Use of a Low Literacy Pictogram-based Intervention to Reduce Medication Administration Errors in Children: An RCT

Use of a Low Literacy Pictogram-based Intervention to Reduce Medication Administration Errors in Children: An RCT HS Yin, MD, BP Dreyer, MD, L van Schaick, MS Ed, GL Foltin, MD, C Dinglas, BA, AL Mendelsohn, MD Department of Pediatrics NYU School of Medicine Bellevue Hospital Center Research funding provided by: CDC T01 CD000146, NYU Department of Pediatrics Dancis Research Fund NEW YORK UNIVERSITY SCHOOL OF MEDICINE Bellevue Hospital Center South Manhattan Healthcare Network

Medication Administration Errors in Children Voluntary withdrawal of OTC cough and cold medicines for infants by manufacturers Food and Drug Administration safety review Ban considered for all children < 6 years old 1969 to 2006 45 pediatric deaths due to decongestants 69 pediatric deaths due to antihistamines

MD instructed patient about dose 55% of time, frequency 58% of the time, length of treatment 34% of time (Tarn 2006)

MD instructed patient about dose 55% of time, frequency 58% of the time, length of treatment 34% of time (Tarn 2006) Pharmacist verbally counseled patients <10% of the time (Metlay 2005) <50% patients report receiving written information from pharmacy (Metlay 2005)

Take one teaspoon by mouth three times daily. ~15% misunderstood in adequate literacy group ~40% misunderstood in low literacy group (Wolf 2007)

~20% misunderstood in higher literacy group ~50% misunderstood in low literacy group ~20% misunderstood in higher literacy group ~90% misunderstood in low literacy group (Davis 2006)

Prescription drug information sheets -2% <8th grade - 69% 9th to 12th grade - 29% >12th grade (Kirksey 2004)

Medication Administration Errors in Children (cont d) Medication administration errors are frequent ~50 to 60% caregivers measure an incorrect dose of liquid medicine or report giving a dose outside of the recommended range (Simon 1997; Li 2000; Frush 2004; McMahon 1997) ~50% pediatric caregivers do not adhere to the prescribed medication regimen (Winnick 2005)

Medication Administration Errors in Children (cont d) Children are at risk Errors in children 2.4x more likely to result in harm (Santell 2005) Potential error types Preparation Storage Dosing Adherence

Risk Factors for Medication Administration Errors Medication specific issues Health provider related issues Caregiver related issues

Risk Factors for Medication Administration Errors (cont d) Medication specific issues Liquid medications difficult to administer Variation in accuracy of dosing instruments Different concentrations Different units of measurement ml / tsp / tbsp

Risk Factors for Medication Administration Errors (cont d) Health provider related issues Level of training / experience Language Time pressure Caregiver related issues Limited English proficiency Low literacy / health literacy Cost

Potential Strategies to Decrease Medication Administration Errors Plain language Illustrations / pictograms Improved medication knowledge (Mansoor & Dowse 2003) Improved adherence (Dowse & Ehlers 2001) Teachback Oral dosing syringes (McMahon 1997; Madlon-Kay 2000)

Development of the HELPix Intervention NYU / Bellevue Department of Pediatrics Linda van Schaick, MS Ed & Benard P. Dreyer, MD HELP Project Health Education and Literacy for Parents Waiting room of Bellevue Pediatric Clinic Collaboration between providers, educators, and parents

Medication Instruction Sheet Patient specific Computer generated English/Spanish Plain language Pictogram representations Preparation Route Frequency Storage Duration

Medication Reminder/ Tracking Sheet Dosing diagram Log Specific to course of medication Course start/end date circled

HELPix Intervention Description Medication counseling using pictogram-based sheets Demonstration of dose and teachback using instrument and sheets Standardized dosing instrument ~1½ minutes

Study Objective To assess whether a plain language, pictogrambased intervention can improve medication knowledge decrease liquid medication dosing errors improve adherence in low SES caregivers of young children.

Study Design Randomized controlled trial Urban public hospital pediatric ED Eligibility criteria Child >30 days old and <8 years old Prescribed a liquid medication Caregiver Responsible for administering medication to child English/Spanish language

Study Overview Enrollment Jul - Dec 2006 Baseline assessment: Sociodemographics Health literacy (TOFHLA)

Study Overview Enrollment Jul - Dec 2006 Randomization Pictogram (sheet+syringe +teachback) Baseline assessment: Sociodemographics Health literacy (TOFHLA) Control

Study Overview Enrollment Jul - Dec 2006 Randomization Assessment of Outcomes Baseline assessment: Sociodemographics Health literacy (TOFHLA) Pictogram (sheet+syringe +teachback) Control Follow-up Assessment: Medication knowledge Dosing accuracy Adherence Prn: Daily: 3-5 days +/- 2 days of last dose

Assessments of Outcomes: Parent Interview Medication knowledge Name Indication Reported dose (within 20%) Frequency Preparation Storage Adherence (daily dose only) Total # doses (within 20%)

Assessments of Outcomes: Observed Dosing Accuracy Caregivers asked to bring in any materials used for dosing at home Standardized medication bottle used Asked to measure dose as they had at home with instrument from home or choosing from set Research staff assessed measured dose considered accurate if within 20% of prescribed Interrater reliability high kappa>0.9, p<0.001

Statistical Analysis prn and daily dose medications analyzed separately Statistical tests Chi square Fisher s exact test

Subject Enrollment 1100 caregivers presented with children 30 days to 9 years old (during daytime/evening hours when research assistants available) 815 caregivers assessed for eligibility 285 caregivers not assessed Excluded (n=522) Child required immediate evaluation (65) No medication prescribed (318) Not primary caregiver (53) Not English/Spanish speaking (67) Visit for behavior/ child protection issue (27) Preference for pill medication (2) 293 caregivers eligible

Subject Enrollment 293 eligible caregivers 251 enrolled 6 Left before randomization 42 refused 245 randomized 124 Pictogram 113 (91.1%) had F/U assessment 121 Control 114 (94.2%) had F/U assessment

Results: Descriptive Data Intervention (n=124) Control (n=121) p Child Age (years) 3.7 (2.2) 3.4 (2.3) 0.3 Hollingshead SES Level 4 or 5 76% 78% 0.8 Caregiver Ethnicity Latino 77% 79% 0.8 Caregiver non-us born 65% 66% 0.9 Caregiver Education HS graduate or equivalent 60% 61% 0.9 Caregiver Health Literacy (TOFHLA) Adequate 70% 69% 0.9 Marginal / Inadequate 30% 31%

Results: Medications Prescribed As needed medication (n=171) Intervention Control p Antipyretic/analgesic 89% 87% 0.8 Antihistamine 10% 11% Cold/cough 1% 2% Daily dose medication (n=107) Intervention Control p Amoxicillin 40% 42% 0.8 Other antibiotic 33% 33% Steroid 21% 24% Antihistamine 6% 2%

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) Error in dosing defined as measuring more than +/- 20% of prescribed dose % subjects incorrect 55 50 45 40 35 30 25 20 15 40% 15.6% 47.8% Control Intervention 10 5 5.4% 0 prn daily dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) Error in dosing defined as measuring more than +/- 20% of prescribed dose prn (n=155) ARR = 24.4% NNT = 4 p=0.003 % subjects incorrect 55 50 45 40 35 30 25 20 15 40% 24.4% 15.6% 47.8% Control Intervention 10 5 5.4% 0 prn daily dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) Error in dosing defined as measuring more than +/- 20% of prescribed dose prn (n=155) ARR = 24.4% NNT = 4 p=0.003 daily dose (n=83) ARR = 42.4% NNT = 2 p=0.0002 % subjects incorrect 55 50 45 40 35 30 25 20 15 10 5 0 40% prn 15.6% 47.8% 42.4% 5.4% daily dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) 55 50 45 40 Daily Dose Medications Control Intervention % subjects 35 30 25 20 15 10 5 0 >80-100 >60-80 >40-60 >20-40 >0-20 0-20 >20-40 >40-60 >60-80 >80-100 below prescribed dose above prescribed dose % deviation from prescribed dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) 55 50 45 40 Daily Dose Medications Control Intervention % subjects 35 30 25 20 15 52.2% control & 94.6% intervention caregivers measured within 20% of the prescribed dose 10 5 0 >80-100 >60-80 >40-60 >20-40 >0-20 0-20 >20-40 >40-60 >60-80 >80-100 below prescribed dose above prescribed dose % deviation from prescribed dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) 55 50 45 40 Daily Dose Medications Control Intervention % subjects 35 30 25 20 15 32.6% control caregivers measured below prescribed dose 10 5 0 >80-100 >60-80 >40-60 >20-40 >0-20 0-20 >20-40 >40-60 >60-80 >80-100 below prescribed dose above prescribed dose % deviation from prescribed dose

Results: Effect of Intervention on Dosing Accuracy (by Direct Observation at Follow-up) 55 50 45 40 Daily Dose Medications Control Intervention % subjects 35 30 25 20 15 15.2% control & 5.4% intervention caregivers measured above the prescribed dose 10 5 0 >80-100 >60-80 >40-60 >20-40 >0-20 0-20 >20-40 >40-60 >60-80 >80-100 below prescribed dose above prescribed dose % deviation from prescribed dose

Results: Effect of Intervention on Adherence (daily dose medications) Poor adherence defined as not giving within 20% of total expected doses % subjects nonadherent 55 50 45 40 35 30 25 20 15 10 38% 9.3% 5 0 control intervention

Results: Effect of Intervention on Adherence (daily dose medications) Poor adherence defined as not giving within 20% of total expected doses daily dose (n=93) ARR = 28.7% NNT = 3 p value = 0.002 % subjects nonadherent 55 50 45 40 35 30 25 20 15 10 5 0 38% 28.7% 9.3% control intervention

Results: Other findings Improvements also noted in Knowledge of preparation Frequency (daily dose medications only) Knowledge of medication name, indication, storage Good accuracy for both groups (>90%) No significant differences between groups

Discussion HELPix intervention associated with large differences in knowledge, accuracy and adherence Clinical impact not ascertained Difficult to relate findings to potential for serious ADE Criteria for dosing accuracy and adherence not standardized across studies Varying cut points associated with similar results

Limitations Difficult to determine which component was responsible for the impact Counseling using pictogram based instruction sheets Provision of standardized dosing instrument Demonstration of dose and teachback utilizing instrument and sheets

Limitations (cont d) Masking not possible Same researcher frequently performed both randomization and assessments Group status clear during assessment of accuracy as caregivers in intervention group had access to pictograms Interview measures highly structured and not likely to be subjective

Next steps Further analysis to determine whether family characteristics are related to intervention benefit - caregiver education - SES - health literacy - primary language

Next steps (cont d) Further development of computer program Expansion to include tablets/pills Inclusion of more languages HELPix Dissemination Pediatric outpatient clinic at Bellevue Hospital Center Effectiveness study

Acknowledgements Funding for HELP Project United Hospital Fund The Auxiliary to Bellevue Hospital Center, Inc The Dreyfus Corporation Funding for Research CDC T01 CD000146, CDC/NYU Medicine and Public Health Research Fellowship Program Dr. Joseph Dancis Research Fund, NYU Department of Pediatrics

Acknowledgements (cont d) Guidance and Mentorship Alan Mendelsohn, MD; Mentor Benard Dreyer, MD; Mentor Linda van Schaick, MS Ed; Bellevue Hospital Health Education and Literacy for Parents (HELP) Program George Foltin, MD; Mentor Mark Schwartz, MD; Fellowship Director Marc Gourevitch, MD; Fellowship PI Additional support Nancy Linn, graphic designer NYC Poison Control Center Liang Yin, software engineer Research assistants Bellevue Hospital Center Pediatric Staff

H. Shonna Yin, MD Department of Pediatrics NYU School of Medicine / Bellevue Hospital Center 550 First Avenue NBV 8S411 New York, NY 10016 yinh02@med.nyu.edu Linda van Schaick, MS Ed HELP Project Department of Pediatrics NYU School of Medicine / Bellevue Hospital Center 462 First Avenue New York, NY 10016 schail01@med.nyu.edu