Observational Study of Expected ARF Recovery

NCT03797313 | Completed

• 3 other identifiers: IRB0019723500181895K01HL141637-01
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Respiratory Failure; Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient expectation error measure using EQ-5D VAS

  6 months after hospital discharge

Study Arms (2)

Patient's expectations met at Hospital discharge

ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later.

Patient's with unmet expectations at Hospital Discharge

ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

survivors of acute respiratory failure (ARF) who are expected to be discharged home alive.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

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MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Alison Turnbull

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: January 22, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-02

Locations

US (4)