search
Back to results

Implementing Pathways to Improve Pediatric Asthma Care (PIPA)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PIPA Intervention Bundle 1
PIPA Intervention Bundle 2
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pathway Intervention 1

Pathway Intervention 2

Control

Arm Description

Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2018
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
Collaborators
American Academy of Pediatrics
search

1. Study Identification

Unique Protocol Identification Number
NCT03736603
Brief Title
Implementing Pathways to Improve Pediatric Asthma Care
Acronym
PIPA
Official Title
The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
American Academy of Pediatrics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pathway Intervention 1
Arm Type
Experimental
Arm Description
Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.
Arm Title
Pathway Intervention 2
Arm Type
Experimental
Arm Description
Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
PIPA Intervention Bundle 1
Intervention Description
The PIPA intervention bundle 1 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation
Intervention Type
Behavioral
Intervention Name(s)
PIPA Intervention Bundle 2
Intervention Description
The PIPA intervention bundle 2 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation Mobile App
Primary Outcome Measure Information:
Title
Hospital/Inpatient: Mean length of hospital stay
Time Frame
1 year
Title
Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization
Time Frame
1 year
Title
Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure
Time Frame
1 year
Title
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
Title
Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge
Time Frame
1 year
Title
Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days
Time Frame
1 year
Title
Hospital/Inpatient: Proportion of children transferred to a higher level of care
Time Frame
1 year
Title
Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage
Time Frame
1 year
Title
Emergency Department: Proportion of children who have chest radiographs performed
Time Frame
1 year
Title
Emergency Department: Proportion of children admitted to the hospital
Time Frame
1 year
Title
Emergency Department: Proportion of children transferred to a higher level of care
Time Frame
1 year
Title
Emergency Department: Mean length of emergency department stay
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunitha V Kaiser, MD MSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Implementing Pathways to Improve Pediatric Asthma Care

We'll reach out to this number within 24 hrs