OSEAR: Observational Study of Expected ARF Recovery

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT03797313

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

180

Enrollment

Locations

34.3

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure Post Intensive Care Syndrome

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 Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Expected Acute Respiratory Failure (ARF) Recovery

Actual Study Start Date :

Jan 22, 2019

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Vanderbilt University	Nashville	Tennessee	United States	37235
4	Intermountain Medical Center	Murray	Utah	United States	84107

Sponsors and Collaborators

Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Alison Turnbull, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03797313

Other Study ID Numbers:

IRB00197235
00181895
K01HL141637-01

First Posted:

Jan 9, 2019

Last Update Posted:

Dec 15, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Respiratory Distress Syndrome

Study Results

No Results Posted as of Dec 15, 2021