Assisting in Decisions in Emergency Departments: (ED-AID) Study

Suicide Clinical Trial

— ED-AID  

Official title:

Assisting in Informing Decisions in Emergency Departments: (ED-AID) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478501
• Other study ID #: 17-2299
• Secondary ID: R34MH113539-01
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: April 9, 2019

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Suicide

Intervention

Behavioral:
• Decision Aid
This intervention is a tablet based Lethal Means Decision Aid with proposed use to augment lethal means counseling in emergency departments for patients at risk of suicide.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Memorial Hospital	Colorado Springs	Colorado
United States	Denver Health	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority, Harvard School of Public Health, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Lethal Means Decision Aid	This will be assessed using the Ottawa Acceptability Questionnaire that captures the patient's feedback on the design, presentation, quality, and information presented in the decision aid through both survey and open ended questions. Questions include likert scale responses (range of responses are specific to each question's content). There are also a series of yes/no/don't know questions related to content presented. Each "no" response asks the participant to elaborate in an open ended response. The participant also has the ability to provide general feedback in open ended feedback format. There are no subscales to this measure.	Baseline
Primary	Decision Making Quality in Emergency Department (ED)	The Decisional Conflict Scale (DCS), low literacy 10 item scale, measures decision quality, uncertainty, personal perceptions and satisfaction. A total score is computed through sum of items 1-10 (Yes=1; unsure=2; no=4) divided by 10, and multiplied by 25. Scores range from 0 (no decision conflict) to 100 (extreme decision conflict). The sum of items 1, 2, 3, divided by 3 and multiplied by 25 is the informed decision subscale (1 extremely informed) to 100 extremely uninformed). The sum of items 4 and 5, divided by 2 and multiplied by 25 is the values clarity (0 feels extremely clear to 100 feels extremely unclear). The sum of items 9 and 10, divided by 2 and multiplied by 25 is the uncertainty subscale (0 feels extremely certain about best choice to 100 feels extremely uncertain about best choice). The sum of items 6, 7, 8, divided by 3 and multiplied by 25 is the support subscale (0 feels extremely supported in decision making to 100 feels extremely unsupported in decision making).	Baseline
Primary	Home Firearm Storage	At both baseline and one week follow up, participants will complete a study specific survey that asks about how they currently store their firearms or current plans to change how they store their firearms to measure change in storage.	Baseline and 1 week follow up
Primary	Decision Making Quality - Follow up	The Decisional Conflict Scale (DCS), low literacy 10 item scale, measures decision quality, uncertainty, personal perceptions and satisfaction. A total score is computed through sum of items 1-10 (Yes=1; unsure=2; no=4) divided by 10, and multiplied by 25. Scores range from 0 (no decision conflict) to 100 (extreme decision conflict). The sum of items 1, 2, 3, divided by 3 and multiplied by 25 is the informed decision subscale (1 extremely informed) to 100 extremely uninformed). The sum of items 4 and 5, divided by 2 and multiplied by 25 is the values clarity (0 feels extremely clear to 100 feels extremely unclear). The sum of items 9 and 10, divided by 2 and multiplied by 25 is the uncertainty subscale (0 feels extremely certain about best choice to 100 feels extremely uncertain about best choice). The sum of items 6, 7, 8, divided by 3 and multiplied by 25 is the support subscale (0 feels extremely supported in decision making to 100 feels extremely unsupported in decision making).	1 week follow up
Primary	Suicidal Ideation and Behavior at One Month	While this pilot trial is not powered to detect a change in mental health outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide attempts and outcomes through medical record chart review.	1 month post baseline
Primary	Suicidal Ideation and Behavior at Three Months	While this pilot trial is not powered to detect a change in mental health outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide attempts and outcomes through medical record chart review.	3 months post baseline
Primary	Vital Statistics (Suicide death)	While this pilot trial is not powered to detect a change in suicide outcomes, as part of the feasibility for a larger trial, the investigators will attempt to track suicide death outcomes through state vital statistics reporting.	3 months post baseline