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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03478501
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : June 24, 2021
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
Denver Health and Hospital Authority
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Suicide Emergencies Behavioral: Decision Aid Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assisting in Informing Decisions in Emergency Departments: (ED-AID) Study
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : April 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Decision Aid Group
Participants randomized to this arm will view the decision aid on a tablet in the emergency department.
 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.
No Intervention: Control Group
Participants randomized to this arm will be asked to review general suicide prevention information on a tablet in the emergency department.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of Lethal Means Decision Aid [ Time Frame: Baseline ]
    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.

  2. Decision Making Quality in Emergency Department (ED) [ Time Frame: Baseline ]
    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).

  3. Home Firearm Storage [ Time Frame: Baseline and 1 week follow up ]
    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.

  4. Decision Making Quality - Follow up [ Time Frame: 1 week 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).

  5. Suicidal Ideation and Behavior at One Month [ Time Frame: 1 month post baseline ]
    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.

  6. Suicidal Ideation and Behavior at Three Months [ Time Frame: 3 months post baseline ]
    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.

  7. Vital Statistics (Suicide death) [ Time Frame: 3 months post baseline ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478501


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Memorial Hospital
Colorado Springs, Colorado, United States, 80909
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Harvard School of Public Health (HSPH)
Denver Health and Hospital Authority
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Marian Betz, MD, MPH University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] February 20, 2018
Informed Consent Form  [PDF] February 20, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03478501    
Other Study ID Numbers: 17-2299
R34MH113539-01 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
firearm
lethal means
decision aid
Additional relevant MeSH terms:
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Emergencies
Suicide
Disease Attributes
 Pathologic Processes
Self-Injurious Behavior
Behavioral Symptoms