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

NCT ID: NCT03478501

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2019-04-09

Brief Summary

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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

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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.

Conditions

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Suicide Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Decision Aid Group

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

Group Type EXPERIMENTAL

Decision Aid

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marian Betz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Memorial Hospital

Colorado Springs, Colorado, United States

Site Status

Denver Health

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32012056 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R34MH113539-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-2299

Identifier Type: -

Identifier Source: org_study_id

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