- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832923
Improving Asthma Care Through Parental Empowerment (PEPAC)
September 10, 2014 updated by: Stephen J. Teach, MD, MPH, Children's National Research Institute
Improving Asthma Care Through Parental Empowerment: Effect on Healthcare Utilization and Parent Self-Efficacy
The overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their children's PCPs as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC Asthma Clinic.
Study Overview
Detailed Description
Asthma is the most common chronic disease of childhood, and it disproportionately affects urban, minority, and disadvantaged children.
When implemented correctly, existing evidence-based guidelines from the National Heart, Lung, and Blood Institute (NHLBI) improve pediatric asthma care and outcomes.
One key component of these guidelines is the importance of longitudinal care as part of a partnership among patient, parents, and a healthcare provider.
Such a partnership depends on effective communication of healthcare status by parents to providers.
Improving the communication skills of inner-city parents may improve their ability to obtain more effective longitudinal asthma care within their primary care homes and thereby to improve their child's asthma health outcomes.
IMPACT DC ("Improving Pediatric Asthma Care in the District of Columbia") is a locally validated emergency department (ED) based intervention that improves multiple measures of asthma care and outcomes through an intensive short-term program of asthma education, medical care, and care coordination.
In spite of these successes, achieving increased subsequent contact and partnership with primary care providers (PCPs) for asthma care after the intervention has not been successful.
Therefore, for the current study, we propose to assess the effectiveness of an enhanced version of the existing IMPACT DC intervention consisting of short-term case management by trained asthma educators.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ages between 12 months and 12 years, inclusive
- prior physician diagnosed asthma
- ability of the parent to identify a specific PCP for their child
- public insurance covering the child
- parent/guardian available for interview
Exclusion Criteria:
- significant medical co-morbidities
- enrollment in another asthma research intervention study
- unavailability for telephone follow-up
- primary language of the caregiver other than English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine IMPACT DC care
Participants receive standard asthma education as routine for IMPACT DC
|
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Experimental: Enhanced care PEPAC Intervention
|
The proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an "asthma care toolkit" to improve communication around asthma care with the child's primary care provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Utilization of Primary Care Provider
Time Frame: 2 months & 6 months after visit
|
2 months & 6 months after visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parental Self-efficacy in communicating about Asthma care with child's primary care provider
Time Frame: 2 months & 6 months after visit
|
2 months & 6 months after visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Estimate)
September 12, 2014
Last Update Submitted That Met QC Criteria
September 10, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAC #207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.