NCT03736603

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. 1.Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
  2. 2.Inpatient/Hospital: Mean length of hospital stay

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

November 7, 2018

Last Update Submit

March 7, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (3)

Pathway Intervention 1

EXPERIMENTAL

Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.

Behavioral: PIPA Intervention Bundle 1

Pathway Intervention 2

EXPERIMENTAL

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

Behavioral: PIPA Intervention Bundle 2

Control

NO INTERVENTION

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).

Interventions

PIPA Intervention Bundle 1BEHAVIORAL

The PIPA intervention bundle 1 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation

Pathway Intervention 1
PIPA Intervention Bundle 2BEHAVIORAL

The PIPA intervention bundle 2 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation 6. Mobile App

Pathway Intervention 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working as a physician at the study site

You may not qualify if:

  • None
  • Patient/child eligibility criteria:
  • Age 2-17 years
  • Primary diagnosis of asthma
  • Transferred in from another inpatient facility
  • Presence of a chronic medical condition that precludes pathway use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sunitha V Kaiser, MD MSc

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 9, 2018

Study Start

January 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)