Psychiatric HospitalizationNCT05294549
Implementation of Caring Contacts
A study testing Caring Contact in people with Psychiatric Hospitalization, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Hospitalization
- What is being tested?
- Caring Contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A primary diagnosis of a Major Neurocognitive Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Psychiatric Hospitalization
- Being tested
- Caring Contact
- Keywords
- Suicide Prevention
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring ContactOther
The Caring Contact intervention is an email with messages of hope, support and resource information sent to patients post-discharge from psychiatric hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Caring Contact | Experimental | Not described Receives: Other: Caring Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback questionnaire
Feedback questionnaire responses using Likert scales will be quantified and compared as a measure of acceptability of the intervention.
Measured: Through study completion about 1 year
Focus group responses
Qualitative thematic analyses will be used to evaluate the focus group transcripts.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, up to 14 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start11 Apr 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rosalie Steinberg, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294549
- Sponsor's protocol ID
- 5262
- Status last verified
- Jul 2023
- First submitted
- 7 Mar 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Caring Contacts Using Patient Feedback to Reduce Suicidal Ideation Following Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT05294549
- Acronym / sponsor ID
- 5262
- Conditions
- Psychiatric Hospitalization
- Keywords
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caring Contact | Experimental | Other: Caring Contact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- A primary diagnosis of a Major Neurocognitive Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caring ContactThe Caring Contact intervention is an email with messages of hope, support and resource information sent to patients post-discharge from psychiatric hospitalization. | Other | Caring Contact |
Primary outcome
Feedback questionnaire
Time frame: Through study completion about 1 year
Feedback questionnaire responses using Likert scales will be quantified and compared as a measure of acceptability of the intervention.
Focus group responses
Time frame: Through first 3 months of study
Qualitative thematic analyses will be used to evaluate the focus group transcripts.
Hopkins Symptom Checklist-25 (HSCL-25)
Time frame: Baseline, up to 14 days post-discharge
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.
The Entrapment Scale
Time frame: Baseline, up to 14 days post-discharge
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.
Beck Scale for Suicidal Ideation (BSI)
Time frame: Baseline, up to 14 days post-discharge
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Contact in people with Psychiatric Hospitalization, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback questionnaire (time frame: Through study completion about 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.