Implementing Pathways to Improve Pediatric Asthma Care

Asthma Clinical Trial

— PIPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736603
• Other study ID #: 17 KA 01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• PIPA Intervention Bundle 1
The PIPA intervention bundle 1 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation
• PIPA Intervention Bundle 2
The PIPA intervention bundle 2 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation Mobile App

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Academy of Pediatrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital/Inpatient: Mean length of hospital stay		1 year
Primary	Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival		1 year
Secondary	Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization		1 year
Secondary	Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure		1 year
Secondary	Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources		1 year
Secondary	Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge		1 year
Secondary	Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days		1 year
Secondary	Hospital/Inpatient: Proportion of children transferred to a higher level of care		1 year
Secondary	Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage		1 year
Secondary	Emergency Department: Proportion of children who have chest radiographs performed		1 year
Secondary	Emergency Department: Proportion of children admitted to the hospital		1 year
Secondary	Emergency Department: Proportion of children transferred to a higher level of care		1 year
Secondary	Emergency Department: Mean length of emergency department stay		1 year