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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895478
• Other study ID #: 210394
• Status: Completed
• Phase: N/A
• First received: July 1, 2013
• Last updated: July 9, 2013
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Rhode Island Hospital Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• PACCI-ED use
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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital / Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day (Assessment occurs at a single time during emergency department visit)	No
Secondary	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.	1 day (Assessment occurs at a single time during emergency department visit)	No
Secondary	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.	1 day (Assessment occurs at a single time during emergency department visit)	No
Secondary	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.	1 day (Assessment occurs at a single time during emergency department visit)	No