Clinical trial NCT04800029: Telehealth to Improve Prevention of Suicide (TIPS)
Official title: Telehealth to Improve Prevention of Suicide in EDs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Risk
Keywords: suicide ideation
suicide attempt
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Community HealthLink
name: Collective Medical
name: National Institute of Mental Health (NIMH)
First posted: 2021-03-16
Enrollment: 44000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-phase interrupted time series design - Experimental Group (TIPS alone); Experimental (TIPS + ED-SAFE); Active Comparator - No intervention, monitoring of Treatment as Usual (TAU)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Stratified as High/Imminent Risk
timeFrame: 24 months
measure: Percentage of Patients Admitted to Inpatient Psychiatric Treatment
timeFrame: 24 months
measure: Emergency Department Psychiatric Boarding Hours for Admitted Patients
timeFrame: 24 months
Secondary outcomes:
measure: Intervention Targets - Behavioral Health Evaluations
timeFrame: 24 months
measure: Intervention Targets - Suicide Risk Assessments
timeFrame: 24 months
measure: Intervention Targets - Observations
timeFrame: 24 months
measure: Intervention Targets - Safety Plans (Total Number)
timeFrame: 24 months
measure: Intervention Targets - Safety Plans (Overall Quality)
timeFrame: 24 months
measure: Intervention Targets - Behavioral Health Appointments
timeFrame: 24 months
measure: Intervention Targets - Post Visit Contacts
timeFrame: 24 months
measure: Door to Behavioral Health Evaluation Time
timeFrame: 24 months
measure: Total Length of Stay
timeFrame: 24 months
measure: Transfer for psychiatric evaluation
timeFrame: 24 months
measure: Suicide composite outcome
timeFrame: 24 months
measure: In-situ intentional self-injury
timeFrame: 24 months
measure: Unintentional injury death
timeFrame: 24 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Edwin Boudreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: