Clinical trial NCT03736603: Implementing Pathways to Improve Pediatric Asthma Care
Official title: The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
First posted: 2018-11-09
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.


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

Primary outcomes:
measure: Hospital/Inpatient: Mean length of hospital stay
timeFrame: 1 year
measure: Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
timeFrame: 1 year
Secondary outcomes:
measure: Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization
timeFrame: 1 year
measure: Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure
timeFrame: 1 year
measure: Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources
timeFrame: 1 year
measure: Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge
timeFrame: 1 year
measure: Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days
timeFrame: 1 year
measure: Hospital/Inpatient: Proportion of children transferred to a higher level of care
timeFrame: 1 year
measure: Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage
timeFrame: 1 year
measure: Emergency Department: Proportion of children who have chest radiographs performed
timeFrame: 1 year
measure: Emergency Department: Proportion of children admitted to the hospital
timeFrame: 1 year
measure: Emergency Department: Proportion of children transferred to a higher level of care
timeFrame: 1 year
measure: Emergency Department: Mean length of emergency department stay
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sunitha V Kaiser, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: