Implementing Pathways to Improve Pediatric Asthma Care

Study Overview
=================
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.

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: PIPA Intervention Bundle 1
* Behavioral: PIPA Intervention Bundle 2


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathway Intervention 1<br>Hospitals randomized to group 1 receive PIPA Intervention Bundle 1. | Behavioral: PIPA Intervention Bundle 1<br>* The PIPA intervention bundle 1 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation<br>|
| Experimental: Pathway Intervention 2<br>Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app. | Behavioral: PIPA Intervention Bundle 2<br>* The PIPA intervention bundle 2 includes: Pathway Implementation Toolkit Local Multidisciplinary Champions Audit and Feedback Educational Seminars/Webinars Practice Facilitation Mobile App<br>|
| No Intervention: Control<br>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). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |