Patient Education and Counseling 91 (2013) 255–260

Care-giver perspectives

Exploring caregiver understanding of medications immediately after a pediatricprimary care visit§

Barbara W. Bayldon a,b,d,*, Mariana Glusman a,b,d, Nicole M. Fortuna a, Adolfo J. Ariza a,b,d,e,Helen J. Binns a,b,c,d,e

a Pediatrics, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, USAb Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, USAc Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, USAd Pediatric Practice Research Group, Chicago, USAe Mary Ann and J. Milburn Smith Child Health Research Program, Children’s Hospital of Chicago Research Center, Chicago, USA

A R T I C L E I N F O

Article history:

Received 27 June 2012

Received in revised form 12 November 2012

Accepted 29 December 2012

Keywords:

Medication

Health literacy

Practice-based research

Primary care

A B S T R A C T

Objective: Assess accuracy of caregiver understanding of children’s prescribed medications and examine

factors associated with accurate recall.

Methods: Cross-sectional, observational study of English- or Spanish-speaking caregivers of primary

care patients aged 0–7 years. Child and visit characteristics and caregiver health literacy (Short Test of

Health Literacy in Adults) were assessed. Post-visit, caregivers completed questionnaires on medications

prescribed. Caregiver and medical record agreement on medication name and administration (dose and

frequency) were examined using chi square and logistic regression.

Results: Analyses included 68 caregivers (28% low health literacy); 96% of children had public insurance.

Caregivers indicated that the doctor provided clear medication information (100%) and they could follow

instructions (98%). 101 medicines were prescribed; 6 were recalled by caregiver only. 71% of medications

were accurately named; 37% of administration instructions were accurately recalled. Accurate naming

was more often found for patients 3–7 years, without conditions requiring repeat visits, and new

medications. Accurate administration responses were associated with having only 1 child at the visit.

Conclusion: Unperceived medication instruction understanding gaps exist at physician visits for

caregivers of all literacy levels. Communication and care delivery practices need further evaluation.

Practice implications: Clinicians should be aware of the frequency of caregiver medication misunder-

standing.

� 2013 Elsevier Ireland Ltd. All rights reserved.

Contents lists available at SciVerse ScienceDirect

Patient Education and Counseling

jo ur n al h o mep ag e: w ww .e lsev ier . co m / loc ate /p ated u co u

1. Introduction

In the United States, almost 50% of children take at least onemedicine within any 2 week period and the rate of out-patientmedication errors is 3% [1,2]. The number of children at risk andmagnitude of potential harm establish this as a significant publichealth issue. Preventable adverse drug events (ADEs) in pediatricout-patients are most often due to errors in parental medicationadministration [3]. Thus, improved parental understanding ofmedicine instructions and administration would have the poten-tial to reduce a large proportion of these preventable ADEs.

§ This project was supported in part by institutional funding from the

Northwestern University Clinical and Translational Sciences Institute.

* Corresponding author at: Ann & Robert H. Lurie Children’s Hospital of Chicago,

225 East Chicago Ave., #16, Chicago, IL 60611-2605, USA. Tel.: +1 312 227 6110;

fax: +1 312 227 9418.

E-mail address: bbayldon@luriechildrens.org (B.W. Bayldon).

0738-3991/$ – see front matter � 2013 Elsevier Ireland Ltd. All rights reserved.

http://dx.doi.org/10.1016/j.pec.2012.12.017

Health literacy has been defined as ‘‘the degree to whichindividuals have the capacity to obtain, process, and understandbasic health information and services needed to make appropriatehealth decisions’’ [4]. Studies in pediatric and adult health settingshave found that low health literacy is associated with knowledgegaps and difficulty with tasks that can lead to errors in medicationadministration [5–7]. Language barriers, such as limited Englishproficiency [3,6,7] also appear to contribute to the problems withmedication use and are associated with low health literacy [8].

Increasingly, researchers and national organizations, such asthe Institute of Medicine, have placed emphasis on the integrationof provider communication, as well as health system complexity,into the conceptual framework of health literacy [9–12]. It is notjust the patient’s skill level, but rather the chasm between the lifeexperience and skills of the patient and those exacted by thehealthcare process that needs to be addressed to improve suchoutcomes as appropriate medication administration.

When a child needs a medication, misunderstanding ormiscommunication can arise at many possible steps in the

B.W. Bayldon et al. / Patient Education and Counseling 91 (2013) 255–260256

pathway from medication prescription to administration. The firstopportunity for a caregiver to gain understanding of medicationinstructions for their child’s medicine is at the physicianencounter. Using experimental scenarios, Yin et al. reportedhigher comprehension of accurate medication administrationpractices in caregivers with higher degrees of health literacy[13]. However, no studies have assessed caregiver understandingof medication instructions and associated factors immediatelyfollowing the medical encounter in the outpatient pediatricsetting. Such data are needed to inform future efforts to decreaseADEs through improved caregiver medication understanding andadministration.

The objectives of this study were to: (1) examine caregiverunderstanding of instructions about medications for their child,e.g., medication name, dose, and frequency, immediately followinga child’s visit; (2) assess the relationship between caregiver healthliteracy and accuracy of understanding of medication instruction;and (3) identify parent, child, or encounter-related factorsassociated with accurate understanding of medication instruc-tions. We hypothesized that the medicine and medicationinstructions for prescriptions given to lower health literate ornon-primary English speaking caregivers would be less wellunderstood.

2. Methods

2.1. Design/setting/participants

We performed a cross-sectional, observational study on aconvenience sample of caregivers (parents or legal guardians)recruited from an urban pediatric outpatient clinic of an academicmedical center from January to July of 2009. During this interval,medication prescriptions were primarily generated from theelectronic medical record (EMR), EPIC, widely used in the US,although prescription pads were also on site. The physician chosethe form and concentration of the medicine in EPIC, typed in dose,frequency and duration, printed the prescription and gave it to theparent.

One research assistant in the health center waiting room, usinga semi-scripted approach, including a description of the entireprotocol, recruited caregivers of patients aged 0–7 years. Onlycaregivers of young patients were included so as to limitconfounding by the child’s own understanding of medicationinstructions. All those who spoke and read English or Spanish wellenough to complete data instruments in either of those languagesand whose child was presenting for a visit with a pediatrician wereeligible; those actually approached were determined by conve-nience. Among the 160 eligible caregivers recruited, data from 68were analyzed. Data on 85 (53%) were excluded because their childdid not receive a medication at the visit and 7 (4%) were excludedbecause the caregiver did not complete post-visit assessments ormedical record data were incomplete. This study was approved bythe Children’s Memorial Hospital Institutional Review Board (nownamed Ann & Robert H. Lurie Children’s Hospital of ChicagoInstitutional Review Board).

2.2. Data instruments

Before the visit, caregivers completed a survey regarding familydemographics, including caregiver country of birth, primarylanguage, race, education, existence of older children as a markerfor experience, reasons for visit, and number of children present atthe visit. We also inquired whether or not the child’s medicalconditions required repeated visits to the primary care clinic orspecialists as proxy indicators of the complexity of the child’smedical conditions.

Health literacy was assessed in English or Spanish (participantpreference) using the Short Test of Health Literacy in Adults (S-TOFHLA). The S-TOFHLA is a validated tool for assessing healthliteracy in English and Spanish speaking patient populations [14].The test consists of a timed test (7 min) of 2 reading passages, in acloze format, the first with 16 blank spaces and the second with 20blanks. The S-TOFHLA is scored as inadequate (0–16), marginal(17–22) and adequate (23–36). It was administered to parents inthe clinic waiting area by a trained research assistant.

Immediately post-visit, caregivers were asked to list themedications prescribed or continued at the visit, indicate if amedication was new for this child, and list administrationinstructions for each medication. Although not prompted to doso, caregivers had the prescriptions with them and thus the optionof reading the prescriptions. Using 5-point Likert scales they alsoindicated how clearly they felt the doctor had explained how togive the medicines and their level of confidence in being able tofollow the doctor’s advice.

To assess accuracy of parent report of medications andadministration instructions, the EMR was reviewed for medica-tions prescribed or noted as having been recommended by thephysician on the indicated visit date. Medications were classifiedby type (prescription required or over-the-counter) and usecharacteristics (maintenance medication, limited use [e.g., adefined number of days] or PRN [a medicine to be taken asneeded]). At this clinic, most medications, including over-the-counter (OTC) medications, were prescribed to facilitate IllinoisMedicaid payment coverage.

2.3. Analysis

We used SPSS, version 19.0, and Stata, version 9, in analyses. Wefirst conducted descriptive analysis on subject and medicationcharacteristics. We defined medication name as accuratelyunderstood if the caregiver and the EMR listed the samemedication name (generic and brand name were interchangeable).Medication name was coded as not in agreement if the caregiverand EMR did not match, or the medication was only named byeither the caregiver or in the EMR. We defined medicationadministration as the combination of dose and frequency ofadministration. Our criteria for caregiver accurate administrationagreement with the EMR required both the dose and the frequencyto be correctly reported.

Next, we examined factors associated with accurate agree-ment between the caregiver and EMR on medication name byapplying a stepwise approach. First, we conducted chi squareanalyses to examine associations with (1) caregiver/familyfactors (education (�high school versus post-high school),caregiver born in US, primary language (English versus other),S-TOFHLA score group (low/marginal versus adequate), presenceof children ages 12–17 years in the home and caregiver level ofworry about the main problem they wanted to discuss at the visit(very worried/worried versus neutral/not worried/not worried atall)), (2) child and visit factors (visit type [well child visit versussick/other], child age [�2 years versus 3–7 years], 1 child at thevisit versus >1 child, child with health conditions requiringrepeated visits to the clinic or a specialist) and (3) medicationfactors (parental recognition of new medication, type ofmedication [OTC versus prescription], medication use character-istics [maintenance, limited use, PRN]). We did not include race/ethnicity group in the model because of its co-linearity withother variables of interest.

Next, factors significant at the p < 0.05 level where examinedindividually in a series of logistic regression (LR) analyses, eachmodel of which also included subject as a random effect. Lastly,factors from each LR analyses which retained significance at

Table 2Characteristics of medications documented in EMR or indicated by parent, and

name and instructions agreement.

Medications (n = 107) n (%)a

Medication type

Over-the-counter medicine 46 (43)

Prescription 60 (56)

Unable to determine 1 (10)

Medication use characteristics

Maintenance medication 35 (33)

Limited use 30 (28)

As needed (PRN) 36 (34)

Not documented 6 (6)

Caregiver perception: medication used in the past

New medication for this child 31 (29)

Have used previously for this child 47 (44)

Did not respond 29 (27)

Medication name agreement

Caregiver and EMRb agree 76 (71)

Caregiver and EMR differ 3 (3)

Named in EMR only 22 (21)

Named by caregiver only 6 (6)

Medication administration instructions agreement (n = 97)

Caregiver and EMR agree on both dose and frequency 36 (37)

Caregiver and EMR differs 61 (63)

B.W. Bayldon et al. / Patient Education and Counseling 91 (2013) 255–260 257

p < 0.05 were entered into a multivariate logistic regressionmodel, which also included subject as a random effect.

The same approach and variables were used for examiningagreement between caregiver and EMR on medication adminis-tration. Only medications that had instructions documented in theEMR on that visit date were used for this last set of analyses.

3. Results

3.1. Characteristics of the study subjects and medicines

Characteristics of participating caregivers and study visits areshown in Table 1. Most caregivers were mothers, black or Hispanic,and 96% accompanied a child that had public health insurance.About half of participants were US born, about half had educationbeyond high school, and about half spoke English as a primarylanguage. Approximately one-quarter (28%) had low or marginalscores on the S-TOFHLA test for health literacy.

Immediately after the visit, all respondents (63/63) thoughtthat the doctor clearly or very clearly explained how to give themedicine. Most caregivers (98%, 63/64) were confident or very

Table 1Family demographics and visit characteristics (n = 68).

n (%)

Family demographicsRelationship to child

Mother 54 (79)

Father 13 (19)

Other 1 (2)

Caregiver race/ethnicity

Black 23 (34)

Hispanic 32 (47)

White 7 (10)

Asian/other 6 (9)

Caregiver born in United States (n = 63)

Yes 30 (48)

No 33 (52)

Caregiver educational level (n = 63)

<High school 13 (21)

High school graduate 14 (22)

Some college or trade school 24 (38)

College graduate 12 (19)

Primary language (n = 66)

English 34 (52)

Spanish 22 (33)

Other 10 (15)

S-TOFHLAa classification (n = 67)

Adequate 48 (72)

Marginal 4 (6)

Low 15 (22)

Sibs ages 12–17 years present in the home (n = 63)

Yes 23 (35)

No 42 (65)

Visit characteristicsReason for visit

Well child check 43 (63)

Sick visit 17 (25)

Otherb 8 (12)

Number of children present at clinic visit (n = 66)

1 child 47 (71)

2 children 14 (21)

3 children 5 (8)

Pre-visit caregiver level of worry about the main problem the caregiver wanted

to discuss with the doctor at the visit (n = 63)

Very worried 16 (25)

Worried 21 (33)

Neutral 13 (21)

Not worried 6 (10)

Not worried at all 7 (11)

a Short Test of Health Literacy in Adults.b ‘‘Other’’ includes visits for immunizations or follow-up of past illness.

a Percentages may not add to 100, due to rounding.b Electronic medical record.

confident that they would be able to follow the doctor’s adviceprovided at the visit.

The majority of visits were for well child care. Child mean agewas 3.2 years (SD 2.1 years) and about half of patients (56%) wereboys. At 29% of visits there were other children accompanying theindex child. About one quarter of caregivers (23%, 15/65) indicatedthat the child had medical conditions requiring repeated visits toeither the primary care clinician or specialists.

A total of 101 medications were recorded in the EMR asprescribed or renewed or recommended by the clinicians at the 68visits and 6 additional medicines were identified by a parent ashaving been discussed at the visit. Table 2 shows characteristics ofthese medications. Slightly more than half required a prescriptionand about one-third were for maintenance use. Caregiversreported that 29% were first time medicines.

3.2. Accuracy of caregiver recall of medication name

Caregivers accurately named 71% of the medications (Table 2),with most of the rest named in the EMR only. In chi squareanalyses, correct naming was more often found (1) for medicationsreported by caregivers having post-high school education (85%versus �high school 66%, p = 0.025, n = 98); (2) for older children(child aged 3–7 years, 83% versus child �2 years, 59%, p = 0.005,n = 107), and (3) for new medications. Nearly all caregivers (97%)indicating that the medication was new for this child correctlynamed the medication (versus not reported as new medication,61%, p < 0.001, n = 107). Medication naming was less oftenaccurate if the child had a condition requiring repeated visits tothe clinic or specialist (48%, versus 79% without condition,p = 0.002, n = 103). None of the other factors examined (seeSection 2) were significantly associated with accurate naming ofthe medicine prescribed at the visit.

In particular, in regard to health literacy, 73% of medicines werecorrectly named when the caregiver was in the adequate S-TOFHLAscore group, versus 66% named correctly if the parent was in themarginal/low S-TOFHLA score group (p = 0.467).

The final model (n = 102), included child age group, medicalcondition requiring repeated visits, and new medication (Table 3).All factors retained significance.

Table 3Logistic regression models for accurate naming of medicines (n = 107).

Unadjusteda Multivariateb

Odds ratio 95% confidence interval Odds ratio 95% confidence interval

Caregiver education

Post-high school education 4.9 (0.8, 30.5)

�High school graduate 1.0 –

Patient with health problem requiring repeated visits to clinic or specialist

Yes 0.06 (0.01, 0.06) 0.04 (0.003, 0.5)

No 1.0 – 1.0 –

Patient age

3–7 years 8.16 (1.1, 60.6) 19.7 (2.0, 195.2)

0–2 years 1.0 – 1.0 –

Parent-reported medicine was new for this patient

Yes 139.2 (4.6, 4191.5) 144.6 (3.3, 6366.2)

No 1.0 – 1.0 –

a Adjusted for subject as a random effect.b Model includes subject as a random effect and other variables which achieved significance in unadjusted models.

B.W. Bayldon et al. / Patient Education and Counseling 91 (2013) 255–260258

3.3. Accuracy of caregiver recall of administration instructions

Caregivers accurately described administrations instructionsfor 37% (36/98) of medications (Table 2). In chi square analyses,accurate administration was more often reported for medicationsby caregivers when: (1) there was only 1 child at the visit (47%,versus >1 child at the visit, 17%, p = 0.006, n = 95); (2) themedication was new for this child (60% versus not new medication,28%, p = 0.003, n = 98); and (3) the medication was for mainte-nance use (53%, versus limited use, 40% and PRN use, 22%,p = 0.031, n = 98). None of the other factors examined (see Section2), including health literacy, were significantly associated withaccurate description of administration of the medicine prescribedat the visit.

When these were examined individually in LR models includingsubject as a random effect, only number of children present andnew medication retained significance. Having >1 child present atthe visit reduced likelihood of accuracy of administrationinstructions recall (adjusted odds ratio 0.15 [95% confidenceinterval, 0.03, 0.81]).

4. Discussion and conclusion

4.1. Discussion

This study demonstrates a lack of caregiver understanding aboutmedications following the physician encounter, which couldcontribute to the occurrence of preventable ADEs. Only three-quarters of medications recommended at a visit were accuratelynamed by the caregiver immediately following the visit, and farfewer, only about one-third, of medication administration instruc-tions were accurately recalled. With e-prescribing unavailable at thetime of study, the parent physically had a paper prescription in hand,and still did not accurately report administration instructions. Theprovider–parent encounter communication yielded a concerninglack of comprehension by caregivers of all literacy levels.

This demonstration of a breakdown in effective communicationabout medications between physician and caregiver underscoresthe important role of communication in patient care, documentedin prior studies [15–19]. Over two decades ago, Simon demon-strated in an informal study that mothers frequently did notunderstand treatment directions, particularly if they wereperceived to be anxious [15]. Since that time, researchers haveexplored adequacy of provider communication [16,17] andcharacteristics of provider communication associated with patientor parent satisfaction and resistance to advice [18–20]. Patient andparent challenges to understanding, such as low literacy andlanguage barriers, have been well documented [21–26].

Our study, now links the provider–parent encounter commu-nication in a primary care setting directly to poor parentalmedication administration comprehension. We did not observethe encounters, and thus are not able to evaluate the relativecontributions of provider communication style and content,written aids or parental factors to misunderstanding but, asPaasche-Orlow suggested [12], the parent lack of health literacyabout their child’s medications likely reflects a combination ofinadequate provider information delivery and parental processingof medication information, further modified by situational factors.

Factors we found to be significantly associated with accuracy ofnaming and administration recall, have not been previouslyreported in the literature. Medicines parents identified as newfor that child and those for ‘‘older’’ children (>3 years) were thosemost likely to be accurately named. A patient having a medicalcondition requiring repeated visits or visits having more than onechild at a visit were both negatively associated with the caregiver’sability to recall instructions. A plausible explanation for higherparental accuracy associated with newly prescribed medicationsmight be the failure of providers to review previously administeredmedicines with caregivers based on physician assumption that areview is not needed. Better recall for medicines given to olderchildren may indicate either greater parental experience withmedicines or a greater ability to focus on the information given at avisit; lack of focus might be more likely with multiple children inthe room. Using repeated visits as a marker of medical complexity,a parent of such a child is likely to be dealing with a more complexmedical regimen or be more stressed. These issues need furtherexploration.

We had fewer individuals with low health literacy than weexpected and were not able to demonstrate an association betweenmedication naming or administration accuracy and health literacystatus, as has been reported by others [6,7]. The 2003 NationalAssessment of Literacy Survey estimated that 36% of adults havelow health literacy (basic or below basic literacy levels, the 2lowest levels of 4 levels) [27]. In our sample of lower socioeco-nomic families, including 43% with high school education or less,only 28% had low or marginal health literacy scores on the S-TOFHLA.

While low health literacy and language barriers have beenspecifically associated with communication challenges and lowerhealth outcomes [2,28,29], our results as well as others [8,30]suggest that medication misunderstanding should probably beseen as an issue for parents of all health literacy levels. A recentreview documented the insufficient data on the epidemiology ofmedication errors, especially in the outpatient setting, and the lackof evidence-based reduction strategies to address errors [31].Addressing communication to reduce error, is supported by

B.W. Bayldon et al. / Patient Education and Counseling 91 (2013) 255–260 259

Kaushal’s finding that 54% of the ADE’s at their outpatient centerswere ameliorable, resulting from inadequate communication [2].Currently, pediatricians’ have varying communication styles andskills [32], and report a low rate of using enhanced communicationtechniques recommended by health literacy experts, despite beingaware of instances of parental misunderstanding and/or acommunication-related error in patient care [33].

As the medical system struggles to address medication errors,there are many possible interventions to consider and the answerwill likely require a combination of approaches. Improvingdelivery of health information and communication are the firsttwo of the ten steps to improve health literacy, listed in the Healthand Human Services National Action Plan to Improve HealthLiteracy [34]. A recent study by Schonlau, demonstrated thevariability of written, oral and aural skills within a singleindividual, suggesting that both written and oral approaches needto be addressed [35]. Support of system change, as well asindividual caregiver practice changes are advocated and understudy [28,34,35]. There have already been examples of diseasespecific interventions to improve communication [15,36–41]. Inthe emergency department (ED) the patients of providers trainedin an interactive communication program had decreased ED useand hospitalization [37] and in the outpatient primary care settinga two pronged parent and physician intervention showed positiveresults in communication behavior specifically related to antibioticuse for ear infections [38]. Finding an intervention effective acrossthe range of situations encountered in a primary care setting willbe a challenge.

The documented ineffective communication in this studyendorses efforts to develop enhanced communication techniquesthat will better ensure understanding in this setting. While severaltechniques might work, the interactive Teach Back techniquewould appear to respond best to this scenario of caregiver lack ofunderstanding despite self-perception of comprehension. TeachBack, a fairly simple intervention that involves the provider askingthe patient or parent to repeat back or to demonstrate theinformation they have just received, has already been shown toimprove understanding of diabetes management [42,43]. Anintervention requiring parents or caregivers to ask for clarification,is not likely to be sufficient. In a recent study, introduction of ASKME 3, a program to encourage patients to ask questions, did notimprove medication adherence [42]. Building on evidence thatboth doctors and pharmacists may be accepted by patients asaccepted medication information educators [44], a collaborativeapproach between medical homes and pharmacies, performingTeach Back at different points in the medication delivery processmay enhance the Teach Back approach, partially address theperceived obstacle of time reported by providers [33], and meritsevaluation.

There are several limitations to this study. This was a smallobservational study conducted on a convenience sample of lowsocioeconomic status families served by our academic outpatientfacility. As such, the results may not be generalizable to thepopulation at large. It is possible we did not have a large enoughsample to reveal important associations such as education, healthliteracy or limited English proficiency. The S-TOFHLA, the test weused to assess health literacy, may underestimate the number ofsubjects with health literacy concerns. Another possibility is thatthere may have been a selection bias in enrollment.

Our study is a cross-sectional observation, precluding anydetermination of causation. Further, we only assessed parentalunderstanding at one step along the pathway of the medicationprescribing, and dispensing process. We also did not actually havethe parents demonstrate whether they could, when at home,successfully administer the correct dose of medicine at the righttime.

4.2. Conclusion

In this exploratory study, we found accuracy of naming amedication and accuracy of knowledge about administration to besuboptimal and parent perception of their level of understandingto be inaccurate at all literacy levels. This suggests that ouracademic primary care clinic, which serves many low-income andimmigrant families, needs to implement systems to improvecommunication about medications.

4.3. Practice implications

Clinicians should be aware of the frequency of caregivermedication misunderstanding at all health literacy levels. Futureefforts to educate clinicians about the importance of this issue, tostudy communication at the medical home and pharmacy and tostudy effective protocols for outpatient general clinical practices toensure understanding, have the potential to positively impactcaregiver medication administration accuracy.

Acknowledgement

The authors gratefully acknowledge the Pediatric PracticeResearch Group practice for their participation in this study: LurieChildren’s Primary Care-Uptown.

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