A Randomized Control Trial of a Digital Health Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

mHealth Intervention for Older Adults

NCT03398590

Type2 Diabetes Obesity

COMPLETED NA

Intern Health Study 2022 and 2023

NCT05436145

Depression Mood Sleep +1 more

COMPLETED NA

Make Better Choices

NCT01249989

Health Behavior

COMPLETED NA

Mobile Health Intervention to Support Healthful Diet

NCT05236712

Frailty

COMPLETED NA

Lifestyle MIND- Feasibility of Wait-list Control

NCT06384521

Type 2 Diabetes Mellitus Serious Mental Illness Schizophrenia +2 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide and Self-harm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Lock to Live Intervention Arm

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.

Group Type ACTIVE_COMPARATOR

Lock to Live

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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/).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No