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

• ClinicalTrials.gov Identifier: NCT03738774
• Recruitment Status: Active, not recruiting
• First Posted: November 13, 2018
• Last Update Posted: August 5, 2022
• Sponsor: Vanderbilt University Medical Center
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): James C. Jackson, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: November 7, 2018
• First Posted Date: November 13, 2018
• Last Update Posted Date: August 5, 2022
• Actual Study Start Date: January 2, 2019
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 8, 2018)

• Number of ER visits [ Time Frame: 3 months after hospital discharge ]
  Number of visits to the emergency department within three months of hospital discharge.
• Healthcare utilization [ Time Frame: Within 3 months of hospital discharge ]
  Gather information about healthcare resources utilization. For example, readmission to hospital after discharge or visits with primary care doctor.
• Cognitive Functional outcome as assessed by Montreal Cognitive Assessment (MoCA) - Blind Instrument [ Time Frame: After 3 months of hospital discharge ]
  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.
• Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index) [ Time Frame: At 3 months after hospital discharge ]
  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.
• Physical function outcome as assessed by Activity of Daily Living (ADL-Katz Index) [ Time Frame: At 6 months after hospital discharge ]
  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.
• Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton) [ Time Frame: At 3 months after hospital discharge ]
  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).
• Physical function outcome as assessed by Instrumental Activity of Daily Living (IADL-Lawton) [ Time Frame: At 6 months after hospital discharge ]
  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).
• Mental health Functional outcome as assessed by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: After 3 months of hospital discharge ]
  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.
• Functional outcomes-Post Traumatic Stress Disorder (PTSD) [ Time Frame: After 3 months of hospital discharge ]
  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.
• Coping or social support [ Time Frame: After 3 months of hospital discharge ]
  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.
• Health related quality of life [ Time Frame: At 3 months after hospital discharge ]
  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.
• Health related quality of life [ Time Frame: At 6 months after hospital discharge ]
  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.
• Number of deaths within 6 Months after discharge [ Time Frame: 6 months after hospital discharge ]
  Number of patients who died within six months of hospital discharge
• Return to work [ Time Frame: 6 month after hospital discharge ]
  Employment status within six month after hospital discharge. Including addition descriptions of return to work, for example, change in duties or change in effectiveness.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
• Official Title: Addressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID)
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Post Intensive Care Syndrome
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 8, 2018): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03738774
• Other Study ID Numbers: IRB181120
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Privacy Concerns

• Current Responsible Party: James C. Jackson, Vanderbilt University Medical Center
• Original Responsible Party: Johns Hopkins University
• Current Study Sponsor: Vanderbilt University Medical Center
• Original Study Sponsor: Johns Hopkins University
• Collaborators: United States Department of Defense

Investigators

• Principal Investigator: Samuel M Brown, MD; Intermountain Medical Center
• Principal Investigator: James C Jackson, PsyD; Vanderbilt University

• PRS Account: Vanderbilt University Medical Center
• Verification Date: August 2022