Suicide and Self-harmL2LNCT05288517

A Randomized Control Trial of a Digital Health Tool

A study testing Lock to Live in people with Suicide and Self-harm, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Suicide and Self-harm
What is being tested?: Lock to Live
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20,131 participants
Where: 1 siteUnited States
Study dates: 19 Apr 2021to 1 Mar 2022
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Colorado, Institute for Health Research
Aurora, Colorado, 80014

Other trials in United States

About this study

Official title: Firearm Safe Storage Decision Aid for Adults With Suicide Ideation

Read the detailed 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.

Conditions: Suicide and Self-harm
Being tested: Lock to Live
Medical subject headings: Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05288517
Study group	Role	What they receive
Control Arm	No intervention	Control patients received three invitations for a survey only and were blind to the L2L intervention.
Lock to Live Intervention Arm	Active comparator	Patients in the Intervention Arm received the invitation to Lock to Live, including up to 3 EHR invitation messages plus three messages to complete a follow-up survey evaluating study outcomes. Receives: Behavioral: Lock to Live

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Between 2 weeks and 4 weeks following invitation to Lock to Live intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20211 Mar 2022

First posted21 Mar 2022
Study start19 Apr 2021
Primary completion31 Dec 2021
Study completion1 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients identified as at risk for suicide using a prediction model were randomized using a 1:1 allocation to receive invitation to visit Lock to Live (L2L) or control.
Masking: Single blind
Who is masked: Participant
Enrolment: 20,131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05288517
Sponsor's protocol ID: 1477456
Acronym: L2L
Status last verified: Mar 2022
First submitted: 10 Mar 2022
Last updated: 4 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29169036
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.
PubMed 32598076
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.
PubMed 30317220
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.
PubMed 24036589
Boggs JM, Quintana LM, Beck A, Clarke CL, Richardson L, Conley A, Buckingham ET, Richards JE, Betz ME. A Randomized Control Trial of a Digital Health Tool for Safer Firearm and Medication Storage for Patients with Suicide Risk. Prev Sci. 2024 Feb;25(2):358-368. doi: 10.1007/s11121-024-01641-6. Epub 2024 Jan 11.
PubMed 38206548

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Firearm Safe Storage Decision Aid for Adults With Suicide Ideation
ClinicalTrials.gov ID: NCT05288517
Acronym / sponsor ID: L2L / 1477456
Conditions: Suicide and Self-harm
Study type: Interventional
Recruitment status: Completed
Enrolment: 20,131 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Study start: 19 Apr 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 1 Mar 2022 (actual)
First posted: 21 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.

Detailed description

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Patients identified as at risk for suicide using a prediction model were randomized using a 1:1 allocation to receive invitation to visit Lock to Live (L2L) or control.

Arm	Type	Receives
Control Arm	No intervention	–Control patients received three invitations for a survey only and were blind to the L2L intervention.
Lock to Live Intervention Arm	Active comparator	Behavioral: Lock to LivePatients in the Intervention Arm received the invitation to Lock to Live, including up to 3 EHR invitation messages plus three messages to complete a follow-up survey evaluating study outcomes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

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

Primary outcome

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

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 4 Apr 2022.
Background: PubMed 29169036Betz 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.
Background: PubMed 32598076Diurba 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.
Background: PubMed 30317220Betz 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.
Background: PubMed 24036589Simon 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.
Derived from this study: PubMed 38206548Boggs JM, Quintana LM, Beck A, Clarke CL, Richardson L, Conley A, Buckingham ET, Richards JE, Betz ME. A Randomized Control Trial of a Digital Health Tool for Safer Firearm and Medication Storage for Patients with Suicide Risk. Prev Sci. 2024 Feb;25(2):358-368. doi: 10.1007/s11121-024-01641-6. Epub 2024 Jan 11.
Decision-aid tool for safer firearm and medication storageLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Jennifer M Boggs, PhD principal investigator

Institute for Health Research, Kaiser Permanente Colorado

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lock to Live in people with Suicide and Self-harm, run by Kaiser Permanente at 1 site in United States.

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 6 inclusion and 6 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 4 Apr 2022. 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 United States. 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?

Anonymous Survey measuring Change Readiness developed after Prochaska and DiClemente's stage of change theory. (time frame: Between 2 weeks and 4 weeks following invitation to Lock to Live intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05288517, which also lists 5 linked publications.

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 4 Apr 2022.