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Interventions for Individuals with LowHealth Literacy: A Systematic ReviewStacey L. Sheridan a , David J. Halpern b , Anthony J. Viera c , NancyD. Berkman d , Katrina E. Donahue c & Karen Crotty ea Department of Medicine , University of North Carolina at ChapelHill , Chapel Hill, North Carolina, USAb Department of Medicine , Duke University , Durham, NorthCarolina, USAc Department of Family Medicine , University of North Carolina atChapel Hill , Chapel Hill, North Carolina, USAd Program on Healthcare Quality and Outcomes, RTI International,Research Triangle Park , North Carolina, USAe Contractor , RTI International , Research Triangle Park, NorthCarolina, USAPublished online: 27 Sep 2011.

To cite this article: Stacey L. Sheridan , David J. Halpern , Anthony J. Viera , Nancy D. Berkman ,Katrina E. Donahue & Karen Crotty (2011) Interventions for Individuals with Low Health Literacy: ASystematic Review, Journal of Health Communication: International Perspectives, 16:sup3, 30-54, DOI:10.1080/10810730.2011.604391

To link to this article: http://dx.doi.org/10.1080/10810730.2011.604391

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Articles

Interventions for Individuals with Low HealthLiteracy: A Systematic Review

STACEY L. SHERIDAN

Department of Medicine, University of North Carolina at Chapel Hill,Chapel Hill, North Carolina, USA

DAVID J. HALPERN

Department of Medicine, Duke University, Durham,North Carolina, USA

ANTHONY J. VIERA

Department of Family Medicine, University of North Carolina at ChapelHill, Chapel Hill, North Carolina, USA

NANCY D. BERKMAN

Program on Healthcare Quality and Outcomes, RTI International,Research Triangle Park, North Carolina, USA

KATRINA E. DONAHUE

Department of Family Medicine, University of North Carolina at ChapelHill, Chapel Hill, North Carolina, USA

KAREN CROTTY

Contractor, RTI International, Research Triangle Park,North Carolina, USA

The U.S. Department of Health and Human Services recently called for action onhealth literacy. An important first step is defining the current state of the literatureabout interventions designed to mitigate the effects of low health literacy. We per-formed an updated systematic review examining the effects of interventions thatauthors reported were specifically designed to mitigate the effects of low health

The authors of this report are responsible for its content. Statements in the report shouldnot be construed as endorsement by the Agency for Healthcare Research and Quality or theU.S. Department of Health and Human Services.

Address correspondence to Stacey L. Sheridan, Department of Medicine, University ofNorth Carolina at Chapel Hill, 5039 Old Clinic Bldg, CB 7110, Chapel Hill, NC 27599,USA. E-mail: sls593@med.unc.edu

Journal of Health Communication, 16:30–54, 2011Copyright # Taylor & Francis Group, LLCISSN: 1081-0730 print=1087-0415 onlineDOI: 10.1080/10810730.2011.604391

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literacy. We searched MEDLINE1, The Cumulative Index to Nursing and AlliedHealth Literature (CINAHL), PsycINFO, Educational Resources InformationCenter (ERIC), and the Cochrane Library databases (2003 forward for health lit-eracy; 1966 forward for numeracy). Two reviewers independently reviewed titles,abstracts, and full-text articles for inclusion and included studies that examined out-comes by health literacy level and met other pre-specified criteria. One reviewerabstracted article information into evidence tables; a second checked accuracy.Two reviewers independently rated study quality using predefined criteria. Among38 included studies, we found multiple discrete design features that improved com-prehension in one or a few studies (e.g., presenting essential information by itselfor first, presenting information so that the higher number is better, adding iconarrays to numerical information, adding video to verbal narratives). In a few studies,we also found consistent, direct, fair or good-quality evidence that intensiveself-management interventions reduced emergency department visits and hospitaliza-tions; and intensive self- and disease-management interventions reduced diseaseseverity. Evidence for the effects of interventions on other outcomes was eitherlimited or mixed. Multiple interventions show promise for mitigating the effects oflow health literacy and could be considered for use in clinical practice.

Health literacy is ‘‘the degree to which individuals can obtain, process, and under-stand the basic health information and services they need to make appropriate healthdecisions’’ (Institute of Medicine, 2004; Ratzan & Parker, 2000; U.S. Department ofHealth and Human Services, 2000) and function effectively in the health careenvironment. It represents a constellation of skills including the ability to interpretdocuments and read and write prose (print literacy), use quantitative information(numeracy), and speak and listen effectively (oral literacy) (Institute of Medicine,2004).

Low health literacy is a significant problem in the United States, affecting 36%of adults (Kutner, Greenberg, Jin, & Paulsen, 2006). Furthermore, low health liter-acy has been linked to poorer health outcomes (DeWalt, Berkman, Sheridan, Lohr,& Pignone, 2004).

Given the enormous burden of low health literacy and the potential to reducepoor outcomes with intervention, the U.S. Department of Health and HumanServices recently released a national action plan on health literacy (National ActionPlan to Improve Health Literacy, 2010). This action plan calls for increased research,development, implementation, and evaluation of interventions to improve health lit-eracy. An important step in this process is defining the current state of the literature.

In this paper, we report the results of a systematic evidence review that evaluatesthe effectiveness of interventions designed to mitigate the effects of low health liter-acy through either single or multiple literacy-directed strategies. This reviewwas commissioned by the Agency for Healthcare Research and Quality (AHRQ)as part of a larger report to determine the effects of health literacy and healthliteracy-directed interventions on health-relevant outcomes. It updates a review thatwe conducted in 2004 (Berkman et al., 2004).

Methods

We developed and followed a standard protocol for this systematic review, seekingguidance from a technical expert panel with expertise in health literacy. A technicalreport providing a detailed description of our methods and full results is available at:http://www.ahrq.gov/clinic/tp/lituptp.htm

Interventions for Low Health Literacy 31

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Key Questions

The key questions we answer in this paper are: for those with low health literacy,what are effective interventions to

. improve use of health care services,

. improve health outcomes,

. affect the costs of care, and

. reduce disparities in health care service use and=or health outcomes amongdifferent racial, ethnic, cultural, or age groups?

Data Sources and Selection

We searched MEDLINE1, the Cumulative Index to Nursing and Allied HealthLiterature (CINAHL), the Cochrane Library, PsycINFO, and the EducationalResources Information Center (ERIC) to identify articles on interventions thatauthors reported were specifically designed to mitigate the effects of low healthliteracy and=or numeracy. For health literacy, we searched from 2003 to May 25,2010 (thereby updating our prior review). For numeracy, we searched from 1966to May 25, 2010 (because numeracy was not originally addressed). For this paper,we updated our searches from May 2010 through February 22, 2011 in order tobe current with the most recent literature. Because no medical subject headings(MeSH) specifically identify health literacy-related articles, we conducted key wordsearches (using the terms health literacy, numeracy, literacy, and terms or phrasesrelated to instruments known to measure these). We also manually searchedreference lists of review articles for additional studies.

We used standard Evidence-based Practice Center methods of dual review todetermine article inclusion (Berkman et al., 2011). Inclusion criteria are shown inTable 1.

Data Extraction and Quality Assessment

After determining article inclusion, one reviewer entered data about studies intoevidence tables and a second checked information for accuracy.

Two reviewers independently rated the quality of studies (good, fair, or poor)using standard predefined criteria (Berkman et al., 2011) that assessed selection bias,measurement bias, confounding, and inadequate power. Reviewers resolved alldisagreements by consensus and excluded poor-quality studies from analysis.

Data Synthesis and Analysis

We synthesized data qualitatively, dividing studies into those that used one specificliteracy-directed strategy and those that used multiple strategies. We did not have asufficient number of studies with similar outcomes or interventions to considermeta-analysis. To aid interpretation of findings, we emailed study authors to obtainadditional details about studied interventions.

Role of the Funding Source

AHRQ commissioned this review, but did not participate in the systematic review orpreparation of the manuscript.

32 S. L. Sheridan et al.

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Results

Our search results are shown in Figure 1. After excluding studies that did not meetour inclusion criteria, including those that were relevant but of poor quality(Bickmore, Pfeifer, & Paasche-Orlow, 2009; Carbone, Lennon, Torres, & Rosal,

Table 1. Inclusion criteria for review

Inclusion category Inclusion criteria

Study population All races, ethnicities, and cultural groups.All ages.Primary language is the same as that of the interventionmaterial.

Health literacy, numeracy, or oral health literacy levels ofindividuals are quantitatively measured and reported.

Health Outcomes Includes a health-related outcome of interesta:. Use of health care services

� Preventive services use� Receipt of recommended treatment� Office visits� Emergency department visits� Hospitalizations

. Health outcomes� Knowledge=comprehension� Accuracy of risk perception� Self-efficacy� Health-related skills (i.e., seeking info, taking meds,

self-monitoring, accessing care)� Intent for behavior� Behavior� Adherence to meds=behavior� Disease severity (i.e., biomarkers, symptoms)� Quality of life� Death

. Costs

. Disparities by age, race, ethnicity, or cultureIntervention Interventions that authors report are designed specifically to

mitigate the effects of low health literacy.Uses single or multiple literacy-directed strategies.

Study Design Experimental study design.Analyses Stratify results by health literacy levels of participants.b

Publication Status English only. Articles in print in peer reviewed journal.

aWe defined outcomes of interest using a logic model based on several models of health lit-eracy and an integrated model of behavioral theory (Fishbein, 2000; Paasche-Orlow & Wolf,2007).

bIn contrast to our full AHRQ report, the analysis for this paper also excludes articles thatdo not stratify results by health literacy (because these studies provide only indirect evidence ofthe intervention effect for those with low literacy).

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2006; Cordasco et al., 2009; DeWalt, Pignone, et al., 2004; Garcia-Retamano &Galesic, 2010; Gazmararian et al., 2010; Kalichman, Cherry, & Cain, 2005; Kandulaet al., 2009; Ntiri & Stewart, 2009; van Servellen et al., 2003, 2005), we included 42

Figure 1. Study flow diagram. Abbreviations: cRCT, cluster randomized controlled trial;RCT, randomized controlled trial.

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studies in our AHRQ review. In this article, we focus on the 26 studies from ourAHRQ review that report results stratified by literacy level and thereby providethe most direct evidence for our key questions (Bryant et al., 2009; Campbell,Goldman, Boccia, & Skinner, 2004; DeWalt et al., 2006; Ferreira et al., 2005;Galesic, Garcia-Retamero, & Gigerenzer, 2009; Galesic, Gigerenzer, & Straubinger,2009; Garcia-Retamero & Galesic, 2009; Gerber et al., 2005; Greene & Peters, 2009;Greene, Peters, Mertz, & Hibbard, 2008; Jay et al., 2009; Kim, Love, Quistberg, &Shea, 2004; Kripalani, Bengtzen, Henderson, & Jacobson, 2008; Paasche-Orlowet al., 2005; Peters, Dieckmann, Dixon, Hibbard, & Mertz, 2007; Robinson, Calmes,& Bazargan, 2008; R. Rothman et al., 2004; R. L. Rothman et al., 2004; Rothmanet al., 2006; Sobel et al., 2009; Sudore et al., 2006; Volandes et al., 2009; Wallaceet al., 2009; Wright, Whitwell, Takeichi, Hankins, & Marteau, 2009; Yates & Pena,2006). We additionally synthesized these results with the results of 7 studies from our2004 AHRQ review (Davis et al., 1996; Davis et al., 1998; Davis, Holcombe, Berkel,Pramanik, & Divers, 1998; Meade, McKinney, & Barnas, 1994; Michielutte,Bahnson, Dignan, & Schroeder, 1992; Murphy, Chesson, Walker, Arnold, &Chesson, 2000; Wydra, 2001) and 5 studies from our February 2011 update thatare stratified by literacy level (Leroy & Miller, 2010; Ross, Ashford, Bleechington,Dark, & Erwin, 2010; Tait, Voepel-Lewis, Zigmund-Fisher, & Fagerlin, 2010;Wilson et al., 2010; Wolf et al., 2011).

Study Characteristics

Of 38 included studies, 22 were randomized controlled trials (RCTs), 1 acluster-randomized trial (cRCT), 5 non-randomized controlled trials (NRCTs) and10 quasi-experimental studies. All were of fair or good quality. Fourteen reportedon the effects of one specific strategy to mitigate the effects of low health literacy(see Table 2); 24 used a mixture of strategies combined into one intervention (seeTable 3). Thirty studies stratified results by health literacy and eight by numeracy.

Effects of Single-Strategy Interventions on Health Care Service Use

No included studies examined the effects of single-strategy interventions on healthcare service use.

Effects of Single-Strategy Interventions on Health Outcomes

Fourteen studies focused on testing discrete design features that might improveoutcomes for individuals with low health literacy. These studies focused exclusivelyon the outcomes of comprehension, health-related skills, and behavioral intent.

Knowledge=ComprehensionTwo RCTs addressed the effects of alternative document design on comprehension(Greene et al., 2008; Peters, Dieckmann, Dixon, Hibbard, & Mertz, 2007). Oneexamined the effects of highlighting the common features of comparative infor-mation (Greene et al., 2008). In this study, presenting 13 features of health plans sideby side with common features first (rather than in random order) provided no bene-fit in comprehension in low- or high-literacy subgroups in unadjusted analyses.However, highlighting the two or four advantages and disadvantages of plans

Interventions for Low Health Literacy 35

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Table

2.Summary

ofstudiesusingsingle

strategyto

mitigate

theeffectsoflow

healthliteracy

Source

Design

(Sample

size)

Population

Healthliteracy

levels

Control

Intervention

Outcomes

Bryantet

al.,

2009

RCT

(232)

Patients

inurology

specialty

clinic

inUS

28%<highschool

onREALM

Standard

American

Urological

Association

BPH

Symptom

Score

(AUA-SS)

Multim

edia

AUA-SS

Comprehensiona

Galesic,

Gigerenzer,

etal.,2009

RCT

(162)

University

students

and

older

adultsin

Germany

Meanscore

9.7

on

12-ptnumeracy

scale

derived

from

Lipkus&

Schwartz

Conditional

probabilities

(%)

dem

onstrating

PPV

ofgenetic

testing

Naturalfrequencies

(x=10,000)

dem

onstratingPPV

ofgenetic

testing

Accuracy

ofrisk

perception

Galesic,

Garcia-

Retamero,

etal.,2009

Factorial

RCT

(171)

University

students

and

older

adultsin

Germany

Meanscore

9.5

on

12-ptnumeracy

scale

derived

from

Lipkus&

Schwartz

NumericalRisk

(presented

alternately

as

ARR

orRRR)

Iconarrays

Accuracy

ofrisk

perception

Garcia-R

etamero

andGalesic,

2009

RCT

(1047)

Population

sample

ofUS

andGerman

adults

49%

Low

numeracy

(>medianscore

on9-item

scale

adaptedfrom

Lipkusand

Schwartz)

b

Numerical

inform

ation

aboutRRR

(including

inform

ation

withvarying

size

denominators)

Numericalinform

ation

(RRR)plusicon

array(including

inform

ation

presentedwith

varying

sizesof

denominators)

Accuracy

ofrisk

perceptiona

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Greeneet

al.,

2008

RCT

(303)

Community

dwellingadults

inUS

50%

Low

(score

less

than10on

DR

Numeracy

Test)

(1)Side-by-side

(random)

comparisonof

characteristics

(2)No

framew

ork

(1)Common=unique

presentationof

characteristics

(2a)Short

framew

ork

(2b)Longframew

ork

Comprehen

sion

Meadeet

al.,

1994

RCT

(192)

Patients

ina

primary

care

clinic

inUS

Medianscore:7th

gradeon

WRAT

Nointervention

(1)Brochure

oncolon

cancerscreening

(5–6th

gradereading

level)

(2)Videotapeoncolon

cancerscreening

(5–6th

gradereading

level)

Knowledge

Murphyet

al.,

2000

NRCT

(192)

Patients

ata

sleepclinic

inUS

40%<9th

grade

onREALM

Brochure

onsleep

apnea.(12th

gradereading

level)

Video

onsleepapnea.

(12th

gradereading

level)

Comprehen

sion

Peterset

al.,

2007

(Study1)

RCT

(303)

Community

dwellingadults

inUS

50%

Low

(score

less

than10on

DR

Numeracy

Test)

Nonordered

,nonquality

info.

(1)Ordered

cost,

quality,non-quality

info.

(2)Cost

andquality

info.only

Comprehen

sion,

Skill

Peterset

al.,

2007

(Study2)

RCT

(303)

Community

dwellingadults

inUS

50%

Low

(score

less

than10on

DR

Numeracy

Test)

Numbersonly

(1)Essentialinfo

accompaniedby

black=whitesymbols

(2)Essentialinfo

accompaniedby

traffic

symbols

Comprehen

sion,

Skill (C

ontinued

)

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Table

2.Continued

Source

Design

(Sample

size)

Population

Healthliteracy

levels

Control

Intervention

Outcomes

(3)Essentialand

non-essen

tialinfo

accompaniedby

black=whitesymbols

(4)Essentialand

non-essen

tialinfo

accompaniedby

traffic

symbols

Peterset

al.,2007

(Study3)

RCT

(303)

Community

dwellingadults

inUS

50%

Low

(score

less

than10on

DR

Numeracy

Test)

Lower

number

isbetterquality,

nosymbols

(1)Higher

number

isbetterquality,no

symbols

(2)Lower

number

isbetterquality,

symbols

(3)Higher

number

isbetterquality,

symbols

Comprehension,

Skill

Taitet

al.,2010

RCT

(408)

Patients

ina

surgical

waitingareain

US

HL

notreported,

although51%

low

numeracy

onsubjective

numeracy

scale

Textpresentation

comparing

benefitsand

risksoftw

ohypothetical

drugs

1)Tabularand2)

pictograph

presentations

comparingbenefits

andrisksoftw

ohypotheticaldrugs

Comprehension

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Volandes

etal.,

2009

RCT

(200)

Patients

in4

primary

care

clinicsin

US

18%�6th

grade

and12%

7th-8th

grade

onREALM

Verbalnarrative

aboutadvanced

dem

entia

Verbal

narrativeþvideo

showingfeaturesof

advanceddem

entia

Knowledgea,

Intent

Wilsonet

al.,

2010

RCT

(435)

Primary

care

clinicsin

2US

cities

15%�6th

grade

and28%

7th-8th

grade

onREALM

Novideo

orprint

material

Printwithprint

take-home

Video

alone

Video

withprint

take-home

Knowledge

Wrightet

al.,

2009

RCT

(140)

Internet

users

inUK

41%

Low

(incorrect

answ

erto

first

questionon

Lipkus

numeracy

scale)

Disperseddot

iconarray(3

differentrisk

magnitudes:

3%,6%,50%)

Grouped

doticon

array(3

differentrisk

magnitudes:3%,6%,

50%)

Comprehension

Abbreviations:

12-pt,12-point;ARR,absolute

risk

reduction;AUA-SS,AmericanUrologicalAssociation-Symptom

Score;BPH,benignprostatichyper-

plasia;info,inform

ation;NRCT,nonrandomized

controlled

trial;PPV,positivepredictivevalue;RCT,randomized

controlled

trial;REALM,Rapid

Estim

ate

ofAdultLiteracy

inMedicine;

RRR,relativerisk

reduction;UK,United

Kingdom;US,United

States;WRAT,WideRangeAchievem

entTest.

aAdjusted

forrelevantconfounders.

bWeightedpercents.

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Table

3.Summary

ofincluded

interventionstudiesusingmixed

interventionsforlow

healthliteracy

Source

Design

(Sample

size)

Population

Health

literacy

levels

Control

Intervention

Outcomes

Campbell

etal.,2004

RCT

(233)

Patients

in1University

MedicalComplexin

US

50%�8th

gradeon

Woodcock

Johnson

Standard

print

consentform

(1)Sim

plified

print

consentform

(2)Video

consent

(3)Computerizedcon-

sent

Comprehensiona

Davisand

Bocchini,

1996

NRCT

(522)

Parents

ofpediatric

patients

inUS

47%<9th

gradeon

REALM

CDC

pamphlet

onpolio

vaccination

Sim

plified

LSU

pamphletonpolio

vaccination

Comprehension

Davis,

Frederickson,

etal.,1998

NRCT

(610)

Parents

ofpediatric

patients

at3clinics

inUS

31%<9th

gradeon

REALM

Improved

CDC

pamphleton

polio

vaccination

Sim

plified

LSU

pamphletonpolio

vaccination

Comprehension

Davis,

Holcombe,

etal.,1998

NRCT

(183)

Patients

inoncology

clinicsandadultsin

low-incomehousing

complexes

inUS

25%<6th

gradeon

REALM

Standard

consent

form

Speciallydeveloped

consentform

Comprehension

DeW

altet

al.,

2006

RCT

(127)

Patients

ingeneral

medicineand

cardiologyclinics

inUS

41%

inadeq.

on

S-TOFHLA

Usualcareþlow

literacy

pamphleton

CHF

CHF

self-m

anagem

ent

program

Knowledgea

Self-efficacy

Behavior

Quality

oflife

Use

ofhealth

care

services

40

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014

Ferreiraet

al.,

2005

cRCT

(113

MDs,

1,978pts)

Patients

at2general

medicineclinicsin

US

31%<9th

gradeon

TOFHLA

b

UsualCare

Literacy

trainingfor

physiciansand

educationon

colorectalcancer

screeningfor

patients

Use

ofHealth

care

Services

Gerber

etal.,

2005

RCT

(144)

Patients

in5outpatient

clinicsin

US

56%<22

(inadeq.or

marginal)on

S-TOFHLA

Usualcareþ

computerized

quizzeson

diabetes-related

concepts

Diabetes

self-m

anagem

ent

intervention

Knowledgea

Self-efficacy

HgbA1c,

Use

ofhealthcare

Services

Greeneand

Peters,2009

RCT

(122)

Medicaid

recipients

in1UScounty

57%

with

TOFHLA

Cloze

score

�18(outof

20)

Standard

Medicaid

healthplan

comparison

chart

Sim

plified

Medicaid

healthplan

comparisonchart

Comprehension

Jayet

al.,2009

RCT

(56)

Adultsatacommunity

outreach

screeningin

US

17%�22

(inadeq.or

marginal)on

S-TOFHLA

Standard

FDA

materials

explaining

nutritionlabel

Nutritionlabel

inform

ationcard

andvideo

tutorial

Comprehensiona

Kim

etal.,2004

Quasi-,

pre-post

(92)

Participants

inadia-

betes

educationclass

at

auniversity

hospitalin

US

23%<22

(inadeq.or

marginal)on

S-TOFHLA

None

Diabetes

self-m

anagem

ent

intervention

Knowledgea

Behavior

HgbA1c

(Continued

)

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Table

3.Continued

Source

Design

(Sample

size)

Population

Health

literacy

levels

Control

Intervention

Outcomes

Kripalaniet

al.,

2008

Quasi-,post

only

(408)

Patients

inprimary

care

clinic

inUS

21%<3rd

grade,

25%

4th–6th

grade,

and

31%

7th–8th

gradeon

REALM

None

(1)ModifiedPrint

inform

edConsent

withOralOverview

Knowledgea

Leroyand

Miller,

2010

Quasi-,

pre-post

(48)

Communitydwelling

adultsin

US

35%

with

REALM-

<9th

grade

None

Healthtopic

overview:

atable

ofcontents

linkingnounphrases

tomedicalwordsin

thetextvia

arrows

andhighlighting

Knowledge

Michielutte

etal.,1992

RCT

(217)

Patients

in1of4clinics

inUS(familypractice,

ob-gyn,family

planning,STI)

Below

median

score

of

46on

WRAT-R

None

(1)Illustrated

brochure

oncervical

cancerscreening

withnarrativetext

(2)Non-illustrated

brochure

withsim-

ple

bulleted

text

Comprehension

Paasche-Orlow

etal.,2005

Quasi-,

pre-post

(73)

Inpatients

at2academ

ichospitalsin

US

22%

inadeq.

on

S-TOFHLA

None

Asthma

Self-Managem

ent

Intervention

Knowledgea

Adherence

Disease

Symptoms

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Robinson

etal.,2008

Quasi-,

pre-post

(110)

Patients

atpediatric

allergyclinic

inUS

Meanscore

3.2

onGilmore

Oral

Reading

Test

None

Asthma

Self-Managem

ent

Intervention

Self-efficacy

a

Use

ofHealth

care

services

Ross

etal.,2010

Quasi-,

pre-post

(49)

Adultsattending

churches

or

communitycenters

in2UScounties

22%

inadeq.

and16%

marginal

literacy

on

TOFHLA

None

Inform

edDecision

MakingVideo

on

PSA

Screening

Knowledge

Rothman,

Malone,

etal.,

2004

Quasi-,

pre-post

(159)

Patients

at1general

medicineclinic

inUS

55%�6th

gradeon

REALM

None

Diabetes

Self-Managem

ent

Intervention

HgbA1c(and

other

biomarkers)

Rothman,

Dew

alt,et

al.,

2004

Rothman,So,

etal.,2006

RCT

(217)

Patients

at1general

medicineclinic

inUS

38%�6th

gradeon

REALM

1-houreducation

session

Diabetes

Self

Managem

ent

Intervention

HgbA1c

(andother

biomarkers)a

Cost

Sobelet

al.,2009

Quasi,

pre-post

(130)

Patients

in1general

medicineclinic

and

adultsattendinga

faithbased

organizationoradult

basiceducationcenter

inUS

26%�6th

gradeand

33%

7th–8th

gradeon

REALM

None

Linearvideo

tutorial

aboutasthmaandits

managem

ent

Knowledgea

Sudore

etal.,

2006

Quasi-,

post-only

(204)

Patients

at1general

medicineclinic

inUS

22%

inadeq.

and18%

marginalon

TOFHLA

None

Sim

plified

consent

form

Comprehensiona

(Continued

)

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Table

3.Continued

Source

Design

(Sample

size)

Population

Health

literacy

levels

Control

Intervention

Outcomes

Wallace

etal.,

2009

Quasi-,

pre-post

(250)

Patients

at3general

medicineclinicsin

US

29%

inadeq.

and14%

marginalon

TOFHLA

None

Diabetes

Self-Managem

ent

Intervention

Knowledge

Self-efficacy

Wolfet

al.,

2011

NRCT

(500)

Patientatprimary

care

clinicsin

2UScities

20%�6th

gradeon

REALM

32%

7th–8th

gradeon

REALM

Usual

prescription

medicinelabel

Patient-centeredlabel

(PCL)thatspecified

exact

timeformed

dosesþ=�

graphic

Comprehension

Wydra,2001

RCT

Patients

at4

comprehensivecancer

centers

inUS

63%�109on

WRAT

Usualcare

Interactivevideodisc

ondealingwith

cancertreatm

ent

fatigue(N

OS)

Behavior

Yatesand

Pena,2006

RCT

(200)

Patients

in1em

ergency

departmentin

New

Zealand

16%

REALM

<9th

gradec

Standard

head

traumaadvice

form

Sim

plified

head

traumaadviceform

Comprehensiona

Abbreviations:

CDC,Centers

forDisease

ControlandPrevention;CHF,congestiveheart

failure;cR

CT,cluster

randomized

controlled

trial;FDA,The

FederalDrugAdministration;HgbA1c,

glycosylatedhem

oglobin;inadeq.,inadequate;LSU,LouisianaState

University;MDs,

medicaldoctors;NOS,not

otherwisespecified;NRCT,non-randomized

controlled

trial;PCL,patient-centeredlabel;PSA,prostate-specific

antigen;ob-gyn,obstetrics-gynecology;pts,

patients;Quasi-,quasi-experim

entalstudy;RCT,randomized

controlled

trial;REALM,Rapid

Estim

ate

ofAdultLiteracy

inMedicine;

STI,

sexuallytrans-

mittedinfection;S-TOFHLA,short

form

TestofFunctionalHealthliteracy

inAdults;TOFHLA,TestofFunctionalHealthLiteracy

inAdults;US,United

States;WideRangeAchievem

entTest;WRAT-R

,WideRangeAchievem

entTest-Revised.

aAdjusted

forrelevantconfounders.

bLiteracy

level

measuredin

only

19%

ofpatients.

c Readfrom

table.

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014

provided small improvements for those with high numeracy (unadjusted difference0.3–0.7 points on a 6-point scale). Unfortunately, it had no effect or actually wor-sened comprehension for those with low numeracy (unadjusted difference for presen-tations of four advantages and disadvantages:�0.5 points on a 6-point scale,p< .05). A second study examined the effects of presenting only essential infor-mation and=or putting essential information first (Peters et al., 2007). In this study,both low- and high-numeracy participants who received only essential informationabout hospital quality (e.g., death rates) had better comprehension of information(unadjusted difference, high numeracy: þ0.3 on a 3-point scale, p< .01; low numer-acy: þ0.7, p< .01) than individuals who received both essential and nonessentialquality information (e.g., death ratesþ hospital satisfaction rates). Additionally,when all quality information was presented, putting the essential information firstimproved comprehension for low- (but not high-) numeracy individuals (unadjusteddifference: þ0.6 on a 3-point scale, p< .01), although there was a notable ceilingeffect in the high-numeracy group.

Three RCTs examined the effects of alternative numerical presentations on com-prehension (Galesic, Gigerenzer et al., 2009; Garcia-Retamero & Galesic, 2009;Peters et al., 2007). One found that presenting information on hospital quality sothat the higher number (rather than the lower number) indicated better quality(i.e., ‘‘nurses per patient’’ rather than ‘‘patients per nurses’’) improved the meannumber of correct responses to comprehension questions in low- but nothigh-numeracy subgroups (unadjusted difference, low numeracy: þ0.7 on a 4-pointscale, p< .01; high numeracy þ0.2, p> .05; Peters et al., 2007). A second study foundthat presenting disease risk and treatment benefit information using the same (versusdifferent) denominators resulted in appreciable improvements in comprehension(adjusted p¼ .001), with a greater effect among those with low (þ25 percentagepoints) versus high numeracy (þ16 percentage points, unadjusted p for numeracyeffect¼ .001) (Garcia-Retamero & Galesic, 2009). A third study found that usingnatural frequencies (rather than percentages) to present information about baselinedisease rates and genetic test characteristics improved the accuracy of participants’estimates of their probability of disease following genetic testing (unadjustedp¼ .001) with similar effects for both high- (þ24 percentage points) and low- (þ27percentage points) numeracy individuals (Galesic, Gigerenzer et al., 2009).

One study (Tait, Voepel-Lewis, Zikmund-Fisher, & Fagerlin, 2010) examinedthe effect of substituting pictorial information for prose. This RCT found that pre-senting comparative information on the harms and benefits of two drugs in tablesrather than text improved understanding, particularly for those with low literacy(þ2.36 on a 5-point scale, p< .05 for understanding essential meaning; þ2.78 on7-point scale, p< .05 for understanding exact meaning). Compared with text, iconarrays (i.e., pictographs representing the proportion of individuals affected by dis-ease) also improved understanding of the essential (but not exact) meaning for thosewith low literacy (þ1.23 on 5-point scale, p< .025).

Five studies (Galesic, Garcia-Retamero et al., 2009; Garcia-Retamero & Galesic,2009; Peters et al., 2007; Wright et al., 2009), including two in the same article, exam-ined the effects of additive or alternative pictorial information on comprehension.Two RCTs examined the effect of adding symbols to numerical information. One(Peters et al., 2007) found that adding plus and minus signs to depict the conceptsof ‘‘more=fewer patients per nurse’’ or ‘‘more=fewer nurses per patient’’ had noeffect on comprehension overall or in the low numeracy subgroups. It slightly

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worsened comprehension, however, in the high-numeracy subgroup (unadjusted dif-ference: �0.3 on a 4-point scale, p< .05). A second study (Peters et al., 2007) foundthat adding black and white circles (i.e., all black, half-black half-white, all white) orcolored traffic light symbols (i.e., green, yellow, red circles) to hospital quality infor-mation to indicate relative quality had no effect on comprehension in either low- orhigh-numeracy individuals.

Two RCTs (Galesic, Garcia-Retamero et al., 2009; Garcia-Retamero & Galesic,2009) showed that adding icon arrays to numerical information improved under-standing for low-literacy individuals. However, one showed that the benefit (unad-justed difference þ23 percentage points, adjusted p¼ .002) was not as great asswitching from relative risk reduction (RRR) to absolute risk reduction (ARR)presentations (absolute difference: þ49 percentage points, p¼ .001). Additionally,the second showed that the added value of icon arrays varied by whether the diseaserisk and treatment benefit information to be interpreted used the same or differentdenominators (unadjusted absolute difference, same denominator: þ11%; differentdenominator: þ32%, p-values not reported). Interestingly, icon arrays worsenedcomprehension for high-literacy individuals if denominators were the same andalready easily interpretable (unadjusted absolute difference: �16 percentage points,p not reported).

One RCT (Wright et al., 2009) examined the effect of providing alternatepictorial information. It found that icon arrays with grouped (rather than dispersed)dots tended to lead to higher comprehension (adjusted OR 2.26; 95% CI 0.799 to6.57), although results weren’t statistically significant.

Four RCTs (Bryant et al., 2009; Campbell et al., 2004; Meade et al., 1994;Wilson et al., 2010) and one NRCT (Murphy et al., 2000) examined the effects ofsubstituting various media for print and found conflicting results.

Health-Related SkillThree RCTs (Peters et al., 2007) reported in the same paper showed that presentingonly essential quality information, presenting higher numbers as better quality, andadding minus symbols to ‘‘lower number is better’’ numerical presentations aided thechoice of higher quality hospitals in individuals with low numeracy (unadjustedabsolute difference ranging from 12–23 percentage points). However, adding coloredtraffic symbols to indicate relative quality tended to worsen choice of higher qualityhospitals (unadjusted absolute difference: �11 percentage points, p> .05) eventhough they improved choices for higher numeracy individuals (þ16 percentagepoints, p< .05).

Behavioral IntentOne RCT found that adding video to a verbal narrative on preference for comfortcare increased preferences for comfort care as an end-of-life strategy (adjusted oddsratio [OR] 3.9, 95% confidence interval [CI], 1.8–8.6) (Volandes et al., 2009).

Effect of Single-Strategy Interventions on Costs and Disparities

No included studies examined the effect of single-strategy interventions on costs ordisparities.

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Effects of Mixed-Strategy Interventions on Health Care Service Use

Use of ServicesOne cRCT showed that an intensive intervention providing clinicians with infor-mation on health literacy and patients with information on colorectal cancer screen-ing (Ferreira et al., 2005) increased completion of any colorectal cancer screening testover 18 months (absolute difference 8.9 percentage points, p¼ .003). The impactdiffered by health literacy level, with an absolute difference of 26 percentage pointsin the low-health-literacy subgroup (p¼ .002) and 3 percentage points in thehigh-health-literacy subgroup (p¼ .65) when adjusting only for the clustering ofpatients within providers. One additional RCT of a minimally intensive diabetesself-management intervention showed no effect on recommended medical servicesin literacy subgroups; however, authors did not describe this outcome in sufficientdetail to allow interpretation.

Emergency Department VisitsOne quasi-experimental study promoting asthma self-management by childrenreported an overall reduction in emergency department visits (unadjusted mean dif-ference �30 percentage points, p< .01), with a striking effect in children who showedimprovements in reading compared to those who didn’t (adjusted OR 0.34, 95% CI,0.22–0.52) (Robinson et al., 2008).

HospitalizationsOneRCT reported no overall reduction in hospitalizations with a congestive heart failure(CHF) self-management intervention, but a significant reduction in a subgroup of indi-viduals with low health literacy (adjusted incidence rate ratio 0.39, 95% CI, 0.16–0.91)(DeWalt et al., 2006). A quasi-experimental study of an asthma self-management inter-vention also reported fewer hospitalizations (adjusted mean difference: �15 percentagepoints, p< .001) (Robinson et al., 2008), although the effect did not differ by literacy level.

Effects of Mixed-Strategy Interventions on Health Outcomes

KnowledgeFour RCTs, 4 NRCTs, and 8 quasi-experimental studies provided conflicting evi-dence on whether mixed-strategy interventions that reduced readability, altereddocument design, or provided education or self-management changed knowledgeor comprehension. (Gerber et al., 2005; Kim et al., 2004; Leroy & Miller, 2010; Rosset al., 2010; Sobel et al., 2009; Wallace et al., 2009).

Self-EfficacyOne RCT and one quasi-experimental study provided mixed evidence regarding theeffects of minimally intensive diabetes self-management interventions on self-efficacy(Gerber et al., 2005; Wallace et al., 2009). The RCT found no effect in either low- orhigh-health-literacy subgroups.

Health-Related SkillOne RCT (Jay et al., 2009) found that label-reading skill was increased after anutrition label card and 8-minute video tutorial on label reading, compared with astandard nutrition label alone (adjusted absolute difference in proportion of

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knowledge questions correct: þ12 percentage points, p< 0.05). The effect was great-er among those with adequate (þ23 percentage points) versus inadequate health lit-eracy (þ1 percentage point) in adjusted analysis, however, analysis of the inadequateliteracy subgroup was underpowered. One NRCT (Wolf et al., 2011) found that amedicine label that specified the exact dosing times (rather than how many timesper day the medicine should be taken) improved patients’ ability to correctly describemedicine use (adjusted relative risk [RR] for low-literacy participants: 1.39, 95% CI1.14 to 1.68). Adding a graphic actually worsened understanding in the overallsample.

Health BehaviorTwo studies examined the effect of interventions on self-care behavior. Onequasi-experimental study (Kim et al., 2004) found a significant overall effect of adiabetes self-management intervention on the number of self-care days in the lastweek (effect size and exact p-value not reported [NR]). However, the effect variedwithin health literacy subgroups. In adjusted analysis, individuals with inadequatehealth literacy had greater improvements in dietary behavior, foot care, and glucosemonitoring, while individuals with adequate health literacy had greater improve-ments in exercise. There was no difference among groups in medication adherence.A second RCT (Wydra, 2001) examined the effect of a videodisc on dealing withcancer fatigue and found an improvement in self-care behaviors (effect size NR,p< .0001) with similar effects, regardless of health literacy level.

AdherenceTwo quasi-experimental studies examined the effects of self-management interven-tions on adherence (Kim et al., 2004; Paasche-Orlow et al., 2005). Both reportedno difference in the effect of their interventions by health literacy level, but providedinsufficient information to determine overall or subgroup effect sizes.

Disease SeverityFour studies examined the effect of self- or disease-management interventions onbiomarkers of disease. One RCT of a minimally intensive (�54 minutes) computer-ized diabetes self-management program found no effect on hemoglobin (Hgb) A1c,blood pressure, or body mass index (BMI) in participants overall or in low-health-literacy subgroups in an adjusted analysis (Gerber et al., 2005). However, other,more intensive, interventions demonstrated significant effects. One quasi-experimental study of a diabetes self-management intervention with 10 hours ofinstruction found a statistically significant decrease in HgbA1c (unadjusted absolutedifference, post-pre: �1.3 percent, exact p-value NR) with no difference in effectamong health literacy subgroups in an adjusted analysis (Kim et al., 2004). Addition-ally, one RCT (R. L. Rothman et al., 2004) testing an intensive disease managementintervention (8 hours of instruction plus pharmacist adjustment of medication)showed a significant decrease in HgbA1c with intervention in the low-health-literacygroup (adjusted absolute difference �1.4 percent, 95% CI, �2.3 to �0.6) and a non-significant decrease in the high-health-literacy group (adjusted absolute difference �0.5 percent, 95% CI, �1.4 to 0.3) (R. L. Rothman et al., 2004). Systolic blood press-ure was also significantly lowered among all participants (adjusted absolute differ-ence �7.6 mmHg, 95% CI, �13 to �2.2 mmHg). A quasi-experimental study ofthe same intervention supported these results (R. Rothman et al., 2004).

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A final quasi-experimental study examined the effects of a minimally intensive(�30 minutes) asthma self-management intervention on asthma symptom control;however, results were underpowered for this analysis, limiting conclusions(Paasche-Orlow et al., 2005).

Quality of LifeOne RCT examined the effects of an intensive CHF self-management intervention(10–16 visits of unspecified length) on heart failure-related quality of life. This studyreported no effects of its intervention on participant scores on the Minnesota Livingwith Heart Failure scale (MLHF; range 0–105) overall (adjusted absolute difference:�2, 95% CI – 5 to 9) or by health literacy subgroup (adjusted absolute difference,inadequate: �1.6, 95% CI – 15 to 12; adequate: �4.2, 95% CI – 14 to 6) (DeWaltet al., 2006).

Effects of Mixed-Strategy Interventions on Costs

One RCT examined the labor and total costs of its successful diabetes diseasemanagement intervention (R. L. Rothman et al., 2004; Rothman et al., 2006). Thisstudy reported total costs of $36.97 per patient per month (range in sensitivity analy-sis $16.22 to $88.56 per patient per month) for an intervention that included an aver-age of 13 hours of education, skill building, and medication adjustment per patient.

Effects of Mixed-Strategy Interventions on Disparities

No included studies addressed the effects of mixed health literacy interventions onhealth disparities.

Discussion

In this systematic review of interventions designed to mitigate the effects of lowhealth literacy, we found several discrete design features that improved participantcomprehension in one or a few studies (e.g., presenting essential information by itselfor first, presenting information so that the higher number is better, presentingnumerical information in tables rather than text, adding icon arrays to numericalinformation, adding video to verbal narrative). Furthermore, we found a few studiesthat provided consistent, direct evidence that intensive mixed-strategy interventionsfocusing on self-management reduced emergency department visits and hospitaliza-tions, and that intensive mixed-strategy interventions focusing on self- and diseasemanagement reduced disease severity. Whenever possible, these latter interventionsshould be considered for use in clinical practice. Evidence for the effects of otherinterventions on other outcomes was either limited or mixed, precluding conclusions.

In this review, we also found significant advances in the field of health literacyresearch. Our 2004 review included few interventions of any type, few outcomesbeyond comprehension, and few studies that stratified their analyses by health liter-acy level (Pignone, DeWalt, Sheridan, Berkman, & Lohr, 2005). In this review, inter-ventions were more varied, the outcomes more diverse, and the subgroup analysesmore frequent. These advances afford greater insights into effective interventionsand support crosscutting observations that begin to illuminate the design featuresthat facilitate intervention success. For instance, common features of interventions

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that changed distal outcomes (e.g., disease biomarkers and hospitalizations) includedtheir high intensity, theory basis, pilot testing, emphasis on skill building, and deliv-ery by a health professional, for example, a pharmacist or a diabetes educator,(DeWalt et al., 2006; Robinson et al., 2008; R. L. Rothman et al., 2004); several alsoemployed simplified text and teach-back methodologies that have been shown to beeffective in the psycholinguistic and educational literatures (Snow, 2002). A smallnumber of studies afford further advances: They have shown that not all interven-tions with intuitive appeal are necessarily successful; some appear to provide nobenefit to populations with low health literacy (Greene et al., 2008) and some appearto incite potential harm (Peters et al., 2007). They also underscore that interventionsmay have different effects on those with low and high health literacy (Greene et al.,2008; Peters et al., 2007), raising questions about whether universal health literacyprecautions will ultimately be the best approach toward improving the health ofthe population.

Despite research advances, there remains much to be done. First, researchshould continue to address the methodological issues that will ensure high-qualityinferences about what works in order to mitigate the effects of low health literacy.Most important, researchers need to give more attention to issues of confounding.Although all studies in this review stratified results by health literacy, few stratifiedrandomization within health literacy subgroups or adjusted for potential confound-ing within subgroups. Additionally, only one study presented baseline characteristicsstratified by literacy level in order to facilitate assessment of potential confounding(DeWalt et al., 2006). Researchers also need to give more attention to issues of sam-ple size. Some studies in this review included too few low-literacy participants to beable to determine intervention effects for this subgroup. Others had too few parti-cipants to be able to determine intervention effects for all studied outcomes. Givenchallenges with recruitment and funding, researchers need creative solutions in orderto ensure adequate samples for high-quality inference. One solution may be theformation of a literacy trial group that would define a set of relevant outcomesfor future study and would plan ahead for meta-analyses that aggregate results fromsmaller studies.

To continue to advance the field of health literacy research, work should alsoproceed on several fronts. First, research should focus on confirming the effective-ness of discrete design features or mixed-strategy interventions that, to date, haveshown success only in limited populations. Second, research should explore yetuntested interventions. Such interventions might include interventions to increasemotivation to process information (e.g., fotonovellas); interventions that workaround the problem of low health literacy (e.g., patient navigators); and interven-tions that change physician behavior, practice structure, or existing health policy.Third, research should continue to explore the features that make health literacyinterventions successful. Although a combination of intervention features has beenshown to ensure the success of interventions, paring away ineffective features couldsave delivery time and be more cost-effective. Finally, research should explore thebest ways to disseminate and implement effective health literacy interventions. Suchan effort might be aided by creating a central, accessible library of literacy-directedinterventions.

In considering such recommendations, readers should consider the limitations ofour review. First, although we performed rigorous reviews of the literature, it is poss-ible we missed relevant literature. Medline has no MeSH term for health literacy,

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necessitating alternate search strategies to identify relevant studies. Second, theremight be publication bias. Third, we included only those studies in which investiga-tors quantitatively measured the health literacy or numeracy of their populations.We may have missed some important interventions examined in studies that mea-sured health literacy only by self-report. Finally, we examined only a predefinedset of outcomes and might have missed outcomes or interventions important to someresearchers, clinicians, and policymakers. These outcomes can be examined in futurereviews.

Conclusions

Despite limitations, we feel our review offers insights to aid a national action plan tomitigate the effects of low health literacy. Specifically, our review outlines (a) effec-tive interventions that could be implemented by practitioners today, (b) future areasin need of research, and (c) conceptual and methodological issues that should beaddressed in future research. Giving attention to these observations will afford usincreasing potential to reduce the negative effects of low health literacy on healthoutcomes.

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