Clinical trial NCT03354325: The Bronchiolitis Follow-up Intervention Trial
Official title: The Bronchiolitis Follow-up Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Office Visits
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2017-11-27
Enrollment: 304
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental Anxiety
timeFrame: Measured at the first data collection phone call (5-9 days following discharge).
Secondary outcomes:
measure: Time From Hospital Discharge to Cough Resolution
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Time From Hospital Discharge to Child Reported Back to Normal
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Number of Clinic Visits Prior to Symptom Resolution
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Any Hospital Re-admission Prior to Symptom Resolution
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Any ED Visit Prior to Symptom Resolution
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Number of Missed Work Days
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Missed Daycare
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids)
timeFrame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
measure: Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray)
timeFrame: Measured by parent report, at the first data collection phone call (5-9 days following discharge).
measure: Relationship With PCP
timeFrame: Measured by parent report via research coordinator phone call at 1 month from discharge.
measure: Report That Care Was Perfect 1 Month After Discharge
timeFrame: Measured by parent report via research coordinator phone call at 1 month from discharge.
measure: Immunizations Received 1 Month After Discharge
timeFrame: Measured by parent report via research coordinator phone call at 1 month from discharge.
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Packard El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Riverton
country: United States
facility: Intermountain Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Coon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Ridd MJ, Lewis G, Peters TJ, Salisbury C. Patient-doctor depth-of-relationship scale: development and validation. Ann Fam Med. 2011 Nov-Dec;9(6):538-45. doi: 10.1370/afm.1322.
citation: Thayaparan AJ, Mahdi E. The Patient Satisfaction Questionnaire Short Form (PSQ-18) as an adaptable, reliable, and validated tool for use in various settings. Med Educ Online. 2013 Jul 23;18:21747. doi: 10.3402/meo.v18i0.21747. No abstract available.
citation: Coon ER, Schroeder AR, Lion KC, Ray KN. Disparities by Ethnicity in Enrollment of a Clinical Trial. Pediatrics. 2022 Feb 1;149(2):e2021052595. doi: 10.1542/peds.2021-052595. No abstract available.
citation: Coon ER, Hester G, Ralston SL. Why Are So Many Children With Bronchiolitis Going to the Intensive Care Unit? JAMA Pediatr. 2022 Mar 1;176(3):231-233. doi: 10.1001/jamapediatrics.2021.5186. No abstract available.
citation: Willer RJ, Johnson MD, Cipriano FA, Stone BL, Nkoy FL, Chaulk DC, Knochel ML, Kawai CK, Neiswender KL, Coon ER. Implementation of a Weight-Based High-Flow Nasal Cannula Protocol for Children With Bronchiolitis. Hosp Pediatr. 2021 Aug;11(8):891-895. doi: 10.1542/hpeds.2021-005814. Epub 2021 Jul 7.
citation: Chi KW, Coon ER, Destino L, Schroeder AR. Parental Perspectives on Continuous Pulse Oximetry Use in Bronchiolitis Hospitalizations. Pediatrics. 2020 Aug;146(2):e20200130. doi: 10.1542/peds.2020-0130. Epub 2020 Jul 16.
citation: Coon ER, Destino LA, Greene TH, Vukin E, Stoddard G, Schroeder AR. Comparison of As-Needed and Scheduled Posthospitalization Follow-up for Children Hospitalized for Bronchiolitis: The Bronchiolitis Follow-up Intervention Trial (BeneFIT) Randomized Clinical Trial. JAMA Pediatr. 2020 Sep 1;174(9):e201937. doi: 10.1001/jamapediatrics.2020.1937. Epub 2020 Sep 8.