Observational Study of Expected ARF Recovery

Completed

• Conditions: Post Intensive Care Syndrome; Acute Respiratory Failure

• Registration Number: NCT03797313
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Study Start: 2019-01-22
• Status Verified: 2021-02
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge	6 months 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.

Secondary Outcome Measures

Name	Time	Method
Patient expectation error measure using EQ-5D VAS	6 months after hospital discharge	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.

Trial Locations

Locations (4)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States