Observational Study of Expected ARF Recovery (OSEAR)

December 14, 2021 updated by: Johns Hopkins University

Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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
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.
6 months after hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient expectation error measure using EQ-5D VAS
Time Frame: 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.
6 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Alison Turnbull, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2019

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00197235
  • 00181895 (Other Identifier: Other)
  • K01HL141637-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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