Clinical trial NCT04720911: Technology-Assisted Systems Change for Suicide Prevention
Official title: Technology-Assisted Systems Change for Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Worcester Polytechnic Institute
First posted: 2021-01-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of Participants With a Suicide Attempt in the Past Three Months
timeFrame: 3 months
measure: Number of Patients With Active Ideation in Past Week at 3-month Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)
timeFrame: 3 months
measure: Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)
timeFrame: 3 months
measure: Drive Subscale of the Behavioral Activation Scale (Continuous)
timeFrame: 3 months
measure: Suicide-related Impulse Control (Continuous)
timeFrame: 3 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Celine Larkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: