Bronchiolitis
Conditions
Keywords
Office Visits
Brief summary
This study evaluates the value of routine follow-up with a child's pediatrician after hospitalization for bronchiolitis. Parents of half of participants will be instructed to follow-up with the child's pediatrician regardless of symptom resolution, while the other half will be instructed to follow-up on an as-needed basis (only if the child worsens, doesn't improve, or other concerns develop).
Detailed description
Bronchiolitis is highly prevalent and burdensome among children less than 2 years of age. For this reason, many therapies have been tried by providers and studied by researchers. Unfortunately, interventions have largely been shown to be ineffective, prompting campaigns to reduce use of ineffective therapies. One commonly prescribed but thus far unstudied intervention often provided to children discharged after hospitalization for bronchiolitis is routine follow up with their pediatrician. Whether the costs and time spent for these visits are worthwhile depends on the extent to which the child and the child's parents benefit.
Interventions
BEHAVIORALScheduled 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.
BEHAVIORALAs 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.
Sponsors
Stanford University
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* Children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis.
Exclusion criteria
* Chronic lung disease * Complex or hemodynamically significant heart disease * Immunodeficiency * Neuromuscular disease * Discharged home with medication for withdrawal * Inpatient team believes the child should follow up with their PCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parental Anxiety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Hospital Discharge to Child Reported Back to Normal | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Number of Clinic Visits Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Any Hospital Re-admission Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Any ED Visit Prior to Symptom Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Number of Missed Work Days | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Time From Hospital Discharge to Cough Resolution | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids) | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
| Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray) | Measured by parent report, at the first data collection phone call (5-9 days following discharge). | — |
| Relationship With PCP | 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. |
| Report That Care Was Perfect 1 Month After Discharge | 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 |
| Immunizations Received 1 Month After Discharge | Measured by parent report via research coordinator phone call at 1 month from discharge. | — |
| Missed Daycare | Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 151 |
| 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. | 153 |
| Total | 304 |
Baseline characteristics
| Characteristic | Scheduled PCP Follow-up | As Needed PCP Follow-up | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 151 Participants | 153 Participants | 304 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 56 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 97 Participants | 214 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 14 Participants | 12 Participants | 26 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) White | 113 Participants | 116 Participants | 229 Participants |
| Sex: Female, Male Female | 58 Participants | 67 Participants | 125 Participants |
| Sex: Female, Male Male | 93 Participants | 86 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 153 |
| other Total, other adverse events | 0 / 151 | 0 / 153 |
| serious Total, serious adverse events | 0 / 151 | 0 / 153 |
Outcome results
Primary
Parental Anxiety
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.
Time frame: Measured at the first data collection phone call (5-9 days following discharge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Parental Anxiety | 4.2 points on a scale | Standard Deviation 3.5 |
| As Needed PCP Follow-up | Parental Anxiety | 3.9 points on a scale | Standard Deviation 3.5 |
Secondary
Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids)
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids) | 16.0 percent | Standard Deviation 3.7 |
| As Needed PCP Follow-up | Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids) | 9.4 percent | Standard Deviation 2.9 |
Secondary
Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray)
Time frame: Measured by parent report, at the first data collection phone call (5-9 days following discharge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray) | 67 percent | Standard Deviation 47 |
| As Needed PCP Follow-up | Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray) | 22 percent | Standard Deviation 42 |
Secondary
Any ED Visit Prior to Symptom Resolution
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Any ED Visit Prior to Symptom Resolution | 3.8 percent | Standard Deviation 1.9 |
| As Needed PCP Follow-up | Any ED Visit Prior to Symptom Resolution | 5.8 percent | Standard Deviation 2.3 |
Secondary
Any Hospital Re-admission Prior to Symptom Resolution
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Any Hospital Re-admission Prior to Symptom Resolution | 3.8 percent | Standard Deviation 1.9 |
| As Needed PCP Follow-up | Any Hospital Re-admission Prior to Symptom Resolution | 2.2 percent | Standard Deviation 1.4 |
Secondary
Immunizations Received 1 Month After Discharge
Time frame: Measured by parent report via research coordinator phone call at 1 month from discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Immunizations Received 1 Month After Discharge | 36.2 percent | Standard Deviation 48.3 |
| As Needed PCP Follow-up | Immunizations Received 1 Month After Discharge | 32.8 percent | Standard Deviation 47.1 |
Secondary
Missed Daycare
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Missed Daycare | 1.2 days | Standard Deviation 3.5 |
| As Needed PCP Follow-up | Missed Daycare | 0.8 days | Standard Deviation 2.9 |
Secondary
Number of Clinic Visits Prior to Symptom Resolution
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Number of Clinic Visits Prior to Symptom Resolution | 1.1 visits | Standard Deviation 0.7 |
| As Needed PCP Follow-up | Number of Clinic Visits Prior to Symptom Resolution | 0.5 visits | Standard Deviation 0.7 |
Secondary
Number of Missed Work Days
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Number of Missed Work Days | 2.1 days | Standard Deviation 4.1 |
| As Needed PCP Follow-up | Number of Missed Work Days | 1.6 days | Standard Deviation 3.2 |
Secondary
Relationship With PCP
Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP.
Time frame: Measured by parent report via research coordinator phone call at 1 month from discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Relationship With PCP | 26.0 points on a scale | Standard Deviation 6.3 |
| As Needed PCP Follow-up | Relationship With PCP | 26.5 points on a scale | Standard Deviation 6.4 |
Secondary
Report That Care Was Perfect 1 Month After Discharge
Measured by a question from the Patient Satisfaction Questionnaire Short Form (PSQ-18), those who indicate agree or strongly agree
Time frame: Measured by parent report via research coordinator phone call at 1 month from discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Report That Care Was Perfect 1 Month After Discharge | 99.2 percent | Standard Deviation 9.3 |
| As Needed PCP Follow-up | Report That Care Was Perfect 1 Month After Discharge | 97.6 percent | Standard Deviation 15.2 |
Secondary
Time From Hospital Discharge to Child Reported Back to Normal
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Time From Hospital Discharge to Child Reported Back to Normal | 9.6 days | Standard Deviation 8.7 |
| As Needed PCP Follow-up | Time From Hospital Discharge to Child Reported Back to Normal | 8.8 days | Standard Deviation 6.8 |
Secondary
Time From Hospital Discharge to Cough Resolution
Time frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scheduled PCP Follow-up | Time From Hospital Discharge to Cough Resolution | 9.8 days | Standard Deviation 8.2 |
| As Needed PCP Follow-up | Time From Hospital Discharge to Cough Resolution | 9.2 days | Standard Deviation 6.7 |