The Bronchiolitis Follow-up Intervention Trial

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Behavioral: Scheduled PCP follow-up; Behavioral: As needed PCP follow-up

• Registration Number: NCT03354325
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-27
• Study Start: 2018-01-01
• Primary Completion: 2019-04-24
• Study Completion: 2019-05-14
• Results First Submitted: 2020-03-24
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Results First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scheduled PCP follow-up	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.
As needed PCP follow-up	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
Immunizations Received 1 Month After Discharge	Measured by parent report via research coordinator phone call at 1 month from discharge.
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.
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

Trial Locations

Locations (4)

Packard El Camino Hospital; 🇺🇸 Mountain View, California, United States

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States

Intermountain Riverton Hospital; 🇺🇸 Riverton, Utah, United States

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States