An interventional study of Decision Aid in Suicide and Emergencies, sponsored by University of Colorado, Denver. Completed at 3 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's enrollment of 49 is below the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Participants randomized to this arm will view the decision aid on a tablet in the emergency department.
Behavioral: Decision Aid
Participants randomized to this arm will be asked to review general suicide prevention information on a tablet in the emergency department.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months post baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Apr 2019, 9 months.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 9 months is below that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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