A Randomized Control Trial of a Digital Health Tool

Suicide and Self-harm Clinical Trial

— L2L  

Official title:

Firearm Safe Storage Decision Aid for Adults With Suicide Ideation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288517
• Other study ID #: 1477456
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial evaluated whether sending population-based invitation messages through the electronic health record to visit Lock to Live (L2L), a web-based decision aid that incorporates patients' values into recommendations for safe storage of firearms and medications, impacted readiness to change firearm and medication storage behaviors.

Description:

Lock to Live (L2L) is a web-based decision aid that incorporates patients' values into recommendations for safe storage of firearms and medications. This randomized trial evaluated whether sending population-based invitation messages to visit L2L through the Electronic Health Record (EHR) to patients treated in primary care and mental health specialty settings with elevated suicide risk, identified using a prediction model, impacted readiness to change firearm and medication storage behaviors.

Patients were identified using previously validated suicide risk prediction models developed within the Mental Health Research Network (MHRN). These models are highly predictive of suicide attempt and death by suicide for both a 30-day and 90-day period. Patients in the 75-99.5th risk percentiles were randomized. Half were randomized to receive L2L+survey (intervention) and half received survey only (control).

and control groups. Over 21,000 unique patients were enrolled over a 6-month period.

Survey respondents were assigned to one of five groups based on readiness for change:

pre-contemplative (do not believe in safe storage), contemplative (believe in safe storage but not doing it), thinking (considering changing storage), preparation (planning to change storage), or action (safely storing). Data will be analyzed using chi-square, logistic and multinomial logit models to test for differences between intervention and control groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20131
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years or older (>18 yrs.)

• suicide risk based on validated risk algorithm (patients falling within the 75th- 99th risk percentile based on the suicide risk algorithm)

• Patients with a recent visit within Mental Health department or within Primary Care department w. Mental Health diagnosis (recent defined as within the prior month from the date of the algorithm run date)

• English noted as primary language, or patient flag for interpreter needed is not set

• Patient is not deceased

• Patient is registered on kp.org to receive online message

Exclusion Criteria:

• A recorded diagnosis of: Dementia/ or other cognitive impairment (including developmental delay), Psychosis, Schizophrenia, Autism Spectrum Disorder

• Non-English speaker

• Receiving home-based palliative care, or hospice care

• In a skilled nursing facility

• On the Research Exclusion list - Do Not Contact

• Patient has flag for health proxy

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicide
• Suicide and Self-harm

Intervention

Behavioral:
• Lock to Live
Lock to Live is an anonymous web-based self-administered decision aid for safe firearm and medication storage (Public URL: http://lock2live.com/).

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado, Institute for Health Research	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (4)

Betz ME, Kautzman M, Segal DL, Miller I, Camargo CA Jr, Boudreaux ED, Arias SA. Frequency of lethal means assessment among emergency department patients with a positive suicide risk screen. Psychiatry Res. 2018 Feb;260:30-35. doi: 10.1016/j.psychres.2017.11.038. Epub 2017 Nov 14. — View Citation

Betz ME, Knoepke CE, Siry B, Clement A, Azrael D, Ernestus S, Matlock DD. 'Lock to Live': development of a firearm storage decision aid to enhance lethal means counselling and prevent suicide. Inj Prev. 2019 Sep;25(Suppl 1):i18-i24. doi: 10.1136/injuryprev-2018-042944. Epub 2018 Oct 13. — View Citation

Diurba S, Johnson RL, Siry BJ, Knoepke CE, Suresh K, Simpson SA, Azrael D, Ranney ML, Wintemute GJ, Betz ME. Lethal Means Assessment and Counseling in the Emergency Department: Differences by Provider Type and Personal Home Firearms. Suicide Life Threat Behav. 2020 Oct;50(5):1054-1064. doi: 10.1111/sltb.12649. Epub 2020 Jun 29. — View Citation

Simon GE, Rutter CM, Peterson D, Oliver M, Whiteside U, Operskalski B, Ludman EJ. Does response on the PHQ-9 Depression Questionnaire predict subsequent suicide attempt or suicide death? Psychiatr Serv. 2013 Dec 1;64(12):1195-202. doi: 10.1176/appi.ps.201200587. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anonymous Survey measuring Change Readiness developed after Prochaska and DiClemente's stage of change theory.	Patient reported readiness to change safe storage behavior for firearms and medications.	Between 2 weeks and 4 weeks following invitation to Lock to Live intervention.

External Links

•   Decision-aid tool for safer firearm and medication storage