Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-02-26
Brief Title:
Edmonton Dyspnea Inventory- Validation Study
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Edmonton Dyspnea Inventory EDI in Interstitial Lung Diseases Understanding Dyspnea Severity and Impact of EDI Use in Individuals With Interstitial Lung Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breathlessness is a common problem for many patients with Interstitial lung disease ILD ILD is a group of lung diseases that cause inflammation swelling and scarring in the lung tissue where gas exchange oxygen and carbon dioxide occurs Unfortunately there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness This limits their ability to live a good life Clinicians do not often recognize assess or treat breathlessness appropriately Breathlessness being a subjective experience cannot be fully understood through objective measurements such as lung function tests the arterial blood gas test etc The objective and subjective measures of breathlessness are frequently disconnected Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves As a result they remain unaware of this disabling symptom and the extent of its impact on patients While there are many tools to measure breathlessness they are not consistently used in routine care or have impacted care in a meaningful way Many such tools are also complex with intricate response systems with possibility of errors and user fatigue As a result easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness Investigators hope that the tool will help clinicians quickly identify the patients breathlessness severity and provide them with an algorithm of what to do next The tool was developed by clinicians with 15 years of experience in ILD and dyspnea Early analysis already suggests the tool is useful to patients and helps improve care
Detailed Description:
Dyspnea or breathlessness is a disabling and distressing symptom that affects every aspect of a patient and caregivers life It is prevalent in progressive pulmonary fibrosis PPF as well as many other fibrotic ILD F-ILD Idiopathic pulmonary fibrosis IPF the most common and well-studied F-ILD with a life expectancy of only 3-4 years has a dyspnea prevalence of 90 at diagnosis Despite the high dyspnea burden in IPF and PPF and its impact on both health-related quality of life HRQOL and mortality healthcare professionals often do not adequately assess or treat dyspnea in practice Many reasons have been proposed for this care gap
Dyspnea is a subjective and complex symptom where experience is shaped by a variety of factors including physiological psychological and environmental influences Degree of lung function impairment does not consistently predict level of breathlessness and cannot be used as a surrogate for direct dyspnea measures Unfortunately dyspnea is not frequently assessed in care Many scales exist including uni- and multidimensional scales MRC a unidimensional scale is the most commonly used dyspnea scale The MRC scale assesses dyspnea by asking which activities ranging from vigorous exercise to minimal activities of daily living are limited by dyspnea The MRC scale has shown good utility in many studies A major drawback of the MRC scale in some populations is the lack of a scale point for patients who experience dyspnea at rest but it is easy to extend the scale to ask about dyspnea at rest However scales such as the MRC are indirect they do not actually ask the patient how much dyspnea they experience Experts have therefore recommended that patients not only be routinely asked about dyspnea but should also be asked to rate its severity In a recent study of over 67000 patients dyspnea severity reported by patients during a rapid nursing assessment on admission was associated with two-fold odds of death in 2 years The authors noted that patients who reported any dyspnea were at an increased risk of death during that hospital stay the greater the dyspnea severity the greater the risk of death Even after adjustment for patient comorbidities demographics and severity of illness increasing dyspnea severity remained associated with inpatient mortality They suggest that routine assessment of dyspnea severity may allow for better monitoring and optimal interventions that could potentially reduce mortality and morbidity A 2015 survey of US-based hospitalists also suggests that dyspnea severity may help guide management Unfortunately routine dyspnea severity assessment is also uncommon in practice
Secondly there are no dyspnea treatment algorithms for clinicians to implement in practice The American Thoracic Society ATS statements and guidelines emphasize the urgent need to assess and manage dyspnea in respiratory disease including IPF but do not provide a treatment algorithm They do recommend evidence-based therapies such as pulmonary rehabilitation anxiolytics and opioids and the treatment of associated psychosocial factors And finally physician perspectives regarding dyspnea and reluctance to use opiates inadequate education and lack of training are all important barriers to effective dyspnea management
To address this care gap in assessment investigator developed an easy-to-use scale Edmonton Dyspnea Inventory EDI in the Multidisciplinary Collaborative ILD Clinic Edmonton Canada EDI is a pilot tool to assess dyspnea severity at rest during activities of daily living and self-reported exercise In addition the tool also documents crisis dyspnea episodes and their triggers to guide management Investigators preliminary work showed that EDI has good internal consistency strong correlation with MRC and weak correlation with lung function data Group based trajectory modelling showed 3 different groups of dyspnea intensity with implications for survival Investigator also showed feasibility of outpatient clinical use over 10 years In addition EDI use led to early institution of dyspnea therapies van Den Bosch AJHPC 2023 This tool facilitated early and personalized dyspnea management that differs both between and within individual MRC grades Kalluri AJHPC 2024 Investigator has also shown this approach to dyspnea assessment and management facilitates patient self-management and mastery allowing reduction in acute care utilization and healthcare costs in IPF This is the only tool to that facilitates both assessment and management of dyspnea Systematic assessment and appropriate dyspnea management is an urgent unmet need in patient care Physicians and clinicians require an easy-to-use tool to assess dyspnea and create a personalized management plan for their patients Investigator believes EDI can serve both purposes as per our early studies Investigator proposes to examine EDIs cross-sectional and longitudinal validity and reliability for use in IPF and F-ILD including PPF Investigator will also explore patient and care provider perceptions on the use of EDI and its potentialactual impact on clinical care using focus group methodology Investigator will recruit participants from all three sites for qualitative analysis
Dyspnea is a subjective and complex symptom where experience is shaped by a variety of factors including physiological psychological and environmental influences Degree of lung function impairment does not consistently predict level of breathlessness and cannot be used as a surrogate for direct dyspnea measures Unfortunately dyspnea is not frequently assessed in care Many scales exist including uni- and multidimensional scales MRC a unidimensional scale is the most commonly used dyspnea scale The MRC scale assesses dyspnea by asking which activities ranging from vigorous exercise to minimal activities of daily living are limited by dyspnea The MRC scale has shown good utility in many studies A major drawback of the MRC scale in some populations is the lack of a scale point for patients who experience dyspnea at rest but it is easy to extend the scale to ask about dyspnea at rest However scales such as the MRC are indirect they do not actually ask the patient how much dyspnea they experience Experts have therefore recommended that patients not only be routinely asked about dyspnea but should also be asked to rate its severity In a recent study of over 67000 patients dyspnea severity reported by patients during a rapid nursing assessment on admission was associated with two-fold odds of death in 2 years The authors noted that patients who reported any dyspnea were at an increased risk of death during that hospital stay the greater the dyspnea severity the greater the risk of death Even after adjustment for patient comorbidities demographics and severity of illness increasing dyspnea severity remained associated with inpatient mortality They suggest that routine assessment of dyspnea severity may allow for better monitoring and optimal interventions that could potentially reduce mortality and morbidity A 2015 survey of US-based hospitalists also suggests that dyspnea severity may help guide management Unfortunately routine dyspnea severity assessment is also uncommon in practice
Secondly there are no dyspnea treatment algorithms for clinicians to implement in practice The American Thoracic Society ATS statements and guidelines emphasize the urgent need to assess and manage dyspnea in respiratory disease including IPF but do not provide a treatment algorithm They do recommend evidence-based therapies such as pulmonary rehabilitation anxiolytics and opioids and the treatment of associated psychosocial factors And finally physician perspectives regarding dyspnea and reluctance to use opiates inadequate education and lack of training are all important barriers to effective dyspnea management
To address this care gap in assessment investigator developed an easy-to-use scale Edmonton Dyspnea Inventory EDI in the Multidisciplinary Collaborative ILD Clinic Edmonton Canada EDI is a pilot tool to assess dyspnea severity at rest during activities of daily living and self-reported exercise In addition the tool also documents crisis dyspnea episodes and their triggers to guide management Investigators preliminary work showed that EDI has good internal consistency strong correlation with MRC and weak correlation with lung function data Group based trajectory modelling showed 3 different groups of dyspnea intensity with implications for survival Investigator also showed feasibility of outpatient clinical use over 10 years In addition EDI use led to early institution of dyspnea therapies van Den Bosch AJHPC 2023 This tool facilitated early and personalized dyspnea management that differs both between and within individual MRC grades Kalluri AJHPC 2024 Investigator has also shown this approach to dyspnea assessment and management facilitates patient self-management and mastery allowing reduction in acute care utilization and healthcare costs in IPF This is the only tool to that facilitates both assessment and management of dyspnea Systematic assessment and appropriate dyspnea management is an urgent unmet need in patient care Physicians and clinicians require an easy-to-use tool to assess dyspnea and create a personalized management plan for their patients Investigator believes EDI can serve both purposes as per our early studies Investigator proposes to examine EDIs cross-sectional and longitudinal validity and reliability for use in IPF and F-ILD including PPF Investigator will also explore patient and care provider perceptions on the use of EDI and its potentialactual impact on clinical care using focus group methodology Investigator will recruit participants from all three sites for qualitative analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None