Clinical trial NCT03478501: Assisting in Decisions in Emergency Departments: (ED-AID) Study
Official title: Assisting in Informing Decisions in Emergency Departments: (ED-AID) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Emergencies
Keywords: firearm
lethal means
decision aid
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Denver Health and Hospital Authority
name: National Institute of Mental Health (NIMH)
First posted: 2018-03-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test a patient decision aid about safe firearm storage during suicidal crisis. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis.

Detailed description: Limiting access to a firearms during suicidal crisis can save lives. This study will test a patient decision aid about safe firearm storage during crisis. The investigators will enroll 60 adult emergency department patients being evaluated for suicidal risk and have at least one firearm at home. If available, the investigators will also enroll a family member or friend. Participants will randomly receive one of two things: the decision aid or general suicide prevention information. A week later, the investigators will call participants to see how both groups choose to store their firearms. This trial tests the acceptability of the decision aid, effects on decision making, effect on home storage, effect on suicide outcomes, and feasibility of a larger trial. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis; should the pilot demonstrate feasibility, in a subsequent larger trial this hypothesis would be tested directly.

Eligibility criteria: Inclusion Criteria:

* Being evaluated in the emergency department for suicidal ideation/suicide attempt
* Deemed medically stable by ED physician
* Age greater than or equal to 18 years old
* Able and willing to have telephone follow up at 1 week
* Report at least one firearm in the home

Exclusion Criteria:

* Unable to participate medically or cognitively (e.g. sustained altered level of consciousness, hostility, psychosis, sexual assault victim, severe vomiting or pain)
* Currently in legal custody
* Live in group home or other supervised custody
* Already enrolled

Primary outcomes:
measure: Acceptability of Lethal Means Decision Aid
timeFrame: Baseline
measure: Decision Making Quality in Emergency Department (ED)
timeFrame: Baseline
measure: Home Firearm Storage
timeFrame: Baseline and 1 week follow up
measure: Decision Making Quality - Follow up
timeFrame: 1 week follow up
measure: Suicidal Ideation and Behavior at One Month
timeFrame: 1 month post baseline
measure: Suicidal Ideation and Behavior at Three Months
timeFrame: 3 months post baseline
measure: Vital Statistics (Suicide death)
timeFrame: 3 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Marian Betz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betz ME, Knoepke CE, Simpson S, Siry BJ, Clement A, Saunders T, Johnson R, Azrael D, Boudreaux ED, Omeragic F, Adams LM, Almond S, Juarez-Colunga E, Matlock DD. An Interactive Web-Based Lethal Means Safety Decision Aid for Suicidal Adults (Lock to Live): Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Jan 29;22(1):e16253. doi: 10.2196/16253.