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Addressing Post-Intensive Care Syndrome (APICS-01) (APICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738774
Recruitment Status : Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
James C. Jackson, Vanderbilt University Medical Center

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.

Condition or disease
Post Intensive Care Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Addressing Post-Intensive Care Syndrome (APICS-01)
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of ER visits [ Time Frame: 3 months after hospital discharge ]
    Number of visits to the emergency department within three months of hospital discharge.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.


  12. 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.


  13. 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

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738774


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37235
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
George Wahlen Salt Lake City Veterans Administration Hospital
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
Vanderbilt University Medical Center
United States Department of Defense
Investigators
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Principal Investigator: Samuel M Brown, MD Intermountain Medical Center
Principal Investigator: James C Jackson, PsyD Vanderbilt University
  Study Documents (Full-Text)

Documents provided by James C. Jackson, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] July 1, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James C. Jackson, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03738774    
Other Study ID Numbers: IRB181120
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Privacy Concerns

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James C. Jackson, Vanderbilt University Medical Center:
Post intensive care syndrome
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes