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

NCT03478501 | Completed DMC

• 2 other identifiers: 17-2299R34MH113539-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

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.

Conditions

Suicide; Emergencies

Keywords

firearm; lethal means; decision aid

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Decision Aid Group

EXPERIMENTAL

Participants randomized to this arm will view the decision aid on a tablet in the emergency department.

Behavioral: Decision Aid

Control Group

NO INTERVENTION

Participants randomized to this arm will be asked to review general suicide prevention information on a tablet in the emergency department.

Interventions

Decision Aid BEHAVIORAL

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.

Decision Aid Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Harvard School of Public Health (HSPH): collaborator
• Denver Health and Hospital Authority: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 32012056 DERIVED

MeSH Terms

Conditions

Suicide; Emergencies

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Marian Betz, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 27, 2018
• Study Start: June 20, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)