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

January 4, 2017 updated by: Jackson Wong, Boston Children's Hospital

The Effects of a Standardized Clinical Assessment Management Plan (SCAMP) on Clinical Outcomes in Children With Critical Asthma

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

273

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Hospital

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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized children 2 years and older requiring intensive care treatment for asthma

Description

Inclusion Criteria:

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The time to intermittent q2 hr albuterol nebulization from continuous albuterol during hospitalization within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Jackson Wong, MD, Boston Children Hospital

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, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006397

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.

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