Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

NCT00388739 | Withdrawn

• 1 other identifier: H-19489
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure. Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in:

1. 1.Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
2. 2.Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure.

Conditions

Asthma

Keywords

Pediatric Asthma; Pulmicort; TEDAS ED; Acute exacerbation of asthma; Chronic asthma

Outcome Measures

Primary Outcomes (1)

• ED and primary care provider utilization

  Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period will be measured by comparisons of total number of ED visits (and unscheduled PCP visits) in each group

  12 months

Secondary Outcomes (1)

• Improved Quality of Life as measured by Bukstein's ITG will utilize the scoring system developed by Bukstein to evaluate individual parameters as well as aggregate scores in the control and intervention group at each of the 3 month intervals. Significan

  Measured at 3, 9, and 12 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Systemic steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day). Subjects will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor. Children in the control group that do not own a nebulization compressor will be given a prescription for an albuterol MDI with mask and spacer with instructions to deliver 2 puffs (90mcg per actuation) 3 times a day as a standard chronic care regimen. Instructions to follow-up with their primary care physician in 3-5 days (as is standard care practice) will be given at discharge for patients in the control or treatment arm.

Drug: Usual care: albuterol + systemic steroids

Usual care + 6 months of inhaled steroids

EXPERIMENTAL

In addition to the usual care described above, patients randomized to the intervention/experimental arm will also be given a one month supply as well as a prescription (for a 6 month supply) for Budesonide respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).

Drug: Intervention: Budesonide; Drug: Usual care: albuterol + systemic steroids

Interventions

Intervention: Budesonide DRUG

Patients 1-5 years of age who are randomly assigned to the treatment arm will be given a one month supply as well as a prescription (for a 6 month supply) for Pulmicort respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).

Also known as: Pulmicort

Usual care + 6 months of inhaled steroids

Usual care: albuterol + systemic steroids DRUG

All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.

Also known as: Albuterol + prednisolone

Usual care; Usual care + 6 months of inhaled steroids

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.

You may not qualify if:

• Patients without a physician's confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Albuterol; Prednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnadienetriols; Pregnadienes

Study Officials

• Andrea T Cruz, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: patients will be randomized to a control and intervention group. Randomization will occur utilizing assignment by a randomized number table. The randomization scheme will then be packaged into sealed envelopes concealed to the educational interventionist at the time of enrollment. Once the patient is enrolled, the interventionist will open the sealed envelope revealing assignment to intervention or control.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This was a health outcomes intervention trial that utilized a randomized clinical trial (non-placebo controlled) with two separate arms. All patients received steroids and bronchodilators, but then were randomized to either no intervention or to Pulmicort respules

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 17, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (1)