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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

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE June 20, 2018
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Acceptability of Lethal Means Decision Aid [ Time Frame: Baseline ]
    This will be assessed using the Ottawa Acceptability Questionnaire that captures the patient's feedback with both survey and open ended questions.
  • Decision Making Quality in 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assisting in Decisions in Emergency Departments: (ED-AID) Study
Official Title  ICMJE Assisting in Informing Decisions in Emergency Departments: (ED-AID) Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Suicide
  • Emergencies
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Decision Aid Group
    Participants randomized to this arm will view the decision aid on a tablet in the emergency department.
    Intervention: Behavioral: Decision Aid
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)		 49
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)		 60
Actual Study Completion Date  ICMJE April 9, 2019
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03478501
Other Study ID Numbers  ICMJE 17-2299
R34MH113539-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Colorado, Denver
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Colorado, Denver
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Harvard School of Public Health (HSPH)
  • Denver Health and Hospital Authority
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Marian Betz, MD, MPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP