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OpenTrials
Completed

NCT Number: NCT03736603

Implementing Pathways to Improve Pediatric Asthma Care

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIPA Intervention Bundle 1

Behavioral

The PIPA intervention bundle 1 includes:

  • Pathway Implementation Toolkit
  • Local Multidisciplinary Champions
  • Audit and Feedback
  • Educational Seminars/Webinars
  • Practice Facilitation

PIPA Intervention Bundle 2

Behavioral

The PIPA intervention bundle 2 includes:

  • Pathway Implementation Toolkit
  • Local Multidisciplinary Champions
  • Audit and Feedback
  • Educational Seminars/Webinars
  • Practice Facilitation
  • Mobile App

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Academy of Pediatrics

Registry information

Official study title

The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial

Acronym: PIPA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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