Skip to main content
OpenTrials
Completed

NCT Number: NCT05288517

A Randomized Control Trial of a Digital Health Tool

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Colorado, Institute for Health Research

Aurora, Colorado, 80014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lock to Live

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Firearm Safe Storage Decision Aid for Adults With Suicide Ideation

Acronym: L2L

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 21, 2022
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.