Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
NCT ID: NCT03137303
Last Updated: 2024-02-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
402 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-01
Study Completion Date
2019-09-30
Brief Summary
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The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.
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Detailed Description
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Asthma and chronic obstructive pulmonary disease (COPD) are common chronic lung diseases that are diagnosed in more than 30 million adults in the United States. However, diagnostic error (DE), is considered one of the most common and harmful of patient-safety problems by the Institute of Medicine, occur frequently with asthma and/or COPD and disproportionately affect minorities and the under-served. DE leads to lost opportunities to identify other chronic conditions, avoidable morbidity and mortality, unnecessary costs to patients and health systems, and poor quality of care. Shortness of breath or dyspnea, which is a common symptom in asthma and COPD, is also common for many other chronic conditions such as cardiovascular disease and obesity. A better understanding of the impact of DE and interventions to improve diagnostic accuracy in asthma and COPD are of particular importance for minorities and the under-served that are disproportionately affected by conditions leading to dyspnea.
Spirometry is a simple, mobile, and essential test that is recommended by all major national and international guidelines for the diagnosis of asthma and COPD. However it is well known that spirometry is not routinely used in the ambulatory primary care setting and minorities and the underserved population are less likely to have spirometry leading to greater prevalence of DE. It has been estimated that 30-50% of people with an existing diagnosis of asthma and COPD were found to be misdiagnosed. Many of these patients misdiagnosed with asthma and/or COPD receive unnecessary respiratory pharmacotherapy which can pose serious risks including pneumonia, cardiovascular events, and mortality. In the setting of DE, these are considered avoidable and unnecessary respiratory pharmacotherapy use in minorities and the underserved that are already disproportionately affected by cardiovascular disease increases the risk of poorer outcomes. There is also DE in the diagnosis of asthma versus COPD, as these are both clinically distinct respiratory disorders with nuances in treatment recommendations. It is reported that African-Americans are considered to have increasing COPD mortality and are disproportionately affected by asthma death rates. However, as spirometry is not routinely performed and DE is prevalent in asthma and COPD, a component of these poor outcomes may be attributable to missed or delayed diagnoses of other chronic conditions or misdiagnosis within asthma and COPD.
Barriers to the use of spirometry in primary care exist at provider and health systems levels. Previous studies show that primary care providers (PCPs) lack knowledge in existing guidelines and in implementing spirometry into primary care clinics. Beyond these barriers, PCPs struggle with logistical challenges such as time and workflow constraints with clinic visits lasting 15 minutes or less in patients with multiple chronic medical conditions. These predisposing and enabling factors explain why prior studies that included interventions to educate PCPs and incorporate spirometry by training personnel in primary care clinics have had limited results.
A new paradigm to improve guideline based care for asthma and COPD which includes spirometry is needed and can lead to a better understanding of DE and improved patient safety and patient-centered outcomes. Health Promoters or Community health workers (CHWs) have been supplementing medical care by disseminating appropriate health care practices for underserved minority populations. However, studies which include diagnostic evaluations with spirometry for asthma and COPD have not been performed. The REDEFINE program (Reducing Diagnostic Error to Improve PatieNt SafEty in COPD and Asthma) will incorporate health promoters working collaboratively with PCPs to address identified barriers to guideline based care which includes spirometry for the diagnosis of asthma and COPD for patients at risk for DE. We propose a comparative effectiveness study to better understand the epidemiology of DE and to evaluate the effectiveness and economic impact of providing the REDEFINE program to an underserved, predominantly minority population with a diagnosis of asthma and/or COPD at risk for DE.
Spirometry is a simple, mobile, and essential test that is recommended by all major national and international guidelines for the diagnosis of asthma and COPD. However it is well known that spirometry is not routinely used in the ambulatory primary care setting and minorities and the underserved population are less likely to have spirometry leading to greater prevalence of DE. It has been estimated that 30-50% of people with an existing diagnosis of asthma and COPD were found to be misdiagnosed. Many of these patients misdiagnosed with asthma and/or COPD receive unnecessary respiratory pharmacotherapy which can pose serious risks including pneumonia, cardiovascular events, and mortality. In the setting of DE, these are considered avoidable and unnecessary respiratory pharmacotherapy use in minorities and the underserved that are already disproportionately affected by cardiovascular disease increases the risk of poorer outcomes. There is also DE in the diagnosis of asthma versus COPD, as these are both clinically distinct respiratory disorders with nuances in treatment recommendations. It is reported that African-Americans are considered to have increasing COPD mortality and are disproportionately affected by asthma death rates. However, as spirometry is not routinely performed and DE is prevalent in asthma and COPD, a component of these poor outcomes may be attributable to missed or delayed diagnoses of other chronic conditions or misdiagnosis within asthma and COPD.
Barriers to the use of spirometry in primary care exist at provider and health systems levels. Previous studies show that primary care providers (PCPs) lack knowledge in existing guidelines and in implementing spirometry into primary care clinics. Beyond these barriers, PCPs struggle with logistical challenges such as time and workflow constraints with clinic visits lasting 15 minutes or less in patients with multiple chronic medical conditions. These predisposing and enabling factors explain why prior studies that included interventions to educate PCPs and incorporate spirometry by training personnel in primary care clinics have had limited results.
A new paradigm to improve guideline based care for asthma and COPD which includes spirometry is needed and can lead to a better understanding of DE and improved patient safety and patient-centered outcomes. Health Promoters or Community health workers (CHWs) have been supplementing medical care by disseminating appropriate health care practices for underserved minority populations. However, studies which include diagnostic evaluations with spirometry for asthma and COPD have not been performed. The REDEFINE program (Reducing Diagnostic Error to Improve PatieNt SafEty in COPD and Asthma) will incorporate health promoters working collaboratively with PCPs to address identified barriers to guideline based care which includes spirometry for the diagnosis of asthma and COPD for patients at risk for DE. We propose a comparative effectiveness study to better understand the epidemiology of DE and to evaluate the effectiveness and economic impact of providing the REDEFINE program to an underserved, predominantly minority population with a diagnosis of asthma and/or COPD at risk for DE.
Conditions
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COPD Asthma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Patient Subject Usual Care
On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit. The following will be performed.
1. Subject demographic and contact information
2. Co-morbid conditions
3. Smoking history
4. Medication history from patient and also from pharmacy used by subjects
5. A respiratory exacerbation history in the past year
6. Modified Medical Research Counsel (mMRC) dyspnea scale
7. Quality of life measures
Subjects will be advised to go to their clinics and be managed by their PCP thereafter.
At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry and undergo the same spirometry protocol as the intervention group.
Group Type
PLACEBO_COMPARATOR
Albuterol
Intervention Type
DRUG
The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
Spirometry at 12-month follow-up
Intervention Type
DEVICE
At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
Patient-Subject Intervention
On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit in the same building as the clinic site. The following information will be collected and procedures will be performed:
1. Subject demographic and contact information
2. Co-morbid conditions
3. Smoking history
4. Medication history from patient and also from pharmacy used by subjects
5. A respiratory exacerbation history in the past year
6. Modified Medical Research Counsel (mMRC) dyspnea scale
7. Quality of life measures
8. Pre and post-bronchodilator using Albuterol (BD) spirometry
Group Type
EXPERIMENTAL
Spirometry at initial visit
Intervention Type
DEVICE
Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.
Albuterol
Intervention Type
DRUG
The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
Interventions
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Spirometry at initial visit
Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.
Intervention Type
DEVICE
Albuterol
The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
Intervention Type
DRUG
Spirometry at 12-month follow-up
At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
Intervention Type
DEVICE
Other Intervention Names
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KoKo Spirometer (Model 313120)
3 Liter Calibration Syringe
Albuterol, Ventolin, Proventil, Accuneb
KoKo Spirometer (Model 313120)
3 Liter Calibration Syringe
Eligibility Criteria
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Inclusion Criteria
* 1.Age ≥40 years of age
* 2\. Use of a maintenance respiratory medication and one of the following in the past year:
* 3\. Diagnosis of asthma and/or COPD
* 4\. No spirometry test performed in the past 3 years
* 5\. Past or current smoker or is exposed to tobacco
* 2\. Use of a maintenance respiratory medication and one of the following in the past year:
* 3\. Diagnosis of asthma and/or COPD
* 4\. No spirometry test performed in the past 3 years
* 5\. Past or current smoker or is exposed to tobacco
Exclusion Criteria
* Unable to perform adequate spirometry
* Non-English speaking
* Pregnancy
* Plans to move from the Chicago Area within the next year
* Seen by pulmonary specialist in the past 3 years
* Any terminal illness with a life expectancy of \<6 months
* Life threatening (e.g. intensive care admission and/or use of mechanical ventilation) respiratory failure event in the past year.
* Non-English speaking
* Pregnancy
* Plans to move from the Chicago Area within the next year
* Seen by pulmonary specialist in the past 3 years
* Any terminal illness with a life expectancy of \<6 months
* Life threatening (e.g. intensive care admission and/or use of mechanical ventilation) respiratory failure event in the past year.
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Sponsor Role
collaborator
University of Illinois at Chicago
OTHER
Sponsor Role
lead
Responsible Party
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Min Joo, MD MPH
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Min Joo, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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CCHHS
Chicago, Illinois, United States
Site Status
UI Health
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
http://www.goldcopd.org
Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2016
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-1209
Identifier Type: -
Identifier Source: org_study_id
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