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The Bronchiolitis Follow-up Intervention Trial (BeneFIT)

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scheduled PCP follow-up
As needed PCP follow-up
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bronchiolitis focused on measuring Office Visits

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Packard El Camino Hospital
  • Lucile Packard Children's Hospital
  • Intermountain Riverton Hospital
  • Primary Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scheduled PCP follow-up

As needed PCP follow-up

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time From Hospital Discharge to Cough Resolution
Time From Hospital Discharge to Child Reported Back to Normal
Number of Clinic Visits Prior to Symptom Resolution
Any Hospital Re-admission Prior to Symptom Resolution
Any ED Visit Prior to Symptom Resolution
Number of Missed Work Days
Missed Daycare
Ambulatory Prescriptions (Albuterol, Antibiotics, Steroids)
Ambulatory Testing (i.e. Pulse Oximetry, Chest X-ray)
Relationship With PCP
Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP.
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
Immunizations Received 1 Month After Discharge

Full Information

First Posted
November 15, 2017
Last Updated
May 5, 2020
Sponsor
University of Utah
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03354325
Brief Title
The Bronchiolitis Follow-up Intervention Trial
Acronym
BeneFIT
Official Title
The Bronchiolitis Follow-up Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Office Visits

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scheduled PCP follow-up
Arm Type
Active Comparator
Arm Description
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.
Arm Title
As needed PCP follow-up
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Scheduled PCP follow-up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
As needed PCP follow-up
Intervention Description
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 Measure Information:
Title
Parental Anxiety
Description
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.
Time Frame
Measured at the first data collection phone call (5-9 days following discharge).
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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).
Title
Relationship With PCP
Description
Measured by the Patient-Doctor Depth-of-Relationship Scale, 0-32 points, with higher scores indicating a stronger relationship with PCP.
Time Frame
Measured by parent report via research coordinator phone call at 1 month from discharge.
Title
Report That Care Was Perfect 1 Month After Discharge
Description
Measured by a question from the Patient Satisfaction Questionnaire Short Form (PSQ-18), those who indicate agree or strongly agree
Time Frame
Measured by parent report via research coordinator phone call at 1 month from discharge.
Title
Immunizations Received 1 Month After Discharge
Time Frame
Measured by parent report via research coordinator phone call at 1 month from discharge.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Coon, MD, MS
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Packard El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Intermountain Riverton Hospital
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6880820
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.
Results Reference
background
PubMed Identifier
22084265
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.
Results Reference
background
PubMed Identifier
23883565
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.
Results Reference
background
PubMed Identifier
35043194
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.
Results Reference
derived
PubMed Identifier
34928316
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.
Results Reference
derived
PubMed Identifier
34234010
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.
Results Reference
derived
PubMed Identifier
32675334
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.
Results Reference
derived
PubMed Identifier
32628250
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.
Results Reference
derived

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The Bronchiolitis Follow-up Intervention Trial

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