Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Number of deaths or hospital readmissions within three months of discharge
研究概览
简要总结
This study will assess the relationship between early unmet needs after hospital discharge and subsequent clinical outcomes among survivors of acute respiratory failure. The investigators hypothesize that early unmet needs are associated with poor outcomes at three months.
详细描述
Despite the accumulation of data documenting the reality of extensive functional impairments following ICU stay, the specific treatment needs of individuals experiencing Post-Intensive Care Syndrome (PICS) are not well known largely because of a relative lack of knowledge about the specific unmet needs of patients at risk for PICS at the time of hospital discharge. These possible needs include oxygen prescriptions, equipment for noninvasive ventilation, durable medical equipment prescriptions, coordination with government assistance and community health programs, physical or occupational therapy in the home or at an outpatient clinic, medications restarted or discontinued as appropriate.
This study will enrol individuals who were diagnosed with acute respiratory failure during an ICU admission and were discharged from the ICU alive. Once enrolled, participants' medical records will be reviewed for demographic and medical information. Questionnaires will be used to assess the participant's status prior to ICU admittance, including comorbidities, medications, physical functioning, quality of life, alcohol/smoking/substance use, social support and healthcare utilization. While in the ICU, participants will receive usual clinical care in this observational study. Data on mechanical ventilation, arterial blood gas values, acute respiratory distress syndrome (ARDS) diagnosis, delirium, and medical status will be collected. Information regarding the patients' postdischarge needs including medical equipment, medication, home care services, dialysis, appointments, counselling and referral will also be collected by reviewing the discharge note. Follow-up evaluations by phone call will occur at 1-4 weeks, 3 and 6 months following the ICU discharge. At 1-4 weeks, the investigators will evaluate, via phone call whether the patient's post-discharge needs are met. At 3 months and 6 months phone calls, standardized surveys will be used to assess mortality status, readmission, healthcare utilization, functional outcomes, quality of life, mental health status, coping and social support and return to work.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Respiratory failure:
- •Mechanical Ventilation via endotracheal tube/tracheostomy ≥ 24hrs
- •continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP) ≥ 24 consecutive hrs (provided for acute respiratory failure not for Obstructive Sleep Apnea or other stable use)
- •High flow nasal cannula ≥ 24 consecutive hrs (FIO2 ≥ 0.5 and flow rate ≥ 30 L/min)
- •Expected to be discharged home alive
- •Within the pandemic expansion cohort, COVID-19 status (defined as a positive result on an appropriately validated molecular diagnostic assay for infection with SARS-CoV-2) will be used to guide enrollment
排除标准
- •Lack of informed consent
- •Patient in the ICU < 24hrs
- •Mechanical ventilation at baseline
- •Residing at a medical institution at the time of hospital admission
- •Homelessness
- •Primary residence not in USA
- •More than mild dementia (either known diagnosis of moderate or worse dementia or Informant Questionnaire on Cognitive Decline in the Elderly (IQ-CODE) > 3.6; screening performed on patient > 50 years old or with family reports of possible memory decline)
- •Patient on hospice at or before time of enrollment
- •Patients who, based solely on pre-existing medical problems (such as poorly controlled neoplasm or other end-stage disease, including Stage IV heart failure or severe burns), would not be expected to survive six months in the absence of the acute respiratory failure.
- •Patient with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
- •Unable to communicate by telephone in English or Spanish
- •Patients mechanically ventilated solely for airway protection or obstruction
结局指标
主要结局
Number of deaths or hospital readmissions within three months of discharge
时间窗: 3 months after hospital discharge
Number of patients who died or were readmitted to the hospital within three month of hospital discharge
次要结局
- Number of ER visits(3 months after hospital discharge)
- Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)(At 6 months after hospital discharge)
- Coping or social support(After 3 months of hospital discharge)
- Return to work(6 month after hospital discharge)
- Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument(After 3 months of hospital discharge)
- Health related quality of life(At 6 months after hospital discharge)
- Healthcare utilization(Within 3 months of hospital discharge)
- Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)(At 6 months after hospital discharge)
- Mental health Functional outcome as assessed by Hospital Anxiety and Depression Scale (HADS)(After 3 months of hospital discharge)
- Number of deaths within 6 Months after discharge(6 months after hospital discharge)
- Functional outcomes-Post Traumatic Stress Disorder (PTSD)(After 3 months of hospital discharge)
研究者
James C. Jackson
Principal Investigator
Vanderbilt University Medical Center