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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00113633
Recruitment Status : Completed
First Posted : June 10, 2005
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE June 9, 2005
First Posted Date  ICMJE June 10, 2005
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE September 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
Follow-up with a Primary Care Physician (PCP) [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department visit ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • Return to the Emergency Department for an asthma-related visit. [ Time Frame: 4 weeks, 3 months and 6 months after Emergency Department 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 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma
Official Title  ICMJE A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Intervention Subjects
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2014)
439
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00113633
Other Study ID Numbers  ICMJE 2004-12-4130
K23HL074250 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Joseph J. Zorc Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP