Clinical trial NCT05656781: Brief Intervention and Contact Program Main Trial
Official title: An Innovative Brief Intervention Contact Program to Improve Healthcare Delivery for Suicidal Behaviour
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Behavior
Keywords: suicide
thoughts
attempts
brief intervention
contact
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 220
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Suicide is a significant public health concern and causes approximately 1.5% of all deaths in the general population in Canada. Research shows that for individuals with comorbid psychiatric illness and suicidal behaviour, the risk of further suicide attempts persists in the first two years post-discharge with the most vulnerable time being the period immediately post discharge.

Several studies have found that alongside usual treatment, follow-up with discharged patients through text messaging, phone calls and letters, contributes to a reduction in attempts and death by suicide, and instances of self-harm. In particular, brief contact interventions have shown positive impacts in reducing further completed suicide and suicidal behaviour in patients presenting to the emergency department following a suicide attempt.

The BIC model followed in this study is adapted from the WHO protocol that was utilised as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS).

Detailed description: Rationale The time post discharge from psychiatric hospital is a vulnerable time for suicide risk especially in patients with past suicidal behaviour as they are less likely to adhere to treatment post discharge with risk of being disengaged from healthcare services. The period after discharge therefore presents as a gap in patient care that needs to be addressed. Brief contact interventions are seen as a potential solution to this gap, thus providing justification for a trial such as this one, to test the effectiveness in a Canadian population.

Significance The rate of death by suicide has been static for past 20 years however suicidal behaviour is more dynamic with variable rates seen in those identified as high risk groups including those with a history of suicidal behaviour, males, youth, and the indigenous community. As such, there is a need to identify a feasible and accessible risk reduction strategy that can mitigate suicidal behaviour and empower individuals to leverage their social support system. We have completed a feasibility and pilot RCT study of BIC in one centre including 60 participants followed up for 6 months, which demonstrates the feasibility and justification of a main trial.

Innovation This is the first RCT that aims to impact and improve healthcare service delivery for patients with suicidal behaviour by testing a pragmatic intervention that can be easily translated into regular medical practice across institutions. This RCT builds on a pilot and feasibility trial, which has allowed for quality improvements that tailor the intervention to fit seamlessly into the discharge process. Specifically,

1. A warm transfer has been incorporated into the study design to help the intervention resemble what it would look like if it were translated into regular medical practice. This warm transfer is also important as the highest loss to follow-up rates were seen in the first point of contact post-discharge. As such, a warm transfer will remind and inform the participant that they will be receiving support and contact post hospital discharge, impacting and improving healthcare service delivery.
2. The Harbinger of Hope letter drafted by a person with lived experience will be given to the participants in the intervention arm, which directly impacts and improves healthcare service delivery by considering communication and peer supports outside of the regular care team. Participants will also be notified about the BeSafe smartphone and web application to access community support services specific to their needs (i.e. peer support, housing support, crisis services etc.), further emphasizing the focus on care outside of the most resources intense healthcare team.
3. The incorporation of a unified text message and phone call system, through a major cellular service provider, combined with the mailing of resources to participants in the intervention arm, represent advanced communication and flexible contact strategies that improve patients' accessibility and delivery of healthcare. Currently using text messaging is not possible through usual hospital communications. Participants in the pilot trial identified text messages as a preferred and low-cost option for them.
4. The incorporation of a qualitative component inquiring about participants experiences with healthcare services and the intervention will encourage participants to continue to engage in the contacts that are provided to them as the open-ended questions may be cathartic and provide a space for them to express their voices. The focus on the participants' voices once again profoundly impacts and improves healthcare service delivery by providing a platform for participants to engage. This this may also reduce disengagement and "no show" rates to appointments.
5. The primary outcomes for this study include a reduction in suicidal behaviour (death by suicide, suicide attempts and thoughts) and healthcare utilization (ER visits \& readmissions), and an observation of the use of crisis service calls. The occurrence of these outcomes was lower in the intervention arm compared to the control arm when assessed in the pilot and feasibility trial (figure 1.0), which provides the justification for selecting these outcomes in a larger trial. Having these synonymous, clear, and measurable outcomes for the RCT will allow for the appropriate assessment of the effectiveness of BIC and will directly inform the translation of BIC into medical practice.
6. Crisis services were alerted during two of the phone contacts in the pilot and feasibility trial due to risk of the participant engaging in a suicide attempt which was averted. This highlights the clinical significance of the pilot and feasibility trial and provides a strong basis to continue the evaluation of the BIC intervention to eventually incorporate it into regular medical practice. It also provides evidence for the improvement of healthcare delivery as these follow-ups with participants provide the opportunity for them to re-engage with mental health services when needed and provides them with more options than an emergency room visit.
7. BIC was implemented by research staff in the pilot and feasibility trial. It will continue to be performed by research assistants that have received the appropriate safety, sensitivity, and informational trainings. This provides yet another key transferable aspect of the intervention into regular medical practice as there is no requirement for the intervention to be carried out by a mental health professional and can be administered by BIC trained personnel thus reducing the demands on services and intensive training required to deliver mental health care.

OBJECTIVES

1. Our primary aims are A) to assess the effectiveness of BIC on reducing suicidal behaviour (i.e., death by suicide and suicide thoughts/ideas and attempts) and healthcare utilization (i.e., ER visits \& readmissions) post hospital discharge. B) assess the effects of BIC on crisis services used post discharge
2. Our secondary aims are to use qualitative semi-structured interviews A) to understand participants' experiences with healthcare services post discharge, including descriptions of:

   1. Participants' satisfaction with healthcare services
   2. Participants' expectations of healthcare services
   3. Participants' perceived level of social connectivity and social support

B) to understand participants' experiences with the BIC intervention, including descriptions of:

1. Participants' satisfaction with the intervention
2. Participants' perspective on the effectiveness of the intervention
3. Changes participants want to make to the intervention
4. Participants' experiences with the Harbinger of Hope letter given to them during the intervention

Eligibility criteria: Inclusion Criteria:

* Admitted following a suicidal behaviour (suicide attempt or with suicidal ideation),
* At least 16 years of age, no restrictions on sex or gender
* Provide written, informed consent,
* Provide consent for research staff to have access to their electronic medical record (EMR),
* Provide consent for research staff to contact their primary care provider, outpatient and other healthcare providers care team, if necessary,
* Provide health card number and consent to share with Institute for Clinical Evaluative Sciences and link to Ontario health records to analyze and evaluate events such as admissions, death by suicide and usage of health care services (such as hospitalizations) in Ontario for the period covering the study time and 2 years post study completion. The 2 years post discharge will not be feasible to continue follow up for this trial and are reported to be a risk period in the literature. Therefore, we opted to leverage administrative health record data to enrich the study impact post study completion.

Exclusion criteria

- We will exclude patients who are unable to understand written and spoken English, as the research staff/clinicians delivering the intervention are limited to English-speaking populations.

Primary outcomes:
measure: Suicidal behaviour
timeFrame: 6 months
measure: Healthcare service utilization
timeFrame: 6 months
measure: Crisis services
timeFrame: 6 months
Secondary outcomes:
measure: Experiences with healthcare services post discharge
timeFrame: 6 months
measure: Experiences with the BIC intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
Study officials:
affiliation: McMaster Unversity
name: Zainab Samaan, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: