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Technology-Assisted Systems Change for Suicide Prevention (TASCS)

Primary Purpose

Suicide, Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-person TASCS
Telehealth TASCS
Self-administered TASCS
Follow-up care
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMass Chan Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

In-person TASCS

Telehealth TASCS

Self-administered TASCS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 18, 2021
Last Updated
January 12, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH), Worcester Polytechnic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04720911
Brief Title
Technology-Assisted Systems Change for Suicide Prevention
Acronym
TASCS
Official Title
Technology-Assisted Systems Change for Suicide Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute of Mental Health (NIMH), Worcester Polytechnic Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person TASCS
Arm Type
Experimental
Arm Description
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
Arm Title
Telehealth TASCS
Arm Type
Active Comparator
Arm Description
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
Arm Title
Self-administered TASCS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
In-person TASCS
Intervention Description
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
Intervention Name(s)
Telehealth TASCS
Intervention Description
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
Intervention Name(s)
Self-administered TASCS
Intervention Description
Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
Intervention Type
Behavioral
Intervention Name(s)
Follow-up care
Intervention Description
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 Outcome Measure Information:
Title
Suicide attempt (binary)
Description
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.
Time Frame
3 months
Title
Suicidal ideation (binary, ordinal)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Behavioral activation (continuous)
Description
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.
Time Frame
3 months
Title
Perceived social support (continuous)
Description
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.
Time Frame
3 months
Title
Suicide-related impulse control (continuous)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celine Larkin, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NIMH will host the trial dataset on the National Database for Clinical Trials related to Mental Illness.

Learn more about this trial

Technology-Assisted Systems Change for Suicide Prevention

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