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Completed

NCT Number: NCT04800029

Telehealth to Improve Prevention of Suicide (TIPS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • < 18 years of age
  • Residing outside Massachusetts

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Patients Stratified as High/Imminent Risk

    Time frame: 24 months

    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

  2. Percentage of Patients Admitted to Inpatient Psychiatric Treatment

    Time frame: 24 months

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

  3. Emergency Department Psychiatric Boarding Hours for Admitted Patients

    Time frame: 24 months

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

Secondary outcomes

  1. Intervention Targets - Behavioral Health Evaluations

    Time frame: 24 months

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

  2. Intervention Targets - Suicide Risk Assessments

    Time frame: 24 months

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

  3. Intervention Targets - Observations

    Time frame: 24 months

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

  4. Intervention Targets - Safety Plans (Total Number)

    Time frame: 24 months

    The intervention target measures the number of safety plans created.

  5. Intervention Targets - Safety Plans (Overall Quality)

    Time frame: 24 months

    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.

  6. Intervention Targets - Behavioral Health Appointments

    Time frame: 24 months

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

  7. Intervention Targets - Post Visit Contacts

    Time frame: 24 months

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

  8. Door to Behavioral Health Evaluation Time

    Time frame: 24 months

    Total time from triage to Behavioral Health evaluation

  9. Total Length of Stay

    Time frame: 24 months

    Total time from registration to patient exiting the Emergency Department

  10. Transfer for psychiatric evaluation

    Time frame: 24 months

    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

  11. Suicide composite outcome

    Time frame: 24 months

    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

  12. In-situ intentional self-injury

    Time frame: 24 months

    Number of intentional self-harm observed during healthcare encounter

  13. Unintentional injury death

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Collective Medical
  • Community HealthLink
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Telehealth to Improve Prevention of Suicide in EDs

Acronym: TIPS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2021
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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