Technology-Assisted Systems Change for Suicide Prevention

NCT ID: NCT04720911

Last Updated: 2024-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Suicide Suicide, Attempted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

In-person TASCS

Intervention Type 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.

Follow-up care

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Telehealth TASCS

Intervention Type 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.

Follow-up care

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Self-administered TASCS

Intervention Type BEHAVIORAL

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

Follow-up care

Intervention Type 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

Interventions

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In-person TASCS

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.

Intervention Type BEHAVIORAL

Telehealth TASCS

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.

Intervention Type BEHAVIORAL

Self-administered TASCS

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

Intervention Type BEHAVIORAL

Follow-up care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Worcester Polytechnic Institute

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Celine Larkin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celine Larkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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Larkin C, Tulu B, Djamasbi S, Garner R, Varzgani F, Siddique M, Pietro J, Boudreaux ED. Comparing the Acceptability and Quality of Intervention Modalities for Suicidality in the Emergency Department: Randomized Feasibility Trial. JMIR Ment Health. 2023 Oct 24;10:e49783. doi: 10.2196/49783.

Reference Type DERIVED
PMID: 37874619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34MH123578

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00020238

Identifier Type: -

Identifier Source: org_study_id

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