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

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ClinicalTrials.gov Identifier: NCT01785017
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jackson Wong, Boston Children’s Hospital

Brief Summary:
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.

Condition or disease
Children Asthma

Detailed Description:
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).

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Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of a Standardized Clinical Assessment Management Plan (SCAMP) on Clinical Outcomes in Children With Critical Asthma
Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Chidren with critical asthma
Pre- and post-SCAMP



Primary Outcome Measures :
  1. Time from initialization of continuous albuterol to time of final every 2 hr albuterol nebulization [ Time Frame: The time to intermittent q2 hr albuterol nebulization from continuous albuterol during hospitalization within 30 days ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized children 2 years and older requiring intensive care treatment for asthma
Criteria

Inclusion Criteria:

  • Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785017


Locations
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United States, Massachusetts
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Jackson Wong, MD Boston Children Hospital

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Responsible Party: Jackson Wong, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01785017     History of Changes
Other Study ID Numbers: 00006397
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: February 2013
Keywords provided by Jackson Wong, Boston Children’s Hospital:
critical
asthma
children
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases