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 (3)

TIPS Alone

EXPERIMENTAL

The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.

Other: Telehealth in preventing suicide (TIPS)

TIPS and ED-SAFE

EXPERIMENTAL

Half of the ED discharged patients with suicide risk will also be invited to receive post-discharge telephone counseling originally developed by Principal Investigator in a previous study, "Emergency Department Safety Assessment and Follow-up Evaluation" (ED-SAFE). The participant will receive three calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators.

Other: Telehealth in preventing suicide (TIPS); Other: Modified ED-SAFE

No intervention, Treatment as Usual

ACTIVE COMPARATOR

No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.

Interventions

Telehealth in preventing suicide (TIPS) OTHER

The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.

TIPS Alone; TIPS and ED-SAFE

Modified ED-SAFE OTHER

Half of the ED discharged patients with suicide risk will be invited to receive post-discharge telephone counseling originally developed during the "Emergency Department Safety Assessment and Follow-up Evaluation" (ED-SAFE) study. The participant will receive three coaching/counseling calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators.

TIPS and ED-SAFE

Treatment as Usual (TAU) OTHER

No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.

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
• Collective Medical: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Telemedicine; Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three-phase interrupted time series design - Experimental Group (TIPS alone); Experimental (TIPS + ED-SAFE); Active Comparator - No intervention, monitoring of Treatment as Usual (TAU)

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 16, 2021
• Study Start: July 12, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 18, 2025

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)