Phase 3
N=402
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
COPD Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03137303 ↗Enrolled (actual)
402
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Total Number of Healthcare Visits — 111; 76; 119; 93 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Spirometry at initial visit (Device); Albuterol (Drug); Spirometry at 12-month follow-up (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Healthcare Visits |
111; 76; 119; 93; 1; 2 | — |
| SECONDARY Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results |
76; 55; 92; 64; 8; 9 | — |
Summary
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.
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.
Data sourced from ClinicalTrials.gov (NCT03137303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.