A Randomized Control Trial of a Digital Health Tool (L2L)
Primary Purpose
Suicide and Self-harm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lock to Live
Sponsored by
About this trial
This is an interventional health services research trial for Suicide and Self-harm
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
Sites / Locations
- Kaiser Permanente Colorado, Institute for Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Arm
Lock to Live Intervention Arm
Arm Description
Control patients received three invitations for a survey only and were blind to the L2L intervention.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05288517
Brief Title
A Randomized Control Trial of a Digital Health Tool
Acronym
L2L
Official Title
Firearm Safe Storage Decision Aid for Adults With Suicide Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
20131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Control patients received three invitations for a survey only and were blind to the L2L intervention.
Arm Title
Lock to Live Intervention Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lock to Live
Intervention Description
Lock to Live is an anonymous web-based self-administered decision aid for safe firearm and medication storage (Public URL: http://lock2live.com/).
Primary Outcome Measure Information:
Title
Anonymous Survey measuring Change Readiness developed after Prochaska and DiClemente's stage of change theory.
Description
Patient reported readiness to change safe storage behavior for firearms and medications.
Time Frame
Between 2 weeks and 4 weeks following invitation to Lock to Live intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M Boggs, PhD
Organizational Affiliation
Institute for Health Research, Kaiser Permanente Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Colorado, Institute for Health Research
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29169036
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.
Results Reference
background
PubMed Identifier
32598076
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.
Results Reference
background
PubMed Identifier
30317220
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.
Results Reference
background
PubMed Identifier
24036589
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.
Results Reference
background
Links:
URL
https://lock2live.org/
Description
Decision-aid tool for safer firearm and medication storage
Learn more about this trial
A Randomized Control Trial of a Digital Health Tool
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