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临床试验/NCT04576065
NCT04576065已完成不适用

Randomized Controlled Trial of the Wake Forest Post-ICU Telehealth (WFIT) Program

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2021年3月19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
413
试验地点
2
主要终点
Incremental Net Benefit (INB) Cost Effectiveness

研究概览

简要总结

Wake Forest Post-Intensive Care Unit Telehealth (WFIT) program consists of a nurse practitioner who has access to daily activity data as well as telehealth capabilities for 6 months post-hospital discharge in order to improve the post-critical illness care of patients. The study team expects that this program will reduce costs to patients. Through this intervention the study team hopes to improve quality of life, patient satisfaction, reduce readmissions and ER visits, and reduce mortality. The study team will perform a formal randomized controlled trial with a cost-effectiveness analysis to demonstrate its value.

详细描述

Wake Forest Baptist Health (WFBH) discharges over 1,000 patients annually after a critical illness such as septic shock and/or acute respiratory failure. This number is expected to be even higher due to the ongoing coronavirus pandemic. To try to bridge this gap, the Wake Forest Intensive Care Unit (ICU) Recovery Clinic was created in 2014. WFBH ICU Recovery Clinic (1 of ~15 nationwide) uses a multidisciplinary approach to transition care for ICU survivors back to Primary Care Physicians (PCPs). However, currently only about 5% of patients leaving the ICU who had respiratory failure and/or septic shock and may benefit from follow-up. In addition, patients seen in WFBH Recovery Clinic typically are only seen one time and then return to the care of their PCPs.

Poor physical function following critical illness is associated with hospital readmissions and mortality. However, barriers to post-ICU follow-up are common and include financial concerns as well as transportation barriers. Additionally, the Wake Forest ICU Recovery Clinic only sees patients once in the post-critical illness period, despite the fact that post-ICU morbidity remains high for at least six months following discharge. Finally, data demonstrates availability of internet services on a daily basis to the vast majority of the population (79% total of NC Congressional Districts 5, 6, and 13 in 2013; 68% in a random sample of 28 medical ICU patients). Taken together, this prompts the study team to propose this Wake Forest Post-ICU Telehealth (WFIT) program of a nurse practitioner who has access to daily activity data as well as telehealth capabilities in order to improve the post-critical illness care of these patients. The study team expects that this program will reduce costs to patients. Through this intervention the study team hopes to improve quality of life, patient satisfaction, reduce readmissions and ER visits, and reduce mortality. The study team will perform a formal randomized controlled trial with a cost-effectiveness analysis to demonstrate its value.

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

入选标准

  • Admission to Wake Forest Baptist Health medical Intensive Care Unit (ICU)
  • North Carolina Residents
  • ICU Diagnosis: Sepsis and/or acute respiratory failure defined by assisted ventilation (includes mechanical ventilation, Bilevel Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure (CPAP), or requiring > 15 Liter of supplemental oxygen
  • Consent to enrollment in the study
  • Survive to hospital discharge

排除标准

  • >2 Hospitalizations in the past year.
  • Admitted from hospice, a skilled nursing facility or Long-Term Acute Care Hospital (LTACH).
  • Discharge to a Skilled Nursing Facility or LTACH or Hospice. We will permit enrollment of patients who are discharged to acute rehabilitation.

结局指标

主要结局

Incremental Net Benefit (INB) Cost Effectiveness

时间窗: 6 months post hospital discharge

Determine if the WFIT Program is cost-effective by measuring INB in the intervention arm (WFIT program) compared to an attention control arm. Incremental net benefit ($) = \[Change in Quality of Adjusted Life Year (QALY) \*100,000\] - \[Change in health care spending\] INB is defined as the difference between change in quality of life evaluated at monetary valuation of 1 QALY (currently $100,000) and change in health care spending. Using this measure, even if WFIT does not affect patient quality of life, then INB will equal the reduction in health care spending.

次要结局

  • Number of Emergency Room (ER) Visits(6 months post hospital discharge)
  • Number of hospital readmissions(6 months post hospital discharge)
  • Mortality Rate(Through 6 months post hospital discharge)
  • Patient Satisfaction Questionnaire 18 (PSQ-18)(6 months post hospital discharge)
  • Euro Quality of Life, 5 Dimension, 5 Level (EQ-5D-5L) Questionnaire(6 months post hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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