Technology-Assisted Systems Change for Suicide Prevention

Study Overview
=================
Brief Summary
-----------------
Effective prevention of suicide among adult emergency department (ED) patients hinges on an indispensable component: the ability to translate evidence-based interventions into routine clinical practice on a broad scale and with fidelity to the intervention components so they can have a maximum public health effect. However, there are critical barriers that prevent such translation, including a lack of trained clinicians, competing priorities in busy EDs, and incompatibility between requirements of evidence-based interventions (such as completing telephone coaching with patients after the ED visit) and the workflow and infrastructure typically present in most EDs. The proposed new intervention will address these barriers by building a suite of technologies that will make it easier to implement the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE), an evidence-based suicide intervention targeting perceived social support, behavioral activation and impulse control, revolutionizing the field's ability to scale and implement this intervention and acting as a model for efforts to implement other existing and emerging suicide interventions.

Detailed Description
-----------------
The TASCS will be the first health information technology designed to enable flexible delivery of the ED-SAFE intervention components with strong fidelity and with responsiveness to the conditions and barriers present in most EDs. This will include an integrated approach to delivering components usually completed during the ED visit, such as personalized safety planning, as well as those completed after the visit, such as coaching to foster mental health treatment engagement. This R34 addresses both patient and implementation outcomes. Aim 1 will use persona development, an innovative human computer interaction approach, to ensure the TASCS is intimately informed by end users. Aim 2 will optimize the TASCS in a small field test in the ED. Aim 3, modeled after a Hybrid Type 2 effectiveness-implementation design, will gather data on usability, acceptability, and implementation of the TASCS ED App using a randomized experiment (n=45) of three modalities: (1) On site (n=15), (2) Telehealth (n=15), and (3) Self-administered (n=15). For 3 months post-discharge, all participants will receive coaching calls, facilitated by the Post-ED Clinician App, and will have access to the Post-ED Patient and Family App. The intervention is intended to decrease suicidal ideation and behavior by improving perceived social support, increasing behavioral activation, and improving suicide-related impulse control. Building a comprehensive suite of integrated enabling technologies to address ED-SAFE translation barriers will not only improve ED-SAFE intervention adoption, it will provide a road map for how to do the same for other suicide interventions, both existing and those yet to be developed, maximizing impact on the field.

Official Title
-----------------
Technology-Assisted Systems Change for Suicide Prevention

Conditions
-----------------
Suicide, Suicide, Attempted

Intervention / Treatment
-----------------
* Behavioral: In-person TASCS
* Behavioral: Telehealth TASCS
* Behavioral: Self-administered TASCS
* Behavioral: Follow-up care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Presenting to selected emergency departments during the study period Screened positive for active suicidal ideation in the past 2 weeks or attempt in the past 6 months Has a smartphone and access to the internet Exclusion Criteria: Cognitively impaired (as assessed by study staff) <18 years of age Prisoner.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person TASCS<br>This intervention is designed to assess the TASCS app administered via an in-person clinician in the ED, with follow-up telephone calls by a clinician | Behavioral: In-person TASCS<br>* In-person clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.<br>Behavioral: Follow-up care<br>* Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan<br>|
| Active Comparator: Telehealth TASCS<br>This comparison condition is designed to assess the telehealth modality of TASCS in the ED (in contrast to in-person clinician modality), with follow-up telephone calls by a clinician | Behavioral: Telehealth TASCS<br>* Telehealth clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.<br>Behavioral: Follow-up care<br>* Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan<br>|
| Active Comparator: Self-administered TASCS<br>This comparison condition is designed to assess the self-administered modality of TASCS (in contrast to clinician modality), with follow-up telephone calls by a clinician | Behavioral: Self-administered TASCS<br>* Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.<br>Behavioral: Follow-up care<br>* Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide attempt (binary) | Suicide Attempt is based upon participant response to Actual Suicide Attempt question within the Suicidal and Self-Injury Behavior subsection of the Columbia Suicide Severity Rating Scale (C-SSRS). The question is a yes/no with a checking of the box selection meaning yes, Actual Suicide Attempt and blank/unchecked means no, no Actual Suicide Attempt. The timeframe applied will be past three months. | 3 months | 
| Suicidal ideation (binary, ordinal) | Presence (yes/no) and severity (a score of 0 being no ideation, least severe, 5 being intent and plan, most severe) of suicidal ideation within the past week and past three months as measured by the 'Suicidal Ideation (Most Severe)' subsection of the Columbia Suicide Severity Rating Scale. A higher score means a worse outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral activation (continuous) | Behavioral activation as measured by the Drive subscale of the Behavioral Activation Scale, part of the BIS/BAS Scale. This Drive subscale has a minimum score of 4 and maximum of 16, with a higher score representing a better outcome. | 3 months | 
| Perceived social support (continuous) | Perceived social support as measured by the Interpersonal Needs Questionnaire (INQ-15). This scale has a minimum score of 15 and maximum of 105, with a higher score representing lower perceived social support. | 3 months | 
| Suicide-related impulse control (continuous) | Suicide-related impulse control will be assessed the Recent Impulsivity Scale, a two-item scale (How strong was the impulse (urgent need) to plan or to act in any suicidal way?; How difficult was it for you to suppress or to restrain the impulse to plan or to act in any suicidal way?) on a five-point scale from Not at all to Extremely. The instrument has a minimum score of 0 and a maximum score of 8, with a higher score representing a worse outcome. | 3 months |