跳至主要内容
临床试验/NCT04007523
NCT04007523已完成不适用

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): a Pilot Randomized Controlled Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Delirium

研究概览

简要总结

This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Decision support systems will be tested that provide targeted alerts and recommendations to the Hospital Elder Life Program and family members for delirium prevention.

详细描述

Delirium is a distressing and common surgical complication, affecting approximately 20-50% of older surgical patients. Postoperative delirium is associated with increased mortality, cognitive and functional decline, and healthcare resource utilization. Prevention programs have been tested with variable success, but the Hospital Elder Life Program (HELP) has consistently been demonstrated to reduce the incidence and impact of delirium. However, substantial resources are needed for program operations, and complementary support systems may help with patient triage and assessment. Family members and caretakers may be able to provide supplementary support with delirium screening and prevention via targeted, therapeutic activities. Thus, an automated postoperative paging system, which elicits additional, focused support from HELP and family members, may augment delirium prevention activities and reduce associated risk.

The primary objectives of this study are to determine whether pager-based clinical decision support systems bolster HELP- and family-based therapeutic activities. A secondary objective will be to identify facilitators and barriers to delivering therapeutic interventions for both HELP and family members. Overall, this pilot trial will test the hypothesis that a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Patients (n=60) will be randomized to one of four groups in a factorial design: usual care (n=15), HELP-based paging system (n=15), family-based paging system (n=15), or both HELP- and family-based paging system (n=15). The support systems will consist of automated pager alerts to the HELP program and/or family members and caretakers, depending on group allocation, for providing additional delirium evaluation and therapeutic prevention activities. Outcomes will include various clinical, neurocognitive, and functional measures, and performance metrics will be collected regarding HELP- and family-based interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥ 70 years of age
  • Major non-cardiac, non-intracranial neurologic, and non-major vascular surgery
  • Anticipated length of stay at least 72 hours
  • At least one family member, or caretaker, available on each of the first three postoperative days for trial operations

排除标准

  • Emergency surgery
  • Severe cognitive impairment (precluding ability to perform delirium assessments)
  • Planned postoperative ICU admission
  • Non-English speaking

结局指标

主要结局

Delirium

时间窗: morning postoperative day one through afternoon of postoperative day three

Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)

次要结局

  • Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)(baseline through postoperative day 2)
  • Discharge Disposition(day of hospital discharge, up to 30 days)
  • Delayed Discharge - Cognitive Impairment(day of hospital discharge, up to 30 days)
  • Length of Hospital Stay(morning of surgery until day of hospital discharge, up to 30 days)
  • Delirium Severity(morning postoperative day one through afternoon of postoperative day three)
  • Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)(baseline through postoperative day 3)
  • Falls(morning postoperative day one through afternoon of postoperative day three)
  • New Non-surgical Site Infection(morning of surgery until day of hospital discharge, up to 30 days)
  • Multidrug Resistant Organism Colonization(morning postoperative day one through 30 days after surgery)
  • Mortality(within 30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Vlisides

Assistant Professor of Anesthesiology

University of Michigan

研究点 (2)

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