Telehealth to Improve Prevention of Suicide (TIPS)

NCT04800029 | Completed DMC

• 2 other identifiers: H000210071R01MH124685
• Study Type: interventional
• Target: 32,406
• Locations: 1 country
• Sites: 1

Brief Summary

The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.

Conditions

Suicide Risk

Keywords

suicide ideation; suicide attempt

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients Stratified as High/Imminent Risk

  The percentage of patients with final stratum of high risk or who are transferred to another hospital for evaluation among all patients with any risk on screener or evaluated by Behavioral Health

  24 months

• Percentage of Patients Admitted to Inpatient Psychiatric Treatment

  Percentage of Patients admitted to inpatient psychiatric treatment among all patients with any risk on screener or evaluated by Behavioral Health

  24 months

• Emergency Department Psychiatric Boarding Hours for Admitted Patients

  Average time from Behavioral Health evaluation in the Emergency Department to transfer to inpatient psychiatric hospital for admission.

  24 months

Secondary Outcomes (13)

• Intervention Targets - Behavioral Health Evaluations

  24 months

• Intervention Targets - Suicide Risk Assessments

  24 months

• Intervention Targets - Observations

  24 months

• Intervention Targets - Safety Plans (Total Number)

  24 months

• Intervention Targets - Safety Plans (Overall Quality)

  24 months

Study Arms (5)

Implementation (TIPS Program)

EXPERIMENTAL

The implementation phase took place over 24 months from the end of Covid TAU phase. The implementation phase established a TIPS condition reflecting only a telehealth evaluation from a mental health clinician proficient in best practices.

Other: TIPS Program

Covid- TAU Phase

NO INTERVENTION

The study design was submitted to NIMH for consideration prior to the COVID-19 pandemic. When COVID-19 happened, all four EDs implemented telehealth mental health evaluation procedures to address the care needs of patients. As a result, we added a COVID-19 TAU phase that represents when telehealth was used but the specific protocols or training to enhance suicide-related care or the post-visit ED-SAFE protocols were not implemented.

Treatment as Usual (TAU)

NO INTERVENTION

This arm establishes a control condition reflecting baseline system metrics, clinician suicide-related care practices (intervention targets), and patient outcomes.

Sustainment

NO INTERVENTION

The final phase of the interrupted time series design involved removing all Intervention related financial subsidies from supporting clinical and technical services. ED-SAFE follow-up is discontinued during this phase. This phase refers to 12 months following completion of the implementation phase.

Implementation (TIPS + ED SAFE)

EXPERIMENTAL

A TIPS+EDSAFE condition was also established during the same 24 months of intervention period, which reflected a randomized subset of discharged patients from the TIPS condition who also received 3 follow-up calls within 3 months after they were discharged.

Other: TIPS Program + ED-SAFE

Interventions

TIPS Program OTHER

TIPS Program where a telehealth evaluation from a mental health clinician proficient in best practices was administered. The goal of which was to improve access and timeliness of evaluations through telehealth and the quality of management of suicidality in the ED. The main focus of TIPS was to replace the usual "call and arrive" or "transfer to a regional ED" models previously offered to a telehealth based evaluation. Components of the TIPS program included: (1) Telehealth evaluations with a masters-level mental health clinician; (2) Evidence informed-risk assessment with the Columbia Suicide Severity Rating Scale (CSSRS), Risk Assessment version; (3) Safety planning using the Stanley-Brown Safety Planning Intervention; (4) Care transitions using NAASP Best Practices in Care Transitions for Individuals with Suicide Risk; and (5) Telepsychiatry evaluation.

Implementation (TIPS Program)

TIPS Program + ED-SAFE OTHER

TIPS+EDSAFE condition in which a random subset of discharged patients who received TIPS also received up to 3 follow-ups call over 3 three months after their initial presentation at the ED. The first call happened within a week, the second within a month and third within 3 months. It was one call to create a safety plan with the patient and 2 more calls to have a value discussion and life plan and check in on whether the safety plan needs to be updated and any barriers to getting outpatient treatment.

Implementation (TIPS + ED SAFE)

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 old
• Adults presenting to ED who either screen positive on the universal suicide risk screener completed at triage or those who the ED treating team decides should have a mental health evaluation
• Research sample limited to those who live in Massachusetts

You may not qualify if:

• \< 18 years of age
• Residing outside Massachusetts

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Community HealthLink: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Collective Medical: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Edwin Boudreaux, PhD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multiphase interrupted time series design - 1. Treatment as usual (TAU) which is the historical period with no intervention implemented; 2. COVID- TAU which is part of historical control, but telehealth was introduced due to Covid but not as part of study implementation. No other intervention protocols were implemented at this time; 3. Experimental phase introducing intervention condition- TIPS program; 4. Experimental phase introducing intervention condition- TIPS + ED-SAFE; 5. Sustainment Phase with all intervention related subsidies removed and ED-SAFE discontinued.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 16, 2021
• Study Start: July 12, 2021
• Primary Completion: September 9, 2025
• Study Completion: November 30, 2025
• Last Updated: June 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We will upload our initial data 6 months after the onset of the implementation of the TIPS intervention into practice, with regular additions approximately every 6 months.
• Access Criteria: See NDA application for details

Locations

US (1)