Trial Outcomes & Findings for The Bronchiolitis Follow-up Intervention Trial (NCT NCT03354325)
NCT ID: NCT03354325
Last Updated: 2020-05-19
Results Overview
Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale (HADS), a 0-28 point scale, with higher values representing higher anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
Measured at the first data collection phone call (5-9 days following discharge).
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
Scheduled PCP Follow-up
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
153
|
|
Overall Study
COMPLETED
|
131
|
138
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Bronchiolitis Follow-up Intervention Trial
Baseline characteristics by cohort
| Measure |
Scheduled PCP Follow-up
n=151 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=153 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
151 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at the first data collection phone call (5-9 days following discharge).Parental anxiety, as measured by the anxiety portion of the Hospital Anxiety and Depression Scale (HADS), a 0-28 point scale, with higher values representing higher anxiety.
Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Parental Anxiety
|
4.2 points on a scale
Standard Deviation 3.5
|
3.9 points on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Time From Hospital Discharge to Cough Resolution
|
9.8 days
Standard Deviation 8.2
|
9.2 days
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Time From Hospital Discharge to Child Reported Back to Normal
|
9.6 days
Standard Deviation 8.7
|
8.8 days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Number of Clinic Visits Prior to Symptom Resolution
|
1.1 visits
Standard Deviation 0.7
|
0.5 visits
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Any Hospital Re-admission Prior to Symptom Resolution
|
3.8 percent
Standard Deviation 1.9
|
2.2 percent
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Any ED Visit Prior to Symptom Resolution
|
3.8 percent
Standard Deviation 1.9
|
5.8 percent
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Number of Missed Work Days
|
2.1 days
Standard Deviation 4.1
|
1.6 days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Missed Daycare
|
1.2 days
Standard Deviation 3.5
|
0.8 days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids)
|
16.0 percent
Standard Deviation 3.7
|
9.4 percent
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Measured by parent report, at the first data collection phone call (5-9 days following discharge).Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray)
|
67 percent
Standard Deviation 47
|
22 percent
Standard Deviation 42
|
SECONDARY outcome
Timeframe: Measured by parent report via research coordinator phone call at 1 month from discharge.Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP.
Outcome measures
| Measure |
Scheduled PCP Follow-up
n=131 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=138 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Relationship With PCP
|
26.0 points on a scale
Standard Deviation 6.3
|
26.5 points on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Measured by parent report via research coordinator phone call at 1 month from discharge.Measured by a question from the Patient Satisfaction Questionnaire Short Form (PSQ-18), those who indicate agree or strongly agree
Outcome measures
| Measure |
Scheduled PCP Follow-up
n=116 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=128 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Report That Care Was Perfect 1 Month After Discharge
|
99.2 percent
Standard Deviation 9.3
|
97.6 percent
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Measured by parent report via research coordinator phone call at 1 month from discharge.Outcome measures
| Measure |
Scheduled PCP Follow-up
n=116 Participants
Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician (PCP) within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
Scheduled PCP follow-up: Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
|
As Needed PCP Follow-up
n=128 Participants
At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician (PCP). Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
As needed PCP follow-up: At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
|
|---|---|---|
|
Immunizations Received 1 Month After Discharge
|
36.2 percent
Standard Deviation 48.3
|
32.8 percent
Standard Deviation 47.1
|
Adverse Events
Scheduled PCP Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
As Needed PCP Follow-up
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