NCT01895478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

July 1, 2013

Last Update Submit

July 9, 2013

Conditions

Asthma

Keywords

asthmapediatricscontrolmedication adherence

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Asthma Trajectory

    1 day (Assessment occurs at a single time during emergency department visit)

  • Medication Adherence

    1 day (Assessment occurs at a single time during emergency department visit)

  • Asthma burden to family

    1 day (Assessment occurs at a single time during emergency department visit)

Study Arms (2)

PACCI-ED

EXPERIMENTAL

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

Behavioral: PACCI-ED use

Control

NO INTERVENTION

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

Interventions

PACCI-ED useBEHAVIORAL

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.

PACCI-ED

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital / Hasbro Children's Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Emergency Medicine Attending Physician

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 10, 2013

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

US(1)