Trial Outcomes & Findings for Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study) (NCT NCT03137303)
NCT ID: NCT03137303
Last Updated: 2024-02-26
Results Overview
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
402 participants
Primary outcome timeframe
1 year
Results posted on
2024-02-26
Participant Flow
Subjects who met the preliminary eligibility criteria were mailed a recruitment letter with the option to opt out. A phone screen was conducted to confirm eligibility. If eligible, we obtained verbal consent to participate in the study. Their scheduled appointment date was confirmed. They were asked to arrive 90 minutes before their clinic visit for enrollment. Recruitment took place from 07/2017 to 09/2019.
Participant milestones
| Measure |
Patient Subject Usual Care
Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
|
Patient-Subject Intervention
Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
|
|---|---|---|
|
T0: Time of Enrollment - Baseline Visit
STARTED
|
231
|
171
|
|
T0: Time of Enrollment - Baseline Visit
COMPLETED
|
231
|
171
|
|
T0: Time of Enrollment - Baseline Visit
NOT COMPLETED
|
0
|
0
|
|
T1: 3-month Follow-up
STARTED
|
231
|
171
|
|
T1: 3-month Follow-up
COMPLETED
|
225
|
161
|
|
T1: 3-month Follow-up
NOT COMPLETED
|
6
|
10
|
|
T2: 6-month Follow-up
STARTED
|
230
|
167
|
|
T2: 6-month Follow-up
COMPLETED
|
225
|
162
|
|
T2: 6-month Follow-up
NOT COMPLETED
|
5
|
5
|
|
T3: 9-month Follow-up
STARTED
|
230
|
167
|
|
T3: 9-month Follow-up
COMPLETED
|
225
|
163
|
|
T3: 9-month Follow-up
NOT COMPLETED
|
5
|
4
|
|
T4: 12-month Follow-up
STARTED
|
229
|
167
|
|
T4: 12-month Follow-up
COMPLETED
|
222
|
162
|
|
T4: 12-month Follow-up
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Patient Subject Usual Care
Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
|
Patient-Subject Intervention
Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
|
|---|---|---|
|
T1: 3-month Follow-up
Withdrawal by Subject
|
1
|
4
|
|
T1: 3-month Follow-up
Lost to Follow-up
|
5
|
6
|
|
T2: 6-month Follow-up
Lost to Follow-up
|
5
|
5
|
|
T3: 9-month Follow-up
Death
|
1
|
0
|
|
T3: 9-month Follow-up
Lost to Follow-up
|
4
|
4
|
|
T4: 12-month Follow-up
Withdrawal by Subject
|
0
|
1
|
|
T4: 12-month Follow-up
Lost to Follow-up
|
7
|
4
|
Baseline Characteristics
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Baseline characteristics by cohort
| Measure |
Patient Subject Usual Care
n=231 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
|
Patient-Subject Intervention
n=171 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
57.5 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Age, Customized
40-64 years
|
181 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Age, Customized
65+ years
|
50 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
363 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American/Black
|
193 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
332 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status
Single/Widowed
|
169 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
297 Participants
n=206 Participants
|
|
Marital Status
Co-habiting/Married
|
62 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Household Income
< $10,000
|
92 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Household Income
$10,000-19,999
|
41 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Household Income
$20,000-29,999
|
26 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Household Income
$30,000+
|
65 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Household Income
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Education
High school or less
|
107 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Education
Vocational/Technical School or Some College
|
83 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Education
Bachelor and above
|
40 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Education
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Health Plan
Medicaid
|
127 participants
n=99 Participants
|
87 participants
n=107 Participants
|
214 participants
n=206 Participants
|
|
Health Plan
Medicare
|
60 participants
n=99 Participants
|
45 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Health Plan
HMO
|
36 participants
n=99 Participants
|
30 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Health Plan
PPO
|
26 participants
n=99 Participants
|
21 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Health Plan
Self-pay
|
23 participants
n=99 Participants
|
13 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Health Plan
Other
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Number of Health Plans per Patient
0-1
|
190 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
336 Participants
n=206 Participants
|
|
Number of Health Plans per Patient
≥2
|
41 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Coexisting Conditions
Hypertension
|
158 participants
n=99 Participants
|
116 participants
n=107 Participants
|
274 participants
n=206 Participants
|
|
Coexisting Conditions
Diabetes
|
76 participants
n=99 Participants
|
53 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
Coexisting Conditions
Dyslipidemia
|
70 participants
n=99 Participants
|
47 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Coexisting Conditions
Osteoarthritis
|
84 participants
n=99 Participants
|
66 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Coexisting Conditions
Depression
|
58 participants
n=99 Participants
|
37 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Coexisting Conditions
Anxiety
|
28 participants
n=99 Participants
|
23 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Coexisting Conditions
Obstructive/sleep apnea
|
21 participants
n=99 Participants
|
16 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Coexisting Conditions
Congestive Heart Failure
|
20 participants
n=99 Participants
|
9 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Coexisting Conditions
Coronary Artery Disease
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Coexisting Conditions
Arrhythmia
|
21 participants
n=99 Participants
|
7 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Coexisting Conditions
Autoimmune Disease
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Coexisting Conditions
Cancer
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Coexisting Conditions
Osteoporosis
|
10 participants
n=99 Participants
|
7 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Coexisting Conditions
Stroke
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Coexisting Conditions
End Stage Kidney Disease
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Coexisting Conditions
Other
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Number of Coexisting Conditions
0
|
28 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Number of Coexisting Conditions
1
|
41 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Number of Coexisting Conditions
2
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Number of Coexisting Conditions
3
|
53 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Number of Coexisting Conditions
4
|
30 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Number of Coexisting Conditions
5+
|
31 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Respiratory Diagnosis
Asthma
|
171 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
298 Participants
n=206 Participants
|
|
Respiratory Diagnosis
COPD
|
28 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Respiratory Diagnosis
Asthma and COPD
|
32 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Respiratory Medications
Short-acting Bronchodilator
|
226 participants
n=99 Participants
|
169 participants
n=107 Participants
|
395 participants
n=206 Participants
|
|
Respiratory Medications
Inhaled Corticosteroids (ICS)
|
145 participants
n=99 Participants
|
107 participants
n=107 Participants
|
252 participants
n=206 Participants
|
|
Respiratory Medications
Long-acting muscarinic antagonists (LAMA)
|
17 participants
n=99 Participants
|
11 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Respiratory Medications
Long-acting beta agonist (LABA)
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Respiratory Medications
ICS + LABA
|
77 participants
n=99 Participants
|
60 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Respiratory Medications
LAMA + LABA
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Respiratory Symptoms
In the past yr., have you had worsened breathing symptoms that caused a change in your medications?
|
52 participants
n=99 Participants
|
29 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Respiratory Symptoms
In the past year, have you been hospitalized for breathing problems?
|
37 participants
n=99 Participants
|
14 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Respiratory Symptoms
In the past year, have you had the a cough continually for a long time (≥ 3 months)?
|
133 participants
n=99 Participants
|
90 participants
n=107 Participants
|
223 participants
n=206 Participants
|
|
Respiratory Symptoms
In the past year, have you had the a shortness of breath continually for a long time (≥ 3 months)?
|
132 participants
n=99 Participants
|
78 participants
n=107 Participants
|
210 participants
n=206 Participants
|
|
Respiratory Symptoms
In the past year, have you had the a sputum continually for a long time (≥ 3 months)?
|
115 participants
n=99 Participants
|
70 participants
n=107 Participants
|
185 participants
n=206 Participants
|
|
Number of Respiratory Symptoms
0
|
62 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Number of Respiratory Symptoms
1
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Number of Respiratory Symptoms
2
|
43 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Number of Respiratory Symptoms
3
|
84 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Tobacco Exposure
Past
|
86 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Tobacco Exposure
Current
|
63 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Tobacco Exposure
Never
|
82 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Second-Hand Smoke Exposure
Yes
|
172 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
304 Participants
n=206 Participants
|
|
Second-Hand Smoke Exposure
No
|
59 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Illicit Substance Use
Yes
|
26 participants
n=99 Participants
|
26 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Illicit Substance Use
Would rather not say
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Modified Medical Research Council Dyspnea Scale
0 = only breathless with strenuous exercise
|
49 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Modified Medical Research Council Dyspnea Scale
1 = short of breath when hurrying or walking up a slight hill
|
73 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Modified Medical Research Council Dyspnea Scale
2 = walk slower or have to stop for breath when walking
|
48 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Modified Medical Research Council Dyspnea Scale
3 = stop for breath after walking about 100 yards or a few minutes
|
50 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Modified Medical Research Council Dyspnea Scale
4 = too breathless to leave the house or when dressing
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intention to treat. Once randomized, patients were included in the analysis.
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
Outcome measures
| Measure |
Patient Subject Usual Care
n=231 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
|
Patient-Subject Intervention
n=171 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
|
|---|---|---|
|
Total Number of Healthcare Visits
New diagnostic tests · Missing
|
1 Participants
|
2 Participants
|
|
Total Number of Healthcare Visits
Emergency room visit · Yes
|
111 Participants
|
76 Participants
|
|
Total Number of Healthcare Visits
Emergency room visit · No
|
119 Participants
|
93 Participants
|
|
Total Number of Healthcare Visits
Emergency room visit · Missing
|
1 Participants
|
2 Participants
|
|
Total Number of Healthcare Visits
Hospitalization · Yes
|
48 Participants
|
17 Participants
|
|
Total Number of Healthcare Visits
Hospitalization · No
|
182 Participants
|
152 Participants
|
|
Total Number of Healthcare Visits
Hospitalization · Missing
|
1 Participants
|
2 Participants
|
|
Total Number of Healthcare Visits
Acute outpatient visit · Yes
|
61 Participants
|
35 Participants
|
|
Total Number of Healthcare Visits
Acute outpatient visit · No
|
169 Participants
|
134 Participants
|
|
Total Number of Healthcare Visits
Acute outpatient visit · Missing
|
1 Participants
|
2 Participants
|
|
Total Number of Healthcare Visits
Routine primary care visits · Yes
|
198 Participants
|
138 Participants
|
|
Total Number of Healthcare Visits
Routine primary care visits · No
|
32 Participants
|
31 Participants
|
|
Total Number of Healthcare Visits
Routine primary care visits · Missing
|
1 Participants
|
2 Participants
|
|
Total Number of Healthcare Visits
New diagnostic tests · Yes
|
126 Participants
|
72 Participants
|
|
Total Number of Healthcare Visits
New diagnostic tests · No
|
104 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
determine differences in the accuracy of diagnosis between groups
Outcome measures
| Measure |
Patient Subject Usual Care
n=176 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit).
|
Patient-Subject Intervention
n=128 Participants
Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
|
|---|---|---|
|
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
Correct initial diagnosis
|
76 Participants
|
55 Participants
|
|
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
Stayed with wrong initial diagnosis
|
92 Participants
|
64 Participants
|
|
Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
Ever removed wrong initial diagnosis
|
8 Participants
|
9 Participants
|
Adverse Events
Patient Subject Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Patient-Subject Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place