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Completed

NCT Number: NCT03354325

The Bronchiolitis Follow-up Intervention Trial

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).

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Packard El Camino Hospital, Mountain View, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scheduled PCP follow-up

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Parental Anxiety

    Time frame: 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. Relationship With PCP

    Time frame: 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.

  11. Report That Care Was Perfect 1 Month After Discharge

    Time frame: 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

  12. Immunizations Received 1 Month After Discharge

    Time frame: Measured by parent report via research coordinator phone call at 1 month from discharge.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Stanford University

Registry information

Acronym: BeneFIT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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