Clinical trial NCT05288517: A Randomized Control Trial of a Digital Health Tool
Official title: Firearm Safe Storage Decision Aid for Adults With Suicide Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide and Self-harm
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 20131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anonymous Survey measuring Change Readiness developed after Prochaska and DiClemente's stage of change theory.
timeFrame: Between 2 weeks and 4 weeks following invitation to Lock to Live intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente Colorado, Institute for Health Research
state: Colorado
Study officials:
affiliation: Institute for Health Research, Kaiser Permanente Colorado
name: Jennifer M Boggs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.