Pictographs for Preventing Medical Mistakes

Recruiting at 3 trial locations

Overseen By Tony Lin, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Pictographs to reduce wrong-patient errors in the NICU, where newborns face a high risk of such mistakes. Pictographs, which include symbols like a rainbow and the baby's name and gender, will appear in the electronic health records (EHR) to aid in correctly identifying newborns. Clinicians placing orders in the NICU will either see the Pictographs or not, and the trial will measure whether these images reduce errors in ordering treatments for babies. Families with newborns admitted to the NICU and healthcare providers who order treatments there participate in this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions that could enhance patient safety in the NICU.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications.

What prior data suggests that this method is safe for newborn identification in the NICU?

Research has shown that using pictures to prevent mistakes with newborns is promising. These pictures include symbols, the baby's name, and a color border to indicate the baby's gender, aiding hospitals in correctly identifying newborns.

No evidence suggests that these pictures cause harm. They are, in fact, designed to enhance safety. A study on similar visual tools demonstrated a reduction in mistakes, particularly among individuals with low health literacy. This indicates that these pictures are likely very safe and well-accepted.

As a safety project, using pictures is a reasonable and safe method to improve care for newborns without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using pictographs in electronic health records to prevent medical mistakes. Unlike traditional methods that rely heavily on text and numbers, pictographs provide a visual aid that can be easier for healthcare providers to quickly understand and verify patient information. This new approach could enhance accuracy and reduce errors in medical settings, offering a fresh, potentially more intuitive way to manage patient data.

What evidence suggests that Pictographs are effective for preventing wrong-patient errors in the NICU?

Research has shown that simple picture symbols, known as pictographs, can enhance understanding and adherence to medical instructions. In past studies, the use of pictographs alongside text led to fewer mistakes in reading medication instructions. For instance, one study found that people made fewer dosing errors with both text and pictographs compared to text alone. This suggests that pictographs can clarify instructions and reduce errors. In this trial, researchers are testing pictographs in newborn intensive care units (NICUs) to determine if they can help prevent errors by simplifying patient identification. Although specific data on using pictographs in NICUs for this purpose is not yet available, these early findings are promising for improving patient safety. ^{1 4 6 7 8}

Who Is on the Research Team?

Jason Adelman, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for newborns in NICUs where an order was placed during the study period, and clinicians authorized to place electronic orders in these units. It aims to prevent mistakes by testing a new identification method using Pictographs.

Inclusion Criteria

I am a clinician authorized to place electronic orders in the NICU and have done so during the study period.

All infants receiving care in the study NICUs for whom an order was placed during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians are randomly assigned to view Pictographs in the EHR or not, to test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU.

2.5 years

Ongoing monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pictograph

Trial Overview The trial tests if displaying Pictographs (symbols representing infants) in electronic health records reduces wrong-patient errors. Clinicians are randomly assigned to use EHR with or without Pictographs and their error rates are compared.

How Is the Trial Designed?

Group I: Pictograph in Banner and Verification Alert Active Control 1 Intervention

Patient Pictograph displayed in the banner (at the top of the screen) AND Pictograph displayed in a verification alert when placing electronic orders.

Group II: No Pictograph Active Control 1 Intervention

No patient Pictographs displayed in the electronic health record.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Pictographs, which are simple line drawings combined with simplified text, are identified as the most effective visual aids for improving discharge instructions for older adults with low literacy skills, based on a review of 44 articles.

Using pictographs can help clarify complex discharge instructions by visually representing step-by-step procedures, making it easier for patients to understand and follow their homecare actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature review: using pictographs in discharge instructions for older adults with low-literacy skills. Choi, J.[2022]

In a study involving 21 adults with low literacy skills, the use of pictographs alongside spoken medical instructions resulted in an impressive 85% recall immediately after training and 71% recall after 4 weeks, demonstrating that pictographs can significantly aid memory retention for medical information.

This research suggests that pictographs can effectively help individuals with low literacy manage complex medical instructions over time, although further studies are needed to assess their impact on symptom management and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using pictographs to enhance recall of spoken medical instructions II. Houts, PS., Witmer, JT., Egeth, HE., et al.[2022]

Pharmaceutical pictograms can significantly enhance understanding of medication instructions among illiterate patients, as shown by a study at Shri Mahant Indresh Hospital where comprehension improved markedly after explanations were provided.

The study emphasizes the importance of combining pictograms with verbal reinforcement to improve patient compliance and therapeutic outcomes, highlighting the need for active involvement from healthcare professionals in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate pharmaceutical pictograms in a multispecialty hospital at dehradun. Joshi, Y., Kothiyal, P.[2022]

A study involving 29 low health literacy adults identified that many commonly used medication pictographs were difficult to understand, highlighting a need for clearer communication tools.

Through participatory design, 20 pictographs were refined for better comprehension, and feedback was gathered on how to effectively deliver these pictographs as medication reminders via smartphones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesigning pictographs for patients with low health literacy and establishing preliminary steps for delivery via smart phones. Wolpin, SE., Nguyen, JK., Parks, JJ., et al.[2022]

A study involving 66 nursing students in Poland validated nine medication safety pictograms, finding that six met ISO standards for comprehensibility and seven for representativeness in the first phase.

By the second phase, all nine pictograms were understood correctly by at least 66.7% of participants, indicating they are valid for use, but should be accompanied by training and written instructions to enhance understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pictograms for safer medication handling by health care workers: a validation study in nursing students in Poland. Merks, P., Vaillancourt, R., Roux, D., et al.[2022]

A study involving 751 pharmacy clients in Lisbon found that not all of the fifteen tested USP pictograms were easily understood, with over 30% of participants struggling with five of them.

Understanding of the pictograms was significantly related to clients' education level, age, and frequency of medicine use, suggesting that these factors should be considered to improve communication and ensure safe medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Legibility of USP pictograms by clients of community pharmacies in Portugal. Soares, MA.[2021]

The review analyzed 56 studies on pictograph development and effectiveness in patient education, finding that most (48 out of 56) supported the use of pictographs to enhance understanding and health management.

Despite the promising results, some studies showed no significant differences in outcomes, highlighting the need for careful development and validation of pictographs tailored to specific patient populations and clinical contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pictographs in improving patient education outcomes: a systematic review. Wang, T., Voss, JG.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03960099

Pictographs for Preventing Wrong-Patient Errors in NICUs The study will pursue the following specific aims: Aim 1: Test the effectiveness of displaying Pictographs in EHR systems for reducing wrong-patient orders ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5495522/

Pictograms, Units and Dosing Tools, and Parent ... Pictograms represent a promising strategy for improving parental understanding of dosing instructions. Use of pictorial-enhanced written materials has been ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285910003529

Use of a Pictographic Diagram to Decrease Parent Dosing ... Text-plus-pictogram recipients were less likely to make an error compared to text-only recipients (43.9% vs 59.0%, P = .01; absolute risk reduction, 15.2% [95% ...

4. researchgate.net researchgate.net/publication/347472957_Effectiveness_of_pictographs_in_improving_patient_education_outcomes_a_systematic_review

Effectiveness of pictographs in improving patient education ... The objective of this review was to investigate process of pictograph development and the effectiveness of pictographs in patient education.

5. withpower.com withpower.com/trial/phase-8-2021-13d34

Pictographs for Preventing Medical Mistakes Research shows that pictographs can help patients understand medical instructions better, which may reduce errors in medication use. Studies indicate that when ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12099398/

Acceptability of pictographs as a novel patient identifier to ... Wrong-patient errors are a serious threat to newborn safety, and newborns are shown to be at a significantly higher risk for this type of error ...

7. genmed.columbia.edu genmed.columbia.edu/news/patient-safety-research-program-gives-quintuplets-pictographs-help-prevent-errors

Patient Safety Research Program Gives Quintuplets ... The Patient Safety Research Program hopes to reduce the risk of wrong-patient errors for all patients, using targeted strategies for newborns and adults.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000577

The effectiveness of checklists and error reporting systems ... The review highlights evidence supporting the efficacy of checklists in reducing medication errors, surgical complications, and other adverse events.