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Improving Asthma Referrals Following Emergency Department Evaluation

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
View PACCI-ED and referral recommendations
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children focused on measuring Asthma, Emergency Department, Children, Referral, Pediatric Asthma Control and Communication Instrument for the Emergency Department, PACCI-ED

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Children's Hospital of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of subspecialty referrals
Proportion of subspecialty referrals for outpatient asthma care (e.g. allergy/immunology, pulmonology) placed in the electronic medical record.
Patient and provider characteristics
Patient (e.g. age, asthma history) and provider (e.g. training, years in practice) self-reported demographics.
Completed outpatient clinic visits following a referral
Number of patients attending the outpatient clinic visit within 30 days of the referral requested in the electronic medical record at the time of the ED visit.

Full Information

First Posted
September 22, 2021
Last Updated
May 4, 2023
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT05072808
Brief Title
Improving Asthma Referrals Following Emergency Department Evaluation
Official Title
Improving Asthma Referrals Following Emergency Department Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

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
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.
Detailed Description
Emergency department (ED) physicians play an important role in the management of pediatric asthma through acute intervention, family education, and appropriate referral to outpatient resources. However, time constraints in the ED limit physicians' ability to appropriately stratify both asthma severity and outpatient referrals. The Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED) improves ED providers assessment of asthma control and disease burden. We hypothesize that implementation of the PACCI-ED at the point of care may help to facilitate appropriate referrals to outpatient asthma care. ED providers will be randomized to the control or intervention group. Providers in the intervention group will receive the results of the parent-completed PACCI-ED accompanied by a one page summary of referral recommendations aligned with asthma guidelines and based upon asthma severity. Providers in the control group will not receive this information and will provide 'usual care'. All providers will complete a brief demographic questionnaire. School-aged children with a history of asthma presenting to the ED for an asthma exacerbation and discharged home who consent to participate will be assigned to the control or the intervention group based upon the ED provider caring for the patient during their ED encounter. Parents will complete a brief demographic questionnaire, the PACCI-ED, and answer two short qualitative audio-recorded questions about barriers to asthma care during their ED visit. Following the ED visit, additional data will be abstracted from the electronic medical record including outpatient referrals placed at the time of ED discharge and follow-up with the referrals within a one-month time-frame.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
Asthma, Emergency Department, Children, Referral, Pediatric Asthma Control and Communication Instrument for the Emergency Department, PACCI-ED

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
View PACCI-ED and referral recommendations
Intervention Description
Results of parent completed PACCI-ED and referral recommendations
Primary Outcome Measure Information:
Title
Proportion of referrals
Description
Proportion of referrals for outpatient asthma care placed in the electronic medical record.
Time Frame
Eight months
Secondary Outcome Measure Information:
Title
Proportion of subspecialty referrals
Description
Proportion of subspecialty referrals for outpatient asthma care (e.g. allergy/immunology, pulmonology) placed in the electronic medical record.
Time Frame
Eight months
Title
Patient and provider characteristics
Description
Patient (e.g. age, asthma history) and provider (e.g. training, years in practice) self-reported demographics.
Time Frame
Eight months
Title
Completed outpatient clinic visits following a referral
Description
Number of patients attending the outpatient clinic visit within 30 days of the referral requested in the electronic medical record at the time of the ED visit.
Time Frame
30 days following the ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting to Children's Hospital of Michigan (CHM), Detroit, Emergency Department (ED) for an acute asthma exacerbation History of asthma as reported by parents Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy M DeLaroche, MBBS
Phone
(313) 745-5260
Email
ADeLaroc@dmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Spencer, MPH
Phone
(313) 745-0631
Email
PSpencer2@dmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M DeLaroche, MBBS
Organizational Affiliation
Detroit Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy M DeLaroche, MBBS
Phone
313-745-5260
Email
ADeLaroc@dmc.org
First Name & Middle Initial & Last Name & Degree
Priya Spencer, MPH
Phone
(313) 745-0631
Email
PSpencer2@@dmc.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
25091437
Citation
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.
Results Reference
background
PubMed Identifier
16777838
Citation
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.
Results Reference
background
PubMed Identifier
24219842
Citation
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.
Results Reference
background
PubMed Identifier
26667853
Citation
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.
Results Reference
background
PubMed Identifier
30663904
Citation
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.
Results Reference
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Improving Asthma Referrals Following Emergency Department Evaluation

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