A Randomized Control Trial of a Digital Health Tool

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Firearm Safe Storage Decision Aid for Adults With Suicide Ideation

Conditions
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Suicide and Self-harm

Intervention / Treatment
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* Behavioral: Lock to Live


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Control patients received three invitations for a survey only and were blind to the L2L intervention. | |
| Active Comparator: Lock to Live Intervention Arm<br>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. | Behavioral: Lock to Live<br>* Lock to Live is an anonymous web-based self-administered decision aid for safe firearm and medication storage (Public URL: http://lock2live.com/).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |