ARTICLEPEDIATRICS Volume 137 , number 1 , January 2016 :e 20150468
A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized StudyH. Shonna Yin, MD, MS,a,b Ruchi S. Gupta, MD,c,d Suzy Tomopoulos, MD,a Alan L. Mendelsohn, MD,a,b Maureen Egan, MD,e Linda van Schaick, MSEd,a Michael S. Wolf, PhD, MPH,f Dayana C. Sanchez, BA,a Christopher Warren, BA,c Karen Encalada, BA,a Benard P. Dreyer, MDa
abstractBACKGROUND AND OBJECTIVES: The use of written asthma action plans (WAAPs) has been
associated with reduced asthma-related morbidity, but there are concerns about their
complexity. We developed a health literacy–informed, pictogram- and photograph-based
WAAP and examined whether providers who used it, with no training, would have better
asthma counseling quality compared with those who used a standard plan.
METHODS: Physicians at 2 academic centers randomized to use a low-literacy or standard
action plan (American Academy of Allergy, Asthma and Immunology) to counsel the
hypothetical parent of child with moderate persistent asthma (regimen: Flovent 110 μg
2 puffs twice daily, Singulair 5 mg daily, Albuterol 2 puffs every 4 hours as needed). Two
blinded raters independently reviewed counseling transcriptions. Primary outcome
measures: medication instructions presented with times of day (eg, morning and night vs
number of times per day) and inhaler color; spacer use recommended; need for everyday
medications, even when sick, addressed; and explicit symptoms used.
RESULTS: 119 providers were randomly assigned (61 low literacy, 58 standard). Providers
who used the low-literacy plan were more likely to use times of day (eg, Flovent morning
and night, 96.7% vs 51.7%, P < .001; odds ratio [OR] = 27.5; 95% confidence interval [CI],
6.1–123.4), recommend spacer use (eg, Albuterol, 83.6% vs 43.1%, P < .001; OR = 6.7; 95%
CI, 2.9–15.8), address need for daily medications when sick (93.4% vs 34.5%, P < .001; OR
= 27.1; 95% CI, 8.6–85.4), use explicit symptoms (eg, “ribs show when breathing,” 54.1%
vs 3.4%, P < .001; OR = 33.0; 95% CI, 7.4–147.5). Few mentioned inhaler color. Mean (SD)
counseling time was similar (3.9 [2.5] vs 3.8 [2.6] minutes, P = .8).
CONCLUSIONS: Use of a low-literacy WAAP improves the quality of asthma counseling by
helping providers target key issues by using recommended clear communication principles.
aDepartment of Pediatrics, New York University School of Medicine and Bellevue Hospital Center, New York, New
York; bDepartment of Population Health, New York University School of Medicine, New York, New York; cCenter
for Community Health, and fHealth Literacy and Learning Program, Center for Communication in Healthcare,
Division of General Internal Medicine, and Institute for Healthcare Studies, Northwestern University Feinberg
School of Medicine, Chicago, Illinois; dSmith Child Health Research Program, Ann & Robert H. Lurie Children’s
Hospital of Chicago, Chicago, Illinois; and eDepartment of Pediatrics, Icahn School of Medicine at Mount Sinai,
New York, New York
Dr Yin conceptualized and designed the study, led the analysis and interpretation of data,
and drafted the manuscript; Dr Gupta conceptualized and designed the study, assisted in
the analysis and interpretation of data, and provided critical revision of the manuscript for
important intellectual content; Drs Tomopoulos, Mendelsohn, Wolf, and Dreyer and Ms van
Schaick participated in the conceptualization and design of the study, assisted in the analysis and
interpretation of data, and provided critical revision of the manuscript for important intellectual
To cite: Yin HS, Gupta RS, Tomopoulos S, et al. A Low-
Literacy Asthma Action Plan to Improve Provider
Asthma Counseling: A Randomized Study. Pediatrics.
2016;137(1):e20150468
WHAT’S KNOWN ON THIS SUBJECT: Asthma action plan use is
recommended to reduce asthma-related morbidity, but there are
concerns about their effectiveness in low-literacy populations.
Health literacy–informed approaches have been linked to improved
patient outcomes but have not been well studied in child asthma.
WHAT THIS STUDY ADDS: A low-literacy, pictographic and
photographic written asthma action plan may help providers target
key issues in asthma management and use recommended principles
of clear health communication, without the need for training and
without increased time burden.
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National and international guidelines
for asthma management include
the recommendation that written
asthma action plans (WAAPs) be
provided to all patients with asthma.1
These action plans help families
understand daily preventive care and
appropriate symptom management.
Provision of WAAPs has been
associated with greater medication
adherence2 and reduced health
care utilization, including fewer
asthma-related hospitalizations and
emergency department visits.3,4
However, there are questions about
the effectiveness of WAAPs when
used with low-literacy populations.
Provider concern that action plans
are too complex may be a reason why
WAAPs are given to less than half of
asthmatic patients.5–9 Key domains of
asthma management cited as being
particularly problematic include
misunderstanding of medication
instructions (confusion about dose
and timing, mix-ups between daily
and preventive medications10,11),
suboptimal spacer use,1,12,13 lack of
controller medication use (persistent
asthmatics),14 and difficulty
recognizing symptoms of serious
exacerbations.15,16
Low health literacy (HL) is likely to
contribute to poor management of
child asthma. Asthmatic children
of parents with low HL are at
risk for worse asthma-related
outcomes, including greater asthma
symptom severity and higher
hospitalization rates.17,18 Use of
HL-informed counseling strategies
(eg, teach back, easy-to-read
written materials) has been found
to improve comprehension, disease
management, and outcomes for
various health conditions but has not
been well studied for asthma.19–24
Low-literacy written materials
used as part of counseling can offer
providers a framework with which to
counsel patients and their families,
prompting them to focus on specific
issues and supporting the use of
plain language.21 Unfortunately, few
low-literacy tools to improve asthma
management exist. US asthma action
plans are commonly written above a
sixth-grade reading level,9 and often
do not use a HL-informed approach
to layout, graphics, and content.9,25 In
addition, many plans must be filled in
by hand,9 contributing to variability
and errors in interpretation. One
strategy that could help standardize
the presentation of medication
instructions and support provider
use of HL principles is the use of a
computer-generated, low-literacy
asthma action plan.6 To date, few
studies of HL-informed approaches
to improve asthma management
have been conducted.26–30 We
therefore sought to examine whether
physicians who use a low-literacy,
pictogram- and photograph-based
WAAP would demonstrate higher-
quality asthma counseling compared
with those who use a standard
plan requiring individual provider
completion, and whether differences
exist by factors previously found
to affect asthma care, including
physician training level, asthma care
experience, and gender.31–35 We
hypothesized that those who used
the low-literacy WAAP would be
more likely to address key asthma
management issues by using clear
communication principles and that
overall the benefit of the low-literacy
WAAP would be similar across
domains regardless of physician
characteristics.
METHODS
Participants, Recruitment, and Randomization
This was a randomized controlled
study to examine whether use of
a low-literacy WAAP can improve
provider asthma counseling, as
assessed with a hypothetical scenario
involving a parent of a child with
persistent asthma. The institutional
review boards of New York
University (NYU) and Northwestern
and the Research Review Committee
of Bellevue Hospital approved this
study.
Study subjects were recruited from
NYU and Northwestern between
June 17, 2012 and October 9, 2012.
A convenience sample of physicians
was assessed to determine eligibility.
We included pediatricians who
care for children with asthma
(ie, residents [minimum end of
intern year], fellows, attendings).
Written informed consent was
obtained. Research assistants (RAs)
emphasized that participation
was voluntary and that collected
information would not be shared
with supervisors.
Enrolled providers were randomly
assigned to receive the low-literacy
WAAP (Fig 1) or a standard WAAP
endorsed by the American Academy
of Allergy, Asthma and Immunology
(AAAAI).36 Randomization was
performed with sealed envelopes
blocked by physician training level
(first, second, third year, fellow or
attending). Trained RAs delivered
the intervention after conducting the
background interview.
Intervention Group: Low-Literacy WAAP
Table 1 compares the features
of the low-literacy and standard
WAAPs. The low-literacy WAAP is
an extension of the HELPix (Health
Education and Literacy for Parents)
pictogram-based medication
instruction sheet intervention.19
It was developed through a
collaborative process that included
parents, pediatricians, asthma
specialists, nurses, health educators,
and health literacy experts, involving
1:1 interviews and group discussions.
Feedback was purposively sought
from parents with low literacy who
had children with moderate to severe
asthma.
Control Group: Standard WAAP
Providers randomly assigned to
receive the standard WAAP were
provided with the AAAAI action plan;
the AAAAI plan is among the better
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PEDIATRICS Volume 137 , number 1 , January 2016
plans of those that are nationally
available with respect to adherence
to HL-informed principles such
as layout and content. Medication
information is filled out by a provider
within a table format.9
Assessments
Trained RAs conducted brief
interviews with each health care
provider. RAs and providers were
blinded to randomization status until
just before the provider was asked
to use either the low-literacy or
standard WAAP to counsel a parent
of an asthmatic patient by using
a hypothetical scenario. Because
providers used the action plan to
counsel the RA, it was not possible
to blind either group once the
counseling portion of the assessment
began. No participant incentives
were provided.
Asthma Counseling Assessment
Providers were asked to use
the assigned WAAP to counsel a
hypothetical parent of a child with
moderate persistent asthma on
the following regimen: Singulair
(montelukast sodium) 5 mg once a
day, Flovent (fluticasone propionate)
110 μg/actuation 2 puffs twice a
day, and Albuterol 90 μg/actuation
2 puffs every 4 hours as needed.
Providers randomly assigned to
receive the AAAAI plan were first
asked to fill out the blank form with
the child’s medication information.
Providers were given the opportunity
to take as much time as they needed
to look at their assigned plan and
demonstrate counseling. Providers
were instructed, “Please pretend
that I am the parent of a child who
has recently been diagnosed with
asthma. Use the action plan as you
normally would for counseling, to
teach me how to manage my child’s
asthma on a symptom free day, when
my child has some symptoms, as well
as when my child has severe asthma
symptoms.” Counseling was audio
recorded. Audio recordings were
transcribed by 1 of 3 trained RAs
blinded to intervention status, with
verification of accurate transcription
by a second RA.
Use of Clear Communication Principles
Primary outcome measures focused
on the use of clear communication
principles during counseling within
4 key domains: presentation of
medication instructions based on
times of day (ie, “morning” and
“night”; preferable to number of
times/day, eg, “2×/day”) and inhaler
colors mentioned; spacer use (inhaler
medications); need for everyday
medications, even when sick,
mentioned generally, and specific
mention of Flovent and Singulair
in yellow zone; and explicit words
used to present symptoms of serious
exacerbation (eg, “ribs show when
breathing” preferred over “difficulty
breathing”).
Selection of the characteristics
examined within each audio-
recorded counseling session was
guided by review of the literature on
aspects considered to be important
from clinical and HL perspectives.1
3
FIGURE 1Pictogram- and photograph-based low-literacy asthma action plan.
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The final list was created with input
from 2 clinicians and HL experts
(H.S.Y., B.P.D.), 2 clinician asthma
experts (S.T., R.S.G.), and a cognitive
scientist and HL expert (M.S.W.).
Transcriptions of each counseling
session were reviewed and
independently coded by 2 RAs (D.C.S.,
C.W.) blinded to intervention status,
trained by 1 of the authors (H.S.Y.).
Additional Counseling-Related Outcomes Assessed
Secondary outcomes included
counseling duration and provider
plan preference. After the audio
recording, providers were shown the
action plan they were not randomly
assigned to and asked, “Which of
these two asthma action plans would
you prefer to use when counseling
parents of children with asthma?”
Provider Sociodemographics and Asthma-Related Experience
We assessed provider
sociodemographic characteristics,
including age, gender, country of
birth, race andethnicity before
provider counseling. Provider
training level was categorized as
resident year 1, 2, 3, and fellow or
attending.
Provider asthma-related experience
was assessed via a structured
questionnaire. Frequency of
providing clinical care to children
with asthma was assessed with
the question, “How often do you
provide clinical care to children
with asthma?” (often, sometimes,
or rarely). Previous use of WAAPs
was assessed with 2 questions:
“How often do you counsel using a
written asthma action plan?” (often,
sometimes, rarely, or never), and
“How confident are you that you
can explain an asthma action plan
to parents so that they understand
how to correctly manage their child’s
asthma?” (confident, somewhat
confident, slightly confident, or not
confident).
4
TABLE 1 Comparison of Features of the Low-Literacy Pictogram- and Photograph-Based Action Plan
and Standard Action Plan
Low-Literacy Action Plan Standard Action
PlanFeatures Supporting Evidence
Overall structure Three color zones used to divide information about everyday care (green
section) from information about when the child is starting to get sick
(yellow; rescue medicine needed) and when the child is very sick (red;
emergency help needed).
General Symptom-based
information for
asthma management.
Evidence suggests that
symptom-based action
plans are superior
to peak fl ow–based
plans with respect to
prevention of acute
care visits.37,38
Symptom-based
information
for asthma
management
and areas where
providers can
fi ll in peak
fl ow–based
information, a
typical feature of
US action plans.9
Presentation of
medication instructions:
Misunderstanding of
asthma medication
instructions is a
contributor to the high
rate of parent and
patient nonadherence
to prescribed asthma
medication regimens24;
misunderstandings
relate to timing
and frequency of
medications, as well as
mix-ups between which
inhaler to take for
emergencies and which
inhaler is for everyday
use.11
Times of day used (eg,
“morning” and
“night”).
Use of medication
instructions relating
to particular times per
day (eg, morning, noon,
evening, bedtime) has
been found to improve
patient understanding,
especially with complex
regimens,39,40 and is
part of new evidence-
based medication
labeling standards
issued by the US
Pharmacopoeia.41
No guidance for
provider given
about how to
present times
of day; most
commonly,
providers
presented
instructions in
times per day
(eg, “2×/day”).
Morning and night
pictograms
emphasize times
of day.
Incorporation of
pictograms in
medication instructions
has been found to
improve medication
self-management.42
No morning and
night pictograms.
Shading used to
“chunk,” or
cluster, information
about morning and
night medication
regimens.
Chunking of information
helps cluster similar
information, which is
easier for the brain to
process.43
No shading used to
chunk
information
about morning
and night
regimens.
Photographs of inhalers
included to help
parents differentiate
between their
everyday and rescue
inhalers; color of
each inhaler evident
from photographs
(Flovent, orange;
Albuterol, blue).
Use of color is a
strategy used to help
support understanding
of key concepts; in
this case, presenting
inhaler color provides
valuable information
to help parents
act on medication
instructions.43
No colors of
inhalers
indicated.
Providers can
choose to write
in inhaler colors.
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Statistical Analysis
Data were analyzed in SPSS 20.0 (IBM
SPSS Statistics, IBM Corporation).
For all analyses, a 2-tailed P value of
≤.05 was considered to be statistically
significant. χ2 and logistic regression
were performed to examine
outcomes by randomization status;
subgroup analyses were conducted
to examine differences by physician
training level (resident vs fellow or
attending), how often clinical care
was provided to asthmatic children
(often vs sometimes/rarely), and
gender. Interrater reliability was high
(κ range 0.76–0.98, median 0.92),
based on agreement or disagreement
for scoring of each action plan
characteristic being present or absent.
A third reviewer (H.S.Y.) provided
an independent review in cases of
discordant rating, with majority rule
used in cases of discordance.
Sample Size Estimation
Sample size estimates were based
on the outcome of spacer use. Spacer
use is associated with better asthma
outcomes,12,45,46 and counseling
about spacer use is considered
the standard of care in asthma
management.1 Based on previously
collected pilot data from our clinic,
we estimated a baseline rate of
provider inclusion of spacer use as
part of action plan counseling as
being ∼50%. We calculated a sample
size of ∼120 parents to achieve 80%
power (2-sided α = 0.05) to detect
an increase in rate to 75% to 80% in
the group receiving the low-literacy
action plan compared with the group
using the standard plan.
Results
In total, 119 providers were enrolled
(61 low-literacy, 58 standard WAAP)
(Fig 2). Across groups, providers
were similar with respect to age,
gender, race,ethnicity, and previous
asthma-related experience (Table 2).
Providers who used the low-
literacy plan were more likely to
recommend a time of day for taking
5
Low-Literacy Action Plan Standard Action
PlanFeatures Supporting Evidence
Presentation of spacer
information: Use of a
spacer with inhaled
asthma medications
is considered to be
essential for maximal
delivery of medication
to the lungs, improving
medication effi cacy.12
Spacer use reinforced
through repetition
of this concept
each time inhaler
information is
provided on action
plan. For each
medication:
Repetition of key
concepts13 encourages
providers to reinforce
the information and
supports parent
understanding.
No spacer use
mentioned in
text. Provider
can choose to
write in need for
spacer.
Spacer use mentioned
in text (eg, “2 puffs
with spacer”).
Pictograms are
particularly effective
for visually reinforcing
concepts,19,21–24,42
in this case, the
importance of spacer
use.
No images of
spacer shown.
Spacer is shown in
pictograms (eg, line
drawing of child
using an inhaler with
a mask and spacer).
Reinforcement of need
for everyday preventive
medications, even when
sick: For asthmatics
with persistent asthma,
use of daily controller
medications has been
shown to be the best
way to prevent asthma
exacerbations, and
they work best if taken
every day, regardless
of whether the child
is sick or well.14 Those
with low HL have been
found to be more likely
to underuse inhaled
steroids10 and are more
likely to believe that
medications work better
if not used all the time.44
Need for everyday
preventive medicine
addressed in the
top banner of green
zone.
Repetition of key
concepts encourages
providers to reinforce
the information and
supports parent
understanding.13
Need for everyday
preventive
medicine
addressed in text
in green zone
(not emphasized
with color).
Concept reiterated in
yellow zone.
Effective use of layout,
including allocation
of adequate space
to particularly
important concepts,
can help highlight key
concepts.9,43
Concept reiterated
in text in yellow
zone (not
emphasized with
color).
Concept mentioned
in text, along the top
banner.
“Snapshot” of the
pictographic and
photographic green
zone medication
information in the
yellow zone section
(which shows images
of both Flovent and
Singular).
TABLE 1 Continued
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daily medications rather than using
number of times per day (eg, Flovent,
96.7% vs 51.7%, P < .001; odds ratio
[OR] = 27.5; 95% confidence interval
[CI], 6.1–123.4) (Table 3).
More than 80% of providers who
used the low-literacy plan mentioned
spacers with Flovent and Albuterol;
fewer than half who used the
standard plan did so (P < .001)
(Table 3).
Providers who used the low-literacy
plan were more likely to reinforce
the need for everyday medications,
even when the child is sick (93.4% vs
34.5%, P < .001; OR = 27.1; 95% CI,
8.6–85.4), including being more likely
to specifically mention medication
names.
Providers who used the low-
literacy plan were more likely to
use explicit respiratory signs and
symptoms such as “ribs show when
breathing” (54.1% vs 3.4%, P <
.001; OR = 33.0; 95% CI, 7.4–147.5)
(Table 3).
The mean (SD) amount of time
used for counseling was similar in
the 2 groups (3.9 [2.5] vs 3.8 [2.6]
minutes, P = .8). More than 90% of
providers in both groups preferred
the low-literacy plan (96.7% vs
93.1%, P = .6).
Subgroup Analyses
No consistent patterns were
found with action plan impacts
by provider characteristics,
although some isolated examples
were present. Presentation of
medication frequency improved
to a greater extent for fellows and
attending physicians compared
with residents because of a smaller
number of standard plan fellows
and attending physicians using the
low-literacy strategy. For example,
recommending Flovent in the
morning and night increased more
for fellows and attending physicians
(100% vs 36.4%, P < .001) than
residents (94.6% vs 61.1%, P =
.002). There was a greater increase
in reinforcement of the need to give
everyday medications, even when
sick, for providers with less asthma
care experience (96.0% vs 22.7%,
P < .001) compared with providers
with more experience (94.3% vs
41.7%, P < .001). Presentation of
symptoms of serious exacerbations
increased to a greater degree for
fellows and attending physicians
than for residents. For example,
mentioning ribs showing increased
more for fellows and attending
physicians (70.8% vs 4.5%, P < .001)
than for residents (43.2% vs 2.8%,
P < .001). There were no differences
by gender.
6
Low-Literacy Action Plan Standard Action
PlanFeatures Supporting Evidence
Presentation of symptoms
of serious exacerbation
(red zone): Diffi culty
recognizing symptoms
of a serious asthma
exacerbation can result
in lack of appropriate
intensifi cation,
or escalation, of
treatment.15,16
Inclusion of
predominantly
explicit symptoms
along the left column
of the action plan
(eg, “ribs show when
breathing,” “can’t
stop coughing,”
“neck pulls in”).
Presentation of explicit
symptoms is helpful
in providing clarity
about what parents
should look for, making
the instructions more
actionable.43
Inclusion of
predominantly
general,
subjective
symptoms along
the left side of
the action plan
(eg, “diffi culty
breathing,”
“coughing,”
“wheezing”).
Symptoms presented
1 at a time in bullet
format.
Symptoms presented 1 at
a time are easier to
read than when
unrelated symptoms
are clustered
together.22
Multiple symptoms
sometimes
grouped under 1
bullet.
TABLE 1 Continued
FIGURE 2Study enrollment.
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PEDIATRICS Volume 137 , number 1 , January 2016
DISCUSSION
This study examines whether a
computer-generated HL-informed
WAAP, used without previous
training, can improve physician
ability to counsel about pediatric
asthma management compared
with a standard WAAP requiring
physician completion. We found that
physicians who used the low-literacy
WAAP to counsel a hypothetical
parent of a child with persistent
asthma were more likely to use clear
communication principles than those
who used the standard plan and that,
overall, physicians preferred the low-
literacy plan.
Although low-literacy written
materials are typically thought
to directly benefit families by
giving them access to easy-to-
understand information, this study
demonstrates how low-literacy
materials can also improve the
quality of physician counseling
by giving providers a framework
for counseling that prompts them
to address key issues known to
be difficult for families to grasp.
Written materials can also be
designed to support provider use
of evidence-based communication
strategies known to maximize
learning, including partitioning, or
grouping information into digestible
chunks, as well as modeling specific
plain language wording to explain
confusing medical concepts.47
Guided by the format used to
portray medication instructions
and the associated pictograms on
the low-literacy WAAP, nearly all
providers randomly assigned to
receive the low-literacy WAAP
gave instructions for when to take
daily medications by using time
of day (eg, “morning and night”)
instead of less specific instructions,
such as “twice a day.” A majority
of providers who used the low-
literacy plan recommended spacer
use and reinforced the importance
of continuing daily medications
even when sick. Modeling of specific
wording led providers who used
the low-literacy plan to use explicit
words to describe respiratory signs
and symptoms. These findings
demonstrate how a thoughtful
redesign of WAAPs can be used to
systematically influence the content
and style of provider counseling.
Additionally, our subgroup analyses
did not reveal robust differences by
provider characteristics, suggesting
that the benefit of the low-literacy
plan is likely to be seen regardless of
physician training level, asthma care
experience, or gender.
Interestingly, although the low-
literacy WAAP we developed
included photographs of the inhalers
as a strategy to address the issue
of parent mix-up of everyday and
rescue medications, few providers
7
TABLE 2 Study Population Characteristics by Randomization Group
Low-Literacy
Action Plan (n =
61), n (%)
Standard Action
Plan (n = 58),
n (%)
P
Provider characteristics
Age, ya
≤30 38 (63.3) 35 (60.3) .8
31–40 10 (16.7) 12 (20.7)
41–50 7 (11.7) 8 (13.8)
≥51b 5 (8.3) 3 (5.2)
Gender, female 45 (75.0) 49 (84.5) .3
Country of birth: US, n (%) 53 (86.9) 51 (87.9) 1.0
Race or ethnicity, n (%)b
Hispanic 4 (6.7) 4 (6.9) .9
Non-Hispanic
White 42 (70.0) 42 (72.4)
Black 2 (3.3) 3 (5.2)
Asian 10 (16.7) 8 (13.8)
Other 2 (3.3) 1 (1.7)
Physician training category
Resident year 1 10 (16.4) 9 (15.5) .9
Resident year 2 16 (26.2) 14 (24.1)
Resident year 3 11 (18.0) 13 (22.4)
Fellow or attending 24 (39.3) 22 (37.9)
Site
NYU 32 (52.5) 32 (55.2) .9
Northwestern 29 (47.5) 26 (44.8)
Asthma-related experience
How often provide clinical care to children
with asthmab
Often 35 (58.3) 36 (62.1) .3
Sometimes 24 (40.0) 18 (31.0)
Rarely 1 (1.7) 4 (6.9)
Ever used a written asthma action plan to
counsel
57 (93.4) 54 (93.1) 1.0
How often do you counsel using a written
asthma action plan
Often 20 (32.8) 12 (20.7) .5
Sometimes 23 (37.7) 28 (48.3)
Rarely 13 (21.3) 14 (24.1)
Never 5 (8.2) 4 (6.9)
Confi dence in ability to explain written asthma
action planc
.8
Confi dent 19 (32.2) 19 (32.8)
Somewhat confi dent 28 (47.5) 24 (41.4)
Slightly confi dent 10 (16.9) 11 (19.0)
Not confi dent 2 (3.4) 4 (6.9)
a No study subjects >60 y of age.b Missing for 1 study subject.c Missing for 2 study subjects.
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YIN et al
mentioned inhaler color as one way
to distinguish between inhaler types.
This may be because providers think
that the color is already evident in
the photographs. Providers may also
think that because generic albuterol
comes in different colors, the color
of the inhaler shown on the action
plan may not match the color of the
inhaler the parent receives from the
pharmacy. Additional study is needed
to examine what strategies would
be most effective for addressing the
problem of daily and rescue inhaler
mix-ups by parents. A systems
approach to this issue could include
industry-wide change such that all
rescue medications are consistently
1 color and maintenance medications
another color, an approach that has
been used in countries outside the
United States.11,48,49
The need for provider training
has been found to be a barrier to
implementation of HL-informed
interventions50; this study
demonstrates that improvements
in provider counseling quality can
occur simply with improved written
materials that serve as a scaffolding
for structured counseling. Notably,
we also found no difference in
counseling duration with the
low-literacy WAAP, supporting the
feasibility of implementing
our pictogram-based WAAP.
Additionally, provider acceptability
was high.
Currently, there exists a wide range
of asthma action plans; no standard
universal plan format is available.25
Implementing the low-literacy
computer-generated WAAP could
help reduce variability in the manner
in which instructions are provided. A
move to having a nationally available,
evidence-based low-literacy asthma
action plan could help improve
parent and patient understanding,
adherence, and, ultimately, asthma
outcomes.
This study has several limitations.
This was not a study of real-world
practice; a hypothetical scenario was
used. Use of the hypothetical scenario
probably limited the interactive
conversations that might typically
occur between parents and providers;
a study is in progress involving actual
medication regimens. We compared
our low-literacy plan with a single
action plan, not with the full range
of plans available. However, because
there is no single standard national
plan, we chose what we considered
to be one of the better plans of those
that were nationally available. We
also did not examine the time it would
take for a provider to fill in patient
regimen information to generate
the patient-specific forms using a
computer application, although we
8
TABLE 3 Provider Counseling Strategies Used by Randomization Group
Low-Literacy Action Plan (n =
61), n (%)
Standard Action Plan (n =
58), n (%)
Pa OR 95% CI
Presentation of medication instructions
How medication frequency described
Flovent: morning and nightb 59 (96.7) 30 (51.7) <.001 27.5 6.1–123.4
Flovent: twice a day, 2×/day 16 (26.2) 45 (77.6) <.001 0.1 0.04–0.2
Singulair: every nightb 54 (88.5) 26 (44.8) <.001 9.5 3.7–24.4
Singulair: once a day, 1×/day 7 (11.5) 32 (55.2) <.001 0.1 0.04–0.3
Color of inhaler described
Flovent (orange)b 10 (16.4) 5 (8.6) .3 2.1 0.7–6.5
Albuterol (blue)b 10 (16.4) 1 (1.7) .01 11.2 1.4–90.4
Presentation of spacer information
Spacer use with Floventb 50 (82.0) 24 (41.4) <.001 6.4 2.8–14.9
Spacer use with Albuterolb 51 (83.6) 25 (43.1) <.001 6.7 2.9–15.8
Reinforcement of need for everyday preventive medications, even when sick
Mentions need to continue to give every day
medicinesb
57 (93.4) 20 (34.5) <.001 27.1 8.6–85.4
Specifi cally names Floventb 35 (57.4) 11 (19.0) <.001 5.8 2.5–13.2
Specifi cally names Singulairb 32 (52.5) 12 (20.7) .001 4.2 1.9–9.5
Presentation of symptoms of serious exacerbation (red zone)
Breathing fastb 31 (50.8) 5 (8.6) <.001 11.0 3.9–31.2
Breathing hardb 24 (39.3) 2 (3.4) <.001 18.2 4.0–81.5
Diffi culty breathing 25 (41.0) 36 (62.1) .03 0.4 0.2–0.9
Cannot stop coughingb 28 (45.9) 1 (1.7) <.001 48.4 6.3–372.0
Coughing 16 (26.2) 19 (32.8) .6 0.7 0.3–1.6
Neck pulls inb 29 (47.5) 1 (1.7) <.001 51.7 6.7–397.2
Ribs show when breathingb 33 (54.1) 2 (3.4) <.001 33.0 7.4–147.5
Trouble talkingb 36 (59.0) 20 (34.5) .01 2.7 1.3–5.8
Trouble walking 18 (29.5) 15 (25.9) .8 1.2 0.5–2.7
Wheezing 3 (4.9) 17 (29.3) <.001 0.1 0.03–0.5
a χ2.b Aspects specifi cally supported by the low-literacy, pictographic action plan.
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PEDIATRICS Volume 137 , number 1 , January 2016
expect that if the generation of action
plans is linked to the electronic
medical record, such information
could easily be prepopulated into
the form, minimizing provider time
burden. Our team has previously
used this model for the generation of
low-literacy medication instruction
sheets for medications prescribed in
the outpatient setting.51 Notably, as
is typical for many action plans, the
AAAAI requires providers to fill in
a patient’s medication regimen. For
this study, we did not examine the
implications of prepopulating the
AAAAI action plan with times of day
for medication administration and
explicit symptoms. In addition, the
low-literacy action plan was studied
as a whole; additional study would be
needed to examine which aspects of
the action plan were most important.
The low-literacy action plan was
also studied as a printed handout;
additional enhancement of the tool
is in progress with the development
of a Web application to generate
the personalized action plan, which
includes links to low-literacy video
demonstrating how to administer
the child’s medication doses with
the inhaler and spacer. Video links
showing specific symptoms could
also be beneficial; currently the
limited space on the 1-page action
plan does not accommodate visuals
of each listed symptom. Finally,
this study involved a convenience
sample of physicians at clinical sites
affiliated with 2 academic centers
that serve low-income populations,
and therefore our findings may not
be generalizable. In particular, we
did not include nurses or health
educators in our study, and given
the growing importance of those
groups in action plan counseling,52–54
it would be useful to understand
whether there are any differences
when the low-literacy plans are used
by other health care providers.
CONCLUSIONS
We found that our low-literacy WAAP
improved the quality of asthma
counseling by providers by helping
them highlight key aspects of asthma
management previously found to be
problematic for families and promoting
the use of plain language principles.
Additional studies are needed
to determine whether improved
counseling, using the low-literacy
action plan, will contribute to improved
parent and patient understanding,
adherence, and child asthma outcomes.
ACKNOWLEDGMENTS
Nancy Linn, MFA, and Rebecca
Solow, MFA, helped design the
graphics for the asthma medication
instruction sheets. We thank
the physicians, nurses, health
educators, staff, and families who
helped guide the development of
the asthma medication instruction
sheets, particularly the Bellevue
Hospital Pediatric Asthma team, as
well as Claudia Aristy, BA, and the
Health Education and Literacy for
Parents (HELP) project team. We
thank Andrea Webster, MD, for her
assistance in reviewing this article.
9
ABBREVIATIONS
AAAAI: American Academy of
Allergy, Asthma and
Immunology
CI: confidence interval
HL: health literacy
NYU: New York University
OR: odds ratio
RA: research assistant
WAAP: written asthma action
plan
content; Dr Egan participated in the conceptualization and design of the study, participated in the acquisition of data, assisted in the analysis and interpretation
of data, and provided critical revision of the manuscript for important intellectual content; Ms Sanchez participated in the design of the study, participated in the
acquisition of data, assisted in the analysis and interpretation of data, and assisted in the drafting of the manuscript; Mr Warren participated in the design of
the study, participated in the acquisition of data, assisted in the analysis and interpretation of data, and assisted in the revision of the manuscript; Ms Encalada
participated in the design of the study, assisted in the analysis and interpretation of data, and assisted in the revision of the manuscript; and all authors
approved the fi nal manuscript as submitted.
This trial has been registered at www. clinicaltrials. gov (identifi er NCT01405625).
DOI: 10.1542/peds.2015-0468
Accepted for publication Sep 28, 2015
Address correspondence to H. Shonna Yin, MD, MS, Department of Pediatrics, New York University School of Medicine, 550 First Avenue, NBV8S4-11, New York, NY
10016. E-mail: [email protected]
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2016 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have no fi nancial relationships relevant to this article to disclose.
FUNDING: Dr Yin is supported by Health Resources and Services Administration (12-191-1077, Academic Administrative Units in Primary Care). Drs Yin and Gupta
were funded by career development grants through the Robert Wood Johnson Physician Faculty Scholars Program at the time this study was conducted. The
Robert Wood Johnson Foundation had no role in the design and conduct of the study, in the collection, management, analysis, or interpretation of the data, or in
the preparation, review, or approval of the manuscript. Funding for this study was also provided by the KiDS of NYU Foundation.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential confl icts of interest to disclose.
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YIN et al
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Randomized StudyA Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A
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