research article engaging stakeholders to design a ... · patterns of beliefs, interactions,...

17J. Comp. Eff. Res. (2016) 5(1), 17–30 ISSN 2042-6305

part of

Research Article

10.2217/cer.15.52 © 2016 Future Medicine Ltd

J. Comp. Eff. Res.

Research Article 2016/01/305

1

2016

Aim: To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. Methods: We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: define design requirements; prototype and refine; and evaluate. Results: Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool over current tools. Conclusion: Engaging end-users in contextual inquiry resulted in CAPE (CHICAGO Action Plan after ED discharge), a new stakeholder-balanced discharge tool, which is being tested in a multicenter comparative effectiveness trial.

First draft submitted: 14 July 2015; Accepted for publication: 4 October 2015; Published online: 21 December 2015

Keywords: asthma • health communication • patient discharge • pediatrics • stakeholder engagement • written action plan

Comparative effectiveness research is intended to address the expressed needs of patients, care-givers and other decision-makers in health-care [1]. Such engagement is considered critical to evaluating interventions relevant to end-users and that are feasible for use in real world clinical settings. National and international asthma guidelines recommend the use of writ-ten instructions to promote appropriate use of medications, avoidance of environmental trig-gers and advice about when to seek additional medical attention [2,3]. However, systematic reviews indicate that the content, format and benefits of such written instructions (usually called action plans) are highly variable, with relatively low rates of use because most action plans are designed by teams of medical experts with relatively little input from patients, caregivers and clinicians [4,5].

The CHICAGO study is a multicenter comparative effectiveness trial funded by the Patient-Centered Outcomes Research Insti-

tute (PCORI) to test strategies to improve the care and outcomes of African–Ameri-can and Latino children with uncontrolled asthma presenting to the emergency depart-ment (ED) in Chicago [6]. In Chicago, African–American and Latino children aged 5–11 years bear a disproportionate share of the burden from asthma [7]. Among the most visible of these disparities is the five- to seven-fold higher rate of visits to the ED for uncontrolled asthma in communities with a high proportion of African–American and Latino children compared with other com-munities [Department of Public Health, Chicago,

Pers. Comm.] . As part of the PCORI-funded CHICAGO study, we employed user-cen-tered design methods to engage caregivers, clinicians and administrators in the develop-ment and evaluation of an asthma discharge tool for African–American and Latino chil-dren who present to the ED for uncontrolled asthma [8]. To our knowledge, this is the first

Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma

Kim Erwin*,1, Molly A Martin2, Tara Flippin1, Sarah Norell1, Ariana Shadlyn1, Jie Yang1, Paula Falco1, Jaime Rivera1, Stacy Ignoffo3, Rajesh Kumar4, Helen Margellos-Anast5, Michael McDermott6, Kate McMahon7, Giselle Mosnaim8, Sharmilee M Nyenhuis2, Valerie G Press9, Jessica E Ramsay5, Kenneth Soyemi10, Trevonne M Thompson2 & Jerry A Krishnan2,11

1IIT Institute of Design, 350 N LaSalle,

Chicago, IL 60654, USA 2University of Illinois at Chicago, 1200 W

Harrison St Chicago, IL 60607, USA 3Chicago Asthma Consortium,

PO Box 31757, Chicago, IL 60631, USA 4Ann & Robert H Lurie Children’s

Hospital of Chicago, 225 E Chicago Ave.,

Chicago, IL 60611, USA 5Sinai Health System, California Avenue,

15th Street, Chicago, IL 60608, USA 6Illinois Emergency Department Asthma

Surveillance Project (IEDASP) 7Respiratory Health Association, 1440 W

Washington Blvd, Chicago, IL 60607,

USA 8Rush University Medical Center, 1653 W

Congress Pkwy, Chicago, IL 60612, USA 9University of Chicago, 5801 S Ellis Ave.,

Chicago, IL 60637, USA 10John H Stroger Jr Hospital of Cook

County, 1901 W Harrison St Chicago,

IL 60612, USA 11University of Illinois Hospital & Health

Sciences System, 1740 W Taylor St

Chicago, IL 60612, USA

*Author for correspondence:

[email protected]

For reprint orders, please contact: [email protected]

18 J. Comp. Eff. Res. (2016) 5(1) future science group

Research Article Erwin, Martin, Flippin et al.

report of methods and outcomes of end-user engage-ment to develop an asthma discharge tool tailored to high-risk children for a comparative effectiveness trial. We are now testing the effectiveness of the asthma dis-charge tool on implementation and clinical outcomes in the multicenter CHICAGO pragmatic clinical trial (ClinicalTrials.gov NCT02319967) [9].

MethodsWe engaged four stakeholder groups: caregivers of minority children with a history of uncontrolled asthma presenting to the ED in the past 12 months; ED physicians and nurses; ED administrators; and outpatient clinicians. Stakeholders from six EDs in Chicago that would serve as the centers for the clinical trial (CHICAGO ED clinical centers) were engaged in a three-phase process that employed vari-ous methods of contextual inquiry (Figure 1): define design requirements with multistakeholder user input; prototype and refine to shape a discharge tool that

fits the content and support needs of all key stake-holders; and evaluate end-user stakeholder prefer-ences for the new and existing discharge tools. The study was approved by institutional review boards (IRBs) at all participating institutions, IRB #2014-0412, 2014-056, 2014-15829, MSH #14-10, 14-0534, 14-095 and 13083001-IRB01 at the University of Illinois at Chicago (IL, USA), Illinois Institute of Technology (IL, USA), Lurie Children’s Hospital (IL, USA), Mount Sinai Hospital (IL, USA), University of Chicago Medicine (IL, USA), Cook County Hospital (IL, USA) and Rush University Medical Center (IL, USA), respectively.

A convenience sample of physician and nonphysician clinicians and administrators from each of the partici-pating six ED clinical centers participated as key infor-mants. Key informants were selected to be representa-tive of their clinical center in their ability to speak to the processes and materials involved in discharge from the ED and as active end-users on the clinical side.

Figure 1. We employed a three-phase design process to develop a stakeholder-balanced asthma discharge tool. Stakeholders included patient caregivers, emergency department clinicians (physicians, nurses, administrators) and ambulatory (outpatient) physicians. A highlight of findings from each stage is also presented. ED: Emergency department.

Contextual stakeholderinterviewsUse of prototypes and toolkitswith stakeholders to draw outdesign requirements

28 total stakeholders

Results Discharge tool requirements Final discharge tool Strong multi-stakeholderpreference for the finaldischarge tool

9 total stakeholders

Illustration-driven formatand medication-optimizedinstruction

Vocabulary clarity

Page count and focus

Visual presentation and format

Medication instruction

Conversation support

participant’s recruitment site; all participantsrecruited from one of six participatingChicago-based EDs

=

20 total stakeholders 57 total

20 total

15 total

11 total

6 total

5 total

Iterative prototyping and testingusing stakeholder reviews

Patientcaregivers

ED doctors

ED nurses

ED admins

Outpatientproviders

Gibson survey to assess purpose,appearance, content, usefulnessand overall impact

Card sort activity to elicitqualitative responses

Methods

Phase 1 Phase 2 Phase 3

Define requirements Prototype + refine Evaluate

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www.futuremedicine.com 19

Figure 2. Sample projectives used with stakeholders in Phase I (from left to right): a caregiver-drawn asthma journey map; a physician-annotated prototype discharge tool; three sample discharge tools built by outpatient providers from a toolkit of preprinted sticky notes.

future science group

Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma Research Article

Similarly, a convenience sample of caregivers of black or Hispanic/Latino children who had visited at least one of the six ED clinical centers in the past 12 months participated in focus groups, user-centered home observations or both. Previous studies have established the critical role of triggers in the home environment and inadequate asthma controller use as risk factors for asthma exacerbations and emergency department visits in children with asthma. Thus, the asthma discharge tool included a focus on both environmental control and appropriate use of asthma medications [10–14].

Phase I: define design requirementsData collection in Phase I employed a user-centered design approach that combines field interviews con-ducted onsite in a user’s home or workplace with direct observation of users engaged in relevant tasks. These methods come from the field of design, which are not typically used in qualitative health research. The pri-mary difference is that design employs a contextual approach that focuses on context of use – not just a tool or its content – and conducts the inquiry using user-centered observations. [15]. Central to contextual inquiry is the belief that human actions can only prop-erly be understood in context, and that all activity is informed by immediate circumstances and therefore is best observed ‘in the wild’ rather than in a lab or through recounting past events with others in focus groups [16]. We, therefore, conducted all inquiry in clinical settings in the ED and ambulatory sites, and in the homes of caregivers. We also employed projectives, which in this study were prototype discharge docu-ments, toolkits from which physicians could construct their own discharge document and probes consisting of stakeholder-drawn visualizations of relevant past and present experiences of asthma management and ED experiences (Figure 2).

We conducted 19 key informant stakeholder interviews with physicians, nurses and administrators from the ED,

and outpatient clinicians. All interviews were conducted in the ED or ambulatory setting for 60–80 min. Two interviewers were present, and interviews were audio-recorded and photographed. The key informant protocol covered three domains: ED patient discharge experience using open-ended questions, discharge simulations and role play to target challenges and barriers in preparing a patient/caregiver for discharge; asthma treatment rec-ommendations on ED discharge, including barriers to implementing these components in their ED or practice; and prototype discharge tool review to elicit feedback about preferred discharge instructions.

We also conducted interviews with caregivers of African–American and Latino children with a his-tory of an ED visit for uncontrolled asthma in the past 12 months in one or more of the CHICAGO ED clinical centers. Eight of the caregivers were Afri-can–American and one was Latino, seven were single mothers, seven had other children and seven had other family members diagnosed with asthma. All interviews were conducted in the home and ranged from 2 to 3 h. They were audio-recorded and transcribed. A digital camera was used to document the home environment and location of relevant artifacts, such as storage of medications and discharge documents. Interviews tar-geted baseline asthma knowledge, self-management practices and recent ED discharge experience across four touchpoints – waiting, triage, treatment and dis-charge. The approach consisted of open-ended ques-tions, review of a prototype discharge document and use of multiple probes and activities to help caregivers express asthma care experiences.

All interview data were coded and analyzed using principles of Grounded Theory to identify recurring patterns of beliefs, interactions, behaviors and needs across stakeholder groups and clustered into design requirements and opportunity areas for concept devel-opment [17,18]. Analysts worked in pairs to ensure intercoder reliability (S Norell, J Rivera and T Flippin).



Phase II: prototype & refineA total of 9 caregivers, ED clinicians (physicians and nurses) and ED administrators were engaged in two iterations of assessment and refinement to converge on a single discharge tool that incorporated health literacy and information design principles (maximum Flesch–Kincaid 6th reading grade level; reduced word count, sentence length, text blocks and medical jargon; consistent use of typographic hierarchy and underlying grid; and key information presented in illustration and callouts) [19–24]. We also evaluated the Flesch–Kincaid reading level of existing discharge documents at the CHICAGO ED clinical centers. The CHICAGO investigators (clinicians, social scientists, community health workers and supervisors) then collaborated in providing feedback to the design team to finalize an asthma discharge tool for use in children presenting to the ED with uncontrolled asthma.

Phase III: evaluate stakeholder preferencesWe then assessed preferences among caregivers and ED clinicians by comparing the documents currently in use in two different CHICAGO ED clinical centers with the newly developed tool. We employed a published quantitative assessment tool (Gibson survey) that evalu-ates five domains (purpose, appearance, usefulness, overall impact and for clinicians, content) developed for patients/caregivers (15 items) and clinicians (30 items) [25]. Participants were asked to respond using a five-point Likert scale (strongly disagree to strongly agree); possible scores are 1–5, with higher scores indi-cating greater preference. To understand the rationale for preferences among caregivers and clinicians, we also employed qualitative methods using a card sorting activ-ity. Card sorting works to surface mental models and evaluate participant agreement by providing a stack of cards containing phrases or words and asking each par-ticipant to sort the cards into categories, as makes sense to them [26,27]. A total of 11 cards were presented to cli-nicians, with another 11 to caregivers. All cards were crafted with first-person statements, such as “I think this document provides more guidance for my patients after discharge” and were structured to capture both partici-pant behaviors and attitudes. Responses were tabulated and assessed for patterns across and within stakeholder segments using data visualization software Nineteen [28].

ResultsPhase I: define design requirementsWe conducted 28 on-site stakeholder interviews with nine caregivers, six ED physicians, four ED nurses, four ED administrators and five outpatient clinicians (Figure 1). Analysis of contextual research data pro-duced eight themes for in-home asthma management

practices and three themes related to ED discharge experiences (Table 1).

Tools to share information, coordinate careCaregivers expressed the need for a discharge tool that facilitates communication, education and coordina-tion of care with others (babysitters, extended family, school, daycare and camp personnel) who share in the care of their children.

Discharge information stored out of sightCurrent discharge documents are often stored in bags, drawers and with stacks of bills, so are not easily available for reference if needed. No caregiv-ers had asthma-related information on display in the home.

Learning through trial & error causes gaps in understanding even in experienced caregiversThe sheer number of contributing factors can make the logic of asthma exacerbations hard to piece together. While our caregivers reported prioritiz-ing their children’s health – by moving, leaving their jobs, delaying promotions to be more available to care for their children, vigorous cleaning or keeping kids inside – interviews suggested their management strat-egies are often based on an incomplete understanding of asthma. The resulting failure of proactive efforts can promote reactive behavior (i.e., ED visits).

Medication workaroundsMedication adherence is tough even for informed care-givers. Inhalers run out, causing families to share or to substitute reliever medicine. Because childcare usually occurs outside the home, shared inhalers must travel to multiple sites and return home without getting lost.

Medication confusionMany caregivers and outpatient clinicians reported confusion between reliever and controller inhalers. Caregivers also expressed distrust of continuous steroid use and potential side effects on their growing child, affecting their commitment to prescribed regimens.

Patient education positioned at the weakest momentDischarge protocols position patient education at the moment when patient caregivers are least prepared to take advantage of it – in the last 20 min of a typically 3–6 h (or longer) ED visit. Several nurses expressed frustration with caregivers’ unwillingness or inability to focus on patient education at discharge. Caregiv-ers also reported frustration related to lengthy dis-charge processes, repetition of information they say

www.futuremedicine.com 21future science group

Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma Research ArticleTa

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ED: Emergency department.



they already know, and the need to manage work, other children and household obligations reduces receptivity to education at discharge.

Fragmented discharge experienceOperational realities can produce an ED discharge experience that is executed piecemeal and by multiple staff members. For example, sometimes the attending physician delivers medication instruction, a resident attempts patient education and a nurse prints and delivers paperwork. This workflow may change based on the number of patients waiting to be seen or acuity of illness among patients in the ED – the pressure to ‘treat and street’ was noted as a driver of practice vari-ation. Clinical staff reported that continuity and pre-dictability in discharge is difficult to provide using hand-offs, especially in EDs where poor site lines can limit communication between staff.

Clinician/caregiver conversations not well-supported by existing toolsCaregivers often receive large amounts of information at an ED visit. Clinic staff across sites reported numer-ous challenges in communicating that information to caregivers in the ED. Many staff said they do not review discharge documents with patients, as time is tight and documents are long, complicated and hard to use with caregivers.

Stakeholder input regarding the design of the dis-charge tool identified several design priorities for the discharge tool (Table 2).

Vocabulary clarity + reading levelReduce complexity and simplify language to include children, more caregivers and others outside the family.

Page count & focusRemove extraneous content and streamline to focus on caregiver action steps.

Visual presentation & formatUse illustrations and layout to make key ideas acces-sible and inclusive, while retaining a professional and serious appearance.

Medication instructionOrganize, clarify and detail all medication-related instruction so as to create a plan that caregivers can understand and follow.

Conversation supportSimplify and structure the protocol for clinicians, support discussion of sensitive topics and make a tool caregivers can use with others.Th

emes

Det

ails

Qu

ote

s

7. F

rag

men

ted

dis

char

ge

pro

cess

‘T

reat

an

d s

tree

t’

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char

ge

dis

trib

ute

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cro

ss s

taff

St

aff

han

d-o

ff a

llow

s in

form

atio

n

to s

lip t

hro

ug

h t

he

crac

ks

“No

rmal

ly, t

he

nu

rse

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co

me

bac

k…w

ith

th

e p

resc

rip

tio

ns

and

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rth

er in

stru

ctio

ns.

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st t

he

do

cto

r al

way

s co

mes

in a

nd

say

s w

hat

ever

, th

en t

he

nu

rse

is t

he

on

e w

ho

co

mes

bac

k an

d g

ives

yo

u y

ou

r d

isch

arg

e” –

Car

egiv

er

”Mu

ltip

le p

rofe

ssio

nal

s co

uld

be

resp

on

sib

le f

or

(dis

char

ge

), y

ou

kn

ow

, so

wh

en m

ult

iple

peo

ple

co

uld

be

invo

lved

, if

each

of

tho

se p

eop

le is

med

iocr

e, y

ou

co

uld

get

dis

char

ged

wit

h p

aper

wo

rk

that

say

s n

oth

ing

” –

ED n

urs

e

8. C

linic

ian

, car

egiv

er

con

vers

atio

ns

no

t w

ell-

sup

po

rted

by

too

ls

Too

ls a

re d

ense

, tex

t-h

eavy

, har

d

to u

se

Co

nve

rsat

ion

is t

he

edu

cati

on

al

tou

chp

oin

t

“Mo

st o

f th

e ti

me

I do

no

t p

ay v

ery

mu

ch a

tten

tio

n t

o t

he

dis

char

ge

pap

er b

ecau

se it

off

ers

me

no

thin

g. I

can

no

t im

agin

e th

at it

off

ers

mu

ch t

o t

he

pat

ien

t” –

ED

nu

rse

”It

get

s to

be

15 p

ages

…yo

u h

and

th

is t

o t

hem

an

d t

hey

are

like

, ‘W

hat

is a

ll th

is s

tuff

?’ I

f th

ere

is s

om

eth

ing

imp

ort

ant,

I tr

y to

cir

cle

it”

– ED

ph

ysic

ian

”W

e d

o n

ot

hav

e g

oo

d e

du

cati

on

to

ols

, an

d e

very

thin

g f

alls

bac

k to

th

e n

urs

e at

th

e en

d o

f th

e lin

e” –

ED

nu

rse

”Th

e va

lue

in a

dis

char

ge

do

cum

ent…

is t

he

teac

hin

g t

hat

hap

pen

s w

hen

yo

u a

re g

ivin

g t

he

do

cum

ent.

Th

e d

ocu

men

t sh

ou

ld b

e a

teac

hin

g t

oo

l, n

ot

on

ly ‘

the

thin

g y

ou

rec

eive

” –

Ou

tpat

ien

t p

rovi

der


Tab

le 1

. Th

emes

fro

m c

on

text

ual

res

earc

h in

th

e h

om

e an

d e

mer

gen

cy d

epar

tmen

t si

tes

(co

nt.

).


Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma Research ArticleTa

ble

2. D

esig

n r

equ

irem

ents

.

Req

uir

emen

tsD

etai

lsQ

uo

tes

1. V

oca

bu

lary

cla

rity

+

read

ing

leve

l Si

mp

lify

lan

gu

age

and

sen

ten

ce

stru

ctu

re

Use

laym

an’s

ter

ms,

no

t m

edic

al

jarg

on

“A lo

t o

f o

ur

pat

ien

ts c

ann

ot

read

, an

d t

hei

r p

aren

ts c

ann

ot

read

, an

d t

hen

yo

u h

and

th

em a

n

asth

ma

acti

on

pla

n a

nd

do

th

e b

est

that

yo

u c

an”

– ED

do

cto

r ”I

n t

he

beg

inn

ing

, yo

u a

re n

ot

fam

iliar

wit

h t

he

med

ical

ter

ms,

so

yo

u k

ind

of

hav

e to

… e

xpla

in

it ju

st a

litt

le s

imp

ler”

– C

areg

iver

”I

see

th

ing

s th

at c

on

fuse

my

pat

ien

ts. F

or

exam

ple

, man

y d

o n

ot

kno

w w

hat

an

MD

I is,

so

cal

l it

som

eth

ing

th

at t

hey

are

go

ing

to

un

der

stan

d”–

ED

nu

rse

2. P

age

cou

nt

+ f

ocu

s

Red

uce

wo

rd c

ou

nt

Pro

mo

te a

ctio

n s

tep

s R

emo

ve e

xtra

neo

us

mat

eria

l

“Th

ere

are

so m

any

pag

es t

hat

no

bo

dy

loo

ks

at a

ny

of

them

…”

– ED

ph

ysic

ian

”T

he

pap

erw

ork

th

at E

Ds

giv

e n

ow

co

mes

fro

m t

he

EMR

, so

it is

fille

d w

ith

gre

at n

ug

get

s b

ut

ther

e is

to

tally

un

nec

essa

ry b

lath

er. W

hen

pat

ien

ts lo

ok

at it

, th

ey c

ann

ot

fin

d t

he

thin

gs

they

ac

tual

ly n

eed

” –

Ou

tpat

ien

t p

rovi

der

”T

hey

giv

e yo

u a

ll th

ese

shee

ts, a

nd

to

be

qu

ite

ho

nes

t, a

s a

par

ent,

just

tel

l me

wh

at is

go

ing

o

n. T

ell m

e w

hat

I n

eed

to

do

. I a

m n

ot

go

ing

to

tak

e ti

me

– al

tho

ug

h m

y so

n is

sic

k, d

o n

ot

get

m

e w

ron

g –

bu

t I a

m n

ot

taki

ng

tim

e to

rea

d t

hro

ug

h a

ll yo

ur

liter

atu

re. J

ust

get

to

th

e p

lan

of

acti

on

her

e” –

Car

egiv

er

3. V

isu

al p

rese

nta

tio

n +

fo

rmat

En

gag

e ki

ds

in c

are

Earn

a s

po

t o

n t

he

refr

iger

ato

r U

se v

isu

als

so a

s to

incl

ud

e ev

eryo

ne

Mak

e ea

sy t

o c

op

y an

d s

har

e

“I n

eed

to

exp

lain

to

him

ab

ou

t as

thm

a an

d t

he

tig

hte

nin

g o

f th

e ch

est

and

all

of

that

, bec

ause

h

e n

eed

s to

kn

ow

… s

o t

hat

on

e d

ay if

I am

no

t th

ere,

he

can

say

it h

imse

lf”

– C

areg

iver

”I

t h

as o

ne

thin

g t

o e

du

cate

car

egiv

ers,

wh

ich

is im

po

rtan

t, b

ut

in t

he

end

, it

has

go

t to

be

the

child

. Th

e ch

ild is

go

ing

to

kn

ow

wh

en h

e ca

nn

ot

bre

ath

e” –

ED

nu

rse

”I w

ou

ld d

efin

itel

y p

ut

som

eth

ing

(vi

sual

) o

n t

he

fro

nt

pag

e so

th

at t

he

kid

kn

ow

s ‘it

is m

ine”

–

ED

ad

min

nu

rse

”All

pat

ien

ts h

ave

dif

fere

nt

lear

nin

g s

tyle

s, r

igh

t? Y

ou

mig

ht

no

t b

e ab

le t

o a

sses

s th

at f

ully

in

an

em

erg

ency

en

cou

nte

r. B

ut

you

co

uld

hit

on

mu

ltip

le a

reas

. Fo

r ex

amp

le, u

se w

ritt

en

edu

cati

on

fro

m t

he

asth

ma

pla

n a

nd

vis

ual

cu

es t

hat

pat

ien

ts c

an id

enti

fy”

– O

utp

atie

nt

pro

vid

er

4. M

edic

atio

n

inst

ruct

ion

C

lear

ly o

rgan

ize

med

icat

ion

typ

es

Cla

rify

tim

ing

, du

rati

on

an

d

do

sag

es

Rei

nfo

rce

med

icat

ion

ad

her

ence

as

pri

ori

ty

“Th

e m

ean

s o

f ad

min

iste

rin

g m

edic

atio

ns,

ho

w t

o u

se t

hem

, wh

en t

o u

se t

hem

is v

ery

con

fusi

ng

. All

the

med

icat

ion

s h

ave

two

dif

fere

nt

nam

es. M

any

of

them

co

me

in m

ult

iple

d

iffe

ren

t fo

rms.

Th

ey m

ay b

e g

iven

tw

o d

iffe

ren

t as

thm

a p

um

ps,

an

d I

thin

k th

ey d

o n

ot

kno

w

the

dif

fere

nce

or

they

may

be

aske

d t

o u

se e

qu

ipm

ent

that

th

ey h

ave

no

fam

iliar

ity

wit

h, l

ike

a sp

acer

or

a n

ebu

lizer

mac

hin

e, o

r fo

r th

at m

atte

r ev

en b

e ex

po

sed

to

med

icat

ion

fo

rms

that

th

ey a

re n

ot

fam

iliar

wit

h”

– O

utp

atie

nt

pro

vid

er

5. C

on

vers

atio

n s

up

po

rt

Stan

dar

diz

e ke

y m

essa

ges

Si

mp

lify

dis

char

ge

con

vers

atio

n

Pro

vid

e a

shar

ed t

oo

l to

an

cho

r th

e co

nve

rsat

ion

H

elp

car

egiv

ers

par

tici

pat

e H

elp

car

egiv

ers

shar

e w

ith

oth

ers

in t

hei

r ca

re c

ircl

e

“Giv

e m

e th

e si

mp

lest

pro

toco

l I c

an r

emem

ber

wh

ile r

un

nin

g f

rom

ro

om

to

ro

om

”

– ED

ph

ysic

ian

”I

th

ink

the

nu

rses

th

emse

lves

do

no

t u

nd

erst

and

wh

at t

hey

nee

d t

o c

om

mu

nic

ate

to t

he

pat

ien

t, t

hin

kin

g t

hat

th

ey (

pat

ien

ts)

wo

uld

just

kn

ow

” –

ED a

dm

in n

urs

e

“I w

ou

ld s

ay m

ost

of

the

tim

e I t

alk

a lo

t an

d w

hen

I am

do

ne

I alw

ays

ask

if t

hey

hav

e g

ot

qu

esti

on

s an

d I

do

no

t g

et m

uch

” –

ED n

urs

e ”(

If t

hey

bri

ng

th

is d

ocu

men

t) I

wo

uld

kn

ow

th

at a

t le

ast

the

edu

cati

on

has

sta

rted

. It

wo

uld

h

elp

me

her

e, t

oo

, bec

ause

so

met

imes

man

y sh

ow

up

wit

ho

ut

any

pap

er w

ork

, an

d I

hav

e g

ot

15 m

in t

o fi

gu

re o

ut

wh

at h

app

ened

”– O

utp

atie

nt

pro

vid

er




Phase II: prototype & refineNine stakeholders participated in prototype reviews (three caregivers; three ED physicians; one ED nurse and two ED administrators, Figure 1). In these reviews, stakeholders were presented with three potential dis-charge tool concepts based on Phase I results and were asked to engage in two cycles of review and collabora-tive editing (Figures 2 & 3). Across stakeholder groups, highly-illustrated visual learning concepts earned the strongest favorable responses for its simplicity, clarity, visual appeal and ease of use. Literacy levels of patients and caregivers were a recurring topic in the formative research. Many ED physicians asked for solutions that used visual strategies to offset the complexity of text. ED nurses sought tools that could engage children directly in self-management. Caregivers also expressed confusion and impatience with materials that were hard to read, apply and share. In response, we custom-ized illustrations to explain key vocabulary and self-management concepts and employed the traffic light construct of green/yellow/red zones to aid caregiver assessment. The final CHICAGO asthma discharge tool, called the CAPE (CHICAGO Action Plan after ED discharge) (Figure 4), has a Flesch–Kincaid read-ing level of 4.7 (compared with existing documents in use across the CHICAGO ED clinical centers that had reading levels of 5.5–7.8). The final discharge tool is also designed to support simplified reading strategies by using multiple principles of information design, such as typographic hierarchy to create prior-ity and aid browsing, use of an underlying grid and white space to reduce visual complexity, reduced line length and text blocks to increase readability and the

option for printing or copying in black and white for low-cost distribution.

Phase III: evaluate stakeholder preferencesResults of the Gibson survey suggested caregiver and clinician preference for the new discharge tool across all categories (Figure 5). Qualitative assessments using the card sorting activity also demonstrated a preference for the new discharge tool (Figure 6). Among clinicians, the card sorting activity elicited strong emotional responses as they shared their frustrations over their current asthma action plans. There was full consen-sus for the new tool for four of eleven questions (items 3, 4, 6 and 10). Clinicians reported that they favored the new tool in part because of its clarity; one physi-cian observed that “for our patient population, this is awesome…it is not too dense, and it is not word over-loaded. This is very succinct. It is easy to understand.” Clinicians also indicated that the new tool could serve as a support for conversations and for teaching self-management. One clinician noted that the new tool was ‘more interactive, so as you go through it people will have a visual and can ask questions’, whereas when using the existing document ‘there is not as much to go through, step-wise, so its less likely that you are going to be able to point and continue a dialog based on what is in the document’.

Caregiver responses also demonstrated a preference for the new discharge tool (Figure 7). However, caregiver responses were strongest for the new tool when queried about behavioral items, such as “This document is more clear about which actions I should take after the Emer-gency Department” (item 3) or “I am more likely to

Figure 3. In Phase II, an early prototype was refined through iterative stakeholder input to develop a new discharge tool, CAPE (CHICAGO Action Plan after emergency department discharge). CHICAGO: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcome; QR: Quick response.

An early-stage prototype...

1. Digital resource focused A stakeholder balanced solution

Includes QR codes that linkto online asthma content tobetter accommodate differinglevels of caregiver expertise

Structured around four action steps

Illustration-driven format fromprototype 3 with supporting textat a reading grade level of 4.7(Flesch–Kincaid)

Also integrates stakeholderpreferred medication instructionfrom prototype 2 and a digitallink from prototype 1

Dedicates an entire page toclarifying inhaler types andmedication regimen

Uses illustration to representkey vocabulary and self-management conceptsto address low-literacypopulations and children

2. Medication optimized

3. Visual learning focused

Drafted collaboratively byCHICAGO Plan investigators;

Organizes content into four clearaction steps:

1. Take medication2. Follow-up with provider3. Recognize symptoms4. Stay on top of asthma (self-management instruction)

...informs three new prototypes ...refined into a finaldischarge tool



Figure 4. The new discharge tool, or CAPE (CHICAGO Action Plan after emergancy discharge), includes several key advances in design to improve communication of medications, symptom recognition and action steps, and trigger recognition and self-management. CHICAGO: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcome; QR: Quick response.

Overall format

Medication clarification

Trigger recognition +self-management tips

A ‘smart’ document

Symptom recognition +action steps

• Four simple steps to organize action, conversation• Written in second person to increase personal relevance• Strong typographic hierarchy and underlying grid to organize content;• Simplified language and reduced medical jargon (Flesch–Kincaid reading grade level of 4.7) • Illustrations average 50% of content and visual space

• Medication instruction broken down into clear steps• Illustrations of tools to clarify/teach unfamiliar terms• Checkboxes required so as to trigger discussion with caregiver• Colored stickers provided to distinguish inhalers

• Stoplight structure to organize action, signal the dangerous progression of asthma• Illustrations to diagnose child’s status;• Friendly style to engage kids• Call-outs to reinforce illustrations – brief and written in jargon-free language

• QR code (bottom) links smart phones to more online asthma resources• Step-by-step instruction to help caregivers understand proper inhaler technique• Simple language and illustration helps kids teach themselves and siblings

• Illustrations of triggers for clinicians to point at to aid conversation• Room fo caregivers – not just doctors – to write so as to promote caregiver role in asthma control• Home environment questions to prompt caregiver engagement• Tips and tricks to help start new self-management practices

2

GREEN ZONE

YELLOW ZONE

Call 911RED ZONE

How to use an inhaler with a spacerWorks as well as nebulizer!

Even if your child shows nosigns of breathing problems,keep using the “controller”medicine every day.

breathes easily

plays as usual

breathes fast whenstanding in place

Go play

Call doctor

Get help

If your child shows any ofthese signs, use “rescue”medicine right away, keepusing “controller” medicine,and call your doctor.

If your child has any of thesesigns, use “rescue” medicine,and go to the emergencyroom or call 911.

hard time saying a fullsentence without a breath

hard time walking

no coughing orwheezing

peak flow is atnormal level

sleeps soundly

coughs a lot at night

hurts to breathe deeply

hard to sleep becauseof breathing problems

breathing does not getbetter within 20 minutesof taking “rescue”medicine

breathing so hard thatthey are drowsy or sleepylips or fingernails aregrey or blue

breathing gets worsewithin 20 minutes oftaking “rescue” medicineribs show whenbreathing

hard time breathingwhen sitting in place

Take cap off the inhaler. Check forand remove any dust, lint, or otherobjects. Shake the inhaler well.

Put lips around device, press inhalerone time. This puts one puff of medicine into the spacer.

If your child needs to take anotherpuff of medicine, wait 1 minute. After one minute, repeat steps 3 to 6.

© 2015 CHICAGO Plan investigators + PCOR1The CHICAGO Plan is a PCOR1-fundedstudy comparing asthma interventions. Forquestions regarding this document or theCHICAGO Plan.contact: Trevonne Thompson, [email protected]

Breathe in deeply and slowly, andhold your breath.

Attach the inhaler to the spacer. Breathe out all the air, away fromthe spacer.

Remove the device from the mouth. Then hold your breath for 5 secs. Thenbreathe normally away from the spacer.

Rinsing is only necessary if the medicine you just took was an inhaled steroid. Haveyour child rinse his or her mouth out with water after the last puff of medicine. Makesure your child spits the water out. Do not allow the child to swallow the water. Recapthe inhaler.

See your child’s doctor within 3 days of your ER visit

From the American College of Chest PhysiciansIllustrations by Paula Falco

1st dose time/date

1st dose time/date

How often

How often

For how long

It is very important you complete the dosage

After that, use ONLY when symptoms occur

Take every day EVEN IF no visibile symptoms

Number of puffs

Number of puffs

Things to know:

Things to know:

Things to know:

Mark your medsat the pharmacy:

Mark your medsat the pharmacy:

• is another powerful “rescue” medicine

• if you were given these in the emergency room, it is very important that

you finish them!

Doctor’s name

What are your child’s triggers?

What might be useful tricks?set an alert on your smartphonekeep medicine by your coffee pot

Clinic telephone number Your appointment date and time

Call your child’s regular doctor as soon as possible to helpyou understand your child’s asthma and home treatment plan.

Build a trigger list of what seems to make your child’s asthmaact up. Add to that list as you notice new triggers. Try to helpyour child avoid these!

If your child has a cold, use your child’s action plan; and helpthem to blow their nose.

Avoid smoking—a known asthma trigger—and avoid havingyour child in a house where someone smokes.

Here are some examples of common asthma triggers:

Review how to use the inhalers with your child’s doctor.

Develop tricks to help remind you to give the medications.

Your child’s doctor is there to help—they want to see how wellyour child is doing and to review your child’s symptom control.

Together you and your doctor will discuss a new AsthmaHome Plan, with instructions for when your child’s asthma isunder control and when it is not well-controlled.

• should be used only if your child is having symptoms during an asthma attack/ with symptoms

• is typically albuterol with a name like: Proventil, Pro-Air, Ventolin, Xopenex

Child’s name

Today’s date

Doctor’s signature Date

Other:

Your “controller”medicine is:

Your “rescue”medicine is:

red sticker for“rescue”medicine

green sticker for“controller”medicine

What is this? This is a QR code. To use it, go to the app store on yoursmartphone, search for ‘QR code readers’ and download the free app.

To learn more about asthma, scan this code with the app to go directlyto the Respiratory Health Association website. Or go to the link below:

www.tinyurl.com/asthmalib

Inhaler Spacer

Mask Nebulizer

3 Read the signs 4 Stay on top of asthma

1 Take your asthma medicine

Pills Liquid

1st dose time/date

How muchHow often

For how long

Your oralsteroid is:

Asthma discharge plan

Don’t wait! Callwith questions

Identify yourchild’s asthmatriggers

Givemedicationsas prescribed

Take your childto the doctorregularly

Inhaler Spacer

Mask Nebulizer

Illustrations by P

aula Falco

• Should be used only if yourchild is having symptomsduring an asthma attack/

with symptoms

• examples include Pulmicort, Flovent, Azmacort, Advair

• may be allergy medication, such as Singulair and Associate



hang this up in my home” (item 4) or “I would prefer to receive this document in the emergency room” (item 5). Overall document preference was more equivocal when statements raised issues that could be interpreted as relating to their competency, such as “This document is harder to read” or “This document is more confusing.” The research team also encountered differences in lan-guage use, with one participant, for example, selecting the new tool as ‘more overwhelming’, as in overwhelm-ingly good. Such responses raise important issues about the wording of questions to fit target populations.

DiscussionIn this report, we presented the methods and outcomes of a three-phase process that employed various methods of contextual inquiry in the design of CAPE, a novel stakeholder-balanced asthma action plan for high-risk African–American and Latino children with uncon-trolled asthma for use on ED discharge. Several aspects of CAPE are noteworthy, including the use of a design that maximizes visual learning and individualization. More important than the final tool, however, is the process employed to create it. The formative process presented here demonstrates a new multistakeholder driven meth-odology to inform the development of interventions suit-able for comparative effectiveness research. This method

is novel because it shifts the design process from one that relies exclusively on teams of medical experts who focus on content to multidisciplinary teams with exper-tise in uncovering the context of use to inform content requirements, which may also help to overcome barriers to implementation in real-world clinical and nonclini-cal settings. Contextual inquiry differs from standard qualitative inquiry because it is designed to immerse the investigator in the everyday practices of the informant, rather than asking the informant to recall their experi-ences, as standard interview or focus group methods do. With informants and investigators both working in situ, informants reveal with their behavior what they often fail to recall when asked, and investigators build firsthand experience with how informants engage in the activity being studied. For the CAPE, as an example, contextual inquiry revealed that complex conversations between stakeholders were taking place unsupported by existing materials. Designing for conversation guided content development and format. We are now testing the effec-tiveness of the asthma discharge tool on implementation and clinical outcomes in the multicenter PCORI-funded CHICAGO comparative effectiveness trial.

Comparative effectiveness research is intended to be a response to the expressed needs of end-users about which interventions are most effective for patients

Figure 5. Using the Gibson survey,clinicians and caregivers report higher levels of preference for the new discharge tool, CAPE (CHICAGO Action Plan after ED discharge), compared with existing documents. CHICAGO: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcome.

Gibson survey results

Overall

1

4.8

3.1

2.3

4.4

3.2

4.6

4.7

3.4

2 3 4 5 1 2 3

3.9

4

4.8

4.7

4.6

3.5

3.8

5

Appearance

Usefulness

Content

Clinician document scores(nurses and physicians; n = 12)

Caregiver document scores(n = 8)

Average scores per categoryHighest possible score = 5

CHICAGO discharge tool

Existing discharge tool



under specific circumstances [1]. To our knowledge, this is the first report to engage end-users in contextual inquiry in designing asthma action tools for children, their caregivers and clinicians providing medical care

in EDs. Contextual inquiry is an important addition to comparative effectiveness research because it creates a new form of evidence. By locating the research team in the context of use, data is collected not just about

Figure 6. The card sorting activitysupports findings from the Gibson survey, indicating greater clinician preference for the new discharge tool, CAPE (CHICAGO Action Plan after emergency department discharge). CHICAGO: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcome.

1. I feel more confident using this document

Physician responses(max = 6)2. I think this document is more likely to facilitate

constructive conversations between EmergencyDepartment clinicians and caregivers

3. I would prefer to use this document with mypatients

4. I would rather use the visuals in this document tocommunicate essential information to my patients

in the emergency department

5. I think this document is more respectful of mytime with my patient

6. I think this document provides more guidance formy patients after discharge

7. I think this document is more accessible forcaregivers with low reading levels

8. I think this document is more effective in helpingmy patients understand their medications

9. I think this document represents a morestandardized protocol for care

10. I think this document will have greater impacton my patient’s health

11. I feel this is a more serious medical document

1 2 3 4 5 6

Nurse responses(max = 6)

Card sorting scores: cliniciansAggregated clinician responses (n = 12)

Document A (CHICAGO discharge tool)

Document B (existing tool)

Both documents

Neither document



patient practices, but how those practices are shaped by interactions with others, how practices become embed-ded (or not) in everyday activities and responsibilities and how practices are negotiated against the inevitable disruptors of everyday life that compete for patients’ time and attention. This evidence is especially produc-tive when seeking to tailor interventions to populations and circumstances for better uptake and adherence. Additionally, contextual inquiry is equally productive when applied to ED clinical staff, who report struggling

with tools and protocols that do not seem designed to fit the complex operational realities of the ED and its many users. Indeed, results of quantitative and qualita-tive assessments suggest substantial preference among clinical staff for the new tool’s ease of use and fit with desired caregiver conversations, compared with existing tools used in the ED.

By design, our new discharge tool shifts the commu-nication paradigm in the ED from delivery of informa-tion (from expert to novice) to supporting collaborative

Figure 7. The card sorting activitysupports findings from the Gibson survey,indicating greater caregiver preference for the new discharge tool. CHICAGO: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcome

1. I think that with this document, my family wouldvisit the emergency department less

2. This document is easier to read

3. This document is more clear about which action Ishould take first after the emergency department

Negative assessmentstatements; lowerscores are better

Card sorting scores: caregiversAggregated caregiver responses (n = 8)

Responses

Positive assessmentstatements; higherscores are better

4. I am more likely to hang this document up inmy home

5. If I was in the emergency room with my child,I would prefer to receive this document

6. This document is more approachable

7. This document is more organized

8. This document is more worthy of my time

9. This document is better for my family

10. This document is more overwhelming

11. This document is more confusing

Document A (CHICAGO discharge tool)

Document B (existing tool)

Both documents

Neither document

1 2 3 4 5 6 7 8



conversation (between equally engaged stakeholders). This is an important shift because it institutional-izes what some clinicians in this study have already acknowledged: that communication is more effective when built with caregivers through an exchange of information in the moment than ‘delivered’ to them in a monologue or handout. The new discharge tool was noted by clinical staff as a tool that ‘at least starts the conversation’, ‘opens up the conversation better’ and ‘is more interactive as you go through it with people’. Shifting to a collaborative model in the ED also creates new conditions that encourage caregivers to see them-selves as partners in asthma control. Current ED expe-riences contribute to caregiver belief that an asthma attack is an event best fixed by a doctor in an ED; a collaborative approach can stress asthma as a chronic condition best managed by caregivers at home.

While our project offers multiple strengths, our approach to engagement was limited to address-ing the needs of elementary school-age high-risk African–American and Latino children with uncon-trolled asthma presenting to the ED. This focus was deliberately given the goals of our PCORI-funded CHICAGO comparative effectiveness trial. However, the discharge tool may not be sufficiently optimized for other populations (e.g., preschoolers, adolescents, adults). While we did include physicians and nurses, our engagement process did not include other clini-cians who provide care to children with uncontrolled asthma (e.g., respiratory therapists, social work-ers, pharmacists). Moreover, most of our children and their caregivers were low income and African–American. The methods employed in this project offer a template for future work that could address the needs of other end-user populations, including those with other conditions (e.g., diabetes, hypertension, sickle cell disease).

ConclusionWe present the application of contextual inquiry of end-user stakeholders to design a novel ED-based asthma action plan (CAPE) for a comparative effectiveness trial

in asthma. We speculate that engaging multiple stake-holders in the design of a discharge tool ‘fit for purpose’ offers a promising approach for improving asthma self-management skills and improving asthma outcomes in African–American and Latino children presenting to the ED for uncontrolled asthma. Our on-going PCORI-funded CHICAGO comparative effectiveness trial will evaluate the effects of employing CAPE (vs usual care) in the ED on implementation and clinical outcomes.

AcknowledgementsThe authors gratefully acknowledge the help of T MacTav-

ish, IIT Institute of Design; JT Senko, JH Stroger, Jr Hospital of

Cook County; CJ Lohff, Chicago Department of Public Health;

ZE Pittsenbarger, Ann and Robert H Lurie Children’s Hospital

of Chicago; J E Kramer, Rush University Medical Center; H

Margellos-Anast, LS Zun, Mount Sinai Hospital; SM Paik and

J Solway, University of Chicago; ML Berbaum, N Bracken, and

HA Gussin, for their role in the development of the CHICAGO

comparative effectiveness trial. The authors thank L Sanker for

her help in the development and conduct of focus groups. The

authors also thank the families and the staff in the CHICAGO

ED clinical centers and partner organizations who contributed

their time to make this study possible.

Financial & competing interests disclosureThe study was sponsored by the Patient-Centered Outcomes

Research Institute (contract #AS-1307-05420). The authors

have no other relevant affiliations or financial involvement

with any organization or entity with a financial interest in or fi-

nancial conflict with the subject matter or materials discussed

in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this

manuscript.

Ethical conduct of researchThe authors state that they have obtained appropriate institu-

tional review board approval or have followed the principles

outlined in the Declaration of Helsinki for all human or animal

experimental investigations. In addition, for investigations in-

volving human subjects, informed consent has been obtained

from the participants involved.

Executive summary

Designing interventions to improve communication in comparative effectiveness research• Multistakeholder driven design methods of contextual inquiry can be successfully employed to inform the

development of interventions for comparative effectiveness research.• Our approach shifted the design process from one that relies exclusively on teams of medical experts who

focus on content to multidisciplinary teams with expertise in uncovering the context of use to inform content requirements, which may also help to overcome barriers to implementation in real-world clinical and nonclinical settings.

• The new discharge tool or CAPE (CHICAGO Action Plan after emergency department discharge) shifts the communicationparadigm in the emergency department from delivery of information (from expert to novice) to supporting collaborative conversation (between equally-engaged stakeholders).



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