Pictographs for Preventing Medical Mistakes

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

Newborns in the neonatal intensive care unit (NICU) are at high risk for wrong-patient errors. Effective 2019, The Joint Commission requires that health systems adopt distinct methods of newborn identification as part of its National Patient Safety Goals. Displaying patient photographs in the electronic health record (EHR) is a promising strategy to improve identification of children and adults, but is unlikely to be effective for identifying newborns. This study assesses the use of Pictographs as a "photo equivalent" for improving identification of newborns in the NICU. This multi-site, two-arm, parallel group, cluster randomized controlled trial will test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU. Pictographs consist of three elements: 1) pictorial symbols of easy-to-remember objects (e.g., rainbow, lion); 2) the infant's given name (when available); and 3) a color-coded border indicating the infant's sex. The study will be conducted at three academic medical centers that utilize Epic EHR. All parents or guardians will be asked to select a unique Pictograph for each infant admitted to the NICU to be displayed on the isolette and in the EHR for the duration of the infant's hospital stay. All clinicians with the authority to place electronic orders in the study NICUs will be randomly assigned to either the intervention arm (Pictographs displayed in the EHR) or the control arm (no Pictographs displayed in the EHR). The main hypothesis is that clinicians assigned to view Pictographs in the EHR will have a significantly lower rate of wrong-patient order errors in the NICU versus clinicians assigned to no Pictographs. The primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. The Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method for identifying wrong-patient orders, will be used as the primary outcome measure. The Wrong-Patient RAR measure identifies one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes. In the validation study conducted at a large academic medical center, real-time telephone interviews with clinicians confirmed that 76.2% of RAR events were correctly identified by the measure as wrong-patient orders.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Pictograph in 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 pictographs are used alongside verbal explanations, patients, especially those with low literacy, can follow medical instructions more accurately. ^{1 2 3 4 5}

How does the treatment Pictograph differ from other treatments for preventing medical mistakes?

Pictographs are unique because they use simple drawings to help patients understand medical instructions, especially benefiting those with low literacy skills. Unlike other treatments that might rely solely on verbal or written information, pictographs enhance recall and comprehension, reducing the likelihood of medication errors. ^{1 2 3 6 7}

Research Team

Jason Adelman, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of pictographs in improving patient education outcomes: a systematic review. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Pictograms for safer medication handling by health care workers: a validation study in nursing students in Poland. [2022]

4. India pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate pharmaceutical pictograms in a multispecialty hospital at dehradun. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Redesigning pictographs for patients with low health literacy and establishing preliminary steps for delivery via smart phones. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Ireland pubmed.ncbi.nlm.nih.gov

Using pictographs to enhance recall of spoken medical instructions II. [2022]