Observational Study of Expected ARF Recovery

Study Overview
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Brief Summary
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This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge.

Detailed Description
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This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant expectations for functional recovery will be assessed before hospital discharge via a standardized questionnaire containing a visual analogue scale and questions about expected ability and importance of being able to perform activities of daily living and instrumental activities of daily living in 6 months. At 6 months, participants will be re-contacted by phone. Study staff will administer questionnaires to assess whether patient expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the EQ-5D-VAS.

Official Title
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Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

Conditions
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Acute Respiratory Failure, Post Intensive Care Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following: Mechanical ventilation via an endotracheal tube ≥ 24 hours OR Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours* *Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of consecutive hours. Expected by the clinical team to be discharged home alive Exclusion Criteria: Patient in ICU < 24 hours Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction Residing in a medical institution at the time of hospital admission Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE > 3.6; screening performed on patients > 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 6 months in the absence of the acute respiratory failure. Patients with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient's expectations met at Hospital discharge<br>ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later. | |
| Patient's with unmet expectations at Hospital Discharge<br>ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge | WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two benchmark items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life. | 6 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient expectation error measure using EQ-5D VAS | A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. | 6 months after hospital discharge |