A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Proportion of visits adherent to protocol
研究概览
简要总结
The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.
详细描述
This study will be a pilot RCT that compares ED-TREAT to usual care. The scientific premise of the proposed project is that an innovative EHR-embedded clinical decision support (CDS) tool can overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. This would help clinicians appropriately invest resources to improve the quality of care for at-risk patients regardless of ultimate medical or psychiatric diagnoses and prevent agitation from occurring.
This pilot trial will (1) test the integrity of the study protocol in preparation for a future full-scale RCT, (2) evaluate randomization protocols, (3) estimate rates of recruitment and retention, (4) assess acceptability and fidelity of the intervention, and (5) determine if the proposed effect size is reasonable.
This registered study is actually the third aim of a larger study where the tool will be developed and assessed using observational data and input from a steering committee in aims 1 and 2 prior to pilot testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •adult (age≥18) patients presenting to the YNHH ED during the pilot trial period
- •deemed to have a mild-moderate or high risk of agitation as determined by ED-TREAT
- •do not require physical restraint orders <30 minutes of arrival
- •with a score of "4" (quiet and awake; normal level of activity) on the Behavioral Activity Rating Scale
- •have comfort with conversational English
- •able to provide verbal consent.
排除标准
- •1. Presence of a restraint order <30 minutes of arrival and presence of a non-violent physical restraint order where indications are not due to agitation (e.g., for protecting intubation or life-preserving equipment)
研究组 & 干预措施
ED-TREAT
EHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting.
干预措施: ED-TREAT (Other)
Usual Care
结局指标
主要结局
Proportion of visits adherent to protocol
时间窗: 12 months
Proportion of visits in the intervention arm that are adherent to \>95% of the observational workflow checklist (primary outcome of fidelity)
次要结局
- System usability scale(Baseline, 15 hours)