Vanderbilt ICU Recovery Program Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Number of Components of the ICU Recovery Program Received
研究概览
简要总结
Every year, millions of Americans are admitted to the intensive care unit. Due to advances in critical care, mortality rates are decreasing, increasing the number of ICU survivors. Survivors of critical illness, however, often face physical, functional, and cognitive deficits that place them at risk for a cycle of re-hospitalization that frequently culminates in premature death. Moreover, post-ICU interventions may be resource-intensive and may be most cost-effective only in a subgroup of patients at highest risk. Whether a multi-disciplinary program to facilitate recovery from critical illness can prevent hospital readmission and improve quality of life among high-risk ICU survivors remains unknown. The primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary ICU Recovery Program and the influence of such a program on process measures including contact with the ICU recovery team and attendance of ICU recovery clinic. The secondary aims are to compare the effect of an ICU Recovery Program on 30-day same-hospital readmission and other clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years
- •Admitted to the Medical Intensive Care Unit (MICU) at Vanderbilt University Medical Center for at least 48 hours
- •Estimated risk of 30-day same-hospital readmission greater than 15%
- •Not previously enrolled in the study.
排除标准
- •Long-term residence at a skilled nursing facility
- •Long-term mechanical ventilation prior to admission
- •Solid organ or stem cell transplantation
- •Recorded primary residency > 200 miles from Vanderbilt
- •Comfort care only
研究组 & 干预措施
VANDERBILT ICU RECOVERY PROGRAM (VIP)
Patients assigned to the Vanderbilt ICU Recovery Program (VIP) group will receive the components of the ICU Recovery Program intervention.
干预措施: VANDERBILT ICU RECOVERY PROGRAM (Other)
Usual care
Patients in the usual care group will receive care as dictated by their clinical team. In usual care in the study institution, patients frequently receive medication reconciliation by and ICU pharmacist at the time of transfer out of the ICU to the hospital ward, medication reconciliation by a physician at the time of hospital discharge, and follow up with their primary care physician within two weeks of hospital discharge. Usual care does not currently include an in-person assessment of the patient's cognitive and functional status or anticipated post-ICU needs by a nurse practitioner between ICU transfer and hospital discharge, access to a 24/7 contact line after hospital discharge, or assessment in a multi-disciplinary ICU Recovery Clinic.
结局指标
主要结局
Number of Components of the ICU Recovery Program Received
时间窗: From the time of study enrollment to 30 days after hospital discharge
Number of components of the ICU Recovery Program intervention received by patients between ICU transfer and 30 days after hospital discharge. The 10-components considered part of the ICU Recovery Program include: (1) nurse practitioner in-person visit between ICU transfer and hospital discharge, (2) ICU Recovery Program pamphlet, (3) pharmacist medication reconciliation at the time of ICU transfer, (4) ICU Recovery Program contact line, (5) nurse practitioner history and physical in ICU Recovery Clinic, (6) pharmacist medication reconciliation in ICU Recovery Clinic, (7) cognitive/mental health assessment and psychoeducation in ICU Recovery Clinic, (8) case management consultation in ICU Recovery Clinic, (9) patient centered consultation with pulmonary and critical care medicine physician in ICU Recovery clinic, (10), directed subspecialty referrals.
次要结局
- Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge(Within 30 days of hospital discharge)
- Number of Participants Death or Readmission in the 30 Days After Hospital Discharge(Within 30 days of hospital discharge)
- Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge(Within 30 days of hospital discharge)
- Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge(Within 30 days of hospital discharge)
研究者
Matthew Semler
Assistant Professor of Medicine
Vanderbilt University Medical Center