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Suicide RiskTIPSNCT04800029

Telehealth to Improve Prevention of Suicide (TIPS)

A study testing TIPS Program and TIPS Program + ED-SAFE in people with Suicide Risk, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide Risk
What is being tested?
TIPS Program and TIPS Program + ED-SAFE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32,406 participants
Where
1 siteUnited States
Study dates
12 Jul 2021to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 18 years of age
  • Residing outside Massachusetts

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UMass Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Telehealth to Improve Prevention of Suicide in EDs

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.

Read the detailed description

Suicide is one of the most pressing public health problems facing the United States (US), ranking as the 10th leading cause of death, with incidence rates increasing year after year in the recent past. The National Action Alliance for Suicide Prevention (NAASP) has prioritized suicide prevention efforts in emergency departments (EDs) because of their well-established safety-net role in treating patients with suicide risk. However, there are serious problems with accessing timely, high-quality behavioral healthcare in many EDs, leading to unnecessary psychiatric hospitalizations, long waiting times, and substandard suicide-related care. As suggested by RFA-MH-20-226, telemental health service delivery has promise for not only improving timely access to behavioral health specialists, it also holds promise for improving adherence to best practice suicide prevention standards.

The study will evaluate whether telehealth can improve behavioral health specialist access and suicide-related care quality using a Type 2 hybrid effectiveness-implementation trial, titled Telehealth to Improve Prevention of Suicide (TIPS) in EDs. The study will involve ED patients with suicide risk from two Intervention EDs that do not currently have on-site behavioral health specialists and two Non-intervention control EDs. The study design will blend a three-phase interrupted time series design with a nested individual level randomized comparative effectiveness trial. Phase 1, Treatment as Usual (TAU), will comprise a historical control for the four EDs. It will use data spanning three years (October 2017 to September 2020) and will include all patients who screened positive on a universally administered, evidence-based screener, or who received a mental health evaluation in the participating EDs, which will allow the study team to establish a stable, representative control sample. Phase 2, Intervention, will involve implementing the TIPS telehealth protocol into routine clinical care for 24 months within the two Intervention EDs. Masters-level behavioral health specialists from an existing mental health center will perform a behavioral health evaluation using synchronous, two-way televideo software and hardware. In addition, for patients with a preliminary decision to be hospitalized, a telepsychiatrist will be consulted, with the goal of reducing hospitalization for those who can be adequately managed in a lower level of care. When needed, the telepsychiatrist will also complete his or her own televideo evaluation of the patient and collaterals. In addition to expanded behavioral health specialist access, the study team will improve the quality of suicide-related care. The study team will not only provide enhanced training for behavioral health specialists on best practice suicide risk assessment, safety planning, and care transition strategies, the study team will leverage fidelity review of recorded televideo evaluations and provide personalized feedback to improve adherence to performance standards.

In addition, during Phase 2, a 50% subset of patients who received the TIPS evaluation during their visit and who are discharged from the ED will be randomly assigned to the evidence-based Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) protocol after the visit (TIPS+EDSAFE). This will allow the Investigators to evaluate the added value of contact after the visit to further decrease suicidal behavior compared to the within-visit components alone (i.e., comparative effectiveness). Phase 3, Sustainment, will be the final phase during which the study team will remove grant financial subsidies for clinical services to definitively ascertain self-sustainability of the interventions. The investigators will collect the same system metrics and clinician behaviors on two Non-intervention EDs across the same time periods. These EDs will not implement the study interventions, and their data will help control for confounders, like macro-system or secular trends.

Conditions
Suicide Risk
Being tested
TIPS Program, TIPS Program + ED-SAFE
Keywords
suicide ideation, suicide attempt
Medical subject headings
Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIPS ProgramOther

    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.

  • TIPS Program + ED-SAFEOther

    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.

Study groups in NCT04800029
Study groupRoleWhat they receive
Implementation (TIPS Program)ExperimentalThe 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.
Receives: Other: TIPS Program
Covid- TAU PhaseNo interventionThe 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 interventionThis arm establishes a control condition reflecting baseline system metrics, clinician suicide-related care practices (intervention targets), and patient outcomes.
SustainmentNo interventionThe 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)ExperimentalA 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.
Receives: Other: TIPS Program + ED-SAFE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

  2. 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

    Measured: 24 months

  3. 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.

    Measured: 24 months

Secondary outcomes (13)
  1. Intervention Targets - Behavioral Health Evaluations

    This intervention target measures the total number of Behavioral Health Evaluations completed

    Measured: 24 months

  2. Intervention Targets - Suicide Risk Assessments

    The intervention target measures the total number of evidence-based suicide risk assessments completed.

    Measured: 24 months

  3. Intervention Targets - Observations

    The intervention target measures the number of one-on-one observations ordered.

    Measured: 24 months

  4. Intervention Targets - Safety Plans (Total Number)

    The intervention target measures the number of safety plans created.

    Measured: 24 months

  5. Intervention Targets - Safety Plans (Overall Quality)

    The intervention target measures the overall level of safety plan quality. The quality of the safety plan is measured using a standardized form known as the SPISA (Safety Plan Intervention Scoring Algorithm). Each line in the safety plan receives a score of 0-2 and then there is a total score that is the summation of the individual lines. Based on the final score, a final quality category will be assigned - Poor, Mediocre, Satisfactory, Good, or Excellent.

    Measured: 24 months

  6. Intervention Targets - Behavioral Health Appointments

    The intervention target measures the number of scheduled Behavioral Health appointments prior to discharge.

    Measured: 24 months

  7. Intervention Targets - Post Visit Contacts

    The intervention target measures the number of post-visit contacts the patient had.

    Measured: 24 months

  8. Door to Behavioral Health Evaluation Time

    Total time from triage to Behavioral Health evaluation

    Measured: 24 months

  9. Total Length of Stay

    Total time from registration to patient exiting the Emergency Department

    Measured: 24 months

  10. Transfer for psychiatric evaluation

    The percentage of patients transferred out of Emergency Department to get Behavioral Health evaluation compared to all patients with any risk on screener or deemed to require a Behavioral Health evaluation

    Measured: 24 months

  11. Suicide composite outcome

    Number of Emergency Department or inpatient visits with an International Classification of Disease (ICD) code or Natural Language Processing (NLP) algorithm indicating suicidal ideation or behavior or death due to intentional self-injury, as coded on death record

    Measured: 24 months

  12. In-situ intentional self-injury

    Number of intentional self-harm observed during healthcare encounter

    Measured: 24 months

  13. Unintentional injury death

    Number of deaths due to injuries not from intentional self-injury

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start12 Jul 2021
  3. Primary completion9 Sep 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
32,406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04800029
Sponsor's protocol ID
H00021007
Other IDs
1R01MH124685
Acronym
TIPS
Status last verified
Nov 2025
First submitted
9 Mar 2021
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The dataset will be shared with the NIMH Data Archive

Questions about this trial

What is this clinical trial studying?

A study testing TIPS Program and TIPS Program + ED-SAFE in people with Suicide Risk, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Stratified as High/Imminent Risk (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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