Clinical trial NCT03738774: Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
Official title: Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post Intensive Care Syndrome
Keywords: Post intensive care syndrome
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the ICUs and/or hospital wards of study hospital, with the intent to evaluate all patients with respiratory failure for at least 24 hours.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 L/min)
2. Expected to be discharged home alive
3. 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

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 or Spanish
* Patients mechanically ventilated solely for airway protection or obstruction

Primary outcomes:
measure: Number of deaths or hospital readmissions within three months of discharge
timeFrame: 3 months after hospital discharge
Secondary outcomes:
measure: Number of ER visits
timeFrame: 3 months after hospital discharge
measure: Healthcare utilization
timeFrame: Within 3 months of hospital discharge
measure: Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument
timeFrame: After 3 months of hospital discharge
measure: Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
timeFrame: At 3 months after hospital discharge
measure: Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
timeFrame: At 6 months after hospital discharge
measure: Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
timeFrame: At 3 months after hospital discharge
measure: Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
timeFrame: At 6 months after hospital discharge
measure: Mental health Functional outcome as assessed by Hospital Anxiety and Depression Scale (HADS)
timeFrame: After 3 months of hospital discharge
measure: Functional outcomes-Post Traumatic Stress Disorder (PTSD)
timeFrame: After 3 months of hospital discharge
measure: Coping or social support
timeFrame: After 3 months of hospital discharge
measure: Health related quality of life
timeFrame: At 3 months after hospital discharge
measure: Health related quality of life
timeFrame: At 6 months after hospital discharge
measure: Number of deaths within 6 Months after discharge
timeFrame: 6 months after hospital discharge
measure: Return to work
timeFrame: 6 month after hospital discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: George Wahlen Salt Lake City Veterans Administration Hospital
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: Samuel M Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: James C Jackson, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akhlaghi N, Needham DM, Bose S, Banner-Goodspeed VM, Beesley SJ, Dinglas VD, Groat D, Greene T, Hopkins RO, Jackson J, Mir-Kasimov M, Sevin CM, Wilson E, Brown SM. Evaluating the association between unmet healthcare needs and subsequent clinical outcomes: protocol for the Addressing Post-Intensive Care Syndrome-01 (APICS-01) multicentre cohort study. BMJ Open. 2020 Oct 23;10(10):e040830. doi: 10.1136/bmjopen-2020-040830.