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

Asthma Clinical Trial

— AsthmaSCAMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785017
• Other study ID #: 00006397
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: January 4, 2017
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2013
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Children

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from initialization of continuous albuterol to time of final every 2 hr albuterol nebulization		The time to intermittent q2 hr albuterol nebulization from continuous albuterol during hospitalization within 30 days	No