Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

This study is a health outcomes intervention trial that utilizes a randomized clinical trial
(non-placebo controlled) with two separate arms. The study will be conducted in the ED of
Texas Children's Hospital, a tertiary care facility that evaluates over 80,000 children per
year. IRB approval has been obtained, and guardians of patients 1-18 years of age will be
consented for enrollment. All children will receive standardized burst steroids and
broncholdilators (albuterol), however, 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. The study will utilize a post hoc analysis of age subgroups (1 through 5 years of
age and 6 through 18 years of age).

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Eligibility. Any child with a diagnosis of asthma meeting an inclusion criteria of an acute
exacerbation of asthma in the emergency department of Texas Children’s Hospital will be
considered for this study. The patient's family must use English or Spanish as a first
language. This study will draw upon pediatric emergency department physicians currently
trained through the Texas Emergency Department Asthma Surveillance project for
classification of chronic severity. Any child who has been identified as having mild or
moderate or severe persistent chronic asthma will be eligible for the study as long as
he/she is not on the NAEPP recommended chronic care regimen. Procedure. Once informed
consent is obtained, demographic information will be collected as well as information
regarding the severity of the acute disease. As per standard ED asthma educational
intervention protocol through the TEDAS intervention project, all patients will undergo
asthma education utilizing the TEDAS ED asthma platform. This is a brief 20-30 minute
personalized laptop-driven intervention delivered by one of the trained TEDAS
interventionists. Patients that are enrolled will be randomly entered into either a
treatment or control arm. Control vs intervention arms. 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 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. Treatment arm for patients 1-5 years of age. 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). Those children 1-5 years of age who do not have
a nebulization compressor delivery system at home will be provided one at no cost to the
patient as part of the study if randomized to the intervention group. Upon the one month
follow-up call after the index ED visit, children who have improved symptoms may have
reduced treatment regimens as follows: children with mild persistent disease will decrease
therapy to 0.25 mg qd, children with moderate persistent disease will decrease therapy to
0.5mg qd, and children with severe persistent disease will continue on 0.5mg bid dosing of
Pulmicort respules. Children with worsening symptoms at one month will be referred back to
their primary care physician or emergency department at Texas Children’s Hospital for
further evaluation. Control vs intervention arms. Children who are 6-18 years of age and
randomized to the control group will be given a standardized steroid burst at discharge from
the ED as outlined above. Additionally, they will 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 already own a nebulization compressor. Children who are
6-18 years of age and randomized to either the control group or treatment group and do not
own a nebulization compressor will be given a prescription for an albuterol MDI with spacer
with instructions to deliver 2 puffs (90mcg per actuation) 3 times a day as a standard
chronic care regimen. Treatment arm for patients 6-18 years of age. Children who are
randomized to the intervention group will receive a Pulmicort TBH (200mcg/puff) with
instructions to deliver 1 puff per twice a day for mild persistent disease or 2 puffs twice
a day if they are of moderate or severe persistent disease. 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. Upon the one month follow-up call
after the index ED visit, children who have improved symptoms may have reduced treatment
regimens as follows: children with mild persistent disease will decrease therapy to
Pulmicort TBH (200mcg/puff) 1 puff once per day for mild persistent disease or 2 puffs once
per day if they are of moderate persistent disease, but will remain on 2 puffs twice a day
if they are of severe persistent disease. Children with worsening symptoms at one month will
be referred back to their primary care physician or emergency department at Texas Children’s
Hospital for further evaluation.

Follow-up. All children (intervention and control groups) will receive follow-up calls at 14
days, and 3, 6, 9 and 12 months. Queries for primary and secondary outcomes will be made.
Patients’ families will be mailed a gift certificate for a local fast-food restaurant or toy
store as a token of gratitude for their time after each follow-up call (5$ per contact for a
maximum of $30 of gift certificates). The regimen for phone-follow is outlined in the PI’s
Educational Intervention Study (Sockrider, et al. Delivering Tailored Asthma Family
Education in a Pediatric Emergency Room Setting: A Pilot Study. Pediatrics, in press). The
one month re-evaluation is only to ascertain that the drug is being used as per recommended
usage (ie as per FDA approved indications). Should the drug be changed by the primary care
physician, the patient will be left on the drug prescribed by the primary care physician. It
is important to remember, as noted in my previous cover letter, that this is not a trial to
test the efficacy of a drug, but an intervention in health outcomes research to evaluate the
effect of starting controller medications on health care utilization while assessing asthma
outcomes. There will be no need to contact the PCP after one-month as the initital contact
with the PCP will include an explanation for decreasing the dose of steroids after the acute
excaerbation to the dosing recommended by the NAEPP guidelines after the first month unless
the patient is experiencing an acute exacerbation. If the PCP changes the therapy, this will
be an important outcome to track as this is both relevant and assures generalibility of the
findings. Unlike a drug efficacy trial, this trial is intended to measure the health
outcomes of the ED intervention of STARTING chronic care. The additional measures for the
one month follow-up only assure the drug is being delivered as per initital ED discussion
(to include the stepdown) or as per the PCP recommendations. If the PCP instructs the parent
not to change the dose or to alter the dose, then this will be taken as priority and the PCP
change in plan will be noted and its impact analyzed.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.