Development and Evaluation of a Health Literacy-Informed Communication Intervention for Discharge Medication Counseling in Hospitalized Children
Phase: NA
Conditions: Medication Management
Sponsor: Vanderbilt University Medical Center

Last Revision: 4/21/2022  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Development and Evaluation of a Health Literacy-Informed Communication Intervention for Discharge 
Medication Counseling in Hospitalized Children 
 
 
Principal Investigator 
Alison R. Carroll, MD 
Pediatric Hospital Medicine Fellow 
Department of Pediatrics 
Monroe Carrel Jr. Children’s Hospital at Vanderbilt 
Vanderbilt University Medication Center 
 
 
Co-Investigators 
Derek J. Williams, MD MPH 
Amanda Mixon, MD, MSPH 
 
 

Last Revision: 4/21/2022  
 
 
Table of Contents: 
 
1.0 
Background 
2.0 
Rationale and Specific Aim 
3.0 
Study Design, Study Population, Statistical Analysis and Sample Size Calculation  
4.0 
Risk to Participants 
5.0 
Privacy/Confidentiality Issues 
6.0 
Reporting of Adverse Events or Unanticipated Problems Involving Risk to Participants 
7.0 
References 
 
 

Last Revision: 4/21/2022  
 
Protocol Summary 
Caregivers of children age < 6 years old who speak English or Spanish and are discharged home from the 
inpatient hospital medicine team at Monroe Carell Jr. Children’s Hospital at Vanderbilt on a new liquid 
medication will be potentially eligible for the study. Caregivers will be randomized at the time of enrollment to 
receive usual care for discharge medication teaching or receive enhanced discharge medication teaching 
which is a health literacy-informed communication intervention including a written medication sheet, teach-
back, provision of an oral dosing syringe and show-back of proper liquid medication administration. Caregivers 
will be enrolled in person prior to their child’s discharge home from the hospital. A follow-up survey conducted 
via myCap will be completed 48 to 72 hours following discharge to assess study outcomes. The anticipated 
study duration is 2 years total of which 12 months is anticipated for subject recruitment and enrollment starting 
July 1, 2021.  
1.0 Background  
One out-of-hospital medication error occurs every 8 minutes among children < 6 years of age.1 Medication 
errors are particularly common in infants and young children, likely due to the near universal use of liquid 
medications in this population. As compared to pills or tablets, oral liquid medications present unique 
challenges (e.g., varying concentrations, dose measurement, and the frequent use of non-standardized dosing 
instruments) and account for the majority of pediatric dosing errors. Prior studies estimate that liquid 
medication dosing errors in children are very common with over 50% of caregivers measuring an incorrect 
dose or reporting giving a dose outside of the recommended range.2–6 Poor medication adherence (e.g. missed 
doses) further compounds the problem of medication errors in children with potential implications for treatment 
failure and, in the case of antibiotics, development of drug resistance.7,8 
More than 1.5 million children are hospitalized in the United States each year, and the transition from 
hospital to home is a vulnerable time for medication errors.9 Most children receive multiple medications during 
a hospital stay.10 Many of these medications are new and many are continued at home. This raises the risk for 
errors as the responsibility of medication administration shifts from trained health care providers to caregivers, 
many of whom experience increased stress and exhaustion during a hospitalization making comprehension of 
medication instructions more difficult.   
Health literacy, or the ability to understand health information to make appropriate health decisions, is a 
key driver of effective communication, especially when discussing medication administration.11 Low health 
literacy is common, present in 29% of US parents, and is associated with increased risk of medication errors.11 
It is thus imperative to consider health literacy as a critical element of effective communication with caregivers 
in the transition from hospital to home in order to minimize medication errors. Several studies in outpatients 
have demonstrated the usefulness of health literacy-informed communication strategies (written instructions, 
teach-back, show-back) for reducing medication errors.12–14 Evaluations of health literacy-informed 
communication interventions calibrated to the unique complexities and needs of caregivers in the transition 
from hospital to home, however, are lacking.  
 
2.0 Rationale and Specific Aim 
Despite the association of poor health literacy of caregivers with worse health outcomes in children, 
actual caregiver health literacy has been assessed in only 5 emergency department studies and no inpatient 
studies which examined medication errors.13,15–18 Addressing health literacy is integral to any proposed solution 
seeking to eliminate out-of-hospital medication errors as children transition from the hospital to home. Given 
the exhaustion and stress of a hospitalization, all caregivers are at risk to perform below their normal level of 
health literacy. Therefore, healthy literacy “universal precautions” should be followed by all health care workers 
which means assuming that all patients and caregivers may have difficulty comprehending health 
information.19 The Joint Commission has stated that unaddressed health literacy issues undermines the safety 
of patients, and health care organizations must identify and meet patient’s oral and written communication 
needs.20 Ways to meet these needs and improve medication safety include using proven communication 
strategies, such as teach-back, show-back, and providing written information.21,22 Use of pictograms along with 
written instructions is associated with improved comprehension and adherence with medical instructions, 

Last Revision: 4/21/2022  
 
especially in those with low health literacy.2,14,23,24 Unfortunately, standardization and utilization of proven 
communication strategies in the hospital is often poor.21,25  
Prior work has highlighted the commonality of liquid medication errors in infants and young children and 
the potential of enhanced communication strategies to reduce errors, resulting in care that is safer and more 
effective. However, few studies have examined health literacy-informed interventions to decrease discharge 
liquid medication administration errors and improve medication adherence in hospitalized children during the 
transition from hospital to home. Our proposed study directly addresses this important knowledge gap. 
The overarching goal of this research is to make post-discharge care for children safer and more 
effective. Our objective is to 1) design and test the efficacy of a health literacy-informed discharge medication 
counseling intervention in the inpatient setting to reduce medication dosing errors by caregivers and improve 
adherence in infants and young children discharged home on a liquid medication. The specific aim of this study 
is: 
 
Specific Aim In a randomized controlled trial, we will test the efficacy of a health literacy-informed 
communication intervention on caregiver discharge medication dosing accuracy, adherence, and 
comprehension. We hypothesize that a useable, health literacy-informed medication counseling intervention 
will be efficacious in reducing liquid medication dosing errors and improve adherence and medication 
comprehension among caregivers following hospital discharge for children receiving liquid medication as 
compared to usual care.  
The primary outcome is observed dosing accuracy assessed via picture of an oral dosing syringe submitted by 
a caregiver 48-72 hours following discharge and compared to the prescribed dose in the chart. The primary 
outcome will be a continuous measure of percent difference of the caregiver submitted photo compared to the 
prescribed dose (in mL). The primary measure will also be assessed as a dichotomous variable as +/- 20% 
from the prescribed dose. Secondary outcomes include caregiver medication adherence and medication 
comprehension assessed via caregiver follow-up survey. 
3.0 Study Design, Study Population, Statistical Analysis and Sample Size Calculation 
3.1 Study Design and Study Population  
We will conduct a randomized controlled trial 
(RCT) over a period of 12 months among English- 
and Spanish-speaking caregivers of children age 
birth to < 6 years being discharged from the 
hospital following an acute care inpatient stay in 
which at least one new liquid medication is 
initiated to be continued at home. Inclusion and 
exclusion criteria are outlined in Table 2. In 
addition, we will only include caregivers who will 
be or have already obtained their child’s medicine from the Vanderbilt Children’s Outpatient Pharmacy and are 
willing to download and use an application on their phone called myCap to complete the follow-up survey. 
3.2 Screening and Enrollment 
Caregivers will be screened for eligibility Monday through Friday from 7 am to 6 pm. The PI or trained research 
assistant(s) will review currently admitted patients on the general hospital medicine teams who meet eligibility 
criteria and contact the attending physician to inquire about discharge status and request permission to 
approach the caregiver. For patients nearing discharge, caregivers will be approached to discuss the study and 
confirm eligibility (see Interest in Participation Script). An eligibility script will be used to standardize this 
process (see included document) Patient-level randomization will occur at the time of enrollment. Allocation to 
intervention or usual care will done by block randomization and will be assigned when individuals are 
determined to be eligible based on the eligibility script. Due to the nature of the intervention, it will not be 
possible to blind study staff or caregivers to the assigned study arm (intervention or usual care).  

Last Revision: 4/21/2022  
 
At the time of enrollment (i.e., either the day prior to discharge, if possible, or the day of discharge), 
caregivers in both groups will complete a demographics questionnaire via a secure web platform called 
REDCap (Research Electronic Data Capture).26  Questions will include patient (child) age, sex, race/ethnicity, 
whether they were receiving any liquid medication prior to admission, number of previous hospitalizations, and 
number of previous daily medications. Demographic questions about caregivers will include age, gender, 
race/ethnicity, education level, caregiver relationship to patient, marital status of caregiver, education level of 
caregiver, employment status, difficulties 
paying bills (proxy for financial stress), 
country of origin, and preferred language. 
The following information will be extracted 
from the electronic health record: child 
discharge diagnosis, medication(s) name, 
number, frequency, dose and duration of 
discharge medication(s), patient insurance 
status, and number of chronic conditions.27 
Caregiver health literacy will be measured 
using the Newest Vital Sign (see included 
document).28 The Newest Vital Sign has 
been translated into Spanish by the 
creators. See Figure 1 for study flow. 
3.3 Intervention 
Intervention: The design of the medication instruction sheet 
was guided by previous research, our previous qualitative 
study (IRB#201452), and work by Yin et al.15 The medication 
instruction sheet will include a pictogram of a syringe 
marked with the correct dose of medication as well as 
information about the dose frequency, route of 
administration, length of treatment, storage and most 
common medication side effects (see example medication 
instruction sheet). The medication instruction sheets will be 
customized for each patient based on the discharge 
medicine, printed and used to facilitate discharge medication 
counseling which will include demonstration of accurate 
dosing with a standardized instrument (i.e., dosing syringe) 
by research staff followed by caregiver “show-back” of how 
they plan to administer the medication at home and “teach-back” regarding dosing amounts, times and end 
dates of medications and common side effects. This will be standardized within an intervention script (see 
included document) and will be piloted prior to implementation. A clear dosing syringe will be provided to the 
family prior to discharge. The syringe will be the smallest syringe that would allow administration of the 
appropriate dose. Caregivers will be given the instruction sheet to use at home. If children receive more than 
one liquid discharge medication, the intervention will be completed for only one randomly selected medication. 
We anticipate the intervention will take approximately 10 minutes. We anticipate that the eligibility screening, 
initial survey and intervention will take approximately 25 minutes to complete.   
Usual Care:  Caregivers in the usual care group will receive standard of care discharge communications per 
unit routine, including counseling regarding prescribed medications and post-discharge instructions, return 
precautions, and follow-up appointments by the pediatric nursing staff. At our institution, children discharged 
with a liquid medication from our outpatient pharmacy are provided with a dosing syringe as part of routine 
care. All communications about discharge medication instructions will be at the discretion of the clinical team 
as part of routine care. An additional dosing syringe will be supplied in a sealed envelope to be used at the 
discharge follow-up visit in order to standardize the assessment of the primary outcome of observed dosing 
accuracy. 
 

Last Revision: 4/21/2022  
 
3.4 Assessment of Outcomes 
Follow-up Survey via myCap: The follow-up survey will be completed 48 to 72 hours following discharge to 
assess study outcomes. This will be done via myCap. myCap is an application that research participants will 
be asked to download on their phones (application is free and available on iPhone and Android phones). 
myCap leverages REDCap to capture participant/patient reported outcomes via mobile devices. myCap is 
HIPPA-compliant and secure. All data collected via myCap converts results into a format compatible with 
REDCap. The primary outcome of dosing accuracy will be assessed along with secondary outcomes 
(medication adherence and medication comprehension) via surveys in myCap. Caregivers will also be asked 
who administered the medication, what kind of teaching they received in the hospital prior to discharged (i.e., 
did teach-back, show-back occur), whether any serious medication errors occurred with the patient or other 
children in the home and/or if there were unplanned visits to a health care provider (see included follow-up 
survey). Caregiver self-efficacy for administering medicines to their children will be assessed using a 
standardized scale called the Medication Understanding and Use Self-Efficacy Scale (MUSE). See included 
document for RCT follow-up survey. We anticipate that the caregiver follow-up survey this will take <15 
minutes to complete. 
Primary Outcome: Dosing accuracy will be the primary outcome and will be assessed through self-report 
(reported dose) and through observation (observed dose) at follow-up. The primary outcome will be observed 
dosing accuracy. For observed dosing accuracy, caregivers will be asked to draw up a dose of their child’s 
medication using the provided oral dosing syringe and send a secure picture of the syringe via myCap  to 
research study staff (see Figure 2 as an example). The primary outcome will be 
assessed as a continuous percent difference from the prescribed dose (in milliliters). 
For reported dose, caregivers will be asked to report the prescribed volume (in 
milliliters) of medication to be given with each dose during the follow-up myCap 
survey. This will be compared to the prescribed dose in the electronic medical 
record. For both measures, dosing accuracy will also be assessed as a dichotomous 
outcome and considered accurate if it is within 20% of the prescribed dose similar to 
prior studies.5,15  
Safety Monitoring Plan: If any dosing errors are detected via the myCap picture 
and/or myCap follow-up survey, the research team will provide additional education 
about proper medication dosing, refer caregivers to the prescribed dose on the 
medication bottle and refer the caregiver back to their child’s health care provider for 
further questions. 
Secondary Outcomes: Secondary efficacy outcomes will include discharge 
medication adherence and caregiver medication comprehension assessed during 
the myCap follow-up survey. Adherence will be calculated based on caregiver report of first and last dose of 
medication (compared to documentation in electronic medical record) and if there were any missed doses or if 
the medication was never obtained from the pharmacy. Caregiver medication comprehension will be assessed 
using survey questions as was done in a previous study.29 We will also assess the kind of medication teaching 
parents received in the hospital and which aspects of the medication teaching caregivers found the most 
useful. Caregiver follow-up survey is included in the application. We will also collect process and exploratory 
outcomes as detailed in Table 3. 
  

Last Revision: 4/21/2022  
 
 
3.5 Data Analysis and Sample Size 
Data analysis: Baseline characteristics of the intervention and control groups will be compared using t tests 
and χ2 tests or Fisher exact tests, as appropriate. Wilcoxon rank-sum tests will be used if the data does not 
appear to be normally distributed. These tests will be performed to also compare those who did and did not 
complete the follow-up assessment.  
Randomization will be done using block permutation at the time of enrollment. Study staff enrolling caregivers 
will not be blinded to group allocation. Caregivers will not 
explicitly be told what group they have been assigned. Study 
staff will be blinded to group allocation when assessing the dose 
in the syringe in the picture submitted during follow-up in order to 
determine the primary outcome of observed dosing accuracy. 
Two independent study staff will assess the picture to determine 
the dose. Any disagreement will be adjudicated by the study PI. 
The primary outcome will be the percent difference in the 
observed dose measured as the difference in millimeters (mL) 
between the dose of medication in the caregiver submitted 
picture during follow-up assessment compared to the prescribed 
dose in the electronic health record divided by the prescribed 
dose. For example, if the observed dose in the caregiver 
submitted picture was 4.5 mL and the prescribed dose in the 
electronic health record was 3 mL then this would be a 50% 
overdosing error. The observed dosing percent difference will be compared between the intervention and 
control groups as medians with interquartile ranges. 
Table 3. Outcomes and measures obtained during myCap follow-up survey 
Primary Outcome 
Outcome 
Measurement definition 
How measurement will be obtained 
Medication Dose 
Accuracy 
Comprehension: >20% deviation from caregiver 
reported dose as compared to dose in electronic health 
record (EHR) 
Adherence: >20% deviation from observed dose as 
compared to dose in (EHR) 
Reported dose accuracy measured via caregiver self-
report during post-discharge video conference call 
 
For observed dose, caregivers will be asked to 
measure out the prescribed volume using a syringe 
and submit a picture of the syringe via myCap 
Secondary Outcomes 
Medication Name  
Comprehension: Error in reporting medication name 
Adherence: N/A 
Caregiver self-report during myCap follow-up survey 
Medication 
Indication 
Comprehension: Error in reporting indication for 
medication 
Adherence: N/A 
Caregiver self-report during  myCap follow-up survey 
Medication 
Frequency  
Comprehension: Any error in reporting frequency for 
medication 
Adherence: Any error in reporting frequency for 
medication 
Caregiver self-report during  myCap follow-up survey 
Medication 
Duration 
Comprehension: Any error in reporting duration for 
medication 
Adherence: Parent report of first and last dose of 
medication compared to prescribed duration 
Caregiver self-report during  myCap follow-up survey 
Medication Side 
Effects 
Comprehension: Unable to report any known side 
effects of the medication (credit for correctly identifying > 
1 known side effort or reporting no known side effects) 
Adherence: N/A 
Caregiver self-report during  myCap follow-up survey 
Exploratory Outcomes 
Clinical Outcomes 
Prevalence and type of major dosing errors  
 
Unplanned visits to health care providers due to 
medication errors 
Caregiver self-report during post-discharge video 
conference call 
 
Review of EHR 30 days following discharge to assess 
for any unplanned health care visits 

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If we detect covariate imbalance in the two groups, we will use propensity score weighting and a multivariable 
linear regression model to conduct an adjusted analysis. Proposed covariates to include in the model are: 
caregiver health literacy, caregiver age, caregiver gender, caregiver race/ethnicity, and caregiver primary 
language. These covariates are likely to have the biggest impact on the primary outcome. The other covariates 
includes caregiver country of origin, socioeconomic status (i.e., binary outcome of do you have difficulty paying 
bills), employment status, education status, and martial status. Patient level covariates include child age, 
gender race/ethnicity, medical complexity, number of previous medications and previous hospitalizations in the 
last year and insurance type. 
We will display our findings for the continuous outcome of observed medication dosing error using either box 
plots or violin plots for the intervention and control groups.  
Given that prior literature in this area has examined medication dose error as a dichotomous variable using +/- 
20% from the prescribed dose (this was felt to be a clinically meaningful dosing error), we will also examine 
and display our primary outcome in this way to allow for comparison to other studies. We will report relative risk 
reduction, absolute risk reduction and number needed to treat along with 95% confidence intervals for the 
primary outcome of both observed dosing accuracy and reported dosing accuracy.  
 
Sample Size: Sample size estimates are based on the outcome of medication dosing accuracy. Using a 
conservative dosing error prevalence of 30% in the control arm,2,4–6,15 and an expected dosing error prevalence 
of 10% in the intervention arm, we will need to enroll 72 subjects in each arm of the study to reject the null 
hypothesis that the dosing error prevalence in the control and intervention arms are equal with 80% power (2-
sided alpha of 0.05). Accounting for 25-30% loss to follow-up, we plan to enroll a total of 200 subjects. From 
July 2018-June 2019, the pediatric hospital medicine service at Vanderbilt discharged 1,742 children <4 years 
of age, at least 50% of whom were discharged home on 1 or more medications (approximately 75 children per 
month), ensuring ample opportunities to achieve our required sample size (see Table 4). 
 
3.6 Potential Limitations and Alternative Approaches for Aim 1 
A potential challenge is slower than anticipated enrollment. If this occurs, we will extend our enrollment period 
and/or consider expanding our enrollment catchment to other clinical teams or older children (e.g. school age 
children). Although our study is powered to detect differences similar to what has been observed in prior 
studies, these assumptions may be inaccurate. Nonetheless, the study would still be very useful in measuring 
potential effect size estimates for future study.  
 
4.0 Risk to Participants 
All study subjects will receive standard of care for discharge medication counseling. Study subjects in the 
intervention group will receive additional and enhanced discharge medication counseling. This poses no 
greater than minimal risk to study participants. The potential benefit of this study would come be the 
development and implementation of more efficacious discharge medication counseling which will, hopefully, 
lead to a reduction in medication dosing errors and a decrease in patient harm. 
 
5.0 Privacy/Confidentiality Issues 
Privacy and confidentiality is of the highest priority, and all efforts will be made to keep personal information 
and research records private throughout these studies.  Records and documents pertaining to the conduct of 
this study will be kept in HIPPA-compliant, secure, password protected databases (i.e., myCap and REDCap) 
or in locked files accessible only by a limited number of study personnel. All patient data will be coded using a 
unique study ID. No PHI will be shared outside of the key study personnel at each institution and no PHI will be 
shared between institutions. The information from the research study may be published using aggregate 
results; however, no individual subject will be identified. 
 

Last Revision: 4/21/2022  
 
 
6.0 Reporting of Adverse Events or Unanticipated Problems Involving Risk to Participants 
The PI and research study staff (with PI oversight) are responsible for ensuring protocol compliance, data 
integrity, and participant safety. This protocol presents minimal risks to participants and adverse events or 
other problems are not anticipated. In the unlikely event that such events occur, unanticipated problems 
involving risks to subjects or others will be reported immediately to the PI and the IRB and in writing within 5 
days to the IRB and any appropriate funding and regulatory agencies. Annual reports will be submitted to the 
responsible IRBs summarizing study progress, adverse events, complaints about the research or withdrawals, 
and any protocol violations.  
 
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