跳至主要内容
临床试验/NCT03423875
NCT03423875Unknown不适用

Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App

Sunnybrook Health Sciences Centre8 个研究点 分布在 1 个国家目标入组 1,375 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,375
试验地点
8
主要终点
Delirium recognition by ED staff

研究概览

简要总结

Delirium is a common and serious complication of medical care that affects 10% of older Emergency Department (ED) patients, which unfortunately is unrecognized in up to 75% of ED patients.Studies have shown that 26 - 42% of patient with delirium are sent home. And 80% of patients sent home with unrecognized delirium are re-hospitalized within 4 days. Unrecognized delirium also has grave consequences for patient care - Kakuma showed that patient with unrecognized delirium who were sent home had 3-8x the mortality rate of patients with recognized delirium at 6 months.

Fluctuating severity over time is a key clinical characteristics of delirium, making its diagnosis challenging. Regardless of cause, failure to recognize delirium means that ED staff cannot meet their patient"s needs. For example, ED staff may miss serious medical conditions associated with delirium, may not provide understandable discharge instructions or ensure a caregiver can supervise and assist a patient with delirium who is discharged. These care adaptations require staff to recognize the presence of delirium. Thus it is not surprising that unrecognized delirium has such grave consequences for patients.

Thus recognition of delirium is critical to improving patient outcomes and reducing repeat ED visits. Patients with delirium may appear to have normal mental status at times, making its diagnosis challenging. High levels of service demand in the ED, plus the competing demands of numerous other initiatives to improve quality and reduce waiting times may explain why delirium continue to go unrecognized despite guidelines promoting routine delirium screening as a top priority in the ED. To address this care gap, the investigators developed an innovative solution. Rather than adding tasks to overburdened ED staff, our solution takes advantage of the long waiting times clients have in the ED for their initial assessments and between interactions with clinical staff. During these times, patients will use the PrEDICT "serious game" - similar to the Whack-a-Mole carnival game. The investigators have developed an algorithm based on participants" performance on this simple but serious game that can identify patients at high risk for delirium.

The investigators propose to conduct a prospective, multi-center randomized clinical trial in 4 provinces. The primary objective of this study is to assess the impact of our tablet technology on the recognition of delirium by ED staff. All eligible patients who agree to participate will be treated in the same manner and will play the PrEDICT tablet based game. The investigators will randomly assign half of patients to have their test performance shared with clinical staff. Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.

This project will allow us to solidly advance this technology from a working prototype (TRL7) to a commercially ready product demonstrated effective in multiple "real-world" environments under expected operational conditions (TRL8). Also it will provide evidence that the PrEDICT tablet app is clinically, technically, commercially and operationally feasible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

盲法说明

To prevent outcome assessment bias, research staff will be masked as to the randomization status of participants until after they have completed and recorded gold-standard delirium assessments of delirium using the Confusion Assessment Method .

Similarly, ED physicians will be blinded to the gold standard assessments of delirium made by research assistants as well as the results of the PrEDICT test scores when they make their baseline clinical assessments of delirium. ED Physicians will also remain masked until they have recorded their discharge plan. The intervention focuses on the impact of revealing the result of the PrEDICT game scores on ED physicians' recognition of delirium, so randomization status must be revealed to them.

入排标准

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

入选标准

  • 65 years of age and older
  • Have been in the ED for a minimum of 4 hours at the time of screening

排除标准

  • Live in a full care nursing home
  • Have a critical illness (Canadian Triage Acuity Score rendering them unable to communicate or provide consent)
  • Have delirium prior to ED arrival
  • Do not assent to study participation
  • Have visual impairment that makes them unable to use the serious game tablet
  • Have other communication difficulties preventing use of the serious game tablet

研究组 & 干预措施

Control

No Intervention

Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.

Intervention

Experimental

PrEDICTgame score (subject's relative risk of delirium) will be shared with ED physicians in the intervention arm. After viewing the tests results, ED physicians will be asked to reassess delirium risk, and indicate if they would change their management based on the PrEDICT app scores.

干预措施: PrEDICT game score (Diagnostic Test)

结局指标

主要结局

Delirium recognition by ED staff

时间窗: Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app.

Design a simple dichotomous question to assess whether MD's clinically diagnose the presence of delirium in a specific patient(not delirious vs. delirious). In addition, ask MD's to rate their certainty of their diagnosis on a 10 point Numeric Rating scale. The primary outcome will be determined based on the dichotomous question

次要结局

  • Unanticipated Barriers to using the PrEDICT app(Day 1(ED visit) to Day 4)
  • Feasibility of Tablet Administration by Other Stakeholders(Day 1(ED visit) to Day 4)
  • Ability of the PrEDICT app to identify patients at high risk for incident delirium(Between 7-14 days of ED discharge)
  • Ability of the PrEDICT app to identify patients with incident delirium(Between 7-14 days of ED discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验