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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ER visits | Number of visits to the emergency department within three months of hospital discharge. | 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Samuel M Brown, MD | Intermountain Health Care, Inc. | Principal Investigator |
| James C Jackson, PsyD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38688808 | Derived | 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. | |
| 36661449 |
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Privacy Concerns
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2019 | Jul 11, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
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| 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 6 month after hospital discharge |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| George Wahlen Salt Lake City Veterans Administration Hospital | Salt Lake City | Utah | 84148 | United States |
| 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. |
| 33099499 | 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. |