Trial · NCT03137303
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
NCT03137303, Phase 3, Completed, University of Illinois Chicago; results first posted 2021-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study). Trials, record NCT03137303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
- NCT number
- NCT03137303
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 402 participants, actual
- Lead sponsor
- University of Illinois Chicago
- Conditions
- COPD Asthma
- Interventions
- Spirometry at initial visit, Albuterol, Spirometry at 12-month follow-up
- First posted
- 2017-05-02
- Last updated
- 2024-02-26
- Results first posted
- 2021-07-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Healthcare Visits | 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 | Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results | 1 year | determine differences in the accuracy of diagnosis between groups |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Healthcare Visits | 1 year | Intention to treat. Once randomized, patients were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results | 1 year | This analysis was only done for patients who had clear yes or no diagnosis accuracy from spirometry. This also excluded those did not have missing spirometry either due to withdraw or lost to follow-up. Two patients with yes or no diagnosis accuracy from spirometry withdrew, but they were either qualified for Correct initial diagnosis or Ever remove wrong initial diagnosis and thus lead to no missing in this table. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Healthcare Visits | Patient Subject Usual Care | Emergency room visit / Yes | 111 | Participants | |
| Total Number of Healthcare Visits | Patient-Subject Intervention | Emergency room visit / Yes | 76 | Participants | |
| Total Number of Healthcare Visits | Patient Subject Usual Care | Emergency room visit / No | 119 | Participants | |
| Total Number of Healthcare Visits | Patient-Subject Intervention | Emergency room visit / No | 93 | Participants | |
| Total Number of Healthcare Visits | Patient Subject Usual Care | Emergency room visit / Missing | 1 | Participants | |
| Total Number of Healthcare Visits | Patient-Subject Intervention | Emergency room visit / Missing | 2 | Participants | |
| Total Number of Healthcare Visits | Patient Subject Usual Care | Hospitalization / Yes | 48 | Participants | |
| Total Number of Healthcare Visits | Patient-Subject Intervention | Hospitalization / Yes | 17 | Participants | |
| Total Number of Healthcare Visits | Patient Subject Usual Care | Hospitalization / No | 182 | Participants | |
| Total Number of Healthcare Visits | Patient-Subject Intervention | Hospitalization / No | 152 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| T0: Time of Enrollment - Baseline Visit | STARTED | Patient Subject Usual Care | 231 | |
| T0: Time of Enrollment - Baseline Visit | STARTED | Patient-Subject Intervention | 171 | |
| T0: Time of Enrollment - Baseline Visit | COMPLETED | Patient Subject Usual Care | 231 | |
| T0: Time of Enrollment - Baseline Visit | COMPLETED | Patient-Subject Intervention | 171 | |
| T0: Time of Enrollment - Baseline Visit | NOT COMPLETED | Patient Subject Usual Care | 0 | |
| T0: Time of Enrollment - Baseline Visit | NOT COMPLETED | Patient-Subject Intervention | 0 | |
| T1: 3-month Follow-up | STARTED | Patient Subject Usual Care | 231 | |
| T1: 3-month Follow-up | STARTED | Patient-Subject Intervention | 171 | |
| T1: 3-month Follow-up | COMPLETED | Patient Subject Usual Care | 225 | |
| T1: 3-month Follow-up | COMPLETED | Patient-Subject Intervention | 161 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patient Subject Usual Care | 1 | 231 |
| Total, all-cause mortality | Patient-Subject Intervention | 0 | 171 |
| Total, other adverse events | Patient Subject Usual Care | 0 | 231 |
| Total, other adverse events | Patient-Subject Intervention | 0 | 171 |
| Total, serious adverse events | Patient Subject Usual Care | 0 | 231 |
| Total, serious adverse events | Patient-Subject Intervention | 0 | 171 |
Source ClinicalTrials.gov
Papers64
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patient-Subject Intervention vs Patient Subject Usual Care: deaths from any cause | Trial comparisons |
| Patient-Subject Intervention vs Patient Subject Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03137303
GET https://conductscience.org/api/trials/v1/NCT03137303/results?page=2