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

Primary Purpose

COPD Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Spirometry at initial visit
Albuterol
Spirometry at 12-month follow-up
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD Asthma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CCHHS
  • UI Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Patient Subject Usual Care

Patient-Subject Intervention

Arm Description

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. Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale 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.

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: Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale Quality of life measures Pre and post-bronchodilator using Albuterol (BD) spirometry

Outcomes

Primary Outcome Measures

Total Number of Healthcare Visits
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

Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
determine differences in the accuracy of diagnosis between groups

Full Information

First Posted
April 14, 2017
Last Updated
July 2, 2021
Sponsor
University of Illinois at Chicago
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03137303
Brief Title
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Acronym
REDEFINE
Official Title
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Subject Usual Care
Arm Type
Placebo Comparator
Arm Description
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. Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale 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.
Arm Title
Patient-Subject Intervention
Arm Type
Experimental
Arm Description
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: Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale Quality of life measures Pre and post-bronchodilator using Albuterol (BD) spirometry
Intervention Type
Device
Intervention Name(s)
Spirometry at initial visit
Other Intervention Name(s)
KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe
Intervention Description
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
Drug
Intervention Name(s)
Albuterol
Other Intervention Name(s)
Albuterol, Ventolin, Proventil, Accuneb
Intervention Description
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
Device
Intervention Name(s)
Spirometry at 12-month follow-up
Other Intervention Name(s)
KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Number of Healthcare Visits
Description
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
Description
determine differences in the accuracy of diagnosis between groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Joo, MD MPH
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCHHS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
UI Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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URL
http://www.goldcopd.org
Description
Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2016

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

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