The Bronchiolitis Follow-up Intervention Trial

Bronchiolitis Clinical Trial

— BeneFIT  

Official title:

The Bronchiolitis Follow-up Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354325
• Other study ID #: 82296
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: May 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: May 14, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Behavioral:
• 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. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured at the first data collection phone call (5-9 days following discharge).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Missed Daycare		Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first.
Secondary	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.
Secondary	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).
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.	Measured by parent report via research coordinator phone call at 1 month from discharge.
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	Measured by parent report via research coordinator phone call at 1 month from discharge.
Secondary	Immunizations Received 1 Month After Discharge		Measured by parent report via research coordinator phone call at 1 month from discharge.