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Completed

NCT Number: NCT04720911

Technology-Assisted Systems Change for Suicide Prevention

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-person TASCS

Behavioral

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.

Telehealth TASCS

Behavioral

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.

Self-administered TASCS

Behavioral

Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.

Follow-up care

Behavioral

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

Primary outcomes

  1. Number of Participants With a Suicide Attempt in the Past Three Months

    Time frame: 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.

  2. Number of Patients With Active Ideation in Past Week at 3-month Follow-up

    Time frame: 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 outcomes

  1. Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)

    Time frame: 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.

  2. Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)

    Time frame: 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 .

  3. Drive Subscale of the Behavioral Activation Scale (Continuous)

    Time frame: 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.

  4. Suicide-related Impulse Control (Continuous)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Worcester Polytechnic Institute

Registry information

Acronym: TASCS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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