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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00832923
Other study ID # RAC #207
Secondary ID
Status Completed
Phase N/A
First received January 29, 2009
Last updated September 10, 2014
Start date January 2009
Est. completion date December 2011

Study information

Verified date September 2014
Source Children's Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 12 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
PEPAC
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.

Locations

Country Name City State
United States Children's Research Institute Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Utilization of Primary Care Provider 2 months & 6 months after visit No
Secondary Parental Self-efficacy in communicating about Asthma care with child's primary care provider 2 months & 6 months after visit No
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