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CompletedNCT03736603PIPAUpdated Mar 21, 2022

Implementing Pathways to Improve Pediatric Asthma Care

An interventional study of PIPA Intervention Bundle 1 and PIPA Intervention Bundle 2 in Asthma, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
303
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Background:

Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care.

Primary Objective:

To evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings.

Primary Endpoints:

  1. Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
  2. Inpatient/Hospital: Mean length of hospital stay

Study Design:

This project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 303 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Participant/Local champion Eligibility Criteria:

Inclusion Criteria:

  • Working as a physician at the study site

Exclusion Criteria:

  • None

Patient/child eligibility criteria:

Inclusion Criteria:

  • Age 2-17 years
  • Primary diagnosis of asthma

Exclusion Criteria:

  • Transferred in from another inpatient facility
  • Presence of a chronic medical condition that precludes pathway use
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
303 participants (actual)

Study arms

  • Experimental
    Pathway Intervention 1

    Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.

    Behavioral: PIPA Intervention Bundle 1

  • Experimental
    Pathway Intervention 2

    Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app.

    Behavioral: PIPA Intervention Bundle 2

  • No intervention
    Control

    Hospitals are in the control arm (usual care) after January 2017 until active implementation begins, which includes 3-6 months of implementation preparation (identifying local multidisciplinary champions, educational sessions/webinars for local champions, one teleconference with an external practice facilitator).

Interventions

  • BehavioralPIPA Intervention Bundle 1

    The PIPA intervention bundle 1 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation

  • BehavioralPIPA Intervention Bundle 2

    The PIPA intervention bundle 2 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation 6. Mobile App

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What researchers measure

Primary outcomes

  1. Hospital/Inpatient: Mean length of hospital stay

    Time frame: 1 year

  2. Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival

    Time frame: 1 year

Secondary outcomes

  1. Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization

    Time frame: 1 year

  2. Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure

    Time frame: 1 year

  3. Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources

    Time frame: 1 year

  4. Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge

    Time frame: 1 year

  5. Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days

    Time frame: 1 year

  6. Hospital/Inpatient: Proportion of children transferred to a higher level of care

    Time frame: 1 year

  7. Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage

    Time frame: 1 year

  8. Emergency Department: Proportion of children who have chest radiographs performed

    Time frame: 1 year

  9. Emergency Department: Proportion of children admitted to the hospital

    Time frame: 1 year

  10. Emergency Department: Proportion of children transferred to a higher level of care

    Time frame: 1 year

  11. Emergency Department: Mean length of emergency department stay

    Time frame: 1 year

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Study locations

1 site
  • University of California
    San Francisco, California 94158, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03736603
Lead sponsor
University of California, San Francisco
Collaborators
American Academy of Pediatrics
Responsible party
Sponsor
First posted
Nov 9, 2018
Start date
Jan 1, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Mar 21, 2022

Study contacts

Sunitha V Kaiser, MD MSc
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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