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Clinical Trials/NCT03797313
NCT03797313
Completed
Not Applicable

Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

Johns Hopkins University4 sites in 1 country180 target enrollmentJanuary 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Johns Hopkins University
Enrollment
180
Locations
4
Primary Endpoint
Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2019
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge

Time Frame: 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 Outcomes

  • Patient expectation error measure using EQ-5D VAS(6 months after hospital discharge)

Study Sites (4)

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