Addressing Post-Intensive Care Syndrome (APICS-01)

Age Range:18 - Any
Start Date:January 2, 2019
End Date:July 2022
Contact:Victor Dinglas, MD PhD
Phone:+1 (410) 502-7040

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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

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.

Inclusion Criteria:

1. 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

2. Expected to be discharged home alive

Exclusion Criteria:

- 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

- Prisoner

- 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

- Patients mechanically ventilated solely for airway protection or obstruction
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