A Low-Literacy Asthma Action Plan to Improve …...2015/11/30 · computer-generated, low-literacy...

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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YIN et al

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.


YIN et al

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.



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



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


YIN et al

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



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.



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.


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.



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.


YIN et al

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originally published online December 2, 2015; Pediatrics Karen Encalada and Benard P. Dreyer

Egan, Linda van Schaick, Michael S. Wolf, Dayana C. Sanchez, Christopher Warren, H. Shonna Yin, Ruchi S. Gupta, Suzy Tomopoulos, Alan L. Mendelsohn, Maureen

Randomized StudyA Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A

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