Clinical trial NCT01881412
Conditions: Asthma
Keywords: Asthma Children Inhaled Corticosteroids Emergency Department
Sponsor: Rhode Island Hospital
Start date: 2012-08-01; Completion date: 2018-04-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma.

This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.

Detailed description:
Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life.

Specific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan.

Arms: arm 1: Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions. arm 2: Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Interventions: intervention 1: fluticasone intervention 2: Standard Asthma Discharge Instructions
Intervention descriptions: intervention 1: During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use. intervention 2: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)

Protocol documents:
Prot_SAP_000.pdf: 
OPTIMIZING DISCHARGE AFTER EMERGENCY DEPARTMENT VISITS FOR 
CHILDREN WITH UNCONTROLLED ASHTMA 
Version 9-28-18 
 
PROJECT SUMMARY: The objective of this project is to develop a systematized 
method to prescribe inhaled corticosteroids (ICS) to children with uncontrolled 
asthma after an emergency department (ED) visit.  ICS are indicated for children 
with uncontrolled asthma according to national guidelines, but it is unclear if 
prescription of ICS in the emergency department setting results in improved 
outcomes.  Currently, ICS prescriptions are provided infrequently (<5% of visits for 
children with asthma).  We will systematize ICS prescription using the Pediatric 
Asthma Control and Communication Instrument (PACCI), which we have 
demonstrated is a useful tool for ED clinicians to rapidly assess asthma control.  The 
PACCI is easy to use, can be completed by families, and contains an algorithm that 
helps clinicians decide when ICS are indicated.  We will use a randomized controlled 
trial (RCT) to compare asthma morbidity in children receiving ICS prescription to 
children receiving routine asthma care. 
PROJECT BACKGROUND: Asthma is a common pediatric illness and results in 
significant morbidity and health care costs.(1)  Use of ICS for children with 
persistent level asthma has been demonstrated to reduce symptom frequency and 
improve quality of life.(2, 3)  Frequently children that meet criteria for ICS use are 
not using these medications; this is particularly true of children who visit EDs for 
acute asthma exacerbations.(4)  ED visits are ideal for interventions in children, as 
during these visits, parents are receptive to interventions because of heightened 
concern based on the acute, visible manifestations of the child’s asthma. 
Interventions for families of children with asthma have been attempted in the ED 
but have not consistently demonstrated improvement in long-term asthma-related 
outcomes.(5-11) Despite these equivocal results, many experts continue to 
emphasize the role of ED clinicians in preventative care,(12, 13) with a focus on 
improving chronic asthma management.(14, 15)  Several recent publications have 
identified ICS prescriptions by ED clinicians for uncontrolled asthma as a feasible 
intervention that is likely to benefit children.(16-18)  This is potentially effective 
given that  ED visits for children with asthma often indicate high-risk asthma.(19, 
20)  Also, children that visit EDs are less likely to have a regular source of care for 
asthma,(4, 21) more likely to have poorly controlled asthma,(17, 22)  are less likely 
to be using appropriate controller medications,(4) and often belong to underserved 
populations that are at risk for asthma-related morbidity.(21, 23-27)  ED visits for 
children with asthma also represent a teachable moment.(13, 28) Manifestations of 
asthma are most salient at these visits, and parents may be more receptive to 
interventions to improve disease management.  Because parents often view asthma 
as episodic rather than chronic in nature, they may be less likely to follow through 
with interventions when disease manifestations are not as readily apparent.(29)  All 


of these factors contribute to the ED being an important setting for interventions to 
improve disease management.  The goal of this research plan is to optimize the 
delivery of ICS prescriptions using a standardized tool (PACCI) to identify children 
with uncontrolled asthma.  Our second goal is to develop an educational component 
to be delivered at the time of ICS prescription to enhance subsequent medication 
adherence. 
In a recent study using the National Hospital Ambulatory Medical Care Survey 
(NHAMCS), we demonstrated that ICS are prescribed during only 4% of pediatric 
asthma visits at U.S. EDs, despite approximately 800,000 visits for pediatric asthma 
annually.(18)  We also calculated that ICS prescriptions are indicated in 20%-23% 
of ED visits for children with asthma exacerbations.  These figures indicate that 
nationally, a systematized approach to prescribing ICS for children with 
uncontrolled asthma in the ED could result in 150,000 children per year having an 
appropriate first-line controller medication prescribed after an ED visit.   
After identifying prescription of ICS as a potential intervention, we investigated a 
mechanism to facilitate use of this strategy in the ED setting.  We validated use of 
the PACCI in the ED in collaboration with colleagues at Johns Hopkins.  The PACCI 
allows clinicians to rapidly assess chronic asthma control based on responses to 
questions about asthma over sub-acute (1-2 weeks) and longer (12 month) time 
periods.(30)    Our preliminary validation of the PACCI in 56 children with asthma in 
our ED has shown that it is: 1) Effective (accuracy of ED clinicians at identifying 
poorly controlled asthma was 95% with PACCI versus 56% without, P=0.03), and 2) 
Raises awareness of the need to assess chronic asthma control during ED visits, 
based on feedback from ED clinicians in the study.    
KEY PERSONNEL: 
Principal Investigator: Aris Garro, MD, MPH 
Co-Investigator: Elizabeth Goldberg, MD 
Research Coordinator: Dominic Wu  
Research Assistant: TBD 
Research Nurses: TBD 
PROTOCOL:   
Participants:  This study will include a convenience sample of children who present 
to the ED with an asthma exacerbation when research staff is present.  Potential 
participants will be identified by research nurses who encounter children with 
complaints of “asthma exacerbation”, “wheezing”, “cough”, “dyspnea” or “shortness 
of breath”. We plan to enroll 143 children 3-12 years old who: 1) have physician-
diagnosed asthma based on parental report, and 2) are not already using an ICS.  
Exclusion criteria will include: 1) Previous participation in the study, 2) Co-morbid 


cardiorespiratory disease (e.g.: cystic fibrosis), 3) If the parents do not speak 
English, or 4) If the children are hospitalized.   
If the child is eligible, a member of the research team will approach the family to 
obtain informed consent for study participation.  Informed consent will include 
permission to review the child’s medical records and pharmacy records using the 
standard release of information forms used in the Hasbro ED.  After consent, the 
participant and their family will complete the PACCI. If the responses indicate that 
they have “controlled” asthma then they will be excluded from further study 
procedures, otherwise they will be eligible for the study procedure and will be 
randomized (see Randomization below).  For each participant, the following 
demographic/clinical data will be collected: date of birth, date of ED visit, gender, 
race/ethnicity (using NIH reporting guidelines),(31) family socioeconomic status 
(using the National Opinion Research Council system(32)), income-to-needs 
ratio,(33) insurance, ETS exposure, name of the child’s primary doctor, 
name/location/phone number of child’s primary pharmacy, and family contact 
information.  A baseline quality of life score will also be obtained using the 
Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF). Treatment by 
the ED staff during the visit will not be affected by study participation.  After data 
collection, researchers will inform parents of the follow up schedule, and pro-rated 
compensation ($10 for the one week doser CT delivery visit, $10 for the one month 
Doser CT retrieval visit, and $20 for completion of the 6 month follow-up phone 
calls).  
Randomization: Participants will be randomized to the ICS prescription arm or the 
routine asthma care arm.  We will use block randomization to balance the number of 
participants in each arm, and varied block sizes (4 – 8) because of incomplete 
blinding of assignments.  The allocation ratio between intervention and control 
arms will be 1:1.  Random treatment assignments in each block will be generated in 
advance using a computer algorithm.  Assignments will be placed in sealed, opaque, 
consecutively numbered envelopes by a person not involved in the study.  When a 
participant is enrolled, the RA will take the next envelope, record the envelope study 
ID for that participant, and open the envelope to determine the assignment.   
ICS Prescription Arm Protocol: Participants in the ICS prescription arm will follow 
the treatment plan, discharge instructions, and follow up recommendations 
provided by the treating clinicians while they are in the ED.  During discharge, the 
study nurse will provide the asthma discharge instructions (see attached 
instructions) to the family and inform them that the child has met criteria for 
prescription of an ICS to help control the asthma.  The families preferred pharmacy 
will be determined and a prescription for the first-line ICS covered by the 
participant’s insurance will be called in within 24 hours by the study PI or co-
Investigator (both licensed clinicians).   Dosing will follow the recommendations 
outlined in the NHLBI asthma guidelines for low dose ICS in this age group for the 
respective medication.(19)  In addition to the standard instructions, the nurse will 
give specific instructions for ICS use including how to administer medication, use of 


spacer devices to be used with the MDI, recommendations for daily use, possible 
side effects of medication use, and distinction between controller and quick-relief 
rescue medications. Parents will be informed that they should follow up with their 
primary care provider to discuss the length of ICS use.   
One week after study enrollment, the pharmacy to which the prescription was called 
will be contacted to determine any prescriptions for asthma medications that were 
filled.  Delivery of a doser CT device, which is used to assess medication adherence, 
will occur approximately one week after study enrollment.  This device will be 
coupled with the ICS MDI (if one was obtained from the pharmacy) or with an 
albuterol MDI (if no ICS was filled),  Families will be called two weeks after the ED 
visit to determine if there are any issues with device use. To ensure proper 
communication, a checking-in mailer will be sent out two weeks post-enrollment. 
This mailer will serve as a reminder to contact staff if participants encounter any 
issues with the doser CT device or if their contact information has changed.  A home 
visit will be scheduled at one month to arrange for retrieval of the doser CT device. 
An “Unable to Contact Mailer” will be sent out to participants if staff are unable to 
contact them after several attempts. 
Routine Asthma Care Arm Protocol: Participants in the routine asthma care arm 
will follow the treatment plan developed by the treating clinicians as part of routine 
care.  The study nurses will provide the same asthma discharge instructions (see 
attached instructions), except for those instructions specific to ICS use.  
One week after study enrollment, the child’s pharmacy will be contacted to 
determine any prescriptions for asthma medications that were filled.  Delivery of a 
doser CT device, which is used to assess medication adherence, will occur 
approximately one week after study enrollment.  Unlike in the ICS Prescription Arm, 
the doser CT device for children in the control arm will be used with their albuterol 
MDI.  Although this data will not be used for analysis, it makes the control arm 
intevention similar to the intervention arm from the perspective of the study 
participants.  Families will be called after two weeks to determine if there are any 
issues with device use. To ensure proper communication, a checking-in mailer will 
be sent out two weeks post-enrollment. This mailer will serve as a reminder to 
contact staff if participants encounter any issues with the doser CT device or if their 
contact information has changed.  A home visit will be scheduled at one month to 
arrange for retrieval of the doser CT device. An “Unable to Contact Mailer” will be 
sent out to participants if staff are unable to contact them after several attempts. 
Summary of Intervention and Control Protocol 
Timing 
after 
enrollment 
Study Procedure 
Purpose 
Intervention 
Arm 
Control 
Arm 


Just prior to 
ED discharge 
Study nurse 
performs discharge 
instructions; ICS 
prescription arm 
provides preferred 
pharmacy info 
To provide 
education to both 
arms (ICS specific 
for ICS 
Prescription Arm) 
X 
X 
Within 24 
hours 
Study clinician (PI) 
calls preferred 
pharmacy  
To arrange ICS 
prescription 
X 
 
Within 7 
days 
Researcher 
contacts pharmacy 
To determine 
which 
participants filled 
an ICS 
prescription  
X 
X 
One week 
Research 
coordinator or RA 
arranges for home 
visit to deliver 
doser CT device* 
To monitor 
medication 
adherence 
 
X 
 
X** 
Two weeks 
RA calls families 
who received 
Doser CT devices. A 
two week 
checking-in mailer 
is sent out.  
To discuss any 
problems with 
the Doser CT 
device and 
changes in 
contact 
information. 
X 
X 
One month 
RA arranges home 
visit to retrieve 
Doser CT devices* 
Retrieve CT Doser 
device 
X 
X 
One, Two 
and four 
months 
RA calls family 
To reduce 
attrition and keep 
family excited 
about study 
X 
X 
Six 
months*** 
Blinded researcher 
follow-up phone 
call 
Outcome data 
collection 
X 
X 
* Participants will be mailed $20 compensation for their effort upon completing the 
6 month follow-up. 


** In Control Arm, Doser CT device will be used with albuterol MDI as sham 
intervention. 
*** If follow-up phone call is unsuccessful, researcher will attempt home visits to 
collect outcome data. 
6 Month Follow-up Phone Call and Outcome Variables:  Six months after study 
enrollment, all participants will be contacted by telephone to collect outcome data.  
The researcher making the follow up phone calls will be blinded to the study arm of 
the participants.  Telephone calls to participants will continue until follow up is 
complete, or further participation is refused. Informed consent at the time of 
enrollment will include permission to perform home-visits if telephone contact is 
unsuccessful.  Participants will be mailed $20 compensation for their effort upon 
completing the 6 month follow-up.      
Outcome data collected will include unscheduled doctor’s office visits, ED visits, 
hospitalizations, or oral steroid courses for asthma in the 6 months following 
enrollment.  Unscheduled doctor’s visits will be corroborated by contacting the 
child’s primary doctor and obtaining a visit history (using the Release of 
Information form signed during consent). Visits in the week following enrollment 
will not be included as they will be considered part of the initial exacerbation.  To 
corroborate oral steroid courses, we will contact the participant’s pharmacy, using 
the Release of Information signed during consent. 
Another outcome variable collected using a script during the telephone call will be 
the quality of life, using the ITG-CASF.   The ITG-CASF has been validated in the ED 
setting for children 2 to 17 years old (34), is reliable (Cronbach’s α =0.70), can be 
administered by telephone (34), requires only 10 questions, and has been used in 
studies with similar follow up timeframes.(10)  Each item is rated on a 5-point scale.  
Each response is scaled as a percentage of the maximum response, and the total 
score is the maximum percentage based on the number of questions answered.  The 
scores range from 0 – 100, with higher scores reflecting better quality of life.  The 
change in ITG-CASF scores for children with improved overall clinical status are 10 
points higher than when children have not improved.(34) 
Data Analysis Plan:  Participants will be analyzed in the group to which they were 
randomized using an intention-to-treat approach.  We hypothesize that children in 
the intervention arm will have less unscheduled health care use at 6 month follow 
up, and increased quality of life compared to children receiving routine asthma care.  
We will use chi-square testing for the health care use variable, and Student’s t-test 
for the continuous quality of life variable.   
Power Analysis: Sample size was calculated to power hypothesis testing for 
dichotomous health care use outcomes as they require the largest sample size.  
Using preliminary data to estimate baseline health care use in our study 
population,(35) we calculated the sample size needed to detect a difference in the 
proportion of children with unscheduled health care use in the intervention arm 


(p1=0.35) compared to the routine asthma care arm (p0=0.6), with 80% power to 
detect a statistically significant difference at an alpha of 0.05.  Assuming 20% of 
participants will not be reached for follow up, and who will not have outcome data 
available when electronic medical records are audited, we will recruit 143 
participants to achieve our sample size of 114.     
Data Safety and Monitoring Plan (DSMP): The goals of the DSMP are three-fold.  
First, it is to ensure that there is no statistical difference in adverse events between 
the two study arms.  Second, all serious adverse events will be reviewed by the 
members to provide direction on study continuation.  Serious adverse events are 
considered very unlikely with this study protocol, since the two treatment 
conditions are both commonly utilized treatments in clinical practice.  The third goal 
is to ensure that the intervention arm is not performing significantly better than the 
routine asthma care arm, as if this was identified early in the study, it would be 
unethical to withhold the intervention from the control arm. 
 
Prior to beginning enrollment, we will have a conference call at which time 
the DSMP will be reviewed by the study PI and 2 Emergency Medicine attendings 
not affiliated with the study.  The first DSMP data review will occur 6 months after 
the first participant has their 6 month data collection.  Therefore this meeting will 
likely occur 12 months after study enrollment begins.  Reviews will occur every 6 
months thereafter. 
 
The following outcome data will be provided to the DSMB along with the 
randomization assignments: 
- 
Unscheduled medical visits to primary doctor’s office for asthma 
- 
ED visits for asthma 
- 
Hospitalization for asthma 
- 
Oral steroid courses for asthma 
- 
Quality-of-life scores from the ITG-CASF 
- 
Adverse events reported by parents at 6 month follow-up phone call 
- 
Adverse events reported by study personnel 
- 
Serious adverse events reported by study personnel* 
* Any serious adverse events will be reported within 24 hours of occurrence to the 
IRB and DSMB.  Study enrollment will be suspended until the DSMB and IRB have 
reviewed the event and made recommendations to the study PI. 
  


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Appendix A. Interviews at Home Visits 
 
Overview: In addition to the RCT, we are adding a series of interviews of participants to help 
design the educational component that ED clinicians will provide to families at the time of ICS 
prescription to promote adherence.  These interviews will occur during the second home visit of 
the original protocol during which the Doser CT devices, used to measure medication adherence 
will be queried.  
 
Recruitment: Parents of children that were part of the ICS prescription arm in the RCT will be 
eligible for these interviews.  Interviews will involve a convenience sample of these participants, 
occurring only when researchers trained in interviewing techniques are performing the home 
visit.  Interviews will be recorded using two electronic recording devices (extra device to protect 
against primary device failure).  Verbal consent will be used as the transcripts of the interviews 
will not include identifying information, and therefore a written consent would be the only link 
identifying the participant in this portion of the protocol. 
 
Participants will be classified in one of three groups: 
 
Group 1 (Did not fill ICS prescription) – Based on pharmacy calls outlined in the original  
protocol, we will determine which participants did not fill the ICS prescription by one  
week after enrollment. 
 
Group 2 (Filled prescription, but non-adherent with appropriate ICS administration) – At  
the home visit, the Doser CT devices will be queried.  Adherence will be defined as ≥ 4  
days in the most recent 4 weeks of data with 4 doses of medication administered.  If  
participants do not meet these criteria, they will be classified as non-adherent and  
included in Interview Group 2. 
 
Group 3 (Filled prescription, and adherent with appropriate ICS administration) – Unlike  
group 2, participants will be in this group if they meet the adherence criteria outlined  
above. 
 
 
Interview Protocol: Using convergent interviewing techniques, we will perform a series of 
interviews with these three participant groups.  Convergent interviewing uses a single open 
ended question, and allows the research participant to respond in an open-ended fashion for as 
long as possible.  Probes are developed in response to these open-ended responses.  After 
interim analysis of interviews, subsequent interviews may involve more focused probes.  
Because of this open-ended interviewing style, an interview guide is not used.  The open-ended 
question that will be posed to early participants will be tailored to the 3 groups as follows: 
 
Group 1 – “One of the ways to treat your child’s asthma is with inhaled steroids.  At your  
recent emergency department visit, this was one of the recommendations made by the  
person that discharged you from the emergency department.  What did you think of this  
recommendation?” 
 


Groups 2 and 3 – “After your child’s recent visit to the emergency department, you filled 
a prescription for an inhaled steroid.  Tell me what you think about using that 
medicine.” 
 
 
Participants will be aware they are being recorded, and will be informed that all 
identifying information will be removed from transcripts that will be made from the recordings.  
Interviews will last approximately 30-45 minutes.  Participants will be compensated $20 for their 
time in completing the interview.  These will be mailed as a check to the participant. 
Interviews will be continued until the point where data saturation is reached which is 
defined by Attwater et al. as when two consecutive interviews occur in which no new themes 
are generated.1 
 
Data analysis: Based on the techniques outlined for convergent interviewing by Attwater, et al.1 
the following steps will be employed: 
 
1. The interviewer will analyze the data by coding the transcript passages into content 
codes using NVivo (version 8) a software program used to facilitate qualitative data 
analysis.  The coding style will involve content analysis with codes in a tree node format. 
 
2. A second researcher will code the same transcript independently. 
 
a. Content codes will be developed during the course of the analysis as follows.  As 
the first two transcripts are being analyzed content codes will be proposed by 
the two coders (one of whom is the PI).  These content codes will be discussed 
and modified by consensus agreement of the two coders.  If a given content 
code is agreed upon, it will be added to the coding scheme. 
 
b. The coding scheme derived after the first two transcripts are analyzed will then 
be used for the next two transcripts. 
 
i. If new content codes are identified by individual coders during coding of 
the second transcript, these will again be discussed and modified by 
consensus agreement and added to the coding scheme if agreed upon. 
 
c. This process will continue with analysis occurring after every two interviews.  
 
3. After every two interviews within a participant group, the interviewers will again meet 
to compare codes assigned to each transcript.  At these meeting, themes developed 
from the content will also be discussed and agreed upon themes recorded. 
 
4. For each theme generated, previous content will be reviewed to look for disagreement 
and agreement.2  
 
a. When agreement with previous content is identified, probes will be developed 
for use in subsequent interviews to test the validity of this apparent agreement 
by looking for disconfirming views, and identify how widely this phenomenon 
occurs. 
 


b. When disagreement with previous content is identified, probes will be 
developed for use in subsequent interviews to provide an explanation for this 
disagreement and identify how widely this phenomenon occurs. 
 
5. This process of recycling will continue until two successive interview within a given 
interview group provide no new information. 
 
Protecting Confidentiality: The content of the focus group discussions will be transcribed and 
de-identified by removing names and any other identifying information.  When transcription is 
complete, digital recording files will be erased.     
 
 
References 
 
1. Attwater W, Hase S. Convergent interviewing and its use in qualitative research.  Accessed at: 
www.business.otago.ac.nz/mgmt/ANZAM2004/CD/Papers/abstract66.htm.  Last accessed on 
July 27, 2012 
 
2. Dick B. Convergent interviewing, session 8 of Areol – action research and evaluation on line. 
Available: http://www.scu.edu.au/schools/gcm/ar/areol/areol-session08.html [accessed 11 
August 2012]