Asthma in ChildrenNCT05072808
Improving Asthma Referrals Following Emergency Department Evaluation
A study testing View PACCI-ED and referral recommendations in people with Asthma in Children, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- View PACCI-ED and referral recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting to Children's Hospital of Michigan (CHM), Detroit, Emergency Department (ED) for an acute asthma exacerbation
- History of asthma as reported by parents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- View PACCI-ED and referral recommendations
- Keywords
- Asthma, Emergency Department, Children, Referral, Pediatric Asthma Control and Communication Instrument for the Emergency Department, PACCI-ED
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
View PACCI-ED and referral recommendationsOther
Results of parent completed PACCI-ED and referral recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of referrals
Proportion of referrals for outpatient asthma care placed in the electronic medical record.
Measured: Eight months
Secondary outcomes (3)
Proportion of subspecialty referrals
Proportion of subspecialty referrals for outpatient asthma care (e.g. allergy/immunology, pulmonology) placed in the electronic medical record.
Measured: Eight months
Patient and provider characteristics
Patient (e.g. age, asthma history) and provider (e.g. training, years in practice) self-reported demographics.
Measured: Eight months
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.
Measured: 30 days following the ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Nov 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Delaroche, Wayne State University
- Investigators
- Amy M DeLaroche, MBBS, Principal investigator, Detroit Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072808
- Sponsor's protocol ID
- IRB-19-09-1259
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25091437Rachelefsky 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.
PubMed 16777838Goldberg 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.
PubMed 24219842Wu 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.
PubMed 26667853Pade 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.
PubMed 30663904
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Referrals Following Emergency Department Evaluation
- ClinicalTrials.gov ID
- NCT05072808
- Acronym / sponsor ID
- IRB-19-09-1259
- Conditions
- Asthma in Children
- Keywords
- Asthma, Emergency Department, Children, Referral, Pediatric Asthma Control and Communication Instrument for the Emergency Department, PACCI-ED
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: View PACCI-ED and referral recommendationsED 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. |
| 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. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Presenting to Children's Hospital of Michigan (CHM), Detroit, Emergency Department (ED) for an acute asthma exacerbation
- History of asthma as reported by parents
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| View PACCI-ED and referral recommendationsResults of parent completed PACCI-ED and referral recommendations | Other | Intervention Group |
Primary outcome
Proportion of referrals
Time frame: Eight months
Proportion of referrals for outpatient asthma care placed in the electronic medical record.
3 secondary outcomes
Proportion of subspecialty referrals
Time frame: Eight months
Patient and provider characteristics
Time frame: Eight months
Completed outpatient clinic visits following a referral
Time frame: 30 days following the ED visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 25091437Akinbami 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.
- Background: PubMed 16777838Rachelefsky 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.
- Background: PubMed 24219842Goldberg 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.
- Background: PubMed 26667853Wu 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.
- Background: PubMed 30663904Pade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy M DeLaroche, MBBS principal investigator
Detroit Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing View PACCI-ED and referral recommendations in people with Asthma in Children, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of referrals (time frame: Eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072808, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.