PIPA: Implementing Pathways to Improve Pediatric Asthma Care

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT03736603

Collaborator

American Academy of Pediatrics (Other)

303

Enrollment

Location

Arms

17.9

Actual Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Behavioral: PIPA Intervention Bundle 1 Behavioral: PIPA Intervention Bundle 2	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

303 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pathway Intervention 1 Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.	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
Experimental: Pathway Intervention 2 Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app.	Behavioral: 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
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).

Arm

Intervention/Treatment

Experimental: Pathway Intervention 1

Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.

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

Experimental: Pathway Intervention 2

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

Behavioral: 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

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).

Outcome Measures

Primary Outcome Measures

Hospital/Inpatient: Mean length of hospital stay [1 year]
Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Francisco	California	United States	94158

Sponsors and Collaborators

University of California, San Francisco
American Academy of Pediatrics

Investigators

Principal Investigator: Sunitha V Kaiser, MD MSc, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT03736603

Other Study ID Numbers:

17 KA 01

First Posted:

Nov 9, 2018

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Mar 21, 2022