Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)

NCT03738774 | Active Not Recruiting

• 1 other identifier: IRB181120
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Post Intensive Care Syndrome

Keywords

Post intensive care syndrome

Outcome Measures

Primary Outcomes (1)

• Number of deaths or hospital readmissions within three months of discharge

  Number of patients who died or were readmitted to the hospital within three month of hospital discharge

  3 months after hospital discharge

Secondary Outcomes (14)

• Number of ER visits

  3 months after hospital discharge

• Healthcare utilization

  Within 3 months of hospital discharge

• Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument

  After 3 months of hospital discharge

• Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)

  At 3 months after hospital discharge

• Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)

  At 6 months after hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (5)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

George Wahlen Salt Lake City Veterans Administration Hospital

Salt Lake City, Utah, 84148, United States

Location

Related Publications (3)

• Bose S, Groat D, Stollings JL, Barney P, Dinglas VD, Goodspeed VM, Carmichael H, Mir-Kasimov M, Jackson JC, Needham DM, Brown SM, Sevin CM; APICS-01 Study Team. Prescription of potentially inappropriate medications after an intensive care unit stay for acute respiratory failure. Aust Crit Care. 2024 Nov;37(6):866-872. doi: 10.1016/j.aucc.2024.02.001. Epub 2024 Apr 29.

  PMID: 38688808 DERIVED

• Bose S, Groat D, Dinglas VD, Akhlaghi N, Banner-Goodspeed V, Beesley SJ, Greene T, Hopkins RO, Mir-Kasimov M, Sevin CM, Turnbull AE, Jackson JC, Needham DM, Brown SM; Addressing Post-Intensive Care Syndrome (APICS-01) Study Team. Association Between Unmet Nonmedication Needs After Hospital Discharge and Readmission or Death Among Acute Respiratory Failure Survivors: A Multicenter Prospective Cohort Study. Crit Care Med. 2023 Feb 1;51(2):212-221. doi: 10.1097/CCM.0000000000005709. Epub 2023 Jan 20.

  PMID: 36661449 DERIVED

• 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.

  PMID: 33099499 DERIVED

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Samuel M Brown, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

• James C Jackson, PsyD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 13, 2018
• Study Start: January 2, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (5)