Safety Planning 6+

Suicide Clinical Trial

— SP6+  

Official title:

Veteran-Centered, ED-based Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216327
• Other study ID #: CDX 24-001
• Secondary ID: 1IK2HX002861-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Suzanne Thomas, MA
• Phone: (303) 399-8020
• Email: Suzanne.thomas4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans seeking emergency care - a population previously identified as having elevated risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA emergency departments and urgent care settings and are identified as having elevated suicide risk.

Description:

The investigators will pilot the ED-based LMS intervention among up to 50 Veterans to assess feasibility and acceptability.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Encounter at VHA ED or urgent care setting ->17 years
• Discharged home from the ED (rather than hospital admission)
• Suicide risk is determined to be intermediate or high based on the CSRE results
• Patient elects to review a new or updated Safety Plan as part of their clinical care
• Patient-reported access to firearms and/or medications

Exclusion Criteria:

• Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
• Unreliable telephone access
• Those currently experiencing unsheltered homelessness
• No mailing address
• Active opioid or stimulant use disorder
• Active alcohol use disorder with daily alcohol consumption

Related Conditions & MeSH terms

• Firearm Injury
• Overdose
• Suicide

Intervention

Behavioral:
• enhanced lethal means Safety Plan
This intervention includes standardized Safety Planning, but is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study recruitment	Ability to recruit 30 Veterans in one year	through study completion, an average of one year
Primary	Feasibility of study follow up	>70% follow up	approximately 30 days
Primary	participant short term intervention satisfaction	>70% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32.	day of intervention delivery - day 0
Primary	participant intervention satisfaction	Qualitative evaluation of participant's experiences	at 4 weeks
Primary	Comfort with intervention discussion	"How comfortable did you feel engaging in the discussion? " Likert responses: Very uncomfortable Uncomfortable Neither Comfortable Very comfortable	day of intervention delivery - day 0
Primary	Intervention helpfulness in medication decisions	"How helpful was your interaction in making decisions about medication storage and safety?" Likert responses: Not at all Slightly helpful Moderately helpful Very helpful Extremely helpful	day of intervention delivery - day 0
Primary	Intervention helpfulness in firearm decisions	"How helpful was your interaction in making decisions about firearm storage?" Likert responses: Not at all Slightly helpful Moderately helpful Very helpful Extremely helpful	day of intervention delivery - day 0
Primary	Respectfulness of the intervention	"To what extent was this intervention respectful of your values as a firearm owner? Likert responses: Very disrespectful Disrespectful Neither Respectful Very respectful	day of intervention delivery - day 0
Secondary	Institutional Trust	On a scale from 0 to 10, where 10 indicates complete trust and 0 indicates complete distrust (so 5 would indicate that you neither trust, nor distrust), please indicate your level of trust in the VA healthcare system?	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Suicide methods knowledge	What is the proportion of veteran suicides that are due to firearm injuries? Answer range: 0 to 100%	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Medication disposal knowledge	How many ways do you know of to dispose of unwanted household medications? Answer range: 0 to 20	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Beliefs about importance of secure medication storage when someone is suicidal	"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important." It is important to securely store medications when I or someone in my household has had recent thoughts of suicide. Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Beliefs about importance of secure medication storage always	"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important." It is always important to securely store medications regardless of suicide risk for someone in the home. Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Beliefs about importance of secure firearm storage when someone is suicidal	"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important." It is important to securely store firearms when I or someone in my household has had recent thoughts of suicide. Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Beliefs about importance of secure firearm storage always	"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important." It is always important to store firearms securely in a locked space, or with a cable/trigger lock, regardless of suicide risk for someone in the home. Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Beliefs about importance of unloaded firearm storage always	"On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important." It is always important to securely store firearms unloaded regardless of suicide risk for someone in the home. Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Firearm storage storage Stage of Change	One thing some people consider to reduce their risk of suicide or injury to others in their household is to securely store all firearms. Can you tell me your thoughts on that? On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]? Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Medication storage storage Stage of Change	One thing some people consider to reduce their risk of suicide or injury to others in their household is to securely store all medications. Can you tell me your thoughts on that? On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]? Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Number of firearms in household	Number of firearms in household: Answer range: 0 to 10,000	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Medication adherence	"To what extent have you had difficulty remembering to take your medications in the past month?" Likert responses: Never Rarely Sometimes Very Often Always	at 4 weeks
Secondary	Change in firearm storage practices	Changes in whether household firearms are present, and whether present firearms are stored securely. Answers: Yes, all of them are locked Yes, some of them are locked None of them are locked I'm not sure	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Change in medication storage practices	Changes in whether household medication is present, and whether present medication is stored securely. Answer options: Yes, all of the medications in my home are locked up Yes, some of the medications in my home are locked up None of the medications in my home are locked up I'm not sure	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Keeping firearms for protection	On a scale of 0 to 10, to what extent do you keep your firearms to protect yourself or your loved ones from other people? Someone who answers 0 does not consider themselves to keep firearms for protection, while someone who answers 10 considers that their firearms are absolutely required for protection. Answer range: 0-10	at 4 weeks
Secondary	Firearm removal stage of change	One of the safest things someone can do while they're going through a difficult time is to store their firearms outside of the home with someone they trust. Is that something you've ever considered? Can you tell me your thoughts on that? On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]? Answer range: 0-10	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Change in access to firearm storage combination	Changes in who has access to household locking combinations.; Answer options: You Your spouse or partner Children under the age of 18 years Children 18 years of age or older A friend A neighbor Other:__________	Day of intervention delivery (day 0) and at 4 weeks
Secondary	Change in ammunition storage practices	Changes in whether household ammunition is present, and whether present ammunition is stored securely. Answer options: Yes, all of the ammunition is locked Yes, some of the ammunition is locked None of the ammunition is locked I'm not sure No ammunition is in my home	Day of intervention delivery (day 0) and at 4 weeks