A Randomized Control Trial of a Digital Health Tool

NCT05288517 | Completed

• 1 other identifier: 1477456
• Study Type: interventional
• Target: 20,131
• Locations: 1 country
• Sites: 1

Brief 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 medication storage behaviors.

Conditions

Suicide and Self-harm

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Lock to Live

Interventions

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/).

Lock to Live Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient has flag for health proxy

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Colorado, Institute for Health Research

Aurora, Colorado, 80014, United States

Location

Related Publications (5)

• 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.

  PMID: 29169036 BACKGROUND

• 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.

  PMID: 32598076 BACKGROUND

• 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.

  PMID: 30317220 BACKGROUND

• 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.

  PMID: 24036589 BACKGROUND

• 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.

  PMID: 38206548 DERIVED

Related Links

• Decision-aid tool for safer firearm and medication storage

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer M Boggs, PhD

  Institute for Health Research, Kaiser Permanente Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: April 19, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)