Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department

July 9, 2013 updated by: Aris Garro, Rhode Island Hospital

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Rhode Island Hospital / Hasbro Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
No Intervention: Control
Control attendings were not given the PACCI-ED use intervention.

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)
Medication Adherence
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
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.
1 day (Assessment occurs at a single time during emergency department visit)
Asthma burden to family
Time Frame: 1 day (Assessment occurs at a single time during emergency department visit)
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.
1 day (Assessment occurs at a single time during emergency department visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

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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