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The Bronchiolitis Follow-up Intervention Trial (BeneFIT)

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ClinicalTrials.gov Identifier: NCT03354325
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Eric Coon, 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).

Condition or disease Intervention/treatment Phase
Bronchiolitis Behavioral: Scheduled PCP follow-up Behavioral: As needed PCP follow-up Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Bronchiolitis Follow-up Intervention Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 10, 2019
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  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 validated tool used in a previous trial among parents whose children had been hospitalized for bronchiolitis.


Secondary Outcome Measures :
  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 hospital re-admissions and emergency visits [ Time Frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. ]
  4. Number of ambulatory visits [ Time Frame: Measured by parent report via weekly research coordinator phone calls, until symptoms resolved or 50 days after discharge, whichever occurs first. ]
  5. Number of missed daycare and 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. ]
  6. 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. ]
  7. 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). ]
  8. 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.

  9. Satisfaction with care [ Time Frame: Measured by parent report via research coordinator phone call at 1 month from discharge. ]
    Measured by the general satisfaction questions from the Patient Satisfaction Questionnaire Short Form (PSQ-18), scored 0-2, where higher scores represent greater satisfaction with care.

  10. Immunizations received [ Time Frame: Measured by parent report via research coordinator phone call at 1 month from discharge. ]
  11. Total charges for ambulatory medical care [ Time Frame: Measured from hospital discharge until 14 days after discharge and until symptom resolution. ]
  12. Perceptions about physiologic monitoring [ Time Frame: Measured by parent interview at the time of study enrollment. ]
  13. Beliefs about the importance of pulse oximetry [ Time Frame: Measured by parent interview at the first data collection phone call (5-9 days following discharge). ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354325


Contacts
Contact: Eric Coon, MD, MS 8016623645 Eric.Coon@hsc.utah.edu
Contact: Alan Schroeder, MD 6507250551 aschroe@stanford.edu

Locations
United States, California
Packard El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Alan Schroeder, MD         
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Alan Schroeder, MD    650-725-0551    aschroe@stanford.edu   
United States, Utah
Intermountain Riverton Hospital Recruiting
Riverton, Utah, United States, 84065
Contact: Eric Coon, MD, MS         
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Eric Coon, MD, MS    801-980-6181    eric.coon@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Stanford University
Investigators
Principal Investigator: Eric Coon, MD, MS University of Utah
  Study Documents (Full-Text)

Documents provided by Eric Coon, University of Utah:

Publications:
Responsible Party: Eric Coon, MD, University of Utah
ClinicalTrials.gov Identifier: NCT03354325     History of Changes
Other Study ID Numbers: 82296
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eric Coon, University of Utah:
Office Visits

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections