跳至主要内容
临床试验/NCT02801851
NCT02801851Unknown不适用

Delirium Screening of the Elderly in the Emergency Department

Northeastern University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Count of Delirium Diagnoses in EHR

研究概览

简要总结

This study will refine and pilot test an innovative, emergency department (ED)-based intervention for delirium screening, initial management, and communication with inpatient providers, and examine the impact of this intervention on the rate of documentation of delirium in the electronic health record by ED and inpatient providers. To achieve this, the study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED, involving 300 older patients (150 newly enrolled intervention participants, 150 historical controls (comparison group) currently being collected), that has 4 key components: systematic screening for delirium using the Confusion Assessment Method (CAM), informing providers of the screening result, a checklist protocol for initial delirium management based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and communication with inpatient providers of delirium screening results.

The study has two primary aims. The first is to refine and test the feasibility and acceptability of the SCREEN-ED intervention. The second is to examine the impact of SCREEN-ED on rate of delirium documentation and secondary outcomes (length of hospital stay, repeat ED visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled intervention group compared with 150 already collected historical controls.

详细描述

The investigators will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED, involving 300 older patients (150 newly enrolled intervention participants, 150 historical controls (comparison group) currently being collected), that has 4 key components: systematic screening for delirium using the CAM, informing providers of the screening result, a checklist protocol for initial delirium management based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and communication with inpatient providers of delirium screening results. The short-term goal is to test the feasibility and acceptability of the intervention, and its immediate impact on documentation of delirium in the EHR. The long-term goal is to utilize the information gleaned from this developmental study to inform a large-scale multi-center randomized clinical trial to test the impact of the SCREEN-ED strategy on clinical outcomes including length of stay, repeat ED visits, rehospitalization, and mortality.

The study will enroll 150 patients to the intervention arm and will screen them for delirium using the CAM. The screening results (positive or negative) will be provided verbally and in the EHR to ED providers, and, in screen positive cases, ED physicians will be provided with a checklist protocol for delirium management that will be embedded in the ED EHR. Additionally, in admitted patients, the screening result will be entered into the inpatient EHR. The study team will review ED and inpatient medical records and compare physician documentation of delirium in SCREEN-ED compared with a historical comparison group currently being collected.

The study will follow all patients (intervention and comparison) through medical record review for 6 months to collect clinical outcomes, which will be examined as secondary outcomes. The study will also examine the acceptability of the intervention with ED and inpatient providers through focus groups prior to the roll-out of SCREEN-ED to refine the intervention components and again in year 2 of the study, after the intervention period is complete, to identify barriers and facilitators to intervention implementation.

Using the same system used to enroll the historical comparison group, patients will be identified using the real-time ED EHR (PulseCheck™), which is populated on arrival with detailed clinical information and links with the hospital EHR. After initial eligibility screen, patients will be approached by trained study staff and introduced to the study. Informed consent will be obtained and study staff will use a standardized Capacity for Informed Consent Instrument that combines capacity assessment questions with interviewer observation and that is used in a prior ED delirium study. If the patient fails the Capacity assessment, a proxy will be asked to provide consent (with patient assent).

The PIs have worked to seamlessly integrate their staff into the workflow of the ED. They expect enrollment to last ~40 weeks, requiring 4 patients be enrolled per week to meet a sample size of 150 in the intervention group (recruitment rate of <10%, assuming 200 patients per week of which 25% are ineligible and 50% refuse).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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 presenting to the ED between 2pm and 11pm (highest ED census) 7 days a week

排除标准

  • Patients who are being evaluated for severe head injury and those who present with delirium tremens due to the difficulty of distinguishing delirium from head injury and because delirium tremens has a distinct etiology, course and outcomes.
  • Patients who are aphasic, comatose, terminally ill, deaf, or are non-English speaking.

结局指标

主要结局

Count of Delirium Diagnoses in EHR

时间窗: 6 months

Count of delirium diagnoses in the EHR of study subjects

次要结局

  • Count of Hospitalizations in participants(6 months)
  • Focus group content analysis for SCREEN-ED intervention feasibility(months 4-16)
  • Count of ED visits in participants(6 months)
  • Length of hospital stay in days in participants(6 months)
  • Mortality(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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