Post Intensive Care SyndromeAPICSNCT03738774
Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
An observational study of Post Intensive Care Syndrome, run by Vanderbilt University Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jan 2019to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University
Nashville, Tennessee, 37235
George Wahlen Salt Lake City Veterans Administration Hospital
Salt Lake City, Utah, 84148
About this study
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.
Read the 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.
- Conditions
- Post Intensive Care Syndrome
- Keywords
- Post intensive care syndrome
- Medical subject headings
- postintensive care syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after hospital discharge
Secondary outcomes (14)
Number of ER visits
Number of visits to the emergency department within three months of hospital discharge.
Measured: 3 months after hospital discharge
Healthcare utilization
Gather information about healthcare resources utilization. For example, readmission to hospital after discharge or visits with primary care doctor.
Measured: Within 3 months of hospital discharge
Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument
Using MoCA-Blind Instrument which assesses different types of cognitive abilities and can be administered via phone. Scores range from 0 to 22 points, with a score of 18 and higher generally considered normal.
Measured: After 3 months of hospital discharge
Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
This will be assessed using the Activity of Daily Living (ADL-Katz Index) instrument. ADL evaluates functional status as a measurement of the patient's ability to perform activities of daily living. Each activity is rated as being completed independently or not. Scores range is 0-6 points, higher score is better.
Measured: At 3 months after hospital discharge
Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
This will be assessed using the Activity of Daily Living (ADL-Katz Index) instrument. ADL evaluates functional status as a measurement of the patient's ability to perform activities of daily living. Each activity is rated as being completed independently or not. Scores range is 0-6 points, higher score is better.
Measured: At 6 months after hospital discharge
Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
This will be assessed using the Instrumental Activity of Daily Living (IADL-Lawton) instrument. IADL evaluates independent living skills. Each activity has specific level of participation that can be selected. Scores range from 0 (low function, dependent) to 8 points (high function, independent).
Measured: At 3 months after hospital discharge
Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
This will be assessed using the Instrumental Activity of Daily Living (IADL-Lawton) instrument. IADL evaluates independent living skills. Each activity has specific level of participation that can be selected. Scores range from 0 (low function, dependent) to 8 points (high function, independent).
Measured: At 6 months after hospital discharge
Mental health Functional outcome as assessed by Hospital Anxiety and Depression Scale (HADS)
Using Hospital Anxiety and Depression Scale (HADS) instrument which scores for anxiety and depression, range: 0-21 points; lower score is better, with scores ≥8 points, indicating substantial symptoms.
Measured: After 3 months of hospital discharge
Functional outcomes-Post Traumatic Stress Disorder (PTSD)
Using Impact of Event Scale-Revised (IES-R) instrument which is a 22-item self-report measure that assesses subjective distress caused by traumatic events. range: 0-4 points; lower score is better, with scores ≥1.6 indicating substantial symptoms. For this outcome mean or median scores can be reported along the with the proportion of patients above the threshold.
Measured: After 3 months of hospital discharge
Coping or social support
Using Multidimensional Scale of Perceived Social Support (MSPSS) instrument which is a brief (12-item) tool designed to measure perceptions of support from three sources: Family, Friends, and a Significant Other. Each item is scored on a 7-point Likert scale (ranging from Very Strongly Disagree to Very Strongly Agree, with midpoint as Neutral). Higher scores indicate greater levels of social support.
Measured: After 3 months of hospital discharge
Health related quality of life
Using EQ-5D instrument which is a standardized instrument for measuring generic health status. EQ-5D-5L consists a descriptive system and the EQ Visual Analogue scale (EQ VAS).
The descriptive system comprises 5 dimensions; Mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each is rated with 5 levels of severity of problems: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.
Measured: At 3 months after hospital discharge
Health related quality of life
Using EQ-5D instrument which is a standardized instrument for measuring generic health status. EQ-5D-5L consists a descriptive system and the EQ Visual Analogue scale (EQ VAS).
The descriptive system comprises 5 dimensions; Mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each is rated with 5 levels of severity of problems: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.
Measured: At 6 months after hospital discharge
Number of deaths within 6 Months after discharge
Number of patients who died within six months of hospital discharge
Measured: 6 months after hospital discharge
Return to work
Employment status within six month after hospital discharge. Including addition descriptions of return to work, for example, change in duties or change in effectiveness.
Measured: 6 month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start2 Jan 2019
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, James C. Jackson, Vanderbilt University Medical Center
- Investigators
- Samuel M Brown, MD, Principal investigator, Intermountain Health Care, Inc.James C Jackson, PsyD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738774
- Sponsor's protocol ID
- IRB181120
- Acronym
- APICS
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2018
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy Concerns
Publications
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.
PubMed 38688808Bose 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.
PubMed 36661449Akhlaghi 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.
PubMed 33099499
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
- ClinicalTrials.gov ID
- NCT03738774
- Acronym / sponsor ID
- APICS / IRB181120
- Conditions
- Post Intensive Care Syndrome
- Keywords
- Post intensive care syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Respiratory failure:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deaths or hospital readmissions within three months of discharge
Time frame: 3 months after hospital discharge
Number of patients who died or were readmitted to the hospital within three month of hospital discharge
14 secondary outcomes
Number of ER visits
Time frame: 3 months after hospital discharge
Healthcare utilization
Time frame: Within 3 months of hospital discharge
Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument
Time frame: After 3 months of hospital discharge
Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
Time frame: At 3 months after hospital discharge
Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index)
Time frame: At 6 months after hospital discharge
Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
Time frame: At 3 months after hospital discharge
Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton)
Time frame: At 6 months after hospital discharge
Mental health Functional outcome as assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: After 3 months of hospital discharge
Functional outcomes-Post Traumatic Stress Disorder (PTSD)
Time frame: After 3 months of hospital discharge
Coping or social support
Time frame: After 3 months of hospital discharge
Health related quality of life
Time frame: At 3 months after hospital discharge
Health related quality of life
Time frame: At 6 months after hospital discharge
Number of deaths within 6 Months after discharge
Time frame: 6 months after hospital discharge
Return to work
Time frame: 6 month after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 38688808Bose 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.
- Derived from this study: PubMed 36661449Bose 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.
- Derived from this study: PubMed 33099499Akhlaghi 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.
- Individual participant dataSharing planned: Undecided. Privacy Concerns
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel M Brown, MD principal investigator
Intermountain Health Care, Inc.
James C Jackson, PsyD principal investigator
Vanderbilt University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome, run by Vanderbilt University Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths or hospital readmissions within three months of discharge (time frame: 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738774, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.