DyspneaNCT05319379
Clinician Assessment of Patient Dyspnea
An observational study of Dyspnea, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 3 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to Rush University Medical Center
Who may be able to join
- 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.
Who cannot join
- Less than 18 years old,
- Non-English-speaking,
- Subjects unable to answer questions about dyspnea for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60187
About this study
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.
Read the 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.
- Conditions
- Dyspnea
- Medical subject headings
- Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between patient and clinician assessment of dyspnea
Measured: 1 year
Secondary outcomes (1)
Patient characteristics that might influence clinician ability to assess dyspnea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Why it stopped: No plans to continue study or publish data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brady Scott, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319379
- Sponsor's protocol ID
- 22020104-IRB01
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Assessment of Patient Dyspnea
- ClinicalTrials.gov ID
- NCT05319379
- Acronym / sponsor ID
- 22020104-IRB01
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No plans to continue study or publish data.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Rush University Medical Center
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Less than 18 years old,
- Non-English-speaking,
- Subjects unable to answer questions about dyspnea for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between patient and clinician assessment of dyspnea
Time frame: 1 year
1 secondary outcome
Patient characteristics that might influence clinician ability to assess dyspnea
Time frame: 1 year
Results and safety
The study was stopped early (reason given: No plans to continue study or publish data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No plans to continue study or publish data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between patient and clinician assessment of dyspnea (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.