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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACCI-ED use
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma, pediatrics, control, medication adherence

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital / Hasbro Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PACCI-ED

Control

Arm Description

PACCI-ED attendings were given the PACCI-ED use intervention.

Control attendings were not given the PACCI-ED use intervention.

Outcomes

Primary Outcome Measures

Asthma Control
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.

Secondary Outcome Measures

Asthma Trajectory
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.
Medication Adherence
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.
Asthma burden to family
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.

Full Information

First Posted
July 1, 2013
Last Updated
July 9, 2013
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01895478
Brief Title
Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, pediatrics, control, medication adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACCI-ED
Arm Type
Experimental
Arm Description
PACCI-ED attendings were given the PACCI-ED use intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control attendings were not given the PACCI-ED use intervention.
Intervention Type
Behavioral
Intervention Name(s)
PACCI-ED use
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control
Description
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.
Time Frame
1 day (Assessment occurs at a single time during emergency department visit)
Secondary Outcome Measure Information:
Title
Asthma Trajectory
Description
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.
Time Frame
1 day (Assessment occurs at a single time during emergency department visit)
Title
Medication Adherence
Description
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.
Time Frame
1 day (Assessment occurs at a single time during emergency department visit)
Title
Asthma burden to family
Description
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.
Time Frame
1 day (Assessment occurs at a single time during emergency department visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rhode Island Hospital / Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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

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