NCT05072808

Brief Summary

Asthma is the most common chronic condition among children and many children seek emergency department (ED) care. A key aspect of ED asthma management at the time of discharge is appropriate outpatient referral. Part of the challenge for ED providers is determining which patients require intensive outpatient support as ED providers often do not have the time or familiarity with the asthma guidelines to appropriately stratify asthma severity. Thus, the aim of this study is to determine whether the proportion of children referred to outpatient asthma care can be improved by incorporating a previously validated tool \[the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI- ED)\] into ED clinical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

September 22, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

September 22, 2021

Last Update Submit

December 7, 2023

Conditions

Keywords

AsthmaEmergency DepartmentChildrenReferralPediatric Asthma Control and Communication Instrument for the Emergency DepartmentPACCI-ED

Outcome Measures

Primary Outcomes (1)

  • Proportion of referrals

    Proportion of referrals for outpatient asthma care placed in the electronic medical record.

    Eight months

Secondary Outcomes (3)

  • Proportion of subspecialty referrals

    Eight months

  • Patient and provider characteristics

    Eight months

  • Completed outpatient clinic visits following a referral

    30 days following the ED visit

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

ED Providers randomized to the Intervention Group will be able to view the results of the parent-completed questionnaire, the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), and outpatient referral recommendations aligned with asthma severity.

Other: View PACCI-ED and referral recommendations

Control Group

NO INTERVENTION

ED providers randomized to the Control Group will neither receive the results of the parent-completed PACCI-ED or specific recommendations for outpatient referrals. Patients randomized to the control group will receive usual care.

Interventions

Results of parent completed PACCI-ED and referral recommendations

Intervention Group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presenting to Children's Hospital of Michigan (CHM), Detroit, Emergency Department (ED) for an acute asthma exacerbation
  • History of asthma as reported by parents

You may not qualify if:

  • Transfer from outside ED for a higher level of care
  • Admitted to the hospital following pediatric ED evaluation
  • Significant co-morbidity (pulmonary, cardiac, or other systemic disease)
  • Hemodynamic instability
  • Non-English speaking
  • Previously enrolled in this study
  • Patients without their primary caregiver at ED presentation
  • Not under the care of CHM ED provider who has consented to be a part of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Related Publications (5)

  • Akinbami LJ, Moorman JE, Simon AE, Schoendorf KC. Trends in racial disparities for asthma outcomes among children 0 to 17 years, 2001-2010. J Allergy Clin Immunol. 2014 Sep;134(3):547-553.e5. doi: 10.1016/j.jaci.2014.05.037. Epub 2014 Aug 1.

    PMID: 25091437BACKGROUND
  • Rachelefsky GS, Kennedy S, Stone A. Enhancing the role of the emergency department in the identification and management of childhood asthma. Pediatrics. 2006 Apr;117(4 Pt 2):S57-62. doi: 10.1542/peds.2005-2000b. No abstract available.

    PMID: 16777838BACKGROUND
  • Goldberg EM, Laskowski-Kos U, Wu D, Gutierrez J, Bilderback A, Okelo SO, Garro A. The Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED) improves physician assessment of asthma morbidity in pediatric emergency department patients. J Asthma. 2014 Mar;51(2):200-8. doi: 10.3109/02770903.2013.859267. Epub 2013 Dec 4.

    PMID: 24219842BACKGROUND
  • Wu DJ, Hipolito E, Bilderback A, Okelo SO, Garro A. Predicting future emergency department visits and hospitalizations for asthma using the Pediatric Asthma Control and Communication Instrument - Emergency Department version (PACCI-ED). J Asthma. 2016;53(4):387-91. doi: 10.3109/02770903.2015.1115520. Epub 2016 Jan 22.

    PMID: 26667853BACKGROUND
  • Pade KH, Agnihotri NT, Vangala S, Thompson LR, Wang VJ, Okelo SO. Asthma specialist care preferences among parents of children receiving emergency department care for asthma. J Asthma. 2020 Feb;57(2):188-195. doi: 10.1080/02770903.2019.1565768. Epub 2019 Jan 21.

    PMID: 30663904BACKGROUND

MeSH Terms

Conditions

AsthmaEmergencies

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amy M DeLaroche, MBBS

    Detroit Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 11, 2021

Study Start

November 15, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations