The Bronchiolitis Follow-up Intervention Trial

NCT03354325 | Completed Results

• 1 other identifier: 82296
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 4

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).

Conditions

Bronchiolitis

Keywords

Office Visits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Scheduled PCP follow-up

ACTIVE COMPARATOR

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

As needed PCP follow-up

EXPERIMENTAL

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

Interventions

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.

Scheduled PCP follow-up

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.

As needed PCP follow-up

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Stanford University: collaborator

Study Sites (4)

Packard El Camino Hospital

Mountain View, California, 94040, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Intermountain Riverton Hospital

Riverton, Utah, 84065, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (9)

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 22084265 BACKGROUND

• 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.

  PMID: 23883565 BACKGROUND

• Willer RJ, Brady PW, Tyler AN, Treasure JD, Coon ER. The Current State of High-Flow Nasal Cannula Protocols at Children's Hospitals. Hosp Pediatr. 2023 May 1;13(5):e109-e113. doi: 10.1542/hpeds.2022-006969.

  PMID: 37051799 DERIVED

• 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.

  PMID: 35043194 DERIVED

• 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.

  PMID: 34928316 DERIVED

• 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.

  PMID: 34234010 DERIVED

• 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.

  PMID: 32675334 DERIVED

• 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.

  PMID: 32628250 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Eric Coon
• Organization: University of Utah

Eric.Coon@hsc.utah.edu

801-662-3645

Study Officials

• Eric Coon, MD, MS

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 27, 2017
• Study Start: January 1, 2018
• Primary Completion: April 24, 2019
• Study Completion: May 14, 2019
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)