The Effects of a Standardized Management Plan on Children With Critical Asthma

NCT ID: NCT01785017

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome.

Detailed Description

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A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. However the effects of the Critical Asthma SCAMP on the clinical outcomes in children with critical asthma are unknown. This study will assess the effectiveness of the SCAMP by comparing retrospective data from medical records in children with critical asthma to prospective clinical PPSQ SCAMP outcome data obtained during the QA process of the SCAMP. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome. There are three specific pathways in the Critical Asthma SCAMP. The primary outcome measure is the length of intensive care length of stay (defined as time to every 2 hr intermittent albuterol nebulization) for all three pathways. The secondary aim is to validate a clinical asthma score to direct critical asthma therapies. To achieve this goal we will determine the relationships of the driver(s) of the SCAMP which includes Boston Children Hospital (BCH) Asthma Severity Score \[HASS\] and non-invasive measures of pCO2 to standard measures of severity of asthma (blood gases and peak flow measurements).

Conditions

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Children Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Chidren with critical asthma

Pre- and post-SCAMP

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jackson Wong

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jackson Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children Hospital

Locations

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Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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00006397

Identifier Type: -

Identifier Source: org_study_id

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