Suicide, Suicide, Attempted
Conditions
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.
Interventions
BEHAVIORALIn-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.
BEHAVIORALTelehealth 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.
BEHAVIORALSelf-administered TASCS
Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
BEHAVIORALFollow-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
Sponsors
National Institute of Mental Health (NIMH)
Worcester Polytechnic Institute
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Suicide Attempt in the Past Three Months | 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. |
| Number of Patients With Active Ideation in Past Week at 3-month Follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15) | 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. |
| Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15) | 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 . |
| Drive Subscale of the Behavioral Activation Scale (Continuous) | 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. |
| Suicide-related Impulse Control (Continuous) | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at a large teaching hospital in the northeast United States, whose emergency department includes a dedicated psychiatric area. Recruitment took place at one emergency department at an academic medical center in the northeast U.S. between February 1 and September 15 2022.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: 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 | 15 |
| Active Comparator: 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 | 15 |
| Active Comparator: 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 | 16 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Active Comparator: Self-administered TASCS | Experimental: In-person TASCS | Active Comparator: Telehealth TASCS |
|---|---|---|---|---|
| Age, Continuous | 26.5 years | 27 years | 33 years | 24 years |
| Behavioral Inhibition & Activation Scales (BIS/BAS) Drive subscale | 11.17 units on a scale STANDARD_DEVIATION 3.04 | 12.38 units on a scale STANDARD_DEVIATION 2.5 | 10.33 units on a scale STANDARD_DEVIATION 3.37 | 10.73 units on a scale STANDARD_DEVIATION 3.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 14 Participants | 14 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Interpersonal Needs Questionnaire perceived burdensomeness subscale | 19.41 units on a scale STANDARD_DEVIATION 10.09 | 19.31 units on a scale STANDARD_DEVIATION 11.06 | 18.27 units on a scale STANDARD_DEVIATION 10.47 | 20.67 units on a scale STANDARD_DEVIATION 9.11 |
| Interpersonal Needs Questionnaire thwarted belongingness subscale | 33.59 units on a scale STANDARD_DEVIATION 13.28 | 31.38 units on a scale STANDARD_DEVIATION 13.88 | 30.93 units on a scale STANDARD_DEVIATION 15.43 | 38.60 units on a scale STANDARD_DEVIATION 9.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 11 Participants | 12 Participants | 12 Participants |
| Sex/Gender, Customized Female | 23 Participants | 10 Participants | 7 Participants | 6 Participants |
| Sex/Gender, Customized Male | 20 Participants | 6 Participants | 7 Participants | 7 Participants |
| Sex/Gender, Customized Non-binary | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Suicide-related impulsivity | 3.00 units on a scale STANDARD_DEVIATION 1.36 | 3.25 units on a scale STANDARD_DEVIATION 1.44 | 2.63 units on a scale STANDARD_DEVIATION 1.27 | 3.10 units on a scale STANDARD_DEVIATION 1.37 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 16 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: In-person TASCS | Number of Participants With a Suicide Attempt in the Past Three Months | 0 Participants |
| Active Comparator: Telehealth TASCS | Number of Participants With a Suicide Attempt in the Past Three Months | 1 Participants |
| Active Comparator: Self-administered TASCS | Number of Participants With a Suicide Attempt in the Past Three Months | 1 Participants |
Primary
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.
Time frame: 3 months
Population: Patients reachable by telephone at three months for follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: In-person TASCS | Number of Patients With Active Ideation in Past Week at 3-month Follow-up | 0 Participants |
| Active Comparator: Telehealth TASCS | Number of Patients With Active Ideation in Past Week at 3-month Follow-up | 3 Participants |
| Active Comparator: Self-administered TASCS | Number of Patients With Active Ideation in Past Week at 3-month Follow-up | 2 Participants |
Secondary
Drive Subscale of the Behavioral Activation Scale (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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: In-person TASCS | Drive Subscale of the Behavioral Activation Scale (Continuous) | 11.43 units on a scale | Standard Deviation 1.72 |
| Active Comparator: Telehealth TASCS | Drive Subscale of the Behavioral Activation Scale (Continuous) | 11.90 units on a scale | Standard Deviation 1.85 |
| Active Comparator: Self-administered TASCS | Drive Subscale of the Behavioral Activation Scale (Continuous) | 12.20 units on a scale | Standard Deviation 3.01 |
Secondary
Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15)
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 .
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: In-person TASCS | Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15) | 10.86 units on a scale | Standard Deviation 4.91 |
| Active Comparator: Telehealth TASCS | Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15) | 11.30 units on a scale | Standard Deviation 5.87 |
| Active Comparator: Self-administered TASCS | Perceived Burdensomeness From Interpersonal Needs Questionnaire (INQ-15) | 14.40 units on a scale | Standard Deviation 11.05 |
Secondary
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 1 and a maximum score of 5, with a higher score representing a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: In-person TASCS | Suicide-related Impulse Control (Continuous) | 1.29 units on a scale | Standard Deviation 0.39 |
| Active Comparator: Telehealth TASCS | Suicide-related Impulse Control (Continuous) | 1.40 units on a scale | Standard Deviation 0.94 |
| Active Comparator: Self-administered TASCS | Suicide-related Impulse Control (Continuous) | 1.60 units on a scale | Standard Deviation 0.99 |
Secondary
Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15)
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: In-person TASCS | Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15) | 23.57 units on a scale | Standard Deviation 4.08 |
| Active Comparator: Telehealth TASCS | Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15) | 26.70 units on a scale | Standard Deviation 9.5 |
| Active Comparator: Self-administered TASCS | Thwarted Belongingness From Interpersonal Needs Questionnaire (INQ-15) | 25.70 units on a scale | Standard Deviation 12.39 |