- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05319379
Clinician Assessment of Patient Dyspnea
Background: Dyspnea, like pain, is subjective and challenging to assess despite the large number of patients that report shortness of breath. Several studies have shown that physicians and nurses inaccurately assess patient dyspnea. Since respiratory therapists care for many patients at risk for dyspnea, an evaluation of their abilities to evaluate dyspnea is needed. Thus, the plan is to evaluate respiratory therapists' ability to assess a patient's dyspnea level, in addition to nurses and physicians.
Methods: This is a prospective study to evaluate the agreement between dyspnea assessment by a patient and respiratory therapist, nurses, and physicians. The primary aim of this study will be to evaluate clinician ability to assess a patients dyspnea level. The secondary aim of this study is to identify patient characteristics that might influence clinician ability to assess dyspnea.
Study Overview
Status
Conditions
Detailed Description
According to the American Thoracic Society (ATS), the term dyspnea characterizes the subjective experience of breathing discomfort of patients. Dyspnea, like pain, is subjective. Currently, there is no single standard evaluation of dyspnea despite the large number of tools designed to help patients accurately quantify patients who report breathing discomfort.2 Many patients report dyspnea, and studies have shown significant physiological responses associated with breathing discomfort. For example, the amygdala is activated with dyspnea and elicits a sense of impending doom. This is concerning because the prevalence of dyspnea varies widely, from as high as 65% in lung cancer patients to as low as 16% in low-risk population. It appears that the prevalence of dyspnea varies vastly between disease processes, but it not clear if clinicians are able to accurately detect breathing discomfort on routine assessments.
Various efforts have been made to understand how well physicians and nurses assess the dyspnea status of patients. In 2017, Binks et al assessed physicians, nurses, and respiratory therapists on their ability to rate dyspnea in patients requiring mechanical ventilation. The study found that those patients experienced dyspnea and at a significantly higher prevalence than any professional had rated. There was also positive correlation between the amount of discomfort and the degree of underestimation, thus undertreatment which can lead to patient suffering. In a prospective observational study conducted by Puntillo et al, 171 patients considered high risk of dying were assessed for symptoms experienced while in the intensive care unit (ICU). In that study, they found that a significant number of patients had unaddressed symptoms that contributed to unnecessary suffering. Dyspnea was found to be the most distressing symptom that patients experienced. Interestingly, dyspnea was noted in patients that required mechanical ventilation and those that did not.
Stefan et al conducted a study to evaluate the agreement of dyspnea in spontaneously breathing patients with that of the physicians or nurses' assessment. The researchers found that physicians underestimated patients' dyspnea 37.9 % of the time and overestimated 25.8% while nurses underestimated 43.5% and overestimated 12.4%. This is worrisome considering the number of patients that suffer from dyspnea.
Several studies have shown that clinicians responsible for respiratory assessments, like physicians and nurses, often inaccurately assess breathing discomfort. Since respiratory therapists care for many patients at risk for dyspnea, an evaluation of their abilities to assess it should be made. Findings from a study involving respiratory therapists, along with findings from other medical professionals, will provide valuable information for future efforts to better train clinicians on how to best assess dyspnea. The primary aim of this study will be to evaluate clinician (respiratory therapist, nurse, and physician) ability to assess patient dyspnea level. The secondary aims of this study are to identify patient characteristics that might influence clinician ability to assess dyspnea.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60187
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult subjects 18 years and older,
- Admitted to RUMC
- Non-intubated,
- Admitted with a diagnosis of heart failure (HF), chronic obstructive pulmonary disease (COPD), asthma, pneumonia, a generic diagnosis of shortness of breath, or requiring supplemental oxygen support.
Exclusion Criteria:
- Less than 18 years old,
- Non-English-speaking,
- Subjects unable to answer questions about dyspnea for any reason.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Agreement between patient and clinician assessment of dyspnea
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient characteristics that might influence clinician ability to assess dyspnea
Time Frame: 1 year
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1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22020104-IRB01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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