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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 31, 2013
First Posted Date February 6, 2013
Last Update Posted Date January 5, 2017
Study Start Date January 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2013)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01785017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effects of a Standardized Management Plan on Children With Critical Asthma
Official Title The Effects of a Standardized Clinical Assessment Management Plan (SCAMP) on Clinical Outcomes in Children With Critical Asthma
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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized children 2 years and older requiring intensive care treatment for asthma
Condition
  • Children
  • Asthma
Intervention Not Provided
Study Groups/Cohorts Chidren with critical asthma
Pre- and post-SCAMP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2017)
273
Original Estimated Enrollment
 (submitted: February 5, 2013)
250
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01785017
Other Study ID Numbers 00006397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jackson Wong, Boston Children’s Hospital
Study Sponsor Boston Children’s Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jackson Wong, MD Boston Children Hospital
PRS Account Boston Children’s Hospital
Verification Date February 2013