Technology-Assisted Systems Change for Suicide Prevention

NCT04720911 | Completed Results DMC

• 2 other identifiers: H00020238R34MH123578
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Suicide, Attempted

Outcome Measures

Primary Outcomes (2)

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

  3 months

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

  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.

  3 months

Secondary Outcomes (4)

• Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)

  3 months

• Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)

  3 months

• Drive Subscale of the Behavioral Activation Scale (Continuous)

  3 months

• Suicide-related Impulse Control (Continuous)

  3 months

Study Arms (3)

In-person TASCS

EXPERIMENTAL

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; Behavioral: Follow-up care

Telehealth TASCS

ACTIVE COMPARATOR

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; Behavioral: Follow-up care

Self-administered TASCS

ACTIVE COMPARATOR

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; Behavioral: Follow-up care

Interventions

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.

In-person TASCS

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.

Telehealth TASCS

Self-administered TASCS BEHAVIORAL

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

Self-administered TASCS

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

In-person TASCS; Self-administered TASCS; Telehealth TASCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitively impaired (as assessed by study staff)
• \<18 years of age
• Prisoner.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Mental Health (NIMH): collaborator
• Worcester Polytechnic Institute: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• 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.

  PMID: 37874619 DERIVED

MeSH Terms

Conditions

Suicide; Suicide, Attempted

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Celine Larkin
• Organization: UMass Chan Medical School

celine.larkin@umassmed.edu

5084211436

Study Officials

• Celine Larkin, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)