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Trial record 22 of 95 for:    asthma | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study) (REDEFINE)

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ClinicalTrials.gov Identifier: NCT03137303
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Min Joo, MD MPH, University of Illinois at Chicago

Brief Summary:
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.

Condition or disease Intervention/treatment Phase
COPD Asthma Device: Spirometry Drug: Albuterol Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
Placebo Comparator: 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.

Device: Spirometry

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.

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.

Other Names:
  • KoKo Spirometer (Model 313120)
  • 3 Liter Calibration Syringe

Experimental: 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
Device: Spirometry

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.

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.

Other Names:
  • KoKo Spirometer (Model 313120)
  • 3 Liter Calibration Syringe

Drug: 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.
Other Name: Albuterol, Ventolin, Proventil, Accuneb




Primary Outcome Measures :
  1. Total number of healthcare visits [ Time Frame: 1 year ]
    Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups


Secondary Outcome Measures :
  1. Proportion with diagnosis of COPD and/or asthma consistent with spirometry results [ Time Frame: 1 year ]
    determine differences in the accuracy of diagnosis between groups

  2. Proportion with additional diagnostic testing including: 1) ECG, 2) echocardiograms, 3) CT, 4) CXR, 5) stress testing, 6) cardiac catheterization, 7) other pulmonary function tests [ Time Frame: 1 year ]
    Determine differences in use of ancillary testing between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137303


Contacts
Contact: Min Joo, MD MPH 312-966-8039 joo@uic.edu

Locations
United States, Illinois
CCHHS Recruiting
Chicago, Illinois, United States, 60612
Contact: Kyungran Shim, MD       kshim@cookcountyhhs.org   
UI Health Recruiting
Chicago, Illinois, United States, 60612
Contact: Min Joo, MD MPH         
Sponsors and Collaborators
University of Illinois at Chicago
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Min Joo, MD MPH University of Illinois at Chicago

Additional Information:
Publications:
National Center for Health Statistics. Chronic Obstructive Pulmonary Disease Among Adults Aged 18 and Over in the United States, 1998-2009. 2011
In: Balogh EP, Miller BT, Ball JR, eds. Improving Diagnosis in Health Care. Washington (DC)2015
Global Initiative for Asthma. Global strategy for asthma management and prevention. Bethesda, MD, USA: GINA;2015
Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. In: National Heart Lung and Blood Institute, ed2012

Responsible Party: Min Joo, MD MPH, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03137303     History of Changes
Other Study ID Numbers: 2016-1209
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action