Technology-Assisted Systems Change for Suicide Prevention

Not Applicable

Completed

Conditions: Suicide
Suicide, Attempted

Interventions: Behavioral: Self-administered TASCS
Behavioral: Telehealth TASCS
Behavioral: In-person TASCS
Behavioral: Follow-up care

Registration Number: NCT04720911

Lead Sponsor: University of Massachusetts, Worcester

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person TASCS	Follow-up care	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
Self-administered TASCS	Self-administered TASCS	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
Telehealth TASCS	Telehealth TASCS	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
Telehealth TASCS	Follow-up care	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
In-person TASCS	In-person TASCS	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
Self-administered TASCS	Follow-up care	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Suicide Attempt in the Past Three Months	3 months	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". We also reviewed the medical chart for ED presentations to ascertain whether the participant presented to the ED for a suicide attempt. The timeframe applied was past three months.
Number of Patients With Active Ideation in Past Week at 3-month Follow-up	3 months	Presence (yes/no) of active suicidal ideation within the past week as measured by the 'Suicidal Ideation (Most Severe)' subsection of the Columbia Suicide Severity Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)	3 months	Thwarted belongingness as a subscale of the Interpersonal Needs Questionnaire (INQ-15). This subscale has a minimum score of 9 and maximum of 63, with a higher score representing higher thwarted belongingness.
Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)	3 months	Perceived burdensomeness as a subscale of the Interpersonal Needs Questionnaire (INQ-15). This subscale has a minimum score of 6 and maximum of 42, with a higher score representing higher perceived burdensomeness .
Drive Subscale of the Behavioral Activation Scale (Continuous)	3 months	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.
Suicide-related Impulse Control (Continuous)	3 months	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 1 and a maximum score of 5, with a higher score representing a worse outcome.