitivity analyses. The cost-utility analysis will adhere to the best practices for conducting 
and reporting of health economic evaluations[53-54]. Both costs and health outcomes will be 
discounted using an annual rate of 1.5% as recommended by the Canadian Agency for Drugs 
and Technologies in Health. The analysis will be performed by a health economist at the 
Ottawa Methods Centre and will be overseen by Dr. Kednapa Thavorn. 
 
4.4. Monitoring  
4.4.1. Data Monitoring 
 
An independent Data and Safety Monitoring Committee (DSMC) has been convened 
to assess the progress of the clinical trial, the integrity of the data, the safety of all 
participants, and to provide recommendations to the Principal Investigators. The members of 
the DSMC serve in an individual capacity and provide their expertise and recommendations.  
The DSMC will review cumulative study data to evaluate safety, study conduct, and 
scientific validity and data integrity of the study. The general responsibilities of the DSMC 
are: 
 To evaluate, on an ongoing basis, the accumulating safety assessments to ensure 
the ongoing safety of study participants; 
 To consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an impact 
on the safety of the participants or the ethics of the study; 
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 To review data on participant recruitment, accrual, and retention, as well as 
assessments of data quality, completeness, timeliness, data retention, data storage, 
data transmission and data access; 
 DSMC members will review Adverse Events (AEs) and Serious Adverse Events 
(SAEs); 
 To make recommendations to continue, modify, or terminate the study. 
 
 
4.4.2. Harms 
 
The anticipated harms in this study are minimal and do not exceed the risks associated 
with usual care.  In this clinical trial, given that all outcome data are routinely collected 
population-level data through ICES and no participants will be enrolled in the study, Adverse 
Events (AEs) will not be collected and assessed. However, all AEs and Serious Adverse 
Events (SAEs) will be collected, monitored and reported as appropriate for all related sub-
studies as this will involve the enrollment and follow-up of participants.  
 
4.4.3. Study Monitoring 
 
A site initiation meeting/videoconference will be conducted once the site has received 
all regulatory and REB approvals, but before recruitment has begun. All study team members 
for this site will attend, in addition to the Research Coordinator, Principal Investigator and 
co-Principal Investigator for the trial. The Principal Investigator and Research Coordinator 
will conduct the site initiation visit and will cover the items listed below in order to ensure 
that all study staff are aware of their delegated duties: 
 Study Protocol;  
 Study-specific SOPs; 
 Complete review of baseline intake and follow-up documentation; 
 ICH-GCP compliance;  
 Adverse Event and Serious Adverse Event recording and reporting; 
 Protocol deviation and violation management; 
 Internal study monitoring procedures and requirements; and 
 Delegated study staff responsibilities (including site co-Principal Investigator). 
 
 
The Principal Investigator, or appropriate delegate, will generate a brief report on the 
material covered and any additional training required. The Principal Investigator, or 
appropriate delegate, will forward the report to the site for review and sign-off no later than 
10 business days from site initiation. Once the site initiation visit is complete, an internal 
monitor will be selected. This monitor will not be involved in data collection activities and 
will be one-step removed from the clinical trial.  
 
 
The internal monitor will perform the first monitoring visit at each site shortly after 
the site has recruited their first participant to ensure that research personnel have 
implemented the appropriate recruitment processes and procedures, such as eligibility sign-
off and consent. This visit will be completed prior to the site recruiting more participants. 
Any corrective actions implemented in regards to inconsistencies identified during the 
previous monitoring visits will be assessed for completeness. Based on the research category 

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and participant/institute risk exposure, on-site monitoring visits will occur every eight months 
after the first monitoring visit. The internal monitor may schedule more visits as needed. 
 
 
During the on-site monitoring visit(s), the monitor will perform the following source 
document verification and study master file review:  
 15% of all Case Report Forms will be audited for accuracy and completeness; 
 All training documentation/records and delegation log; and 
 All regulatory documentation including REB approvals/amendments. 
 
If the monitor notices a large number of discrepancies during the visit, they may 
perform additional verification of source documents and/or recommend additional internal 
monitoring visits as needed. 
 
 
The monitor will also conduct close-out procedures once the last enrolled participant 
has completed his/her final study visit. During close-out, the monitor will perform the 
following tasks: 
 
 Ensure all previous monitoring corrections have been addressed; 
 Collect outstanding patient data forms and study forms such as Case Report 
Forms; 
 Perform a final review of the study file documents; 
 Review the plans for record retention; 
 Ensure that the local REB has been notified of the site closure. 
 
The monitor will prepare the final monitoring report and send it to the site for their records. 
The site will address all monitoring observations (including observations from previous 
monitoring reports) prior to final study closeout. 
5. ETHICS AND DISSEMINATION 
5.1. Research Ethics Approval 
 
Trial design and conduct has been informed by TCPS 2 and ICH GCP, an 
international ethical and scientific quality standard for designing, conducting, recording and 
reporting trials that involve the participation of human subjects. Compliance with these 
standards provides public assurance that the rights, safety and well-being of trial subjects are 
protected, consistent with the principles that have their origin in the Declaration of Helsinki, 
and that clinical trial data are credible. This study protocol will be reviewed and approved by 
the Research Ethics Board (REB) of Record, as assigned by Clinical Trials Ontario (CTO), 
and any other local REB required by participating sites. Subsequent to initial review, the 
Principal Investigator will complete progress reports, to be submitted to the REB annually, 
which will describe the progress of the trial, including recruitment and follow-up rates, 
participant safety and any changes to the study protocol and/or Informed Consent Forms. 
 
 
 
This study protocol will be published in Trials Journal, will be reported in accordance 
with CONSORT guidelines for cluster randomized trials [55], and will be registered with 
clinicaltrials.gov.  
 
 
 

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5.2. Protocol Amendments 
 
Any subsequent modifications to the study protocol, including changes to study 
objectives, study design, patient population, sample sizes, study procedures, or significant 
administrative changes will be agreed upon by the Steering Committee and submitted to the 
REB for review and approval prior to implementation. 
 
5.3. Consent 
5.3.1. Waiver of Consent 
 
In order to appropriately address the research questions and objectives of this study, 
we will be requesting a waiver of informed consent from the 25 Emergency Departments to 
be included in this study. We will not ask patients presented to Emergency Departments for 
their consent to take part in the study as the outcome data that we are collecting are already 
routinely collected by ICES. As per the Tri-Council Policy Statement: Ethical Conduct for 
Research Involving Humans (TCPS 2), an exception to the requirement to seek prior consent 
may be requested if the clinical trial meets the following criteria: 
 
1. The research involves no more than minimal risk to the participants; 
2. The alteration to consent requirements is unlikely to adversely affect the welfare 
of participants; 
3. It is impossible or impracticable to carry out the research and to address the 
research question properly, given the research design, if the prior consent of 
participants is required; 
4. In the case of a proposed alteration, the precise nature and extent of any proposed 
alteration is defined; and 
5. The plan to provide a debriefing (if any) which may also offer participants the 
possibility of refusing consent and/or withdrawing data and/or human biological 
materials, shall be in accordance with Article 3.7B [56]. 
 
We will be conducting a sub-study of the effectiveness of smartphone-assisted PST at the 
intervention sites. Eligible patients in this sub-study will be consented and enrolled according 
to TCPS 2 and GCP recommended guidelines. There are numerous precedents of studies 
analyzing ICES data which do not ask for individual patient consent to use their data [57]. 
 
5.4. Ancillary Studies 
 
There is a cohort study planned for this protocol which will evaluate the effectiveness 
of smartphone-assisted PST. The protocol for this ancillary study will be submitted to the 
REB and, upon approval of the REB, all participants involved in this ancillary study will be 
asked to sign an Informed Consent Form. Copies of all REB approvals for the ancillary study 
will be stored at the study site as well as the Coordinating Study Site. All study files will be 
stored at the study site according to TCPS 2 and GCP guidelines. 
 
5.5. Confidentiality 
 
All study-related cohorts will be created by Data Analytic Services at ICES Central. 
These cohorts will be transmitted to The Ottawa Hospital Civic Campus, a satellite ICES 

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location, for analyses by statisticians affiliated with the Ottawa Methods Centre at The 
Ottawa Hospital. All data provided by ICES are de-identified, anonymized routinely 
collected data.  
 
 
All study-related documentation will be double-locked in areas with limited access at 
the appropriate study site. All documentation, including Case Report Forms will be stored in 
double-locked filing cabinets in areas with limited access. All study records will be kept for a 
period of ten years, as indicated in the ICH GCP guidelines, or more depending on local 
regulations. 
5.6. Declaration of Interests 
The study Investigators have the following interests to declare: 
 
1. Dr. Sakina Rizvi: Is a co-Investigator with the Canadian Biomarker Integration 
Network in Depression (CAN-BINDED), funded by the Ontario Brain Institute 
(OBI). She also received research grant funding from Pfizer Canada.  
 
5.7. Access to Data 
 
The Coordinating Study Site will be responsible for the sharing of data between study 
Investigators. Upon request, all Investigators will be provided with cleaned copies of the 
study datasets (refer to Section 5.8.3 “Reproducible Research” regarding the sharing of data). 
All trial data will be stored on the OHRI secured server at the Coordinating Study Site and 
will be password-protected. Site co-Principal Investigators will have direct access to data 
collected from their site and may obtain access to the data from other sites upon request (refer 
to Section 5.8.3 “Reproducible Research” regarding the sharing of data). In order to protect 
participant confidentiality, all potentially identifying information will be removed from the 
datasets prior to intra-study sharing.  
 
5.8. Ancillary and Post-Trial Care 
 
As participants will not be enrolled in this study, in the event of injury or illness, all 
patients will receive usual care through the hospital or service provider of their choice. 
 
5.9. Dissemination Policy 
5.9.1. Trial Results 
Data Analysis and Release of Results 
 
 
To protect the scientific integrity of this study, data from all clusters will be analyzed 
and reported together. Although sub-analyses with specific groups will be conducted, no 
centre is expected to report data collected from their centre alone. The primary data analysis 
will be conducted by the Ottawa Methods Centre (OMC) at OHRI in conjunction with ICES. 
All statisticians will be blind to the allocation of the study sites. All study publications and 
presentations are expected to adhere to the BEACON Study objectives as detailed in this 
protocol. 
 
 

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Review Process 
 
 
A Publications Committee, a subcommittee of the Steering Committee, will be 
established to coordinate all study publications and presentations. All presentation and 
publication abstracts must be submitted for review by the Publications Committee. This 
committee will create a running list of all potential publications, review all abstracts 
submitted for publication by the Investigative Team, identify a lead author for each 
publication, review all publication manuscripts, and submit publications to peer-reviewed 
journals for publication. They will also ensure that all publication guidelines and regulations 
are respected, including adherence to the study’s objectives and the CONSORT statement for 
cluster RCTs. 
 
 
Each presentation or publication abstract/manuscript must be submitted to the 
Research Coordinator prior to each Publications Committee Meeting. The abstracts will be 
reviewed at the subsequent Publications Committee meeting. All members will vote on each 
abstract and will provide feedback. The Research Coordinator will include all feedback in the 
meeting minutes and, after each meeting, will circulate all feedback appropriately. Authors 
will be expected to review the committee’s feedback and re-submit their final abstract or 
manuscript for final approval by the Publications Committee. 
 
Primary Outcome Publications 
 
 
The Publications Committee will ensure that no presentation or publication 
undermines the dissemination of any primary outcomes publications. Primary outcomes 
publications refer to any presentation or publication that presents data on the primary 
outcomes as detailed in this protocol. During the review process, the Publications Committee 
will determine if an abstract/manuscript will undermine any primary outcome publications. If 
it is determined that this is the case, the author will be asked to delay publication until such a 
time as the primary outcome publication is released. 
 
Other Study Papers, Abstracts and Presentations 
 
 
This refers to all presentations and publications that do not report on the primary 
outcome of this trial, as detailed in this protocol. All presentation and publications 
abstracts/manuscripts must be reviewed and approved by the Publications Committee prior to 
submission.  
 
Close-Out Procedures 
 
The primary outcome publication is expected to be submitted for publication within 
two years of the completion of follow-up data collected (i.e. after the last study participant 
has completed the study). However, this may occur at an earlier or later date if the 
circumstances warrant. Study close-out will occur in two stages: 
 
 Period of analysis and documentation of primary outcome results; and 
 Debriefing of participants and dissemination of all other study results. 
 
 
 

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Reporting of Study Results 
 
 
All study results will be released to study participants, referring clinicians, patients 
and the general medical community. Results will be communicated to study participants 
through the use of a newsletter or presentation, as per the overall preference of the 
participants. Other forms of dissemination include: academic publications, conference 
presentations and presentations to the general public. 
 
5.9.2. Authorship 
 
Authorship guidelines to be followed for this trial have been adapted from the OHRI 
Authorship Guidelines for Researchers and criteria recommended by the International 
Committee of Medical Journal Editors (ICMJE). 
 
Qualification for Authorship 
 
 
Whether or not investigators and/or research staff members are eligible for authorship 
credit will be determined using the following ICMJE criteria: 
 
1. Substantial contributions to the conception or design of the work; or the 
acquisition, analysis, or interpretation of data for the work; AND 
 
2. Drafting the work or revising it critically for important intellectual content; AND 
3. Final approval of the version to be published; AND 
4. Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved. 
 
Anyone who qualifies for authorship, based on the above, should be listed, including research 
staff, consultants, trainees and students. Those who do not meet all four of the above criteria 
should be acknowledged (refer to “Acknowledgements”).  These criteria are not intended to 
be used as a means of disqualifying study Investigators from authorship. Anyone who meets 
the first criterion will be given the opportunity to participate in the review, drafting, and final 
approval of the manuscript. 
 
Author’s Contribution 
 
 
Prior to the launch of the study, co-authors who are responsible for the various aspects 
of the trial will be identified. Some journals require that information is published about the 
relative contributions of each author on the manuscript. Where this is not a requirement of the 
journal, if possible, this information will be provided in the acknowledgements section of the 
manuscript. Since authorship itself does not specify the relative contributions of each author, 
a brief author contribution statement will be included in order to resolve any potential 
ambiguity surrounding contributions. 
 
Order of Authorship 
 
 
For this trial, order of authorship will be determined by contribution: the person who 
took the lead in writing the manuscript or doing the research will be listed first and the most 

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experienced contributor will be listed last. All other co-authors will be listed in order of 
contribution.  
 
 
 
In order to avoid any disputes as to the order of authorship, the following precautions 
will be taken: 
 
1. The authors will decide on authorship and authorship order together, prior to 
drafting their manuscript; 
 
2. Authors should specify in their manuscript a description of the contributions of 
each author so that readers can interpret their roles correctly. 
 
Acknowledgments 
 
 
All those who have made a contribution to the work, but who do not fulfil the criteria 
for authorship (noted above in the “Qualification for Authorship” section), should be 
acknowledged by name in the manuscripts’ acknowledgement section. Authors should 
request permission before acknowledging anyone. Examples of individuals who may be 
appropriate to acknowledge include: those responsible for general supervision of a research 
group, or those who provided administrative, clinical or technical support, including those 
who have completed their involvement with the study. 
 
5.9.3. Reproducible Research 
 
The Coordinating Study Site will be responsible for the sharing of data between study 
Investigators. The Principal Investigator and co-Principal Investigator will retain exclusive 
access to the data for two years post-study closeout. After this time, the data will be available 
to the wider study team for sub-analyses for a period of 3 years. At 5 years post-study 
closeout, de-identified data will become publically available upon request.  
6. APPENDCIES 
6.1. Appendix A – Complete List of Study Sites 
 Brant Community Health System (Brantford General Hospital Site), Brantford, ON ; 
 Cambridge Memorial Hospital, Cambridge, ON; 
 Grand River Memorial Hospital Corporation (Waterloo Site), Waterloo, ON; 
 Guelph General Hospital, Guelph, ON; 
 Halton Healthcare Services Corporation (Oakville Site), Oakville, ON; 
 Health Sciences North (Laurentian Site), Sudbury, ON; 
 Hotel-Dieu Grace Healthcare (St. Joseph’s Site), Windsor, ON; 
 Kingston General Hospital, Kingston, ON; 
 Lakeridge Health (Oshawa Site), Oshawa, ON; 
 London Health Sciences Centre (Victoria Hospital Site), London, ON; 
 Mount Sinai Hospital, Toronto, ON; 
 Niagara Health System (Greater Niagara and St. Catharines General Sites), Greater 
Niagara and St. Catharines, ON; 
 The Ottawa Hospital (General and Civic Sites), Ottawa, ON; 

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 Peterborough Regional Health Centre, Peterborough, ON; 
 Queensway-Carleton Hospital; Ottawa, ON; 
 Royal Victoria Regional Health Centre, Barrie, ON; 
 Sault Area Hospital, Sault Ste. Marie, ON; 
 Sioux Lookout Meno-Ya-Win Health Centre, Sioux Lookout, ON; 
 St. Joseph’s Healthcare System (Hamilton Site), Hamilton, ON; 
 St. Joseph’s Healthcare Centre, Toronto, ON; 
 St. Michael’s Hospital, Toronto, ON; 
 Sunnybrook Health Sciences Centre, Toronto, ON; 
 Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON; 
 Trillium Health Partners (Mississauga Site), Mississauga, ON; 
 William Osler Health System (Civic Site), Brampton, ON. 
 
6.2. Appendix B – ICD-10-CM Self-Harm Codes Included in Collection 
Code* 
Description 
Self-Injury 
X710XXA, X710XXD, 
X710XXS 
Intentional self-harm by drowning or submersion while in 
bathtub. 
X711XXA, X711XXD, 
X711XXS 
Intentional self-harm by drowning or submersion while in 
swimming pool. 
X712XXA, X712XXD, 
X712XXS 
Intentional self-harm by drowning or submersion after 
jump into swimming pool. 
Self-Injury 
X713XXA, X713XXD, 
X713XXS 
Intentional self-harm by drowning and submersion in 
natural water.  
X718XXA, X718XXD, 
X718XXS 
Other intentional self-harm by drowning or submersion. 
X719XXA, X719XXD, 
X719XXS 
Intentional self-harm by drowning or submersion, 
unspecified.  
X72XXXA, X72XXXD, 
X72XXXS 
Intentional self-harm by handgun discharge. 
X730XXA, X730XXD, 
X730XXS 
Intentional self-harm by shotgun discharge. 
X731XXA, X731XXD, 
X731XXS 
Intentional self-harm by hunting rifle discharge. 
X732XXA, X732XXD, 
X732XXS 
Intentional self-harm by machine-gun discharge. 
X738XXA, X738XXD, 
X738XXS 
Intentional self-harm by other larger firearm discharge. 
X739XXA, X739XXD, 
X739XXS 
Intentional self-harm by unspecified larger firearm 
discharge. 
X7401XA, X7401XD, 
X7401XS 
Intentional self-harm by airgun. 
X7402XA, X7402XD, 
X7402XS 
Intentional self-harm by paintball gun.  

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Self-Injury 
X7409XA, X7409XD, 
X7409XS 
Intentional self-harm by other gas, air or spring operated 
gun. 
X748XXA, X748XXD, 
X748XXS 
Intentional self-harm by other firearm discharge. 
X749XXA, X749XXD, 
X749XXS 
Intentional self-harm by unspecified firearm discharge. 
X75XXXA, X75XXXD, 
X75XXXS 
Intentional self-harm by explosive material. 
X76XXXA, X76XXXD, 
X76XXXS 
Intentional self-harm by smoke, fire and flames. 
X770XXA, X770XXD, 
X770XXS 
Intentional self-harm by steam or hot vapours. 
X771XXA, X771XXD, 
X771XXS  
Intentional self-harm by hot tap water. 
X772XXA, X772XXD, 
X772XXS 
Intentional self-harm by other hot fluids. 
X773XXA, X773XXD, 
X773XXS 
Intentional self-harm by hot household appliances.  
X778XXA, X778XXD, 
X778XXS 
Intentional self-harm by other hot objects. 
X779XXA, X779XXD, 
X779XXS 
Intentional self-harm by unspecified hot objects. 
X780XXA, X780XXD, 
X780XXS  
Intentional self-harm by sharp glass. 
X781XXA, X781XXD, 
X781XXS 
Intentional self-harm by knife. 
X782XXA, X782XXD, 
X782XXS  
Intentional self-harm by sword or dagger. 
X788XXA, X788XXD, 
X788XXS 
Intentional self-harm by other sharp object. 
X789XXA, X789XXD, 
X789XXS 
Intentional self-harm by unspecified sharp object.  
X79XXXA, X79XXXD, 
X79XXXS 
Intentional self-harm by blunt object.  
X80XXXA, X80XXXD, 
X80XXXS 
Intentional self-harm by jumping from a high place. 
X810XXA, X810XXD, 
X810XXS 
Intentional self-harm by jumping or lying in front of a 
motor vehicle. 
X811XXA, X811XXD, 
X811XXS 
Intentional self-harm by jumping or lying in front of 
(subway) train. 
X818XXA, X818XXD, 
X818XXS 
Intentional self-harm by jumping or lying in front of other 
moving object.  
X820XXA, X820XXD, 
X820XXS 
Intentional collision of motor vehicle with other motor 
vehicle. 
X821XXA, X821XXD, 
X821XXS 
Intentional collision of motor vehicle with train. 

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Self-Injury 
X822XXA, X822XXD, 
X822XXS 
Intentional collision of motor vehicle with tree. 
X828XXA, X828XXD, 
X828XXS 
Other intentional self-harm by crashing of motor vehicle. 
X830XXA, X830XXD, 
X830XXS 
Intentional self-harm by crashing of aircraft. 
X831XXA, X831XXD, 
X831XXS  
Intentional self-harm by electrocution 
X832XXA, X832XXD, 
X832XXS 
Intentional self-harm by exposure to extremes of cold 
X838XXA, X838XXD, 
X838XXS 
Intentional self-harm by other specified means. 
 
Poisoning: 
T360X2A, T360X2D, T360X2S 
Poisoning by penicillins, intentional self-harm. 
T361X2A, T361X2D, T361X2S 
Poisoning by cephalosporins and other beta-lactam antibiotics, 
intentional self-harm. 
T362X2A, T362X2D, T362X2S 
Poisoning by chloramphenicol group, intentional self-harm. 
T363X2A, T363X2D, T363X2S 
Poisoning by macrolides, intentional self-harm. 
T364X2A, T364X2D, T364X2S 
Poisoning by tetracyclines, intentional self-harm. 
T365X2A, T365X2D, T365X2S 
Poisoning by aminoglycosides, intentional self-harm. 
T366X2A, T366X2D, T366X2S  
Poisoning by rifampicins, intentional self-harm.  
T367X2A, T367X2D, T367X2S  
Poisoning by antifungal antibiotics, intentional self-harm.  
T368X2A, T368X2D, T368X2S  
Poisoning by other systemic antibiotics, intentional self-harm.  
T3692XA, T3692XD, T3692XS  
Poisoning by unspecified systemic antibiotic, intentional self-
harm. 
T370X2A, T370X2D, T370X2S  
Poisoning by sulfonamides, intentional self-harm. 
T371X2A, T371X2D, T371X2S 
Poisoning by antimycobacterial drugs, intentional self-harm. 
T372X2A, T372X2D, T372X2S 
Poisoning by antimalarials and drugs acting on other blood 
protozoa, intentional self-harm. 
T373X2A, T373X2D, T373X2S 
Poisoning by other antiprotozoal drugs, intentional self-harm. 
T374X2A, T374X2D, T374X2S  
Poisoning by anthelminthics, intentional self-harm.  
T375X2A, T375X2D, T375X2S 
Poisoning by antiviral drugs, intentional self-harm. 
T378X2A, T378X2D, T378X2S  
Poisoning by other specified systemic anti-infectives and 
antiparasitics, intentional self-harm. 
T3792XA, T3792XD, T3792XS 
Poisoning by unspecified systemic anti-infective and 
antiparasitics, intentional self-harm. 
T380X2A, T380X2D, T380X2S 
Poisoning by glucocorticoids and synthetic analogues, 
intentional self-harm. 
T381X2A, T381X2D, T381X2S 
Poisoning by thyroid hormones and substitutes, intentional self-
harm. 
T382X2A, T382X2D, T382X2S  
Poisoning by antithyroid drugs, intentional self-harm. 
T383X2A, T383X2D, T383X2S  
Poisoning by insulin and oral hypoglycemic [antidiabetic] 
drugs, intentional self-harm. 
T384X2A, T384X2D, T384X2S 
Poisoning by oral contraceptives, intentional self-harm. 
T385X2A, T385X2D, T385X2S  
Poisoning by other estrogens and progestogens, intentional self-
harm. 
T386X2A, T386X2D, T386X2S  
Poisoning by antigonadotrophins, antiestrogens, antiandrogens, 
not elsewhere classified, intentional self-harm. 

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Poisoning: 
T387X2A, T387X2D, T387X2S  
Poisoning by androgens and anabolicongeners, intentional self-
harm. 
T38802A, T38802D, T38802S  
Poisoning by unspecified hormones and synthetic substitutes, 
intentional self-harm.  
T38812A, T38812D, T38812S  
Poisoning by anterior pituitary [adenohypophyseal] hormones, 
intentional self-harm.  
T38892A, T38892D, T38892S 
Poisoning by other hormones and synthetic substitutes, 
intentional self-harm.  
T38902A, T38902D, T38902S  
Poisoning by unspecified hormone antagonists, intentional self-
harm. 
T39012A, T39012D, T39012S  
Poisoning by aspirin, intentional self-harm.  
T39092A, T39092D, T39092S 
Poisoning by salicylates, intentional self-harm.  
T391X2A, T391X2D, T391X2S  
Poisoning by 4-Aminophenol derivatives, intentional self-harm. 
T392X2A, T392X2D, T392X2S  
Poisoning by pyrazolone derivatives, intentional self-harm.  
T39312A, T39312D, T39312S 
Poisoning by propionic acid derivatives, intentional self-harm.  
T39392A, T39392D, T39392S 
Poisoning by other nonsteroidal anti-inflammatory drugs 
[NASID], intentional self-harm.  
T394X2A, T394X2D, T394X2S 
Poisoning by antirheumatics, not elsewhere classified, 
intentional self-harm.  
T398X2A, T398X2D, T398X2S  
Poisoning by other nonopioid analgesics and antipyretics, not 
elsewhere classified, intentional self-harm. 
T3992XA, T3992XD, T3992XS 
Poisoning by unspecified nonopioid analgesic, antipyretic and 
antirheumatic, intentional self-harm.  
T400X2A, T400X2D, T400X2S  
Poisoning by opium, intentional self-harm. 
T401X2A, T401X2D, T401X2S  
Poisoning by heroin, intentional self-harm. 
T402X2A, T402X2D, T402X2S  
Poisoning by other opioids, intentional self-harm. 
T403X2A, T403X2D, T403X2S 
Poisoning by methadone, intentional self-harm. 
T404X2A, T404X2D, T404X2S  
Poisoning by other synthetic narcotics, intentional self-harm. 
T405X2A, T405X2D, T405X2S 
Poisoning by cocaine, intentional self-harm. 
T40602A, T40602D, T40602S  
Poisoning by unspecified narcotics, intentional self-harm. 
T407X2A, T407X2D, T407X2S  
Poisoning by cannabis (derivatives), intentional self-harm. 
T408X2A, T408X2D, T408X2S  
Poisoning by lysergide [LSD], intentional self-harm. 
T40902A, T40902D, T40902S  
Poisoning by unspecified psychodysleptics [hallucinogens], 
intentional self-harm. 
T40992A, T40992D, T40992S  
Poisoning by other psychodysleptics [hallucinogens], 
intentional self-harm. 
T410X2A, T410X2D, T410X2S  
Poisoning by inhaled anesthetics, intentional self-harm. 
T411X2A, T411X2D, T411X2S  
Poisoning by intravenous anesthetics, intentional self-harm. 
T41202A, T41202D, T41202S  
Poisoning by unspecified general anesthetics, intentional self-
harm. 
T41292A, T41292D, T41292S 
Poisoning by other general anesthetics, intentional self-harm. 
T413X2A, T413X2D, T413X2S 
Poisoning by local anesthetics, intentional self-harm. 
T4142XA, T4142XD, T4142XS 
Poisoning by unspecified anesthetic, intentional self-harm. 
T415X2A, T415X2D, T415X2S  
Poisoning by therapeutic gases, intentional self-harm.  
T420X2A, T420X2D, T420X2S 
Poisoning by hydantoin derivatives, intentional self-harm. 
T421X2A, T421X2D, T421X2S 
Poisoning by iminostilbenes, intentional self-harm. 
T422X2A, T422X2D, T422X2S 
Poisoning by succinimides and oxazolidinediones, intentional 
self-harm. 
T423X2A, T423X2D, T423X2S 
Poisoning by barbiturates, intentional self-harm. 
T424X2A, T424X2D, T424X2S 
Poisoning by benzodiazepines, intentional self-harm. 

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Poisoning: 
T425X2A, T425X2D, T425X2S 
Poisoning by mixed antiepileptics, intentional self-harm. 
T426X2A, T426X2D, T426X2S 
Poisoning by other antiepileptic and sedative-hypnotic drugs, 
intentional self-harm. 
T428X2A, T428X2D, T428X2S 
Poisoning by antiparkinsonism drugs and other central muscle-
tone depressants, intentional self-harm. 
T43012A, T43012D, T43012S  
Poisoning by tricyclic antidepressants, intentional self-harm. 
T431X2A, T431X2D, T431X2S 
Poisoning by monoamine-oxidase-inhibitor antidepressants, 
intentional self-harm. 
T43202A, T43202D, T43202S  
Poisoning by unspecified antidepressants, intentional self-harm. 
T43212A, T43212D, T43212S  
Poisoning by selective serotonin and norepinephrine reuptake 
inhibitors, intentional self-harm. 
T43222A, T43222D, T43222S  
Poisoning by selective serotonin reuptake inhibitors, intentional 
self-harm. 
T43292A, T43292D, T43292S  
Poisoning by other antidepressants, intentional self-harm. 
T433X2A, T433X2D, T433X2S  
Poisoning by phenothiazine antipsychotics and neuroleptics, 
intentional self-harm. 
T434X2A, T434X2D, T434X2S 
Poisoning by butyrophenone and thiothixene neuroleptics, 
intentional self-harm. 
T43502A, T43502D, T43502S  
Poisoning by unspecified antipsychotics and neuroleptics, 
intentional self-harm. 
T43592A, T43592D, T43592S  
Poisoning by other antipsychotics and neuroleptics, intentional 
self-harm. 
T43602A, T43602D, T43602S 
Poisoning by unspecified psychostimulants, intentional self-
harm. 
T43612A, T43612D, T43612S  
Poisoning by caffeine, intentional self-harm. 
T43622A, T43622D, T43622S 
Poisoning by amphetamines, intentional self-harm. 
T43632A, T43632D, T43632S 
Poisoning by methylphenidate, intentional self-harm. 
T43692A, T43692D, T43692S 
Poisoning by other psychostimulants, intentional self-harm. 
T438X2A, T438X2D, T438X2S  
Poisoning by other psychotropic drugs, intentional self-harm. 
T4392XA, T4392XD, T4392XS  
Poisoning by unspecified psychotropic drug, intentional self-
harm. 
T440X2A, T440X2D, T440X2S 
Poisoning by anticholinesterase agents, intentional self-harm. 
T441X2A, T441X2D, T441X2S  
Poisoning by other parasympathomimetics [cholinergics], 
intentional self-harm. 
T442X2A, T442X2D, T442X2S 
Poisoning by ganglionic blocking drugs, intentional self-harm. 
T443X2A, T443X2D, T443X2S  
Poisoning by other parasympatholytics [anticholinergics and 
antimuscarinics] and spasmolytics, intentional self-harm. 
T444X2A, T444X2D, T444X2S 
Poisoning by predominantly alpha-adrenoreceptor agonists, 
intentional self-harm. 
T446X2A, T446X2D, T446X2S 
Poisoning by alpha-adrenoreceptor antagonists, intentional self-
harm. 
T447X2A, T447X2D, T447X2S 
Poisoning by beta-adrenoreceptor antagonists, intentional self-
harm.  
T448X2A, T448X2D, T448X2S 
Poisoning by centrally-acting and adrenergic-neuron-blocking 
agents, intentional self-harm. 
T44902A, T44902D, T44902S 
Poisoning by unspecified drugs primarily affecting the 
autonomic nervous system, intentional self-harm. 
T450X2A, T450X2D, T450X2S  
Poisoning by antiallergic and antiemetic drugs, intentional self-
harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 37 of 51 
 
Poisoning: 
T451X2A, T451X2D, T451X2S 
Poisoning by antineoplastic and immunosuppressive drugs, 
intentional self-harm. 
T452X2A, T452X2D, T452X2S 
Poisoning by vitamins, intentional self-harm. 
T453X2A, T453X2D, T453X2S 
Poisoning by enzymes, intentional self-harm. 
T454X2A, T454X2D, T454X2S 
Poisoning by iron and its compounds, intentional self-harm. 
T45512A, T45512D, T45512S  
Poisoning by anticoagulants, intentional self-harm. 
T45522A, T45522D, T45522S 
Poisoning by antithrombotic drugs, intentional self-harm. 
T45602A, T45602D, T45602S 
Poisoning by unspecified fibrinolysis-affecting drugs, 
intentional self-harm. 
T45612A, T45612D, T45612S 
Poisoning by thrombolytic drug, intentional self-harm. 
T45622A, T45622D, T45622S 
Poisoning by hemostatic drug, intentional self-harm. 
T45692A, T45692D, T45692S 
Poisoning by other fibrinolysis-affecting drugs, intentional self-
harm. 
T457X2A, T457X2D, T457X2S 
Poisoning by anticoagulant antagonists, vitamin K and other 
coagulants, intentional self-harm. 
T458X2A, T458X2D, T458X2S 
Poisoning by other primarily systemic and hematological 
agents, intentional self-harm. 
T460X2A, T460X2D, T460X2S  
Poisoning by cardiac-stimulant glycosides and drugs of similar 
action, intentional self-harm. 
T461X2A, T461X2D, T461X2S 
Poisoning by calcium-channel blockers, intentional self-harm. 
T462X2A, T462X2D, T462X2S 
Poisoning by other antidysrhythmic drugs, intentional self-
harm. 
T463X2A, T463X2D, T463X2S 
Poisoning by coronary vasodilators, intentional self-harm. 
T464X2A, T464X2D, T464X2S 
Poisoning by angiotensin-converting-enzyme inhibitors, 
intentional self-harm. 
T465X2A, T465X2D, T465X2S 
Poisoning by other antihypertensive drugs, intentional self-
harm. 
T466X2A, T466X2D, T466X2S 
Poisoning by antihyperlipidemic and antiarteriosclerotic drugs, 
intentional self-harm. 
T467X2A, T467X2D, T467X2S 
Poisoning by peripheral vasodilators, intentional self-harm. 
T468X2A, T468X2D, T468X2S 
Poisoning by antivaricose drugs, including sclerosing agents, 
intentional self-harm. 
T46902A, T46902D, T46902S 
Poisoning by unspecified agents primarily affecting the 
cardiovascular system, intentional self-harm. 
T46992A, T46992D, T46992S  
Poisoning by other agents primarily affecting the 
cardiovascular system, intentional self-harm. 
T470X2A, T470X2D, T470X2S  
Poisoning by histamine H2-receptor blockers, intentional self-
harm. 
T471X2A, T471X2D, T471X2S  
Poisoning by other antacids and anti-gastric-secretion drugs, 
intentional self-harm. 
T472X2A, T472X2D, T472X2S 
Poisoning by stimulant laxatives, intentional self-harm. 
T473X2A, T473X2D, T473X2S 
Poisoning by saline and osmotic laxatives, intentional self-
harm. 
T474X2A, T474X2D, T474X2S 
Poisoning by other laxatives, intentional self-harm. 
T475X2A, T475X2D, T475X2S  
Poisoning by digestants, intentional self-harm. 
T476X2A, T476X2D, T476X2S 
Poisoning by antidiarrheal drugs, intentional self-harm. 
T477X2A, T477X2D, T477X2S 
Poisoning by emetics, intentional self-harm. 
T478X2A, T478X2D, T478X2S 
Poisoning by other agents primarily affecting gastrointestinal 
system, intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 38 of 51 
 
Poisoning: 
T4792XA, T4792XD, T4792XS  
Poisoning by unspecified agents primarily affecting 
gastrointestinal system, intentional self-harm. 
T480X2A, T480X2D, T480X2S  
Poisoning by oxytocic drugs, intentional self-harm. 
T481X2A, T481X2D, T481X2S 
Poisoning by skeletal muscle relaxants [neuromuscular 
blocking agents], intentional self-harm. 
T48202A, T48202D, T48202S  
Poisoning by unspecified drugs acting on muscles, intentional 
self-harm. 
T483X2A, T483X2D, T483X2S 
Poisoning by antitussives, intentional self-harm. 
T484X2A, T484X2D, T484X2S 
Poisoning by expectorants, intentional self-harm. 
T485X2A, T485X2D, T485X2S 
Poisoning by other anti-common-cold drugs, intentional self-
harm. 
T486X2A, T486X2D, T486X2S 
Poisoning by antiasthmatics, intentional self-harm. 
T48902A, T48902D, T48902S  
Poisoning by unspecified agents primarily acting on the 
respiratory system, intentional self-harm. 
T48992A, T48992D, T48992S 
Poisoning by other agents primarily acting on the respiratory 
system, intentional self-harm. 
T490X2A, T490X2D, T490X2S  
Poisoning by local antifungal, anti-infective and anti-
inflammatory drugs, intentional self-harm. 
T491X2A, T491X2D, T491X2S  
Poisoning by antipruritics, intentional self-harm. 
T492X2A, T492X2D, T492X2S 
Poisoning by local astringents and local detergents, intentional 
self-harm. 
T493X2A, T493X2D, T493X2S 
Poisoning by emollients, demulcents and protectants, 
intentional self-harm. 
T494X2A, T494X2D, T494X2S 
Poisoning by keratolytics, keratoplastics, and other hair 
treatment drugs, intentional self-harm. 
T495X2A, T495X2D, T495X2S 
Poisoning by ophthalmological drugs and preparations, 
intentional self-harm. 
T496X2A, T496X2D, T496X2S 
Poisoning by otorhinolaryngological drugs and preparations, 
intentional self-harm. 
T497X2A, T497X2D, T497X2S 
Poisoning by dental drugs, topically applied, intentional self-
harm. 
T498X2A, T498X2D, T498X2S 
Poisoning by other topical agents, intentional self-harm. 
T4992XA, T4992XD, T4992XS  
Poisoning by unspecified topical agent, intentional self-harm. 
T500X2A, T500X2D, T500X2S  
Poisoning by mineralocorticoids and their antagonists, 
intentional self-harm. 
T501X2A, T501X2D, T501X2S 
Poisoning by loop [high-ceiling] diuretics, intentional self-
harm. 
T501X2A, T501X2D, T501X2S 
Poisoning by carbonic-anhydrase inhibitors, benzothiadiazides 
and other diuretics, intentional self-harm. 
T503X2A, T503X2D, T503X2S 
Poisoning by electrolytic, caloric and water-balance agents, 
intentional self-harm. 
T504X2A, T504X2D, T504X2S 
Poisoning by drugs affecting uric acid metabolism, intentional 
self-harm. 
T505X2A, T505X2D, T505X2S 
Poisoning by appetite depressants, intentional self-harm. 
T506X2A, T506X2D, T506X2S 
Poisoning by antidotes and chelating agents, intentional self-
harm. 
T507X2A, T507X2D, T507X2S 
Poisoning by analeptics and opioid receptor antagonists, 
intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 39 of 51 
 
Poisoning: 
T508X2A, T508X2D, T508X2S 
Poisoning by diagnostic agents, intentional self-harm.  
T50A12A, T50A12D, T50A12S  
Poisoning by pertussis vaccine, including combinations with a 
pertussis component, intentional self-harm. 
T50A22A, T50A22D, T50A22S 
Poisoning by mixed bacterial vaccines, intentional self-harm. 
T50A92A, T50A92D, T50A92S 
Poisoning by other bacterial vaccines, intentional self-harm. 
T50B12A, T50B12D, T50B12S 
Poisoning by smallpox vaccines, intentional self-harm.  
T50B92A, T50B92D, T50B92S 
Poisoning by other viral vaccines, intentional self-harm. 
T50Z12A, T50Z12D, T50Z12S  
Poisoning by immunoglobulin, intentional self-harm. 
T50Z92A, T50Z92D, T50Z92S 
Poisoning by other vaccines and biological substances, 
intentional self-harm. 
T50902A, T50902D, T50902S 
Poisoning by unspecified drugs medicaments, and biological 
substances, intentional self-harm. 
T50992A, T50992D, T50992S 
Poisoning by other drugs, medicaments and biological 
substances, intentional self-harm. 
 
Toxic Effects 
T510X2A, T510X2D, T510X2S 
Toxic effect of ethanol, intentional self-harm. 
T511X2A, T511X2D, T511X2S 
Toxic effect of methanol, intentional self-harm. 
T512X2A, T512X2D, T512X2S 
Toxic effect of 2-Propanol, intentional self-harm. 
T513X2A, T513X2D, T513X2S 
Toxic effect of fusel oil, intentional self-harm. 
T518X2A, T518X2D, T518X2S 
Toxic effect of other alcohols, intentional self-harm. 
T519X2A, T519X2D, T519X2S 
Toxic effect of unspecified alcohol, intentional self-harm. 
T520X2A, T520X2D, T520X2S  
Toxic effect of petroleum products, intentional self-harm. 
T521X2A, T521X2D, T521X2S 
Toxic effect of benzene, intentional self-harm. 
T522X2A, T522X2D, T522X2S 
Toxic effect of homologues of benzene, intentional self-harm. 
T523X2A, T523X2D, T523X2S 
Toxic effect of glycols, intentional self-harm. 
T524X2A, T524X2D, T524X2S 
Toxic effect of ketones, intentional self-harm. 
T528X2A, T528X2D, T528X2S 
Toxic effect of other organic solvents, intentional self-harm. 
T5292XA, T5292XD, T5292XS 
Toxic effect of unspecified organic solvents, intentional self-
harm. 
T530X2A, T530X2D, T530X2S  
Toxic effect of carbon tetrachloride, intentional self-harm. 
T531X2A, T531X2D, T531X2S 
Toxic effect of chloroform, intentional self-harm. 
T532X2A, T532X2D, T532X2S 
Toxic effect of trichloroethylene, intentional self-harm. 
T534X2A, T534X2D, T534X2S 
Toxic effect of dichloromethane, intentional self-harm. 
T535X2A, T535X2D, T535X2S 
Toxic chlorofluorocarbons, intentional self-harm. 
T536X2A, T536X2D, T536X2S 
Toxic effect of other halogen derivative of aliphatic 
hydrocarbons, intentional self-harm. 
T537X2A, T537X2D, T537X2S 
Toxic effect of other halogen derivative of aromatic 
hydrocarbons, intentional self-harm. 
T5392XA, T5392XD, T5392XS  
Toxic effect of unspecified halogen derivative of aliphatic and 
aromatic hydrocarbons, intentional self-harm. 
T540X2A, T540X2D, T540X2S 
Toxic effect of phenol and phenol homologues, intentional self-
harm. 
T541X2A, T541X2D, T541X2S 
Toxic effect of other corrosive organic compounds, intentional 
self-harm. 
T542X2A, T542X2D, T542X2S 
Toxic effect of corrosive acids and acid-like substances, 
intentional self-harm. 
T543X2A, T543X2D, T543X2S 
Toxic effect of corrosive alkalis and alkali-like substances, 
intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 40 of 51 
 
Toxic Effects 
T5492XA, T5492XD, T5492XS  
Toxic effect of unspecified corrosive substance, intentional 
self-harm. 
T550X2A, T550X2D, T550X2S  
Toxic effect of soaps, intentional self-harm. 
T551X2A, T551X2D, T551X2S 
Toxic effect of detergents, intentional self-harm. 
T560X2A, T560X2D, T560X2S 
Toxic effect of lead and its compounds, intentional self-harm. 
T561X2A, T561X2D, T561X2S 
Toxic effect of mercury and its compounds, intentional self-
harm. 
T562X2A, T562X2D, T562X2S 
Toxic effect of chromium and its compounds, intentional self-
harm. 
T563X2A, T563X2D, T563X2S 
Toxic effect of cadmium and its compounds, intentional self-
harm. 
T564X2A, T564X2D, T564X2S 
Toxic effect of copper and its compounds, intentional self-
harm. 
T565X2A, T565X2D, T565X2S 
Toxic effect of zinc and its compounds, intentional self-harm. 
T566X2A, T566X2D, T566X2S 
Toxic effect of tin and its compounds, intentional self-harm. 
T567X2A, T567X2D, T567X2S 
Toxic effect of beryllium and its compounds, intentional self-
harm. 
T56812A, T56812D, T56812S 
Toxic effect of thallium and its compounds, intentional self-
harm. 
T56892A, T56892D, T56892S 
Toxic effect of other metals, intentional self-harm. 
T5692XA, T5692XD, T5692XS  
Toxic effect of unspecified metal, intentional self-harm. 
T570X2A, T570X2D, T570X2S  
Toxic effect of arsenic and its compounds, intentional self-
harm. 
T571X2A, T571X2D, T571X2S 
Toxic effect of phosphorus and its compounds, intentional self-
harm. 
T572X2A, T572X2D, T572X2S 
Toxic effect of manganese and its compounds, intentional self-
harm. 
T573X2A, T573X2D, T573X2S 
Toxic effect of hydrogen cyanide, intentional self-harm. 
T578X2A, T578X2D, T578X2S  
Toxic effect of other specified inorganic substances, intentional 
self-harm. 
T579X2A, T579X2D, T579X2S 
Toxic effect of unspecified inorganic substances, intentional 
self-harm. 
T5802XA, T5802XD, T5802XS 
Toxic effect of carbon monoxide from motor vehicle exhaust, 
intentional self-harm. 
T5812XA, T5812XD, T5812XS 
Toxic effect of carbon monoxide from utility gas, intentional 
self-harm. 
T582X2A, T582X2D, T582X2S  
Toxic effect of carbon monoxide from incomplete combustion 
of domestic fuels, intentional self-harm. 
T588X2A, T588X2D, T588X2S 
Toxic effect of carbon monoxide from other source, intentional 
self-harm. 
T5892XA, T5892XD, T5892XS  
Toxic effect of carbon monoxide from unspecified source, 
intentional self-harm. 
T590X2A, T590X2D, T590X2S  
Toxic effect of nitrogen oxides, intentional self-harm. 
T591X2A, T591X2D, T591X2S 
Toxic effect of sulfur dioxide, intentional self-harm. 
T592X2A, T592X2D, T592X2S 
Toxic effect of formaldehyde, intentional self-harm. 
T593X2A, T593X2D, T593X2S 
Toxic effect of lacrimogenic gas, intentional self-harm. 
T594X2A, T594X2D, T594X2S 
Toxic effect of chlorine gas, intentional self-harm. 
T595X2A, T595X2D, T595X2S 
Toxic effect of fluorine gas and hydrogen fluoride, intentional 
self-harm. 
T596X2A, T596X2D, T596X2S 
Toxic effect of hydrogen sulfide, intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 41 of 51 
 
Toxic Effects 
T597X2A, T597X2D, T597X2S 
Toxic effect of carbon dioxide, intentional self-harm. 
T59812A, T59812D, T59812S  
Toxic effect of smoke, intentional self-harm. 
T59892A, T59892D, T59892S  
Toxic effect of other gases, fumes and vapors, intentional self-
harm. 
T5992XA, T5992XD, T5992XS  
Toxic effect of unspecified gases, fumes and vapors, intentional 
self-harm. 
T600X2A, T600X2D, T600X2S  
Toxic effect of organophosphate and carbamate insecticides, 
intentional self-harm. 
T601X2A, T601X2D, T601X2S 
Toxic effect of halogenated insecticides, intentional self-harm. 
T602X2A, T602X2D, T602X2S 
Toxic effect of other insecticides, intentional self-harm. 
T603X2A, T603X2D, T603X2S 
Toxic effect of herbicides and fungicides, intentional self-harm. 
T604X2A, T604X2D, T604X2S 
Toxic effect of rodenticides, intentional self-harm. 
T608X2A, T608X2D, T608X2S 
Toxic effect of other pesticides, intentional self-harm. 
T6092XA, T6092XD, T6092XS  
Toxic effect of unspecified pesticide, intentional self-harm. 
T6102XA, T6102XD, T6102XS  
Ciguatera fish poisoning, intentional self-harm. 
T6112XA, T6112XD, T6112XS 
Scombroid fish poisoning, intentional self-harm. 
T61772A, T61772D, T61772S  
Other fish poisoning, intentional self-harm. 
T61782A, T61782D, T61782S  
Other shellfish poisoning, intentional self-harm. 
T618X2A, T618X2D, T618X2S  
Toxic effect of other seafood, intentional self-harm. 
T619X2A, T619X2D, T619X2S 
Toxic effect of unspecified seafood, intentional self-harm. 
T620X2A, T620X2D, T620X2S  
Toxic effect of ingested mushrooms, intentional self-harm. 
T621X2A, T621X2D, T621X2S 
Toxic effect of ingested berries, intentional self-harm. 
T622X2A, T622X2D, T622X2S 
Toxic effect of other ingested (parts of) plant(s), intentional 
self-harm. 
T628X2A, T628X2D, T628X2S 
Toxic effect of other specified noxious substances eaten as 
food, intentional self-harm. 
T6292XA, T6292XD, T6292XS 
Toxic effect of unspecified noxious substance eaten as food, 
intentional self-harm. 
T63002A, T63002D, T63002S  
Toxic effect of unspecified snake venom, intentional self-harm. 
T63012A, T63012D, T63012S 
Toxic effect of rattlesnake venom, intentional self-harm. 
T63022A, T63022D, T63022S 
Toxic effect of coral snake venom, intentional self-harm. 
T63032A, T63032D, T63032S 
Toxic effect of taipan venom, intentional self-harm. 
T63042A, T63042D, T63042S 
Toxic effect of cobra venom, intentional self-harm. 
T63062A, T63062D, T63062S 
Toxic effect of venom of other North and South American 
snake, intentional self-harm. 
T63072A, T63072D, T63072S 
Toxic effect of venom of other Australian snake, intentional 
self-harm. 
T63082A, T63082D, T63082S 
Toxic effect of venom of African and Asian snake, intentional 
self-harm. 
T63092A, T63092D, T63092S 
Toxic effect of venom of other snake, intentional self-harm. 
T63112A, T63112D, T63112S  
Toxic effect of venom of gila monster, intentional self-harm. 
T63122A, T63122D, T63122S 
Toxic effect of venom of other venomous lizard, intentional 
self-harm. 
T63192A, T63192D, T63192S 
Toxic effect of venom of other reptiles, intentional self-harm. 
T632X2A, T632X2D, T632X2S  
Toxic effect of venom of scorpion, intentional self-harm. 
T63302A, T63302D, T63302S 
Toxic effect of venom of unspecified spider venom, intentional 
self-harm. 
T63312A, T63312D, T63312S 
Toxic effect of venom of black widow spider, intentional self-
harm. 
T63322A, T63322D, T63322S 
Toxic effect of venom of tarantula, intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 42 of 51 
 
Toxic Effects 
T63332A, T63332D, T63332S 
Toxic effect of venom of brown recluse spider, intentional self-
harm. 
T63392A, T63392D, T63392S 
Toxic effect of venom of other spider, intentional self-harm. 
T63412A, T63412D, T63412S  
Toxic effect of venom of centipedes and venomous millipedes, 
intentional self-harm. 
T63422A, T63422D, T63422S 
Toxic effect of venom of ants, intentional self-harm. 
T63432A, T63432D, T63432S 
Toxic effect of venom of caterpillars, intentional self-harm. 
T63442A, T63442D, T63442S 
Toxic effect of venom of bees, intentional self-harm. 
T63452A, T63452D, T63452S 
Toxic effect of venom of hornets, intentional self-harm. 
T63462A, T63462D, T63462S 
Toxic effect of venom of wasps, intentional self-harm. 
T63482A, T63482D, T63482S 
Toxic effect of other arthropod, intentional self-harm. 
T63512A, T63512D, T63512S  
Toxic effect of contact with stingray, intentional self-harm. 
T63592A, T63592D, T63592S 
Toxic effect of contact with other venomous fish, intentional 
self-harm. 
T63612A, T63612D, T63612S  
Toxic effect of contact with Portuguese Man-o-war, intentional 
self-harm. 
T63622A, T63622D, T63622S 
Toxic effect of contact with sea anemone, intentional self-harm. 
T63692A, T63692D, T63692S 
Toxic effect of contact with other venomous marine animals, 
intentional self-harm. 
T63712A, T63712D, T63712S  
Toxic effect of contact with venomous marine plant, intentional 
self-harm. 
T63812A, T63812D, T63812S  
Toxic effect of contact with venomous frog, intentional self-
harm. 
T63822A, T63822D, T63822S 
Toxic effect of contact with venomous toad, intentional self-
harm. 
T63832A, T63832D, T63832S 
Toxic effect of contact with other venomous amphibian, 
intentional self-harm. 
T63892A, T63892D, T63892S 
Toxic effect of contact with other venomous animals, 
intentional self-harm. 
T6392XA, T6392XD, T6392XS 
Toxic effect of contact with unspecified venomous animal, 
intentional self-harm. 
T6402XA, T6402XD, T6402XS  
Toxic effect of aflatoxin, intentional self-harm. 
T6482XA, T6482XD, T6482XS 
Toxic effect of other mycotoxin food contaminants, intentional 
self-harm. 
T650X2A, T650X2D, T650X2S  
Toxic effect of cyanides, intentional self-harm. 
T651X2A, T651X2D, T651X2S  
Toxic effect of strychnine and its salts, intentional self-harm. 
T65212A, T65212D, T65212S  
Toxic effect of chewing tobacco, intentional self-harm. 
T65222A, T65222D, T65222S  
Toxic effect of tobacco cigarettes, intentional self-harm. 
T65292A, T65292D, T65292S 
Toxic effect of other tobacco and nicotine, intentional self-
harm. 
T653X2A, T653X2D, T653X2S  
Toxic effect of nitroderivatives and aminoderivatives of 
benzene and its homologues, intentional self-harm. 
T654X2A, T654X2D, T654X2S 
Toxic effect of carbon disulfide, intentional self-harm. 
T655X2A, T655X2D, T655X2S 
Toxic effect of nitroglycerin and other nitric acids and esters, 
intentional self-harm. 
T656X2A, T656X2D, T656X2S 
Toxic effect of paints and dyes, not elsewhere classified, 
intentional self-harm. 
T65812A, T65812D, T65812S 
Toxic effect of latex, intentional self-harm. 
T65822A, T65822D, T65822S 
Toxic effect of harmful algae and algae toxins, intentional self-
harm. 
T65832A, T65832D, T65832S 
Toxic effect of fiberglass, intentional self-harm. 

BEACON Suicide Prevention in Men Study – Dr. Simon Hatcher 
Study Protocol 
Version 1, Date: December 1, 2017 
Page 43 of 51 
 
Toxic Effects 
T65892A, T65892D, T65892S 
Toxic effect of other specified substances, intentional self-
harm. 
T6592XA, T6592XD, T6592XS  
Toxic effect of unspecified substance, intentional self-harm. 
 
Asphyxiation: 
T71112A, T71112D, T71112S 
Asphyxiation due to smothering under pillow, intentional self-
harm. 
T71122A, T71122D, T71122S 
Asphyxiation due to plastic bag, intentional self-harm. 
T71132A, T71132D, T71132S 
Asphyxiation due to being trapped in bed linens, intentional 
self-harm. 
T71152A, T71152D, T71152S 
Asphyxiation due to smothering in furniture, intentional self-
harm. 
T71162A, T71162D, T71162S 
Asphyxiation due to hanging, intentional self-harm. 
T71192A, T71192D, T71192S 
Asphyxiation due to mechanical threat to breathing due to other 
causes, intentional self-harm. 
T71222A, T71222D, T71222S  
Asphyxiation due to being trapped in a car trunk, intentional 
self-harm. 
T71232A, T71232D, T71232S  
Asphyxiation due to being trapped in a (discarded) refrigerator, 
intentional self-harm. 
* Note: Please note that all codes end in either A, D or S. These codes refer to (A) Initial Encounter, (D) 
Subsequent Encounter, or (S) Sequela. 
 
 
6.3. List of Substance Abuse ICD-10-CM Codes Included in Data Collection 
Code 
Description 
Alcohol: 
F1010 
Alcohol abuse, uncomplicated. 
F10120 
Alcohol abuse with intoxication, uncomplicated. 
F10121 
Alcohol abuse with intoxication delirium. 
F10129 
Alcohol abuse with intoxication, unspecified. 
F1014 
Alcohol abuse with alcohol-induced mood disorder. 
F10150 
Alcohol abuse with alcohol-induced psychotic disorder with 
delusions. 
F10151 
Alcohol abuse with alcohol-induced psychotic disorder with 
hallucinations. 
F10159 
Alcohol abuse with alcohol-induced psychotic disorder, 
unspecified. 
Alcohol: 
F10180 
Alcohol abuse with alcohol-induced anxiety disorder. 
F10181 
Alcohol abuse with alcohol-induced sexual dysfunction. 
F10182 
Alcohol abuse with alcohol-induced sleep disorder. 
F10188 
Alcohol abuse with other alcohol-induced disorder  
F1019 
Alcohol abuse with unspecified alcohol-induced disorder.  
 
Opioids: 
F1110 
Opioid abuse, uncomplicated. 
F11120 
Opioid abuse with intoxication, uncomplicated. 
F11121 
Opioid abuse with intoxication delirium. 
F11122 
Opioid abuse with intoxication with perceptual disturbance. 

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Opioids: 
F11129 
Opioid abuse with intoxication, unspecified. 
F1114 
Opioid abuse with opioid-induced mood disorder. 
F11150 
Opioid abuse with opioid-induced psychotic disorder with 
delusions. 
F11151 
Opioid abuse with opioid-induced psychotic disorder with 
hallucinations. 
F11159 
Opioid abuse with opioid-induced psychotic disorder, 
unspecified. 
F11181 
Opioid abuse with opioid-induced sexual dysfunction. 
F11182 
Opioid abuse with opioid-induced sleep disorder. 
F11188 
Opioid abuse with other opioid-induced disorder. 
F1119 
Opioid abuse with unspecified opioid-induced disorder. 
 
Cannabis: 
F12120 
Cannabis abuse with intoxication, uncomplicated. 
F12121 
Cannabis abuse with intoxication delirium. 
F12122 
Cannabis abuse with intoxication with perceptual disturbance. 
F12129 
Cannabis abuse with intoxication, unspecified. 
F12150 
Cannabis abuse with psychotic disorder with delusions. 
F12151 
Cannabis abuse with psychotic disorder with hallucinations. 
F12159 
Cannabis abuse with psychotic disorder, unspecified. 
F12180 
Cannabis abuse with cannabis-induced anxiety disorder. 
F12188 
Cannabis abuse with other cannabis-induced disorder. 
F1219 
Cannabis abuse with unspecified cannabis-induced disorder. 
 
Sedatives: 
F1310 
Sedative, hypnotic or anxiolytic abuse, uncomplicated. 
F13120 
Sedative, hypnotic or anxiolytic abuse with intoxication, 
uncomplicated. 
F13121 
Sedative, hypnotic or anxiolytic abuse with intoxication 
delirium. 
F13129 
Sedative, hypnotic or anxiolytic abuse with intoxication, 
unspecified. 
F1314 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced mood disorder. 
F13150 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced psychotic disorder with delusions. 
F13151 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced psychotic disorder with hallucinations. 
F13159 
Sedative hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced psychotic disorder, unspecified. 
F13180 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced anxiety disorder. 
F13181 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced sexual dysfunction. 
F13182 
Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic 
or anxiolytic-induced sleep disorder. 
F13188 
Sedative, hypnotic or anxiolytic abuse with other sedative, 
hypnotic or anxiolytic-induced disorder. 
F1319 
Sedative, hypnotic or anxiolytic abuse with unspecified 
sedative, hypnotic or anxiolytic-induced disorder. 

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Stimulants: 
F1410 
Cocaine abuse, uncomplicated. 
F14120 
Cocaine abuse with intoxication, uncomplicated. 
F14121 
Cocaine abuse with intoxication with delirium. 
F14122 
Cocaine abuse with intoxication with perceptual disturbance. 
F14129 
Cocaine abuse with intoxication, unspecified. 
F1414 
Cocaine abuse with cocaine-induced mood disorder. 
F14150 
Cocaine abuse with cocaine-induced psychotic disorder with 
delusions. 
F14151 
Cocaine abuse with cocaine-induced psychotic disorder with 
hallucinations. 
F14159 
Cocaine abuse with cocaine-induced psychotic disorder, 
unspecified. 
F14180 
Cocaine abuse with cocaine-induced anxiety disorder. 
F14181 
Cocaine abuse with cocaine-induced sexual dysfunction. 
F14182 
Cocaine abuse with cocaine-induced sleep disorder. 
F14188 
Cocaine abuse with other cocaine-induced disorder. 
F1419 
Cocaine abuse with unspecified cocaine-induced disorder. 
F1510 
Other stimulant abuse, uncomplicated. 
F15120 
Other stimulant abuse with intoxication, uncomplicated. 
F15121 
Other stimulant abuse with intoxication delirium. 
F15122 
Other stimulant abuse with intoxication with perceptual 
disturbance. 
F15129 
Other stimulant abuse with intoxication, unspecified. 
F1514 
Other stimulant abuse with stimulant-induced mood disorder. 
F15150 
Other stimulant abuse with stimulant-induced psychotic 
disorder with delusions. 
F15151 
Other stimulant abuse with stimulant-induced psychotic 
disorder with hallucinations. 
F15159 
Other stimulant abuse with stimulant-induced psychotic 
disorder, unspecified. 
F15180 
Other stimulant abuse with stimulant-induced anxiety disorder. 
F15181 
Other stimulant abuse with stimulant-induced sexual 
dysfunction. 
F15182 
Other stimulant abuse with stimulant-induced sleep disorder. 
F15188 
Other stimulant abuse with other stimulant-induced disorder. 
F1519 
Other stimulant abuse with unspecified stimulant-induced 
disorder. 
 
 
Hallucinogens: 
F1610 
Hallucinogen abuse, uncomplicated. 
F16120 
Hallucinogen abuse with intoxication, uncomplicated. 
F16121 
Hallucinogen abuse with intoxication with delirium. 
F16122 
Hallucinogen abuse with intoxication with perceptual 
disturbance. 
F16129 
Hallucinogen abuse with intoxication, unspecified. 
F1614 
Hallucinogen abuse with hallucinogen-induced mood disorder. 
F16150 
Hallucinogen abuse with hallucinogen-induced psychotic 
disorder with delusions. 

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Hallucinogens: 
F16151 
Hallucinogen abuse with hallucinogen-induced psychotic 
disorder with hallucinations. 
F16159 
Hallucinogen abuse with hallucinogen-induced psychotic 
disorder, unspecified. 
F16180 
Hallucinogen abuse with hallucinogen-induced anxiety 
disorder. 
F16183 
Hallucinogen abuse with hallucinogen persisting perception 
disorder (flashbacks). 
F16188 
Hallucinogen abuse with other hallucinogen-induced disorder. 
F1619 
Hallucinogen abuse with unspecified hallucinogen-induced 
disorder. 
 
Inhalants: 
F1810 
Inhalant abuse, uncomplicated. 
F18120 
Inhalant abuse with intoxication, uncomplicated. 
F18121 
Inhalant abuse with intoxication delirium. 
F18129 
Inhalant abuse with intoxication, unspecified 
F1814 
Inhalant abuse with inhalant-induced mood disorder. 
F18150 
Inhalant abuse with inhalant-induced psychotic disorder with 
delusions. 
F18151 
Inhalant abuse with inhalant-induced psychotic disorder with 
hallucinations. 
F18159 
Inhalant abuse with inhalant-induced psychotic disorder, 
unspecified. 
F1817 
Inhalant abuse with inhalant-induced dementia. 
F18180 
Inhalant abuse with inhalant-induced anxiety disorder. 
F18188 
Inhalant abuse with other inhalant-induced disorder. 
F1819 
Inhalant abuse with unspecified inhalant-induced disorder 
 
Other Psychoactive Substances: 
F1910 
Other psychoactive substance abuse, uncomplicated. 
F19120 
Other psychoactive substance abuse with intoxication, 
uncomplicated. 
F19121 
Other psychoactive substance abuse with intoxication delirium. 
F19122 
Other psychoactive substance abuse with intoxication with 
perceptual disturbances. 
F19129 
Other psychoactive substance abuse with intoxication, 
unspecified. 
F1914 
Other psychoactive substance abuse with psychoactive 
substance-induced mood disorder. 
F19150 
Other psychoactive substance abuse with psychoactive 
substance-induced psychotic disorder with delusions. 
F19151 
Other psychoactive substance abuse with psychoactive 
substance-induced psychotic disorder with hallucinations. 
F19159 
Other psychoactive substance abuse with psychoactive 
substance-induced psychotic disorder, unspecified. 
F1916 
Other psychoactive substance abuse with psychoactive 
substance-induced persisting amnestic disorder. 

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Other Psychoactive Substances: 
F1917 
Other psychoactive substance abuse with psychoactive 
substance-induced persisting dementia. 
F19180 
Other psychoactive substance abuse with psychoactive 
substance-induced anxiety disorder. 
F19181 
Other psychoactive substance abuse with psychoactive 
substance-induced sexual dysfunction. 
F19182 
Other psychoactive substance abuse with psychoactive 
substance-induced sleep disorder. 
F19188 
Other psychoactive substance abuse with other psychoactive 
substance-induced disorder. 
 
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