A Randomized Control Trial of a Digital Health Tool (L2L)

Kaiser Permanente

Status: Completed

Conditions: Suicide and Self-harm

Treatments: Behavioral: Lock to Live

Study type: Interventional

Funder types: Other

Identifiers

NCT05288517

1477456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,131 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Control patients received three invitations for a survey only and were blind to the L2L intervention.

Lock to Live Intervention Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Lock to Live