NCT05319379

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

March 31, 2022

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Agreement between patient and clinician assessment of dyspnea

    1 year

Secondary Outcomes (1)

  • Patient characteristics that might influence clinician ability to assess dyspnea

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Rush University Medical Center

You may qualify if:

  • 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.

You may not qualify if:

  • Less than 18 years old,
  • Non-English-speaking,
  • Subjects unable to answer questions about dyspnea for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60187, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

April 1, 2022

Primary Completion

January 3, 2024

Study Completion

January 3, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations