The Bronchiolitis Follow-up Intervention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Bronchiolitis Follow-up Intervention Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Behavioral: Scheduled PCP follow-up
* Behavioral: As needed PCP follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scheduled PCP follow-up<br>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. | Behavioral: Scheduled PCP follow-up<br>* 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.<br>|
| Experimental: As needed PCP follow-up<br>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. | Behavioral: As needed PCP follow-up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured at the first data collection phone call (5-9 days following discharge). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Missed Daycare |  | 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 the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP. | Measured by parent report via research coordinator phone call at 1 month from discharge. | 
| 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 | Measured by parent report via research coordinator phone call at 1 month from discharge. | 
| Immunizations Received 1 Month After Discharge |  | Measured by parent report via research coordinator phone call at 1 month from discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Office Visits