Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00113633
First received: June 9, 2005
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Intervention Subjects

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Follow-up with a Primary Care Physician (PCP) [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Return to the Emergency Department for an asthma-related visit. [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit. ] [ Designated as safety issue: No ]
    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 visits which have been made to the Emergency Department. Information provided by families will be verified by medical record review.

  • Persistent asthma symptoms [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, all subjects will complete a screening instrument to assess the symptoms of persistent asthma (including cough, wheeze, shortness of breath). 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 asthma symptoms and information will be compared to baseline.

  • Asthma Controller prescriptions by Primary Care Physician (PCP) [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies. 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 controller medication prescriptions made by their Primary Care Physician. Information provided by families will be verified by medical record review.

  • Asthma controller medication use [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies. 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 current asthma controller controller medication use.

  • Days of school/work missed [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, all subjects will complete a screening interview which will assess asthma history. 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 missed work/school days due to asthma-related reasons.

  • Peak expiratory flow [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, all subjects over the age of 6 will receive a peak expiratory flow meter and instruction as per standard care in the Emergency Department. Follow-up telephone contact will be made by the Primary Investigator or a research assistant. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about peak expiratory flow meter testing since the initial Emergency Department visit.

  • Quality of life [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ] [ Designated as safety issue: No ]
    At baseline, parents will be asked to complete the Integrated Therapeutics Group Child Asthma Short Form (8-item asthma-related quality of life questionnaire). Follow-up telephone contact will be made by the Primary Investigator or a research assistant. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the asthma-related quality of life since the initial Emergency Department visit.


Enrollment: 439
Study Start Date: September 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Subjects
These subjects will receive standard discharge instructions that recommend follow-up with a PCP within 3-5 days.
Experimental: Intervention Subjects
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
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.

Detailed Description:

Inner-city children are particularly at risk for poor asthma treatment outcomes and frequently obtain their asthma care in the ED. Prior studies have had limited success in improving primary care follow-up, quality of care, and long-term outcomes after a pediatric ED visit for asthma. Prior ED-based interventions have been designed to address barriers to follow-up with a primary care provider (PCP) such as an inability to obtain a follow-up appointment or lack of transportation. Focus groups and surveys of inner-city families have found that beliefs about the benefits of follow-up care and the role of preventive asthma medications have a strong impact on adherence to therapy.

This study will develop a brief educational video about the benefits of follow-up asthma care using a multi-disciplinary panel of experts at the Children's Hospital of Philadelphia and focus groups of parents of children with asthma. This educational video will then be combined into an intervention along with symptom screening and a reminder phone call that has been demonstrated to improve follow-up rates in a previous study. The combined intervention will be tested using a randomized trial design to determine its efficacy on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an ED visit. The research is conducted as part of a research career development award.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior study enrollment
  • Parent unable to speak English
  • No telephone to be reachable for follow-up calls
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113633

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Joseph J. Zorc Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00113633     History of Changes
Other Study ID Numbers: 2004-12-4130, K23HL074250
Study First Received: June 9, 2005
Last Updated: March 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Asthma
Emergency
Primary Care
Children

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Disease Attributes
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014