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临床试验/NCT04800029
NCT04800029已完成不适用

Telehealth to Improve Prevention of Suicide in EDs

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 32,406 人开始时间: 2021年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32,406
试验地点
2
主要终点
Emergency Department Psychiatric Boarding Hours for Admitted Patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • < 18 years of age
  • Residing outside Massachusetts

研究组 & 干预措施

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.

干预措施: TIPS Program (Other)

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.

干预措施: TIPS Program + ED-SAFE (Other)

结局指标

主要结局

Emergency Department Psychiatric Boarding Hours for Admitted Patients

时间窗: 24 months

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

Percentage of Patients Stratified as High/Imminent Risk

时间窗: 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

Percentage of Patients Admitted to Inpatient Psychiatric Treatment

时间窗: 24 months

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

次要结局

  • Intervention Targets - Suicide Risk Assessments(24 months)
  • Intervention Targets - Observations(24 months)
  • Door to Behavioral Health Evaluation Time(24 months)
  • Total Length of Stay(24 months)
  • In-situ intentional self-injury(24 months)
  • Suicide composite outcome(24 months)
  • Intervention Targets - Safety Plans (Overall Quality)(24 months)
  • Transfer for psychiatric evaluation(24 months)
  • Intervention Targets - Safety Plans (Total Number)(24 months)
  • Intervention Targets - Behavioral Health Appointments(24 months)
  • Intervention Targets - Post Visit Contacts(24 months)
  • Intervention Targets - Behavioral Health Evaluations(24 months)
  • Unintentional injury death(24 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edwin Boudreaux

Professor

University of Massachusetts, Worcester

研究点 (2)

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