- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895478
Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.
This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Rhode Island Hospital / Hasbro Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Child presented to study institution emergency department during study period
- Child was 1 - 17 years-old
- Child has physician-diagnosed asthma by parent report
- Attending physician for child believed emergency department visit was due to asthma
- Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study
Exclusion Criteria:
- Child has major pulmonary or cardiac co-morbid illness
- Family of child was non-English speaking
- Child was triaged to the med-trauma bay for severe respiratory distress
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PACCI-ED
PACCI-ED attendings were given the PACCI-ED use intervention.
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Attending physicians were allowed to view the patient's PACCI-ED prior to completing the assessment form.
Attendings were told at the time of the child's ED visit that the PACCI-ED is used to assess a child's asthma control and medication adherence, and that they could use it to complete the outcomes assessment form.
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No Intervention: Control
Control attendings were not given the PACCI-ED use intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Control
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
|
Attending physician answered "Which of the following best describes this patient's asthma control over the past 12 months?"
(RESPONSES: Controlled, partly controlled, mildly uncontrolled, moderately uncontrolled, severely uncontrolled).
Responses were compared to equivalent categories of control based on PACCI algorithm.
|
1 day (Assessment occurs at a single time during emergency department visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Trajectory
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
|
Attending physician answered "Which of the following best describes the changes in this patient's asthma status over the past 12 months?"
(RESPONSES: No change, getting worse, getting better).
Responses were compared to equivalent categories of trajectory based on PACCI algorithm.
|
1 day (Assessment occurs at a single time during emergency department visit)
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Medication Adherence
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
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Attending physician answered "In your clinical judgment, during the past week, how often does this patient use his/her daily controller asthma medicine?"
(RESPONSES: Not at all (0 days/week), sometimes (1-3 days/week), most of the time (4-6 days/week), all of the time (7 days/week)).
Responses were compared to equivalent categories of medication adherence based on PACCI algorithm.
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1 day (Assessment occurs at a single time during emergency department visit)
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Asthma burden to family
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
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Attending physician answered "Which of the following best describes how burdensome to the caregiver this patient's asthma has been over the past 12 months?"
(RESPONSES: Not at all burdensome, somewhat burdensome, very burdensome).
Responses were compared to equivalent categories of asthma burden based on PACCI algorithm.
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1 day (Assessment occurs at a single time during emergency department visit)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210394
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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