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

NCT03137303 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2016-1209
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COPD Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results

  1 year

Study Arms (2)

Patient Subject Usual Care

PLACEBO COMPARATOR

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.

Drug: Albuterol; Device: Spirometry at 12-month follow-up

Patient-Subject Intervention

EXPERIMENTAL

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 at initial visit; Drug: Albuterol

Interventions

Spirometry at initial visit 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.

Also known as: KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe

Patient-Subject Intervention

Albuterol 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.

Also known as: Albuterol, Ventolin, Proventil, Accuneb

Patient Subject Usual Care; Patient-Subject Intervention

Spirometry at 12-month follow-up 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.

Also known as: KoKo Spirometer (Model 313120), 3 Liter Calibration Syringe

Patient Subject Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years of age
• \. Use of a maintenance respiratory medication and one of the following in the past year:
• \. Diagnosis of asthma and/or COPD
• \. No spirometry test performed in the past 3 years
• \. Past or current smoker or is exposed to tobacco

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

CCHHS

Chicago, Illinois, 60612, United States

Location

UI Health

Chicago, Illinois, 60612, United States

Location

Related Publications (67)

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Related Links

• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2016

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Min J. Joo, MD MPH
• Organization: University of Illinois at Chicago

joo@uic.edu

312-996-8039

Study Officials

• Min Joo, MD MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 2, 2017
• Study Start: July 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 26, 2024
• Results First Posted: July 22, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)