- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294549
Implementation of Caring Contacts
Implementation of Caring Contacts Using Patient Feedback to Reduce Suicidal Ideation Following Psychiatric Hospitalization
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4H 1R1
- Sunnybrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
For inclusion in the outpatient focus groups participants must additionally have previous lived experience of psychiatric hospitalization with suicidal ideation or behaviour.
For inclusion in the inpatient focus groups during phase one and for inclusion in the second and third phases of the project, participants must additionally 1) be an inpatient on the Sunnybrook Adult Inpatient Psychiatry Unit at the time of recruitment and 2) they must have been admitted to the unit with suicidal ideation or behaviour as determined by their C-SSRS score at admission.
Exclusion Criteria:
- A primary diagnosis of a Major Neurocognitive Disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caring Contact
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The Caring Contact intervention is an email with messages of hope, support and resource information sent to patients post-discharge from psychiatric hospitalization.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feedback questionnaire
Time Frame: Through study completion about 1 year
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Feedback questionnaire responses using Likert scales will be quantified and compared as a measure of acceptability of the intervention.
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Through study completion about 1 year
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Focus group responses
Time Frame: Through first 3 months of study
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Qualitative thematic analyses will be used to evaluate the focus group transcripts.
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Through first 3 months of study
|
Hopkins Symptom Checklist-25 (HSCL-25)
Time Frame: Baseline, up to 14 days post-discharge
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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
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The Entrapment Scale
Time Frame: Baseline, up to 14 days post-discharge
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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.
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Baseline, up to 14 days post-discharge
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Beck Scale for Suicidal Ideation (BSI)
Time Frame: Baseline, up to 14 days post-discharge
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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.
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Baseline, up to 14 days post-discharge
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5262
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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