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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05072808
Other study ID # IRB-19-09-1259
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date April 30, 2023

Study information

Verified date December 2023
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
View PACCI-ED and referral recommendations
Results of parent completed PACCI-ED and referral recommendations

Locations

Country Name City State
United States Children's Hospital of Michigan Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of referrals Proportion of referrals for outpatient asthma care placed in the electronic medical record. Eight months
Secondary Proportion of subspecialty referrals Proportion of subspecialty referrals for outpatient asthma care (e.g. allergy/immunology, pulmonology) placed in the electronic medical record. Eight months
Secondary Patient and provider characteristics Patient (e.g. age, asthma history) and provider (e.g. training, years in practice) self-reported demographics. Eight months
Secondary 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. 30 days following the ED visit
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