The Bronchiolitis Follow-up Intervention Trial

NCT ID: NCT03354325

Last Updated: 2020-05-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-05-14

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Scheduled PCP follow-up

Intervention Type 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

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.

Group Type EXPERIMENTAL

As needed PCP follow-up

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Coon

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Coon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Packard El Camino Hospital

Mountain View, California, United States

Site Status

Lucile Packard Children's Hospital

Palo Alto, California, United States

Site Status

Intermountain Riverton Hospital

Riverton, Utah, United States

Site Status

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22084265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23883565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37051799 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35043194 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34928316 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34234010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32675334 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32628250 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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82296

Identifier Type: -

Identifier Source: org_study_id

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