NCT00113633

Brief Summary

The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Sep 2003

Typical duration for not_applicable asthma

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

June 9, 2005

Last Update Submit

March 3, 2014

Conditions

Asthma

Keywords

AsthmaEmergencyPrimary CareChildren

Outcome Measures

Primary Outcomes (1)

  • Follow-up with a Primary Care Physician (PCP)

    At baseline, all subjects will complete the Parental Impressions of the Benefits (pros) and barriers (cons) of Follow-Up Care Scale (24-item instrument designed to measure perceived benefits and barriers to follow-up after an ED visit). Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the number of asthma-related follow-up visits which have been made to the Primary Care Physician. Information provided by families will be verified by medical record review.

    4 weeks, 3 months and 6 months after Emergency Department visit

Secondary Outcomes (7)

  • Return to the Emergency Department for an asthma-related visit.

    4 weeks, 3 months and 6 months after Emergency Department visit.

  • Persistent asthma symptoms

    4 weeks, 3 months and 6 months after Emergency Department visit

  • Asthma Controller prescriptions by Primary Care Physician (PCP)

    4 weeks, 3 months and 6 months after Emergency Department visit

  • Asthma controller medication use

    4 weeks, 3 months and 6 months after Emergency Department visit

  • Days of school/work missed

    4 weeks, 3 months and 6 months after Emergency Department visit

  • +2 more secondary outcomes

Study Arms (2)

Control Subjects

NO INTERVENTION

These subjects will receive standard discharge instructions that recommend follow-up with a PCP within 3-5 days.

Intervention Subjects

EXPERIMENTAL

As part of the intervention, the family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups. For children reporting persistent asthma symptoms, a letter will be given to the family to bring to their PCP stating that screening revealed symptoms that may require further treatment with controller medications. A mailed reminder to schedule a follow-up appointment will be sent to the family.

Behavioral: Intervention Subjects

Interventions

Intervention SubjectsBEHAVIORAL

The subject's family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups; a mailed reminder will be sent to the family to schedule a follow-up appointment.

Intervention Subjects

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 1-18 years
  • History of Asthma:
  • At least 2 prior episodes of bronchodilator treatment
  • No underlying cardiac disease
  • No other chronic lung disease
  • Residence within Philadelphia city limits
  • Discharged from ED after treatment for asthma

You may not qualify if:

  • Prior study enrollment
  • Parent unable to speak English
  • No telephone to be reachable for follow-up calls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Zorc JJ, Chew A, Allen JL, Shaw K. Beliefs and barriers to follow-up after an emergency department asthma visit: a randomized trial. Pediatrics. 2009 Oct;124(4):1135-42. doi: 10.1542/peds.2008-3352. Epub 2009 Sep 28.

    PMID: 19786448RESULT

MeSH Terms

Conditions

AsthmaEmergencies

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph J. Zorc

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

US(1)