NCT05294549

Brief Summary

This quality improvement (QI) project will adapt and improve an evidence-based suicide-prevention initiative for Sunnybrook patients at high risk of suicide following psychiatric inpatient discharge, targeting one of Sunnybrook's QI Plan goals of reducing suicide at Sunnybrook. Caring Contacts, brief communications of hope, support and information sent to patients post-discharge, are a simple and low-cost intervention with proven effectiveness in reducing suicide attempts, suicidal ideation, and loneliness, while increasing hopefulness and feelings of connection to the health care system. Pilot data provides some initial, promising evidence however additional patient input is required to improve the acceptability and effectiveness of the intervention to reduce suicide-related outcomes. Feedback from patients and peer advisors will guide iterative improvements with the ultimate goal of implementing an improved version of Caring Contacts as a standard clinical practice for all patients discharged from the Sunnybrook Adult Inpatient Psychiatry Unit. For phase one of this QI project, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality and community members with lived experience of psychiatric hospitalization and suicidality. Investigators will conduct focus groups on the inpatient unit of 8-12 inpatient participants to gather feedback about the current Caring Contact intervention. For community members virtual focus groups will be conducted. For phase two, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality. The updated intervention will be sent to 8-12 participants. Then investigators will host virtual focus groups to gather feedback from these participants about the intervention. For phase three, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality. Investigators will send the revised intervention to 30-40 participants. Participants will complete symptom and feedback questionnaires when they receive the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

March 7, 2022

Last Update Submit

July 7, 2023

Conditions

Keywords

Suicide Prevention

Outcome Measures

Primary Outcomes (5)

  • Feedback questionnaire

    Feedback questionnaire responses using Likert scales will be quantified and compared as a measure of acceptability of the intervention.

    Through study completion about 1 year

  • Focus group responses

    Qualitative thematic analyses will be used to evaluate the focus group transcripts.

    Through first 3 months of study

  • Hopkins Symptom Checklist-25 (HSCL-25)

    The HSCL-25 is a widely used self-report questionnaire using a Likert scale to measure mood symptoms. The HSCL-25 has an item for suicidal ideation. Total change scores and suicidal ideation change scores will be used to assess the effectiveness of intervention. Minimum total score is 25, maximum is 100. A higher score equals a worse outcome.

    Baseline, up to 14 days post-discharge

  • The Entrapment Scale

    The Entrapment scale is a 16 item scale used to identify feelings of entrapment, which is a driver for suicidal behaviour. Total change scores will be used to assess the effectiveness of the intervention. Minimum total score is 0, maximum is 80. A higher score equals a worse outcome.

    Baseline, up to 14 days post-discharge

  • Beck Scale for Suicidal Ideation (BSI)

    The BSI is a self-report questionnaire with 21 items used to detect and measuring the current intensity of an individual's attitudes, behaviors, and plans to commit suicide during the past week. Total change scores will be used to assess the effectiveness of the intervention.

    Baseline, up to 14 days post-discharge

Study Arms (1)

Caring Contact

EXPERIMENTAL
Other: Caring Contact

Interventions

The Caring Contact intervention is an email with messages of hope, support and resource information sent to patients post-discharge from psychiatric hospitalization.

Caring Contact

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of written informed consent
  • Age 18 or above
  • Ability to read and understand English
  • Have an email address
  • The ability to understand and comply with the requirements of the project and capable of providing informed consent

You may not qualify if:

  • A primary diagnosis of a Major Neurocognitive Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4H 1R1, Canada

Location

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 24, 2022

Study Start

April 11, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations