Peanut allergy in children is a population health problem. Evidence suggests early peanut introduction (EPI) for infants can reduce the development of peanut allergy. Primary care settings have not widely adopted guidelines recommending EPI. Peanut allergy prevention depends on primary care providers incorporating EPI guidelines into well-child check (WCC) encounters. We aimed to improve guideline adherence in a primary care setting by implementing a bundle of clinical decision support (CDS) tools.
Using quality improvement methodology, the team developed a standardized work protocol and CDS tools within an electronic medical record (EMR) at 4, 6, and 9-month WCC encounters. The team executed changes and modifications through plan-do-study-act cycles and analyzed results with statistical process control charts.
We collected data from 445 WCC encounters from baseline through sustainability. EMR documentation of EPI guidance at 4, 6, and 9-month WCCs shifted from 13.9% to 83.5% over 12 months. Provider adoption of smart lists and templates increased from 2% to 73%, the distribution of home peanut introduction handouts increased from 5.2% to 54.1%, and caregiver-reported peanut ingestion increased from 0% to 34.6%. Diphtheria-tetanus-acellular pertussis vaccination rates remained at 100% for 6-month visits, and patient in-room time remained at 65 minutes.
Quality improvement methodology improved documentation of EPI guidance and increased reported peanut ingestion at routine WCC encounters without impacting other measures. Broader use of bundled CDS tools and EMR standardization could further improve guideline adherence and increase early peanut introduction to prevent peanut allergy in infants.
Peanut allergy is a common problem among children. Its prevalence in children has increased by more than 50% from 2001 to 2017 in the United States.1 Allergic reactions to peanuts are the leading cause of anaphylaxis in children.2 Families living with peanut allergies can suffer financial and psychological burdens.3
Early exposure to allergens through disrupted skin barriers, as in infants with eczema, can lead to the development of food allergies.4 Evidence from the Learning Early About Peanut (LEAP) study suggests that early peanut introduction (EPI) for infants, especially those with eczema, can reduce the risk of developing peanut allergy.1,2,5,6 This was a large shift in practice for pediatricians and families from prior American Academy of Pediatrics (AAP) guidelines that recommended that high-risk infants avoid peanuts until 3 years of age. Current AAP guidelines, updated in 2019 after the initial release in 2017, recommend early introduction of peanuts but have not been widely adopted in primary care settings. Currently, clinicians, caregivers, and policy-makers struggle to optimize the guidelines’ implementation strategies.7,8
Cost, time, resource utilization, and practice infrastructures are documented barriers to EPI guideline adherence.9–11 Lack of provider confidence, time, willingness, and knowledge around screening procedures, interpretation of serum immunoglobulin E, skin prick tests, and oral food challenges to peanuts are common obstacles throughout the literature.9,12,13 Eczema severity classification can be challenging in the primary care setting.14–16 There is also concern that guidance around EPI might result in overmedicalization of food introduction and delayed introduction of other foods.17,18 It is also important to note that although our clinical setting is in the United States and follows guidance from the AAP, screening for peanut allergy varies between national allergy societies. Societies recommend EPI, but there is variability in recommendations for screening and some do not recommend any standard screening or endorse precautions around introduction.5
Eczema remains the highest risk factor for developing IgE-mediated food allergies.5 The LEAP study found an 86.1% relative reduction in the prevalence of peanut allergy among infants randomized into either a peanut consumption group or a peanut avoidance group through age 60 months.2 However, a gap remains in incorporating this new knowledge in primary care settings. Results from a retrospective chart review conducted by other researchers at The University of North Carolina (UNC) several years before our baseline data collection found that only 0.8% of clinical encounters for infants under 12 months of age presenting for either a well-child check (WCC) or eczema-focused visit had documentation of EPI guidance.19
Peanut allergy prevention success in infants depends on primary care providers (PCPs) incorporating the addendum guidelines into routine WCC encounters at 4 and 6 months of age.20,21 Even infants with mild to moderate eczema should receive guidance on EPI.13,18,22,23 Evidence shows that primary care settings using clinical decision support (CDS) tools, electronic medical record (EMR) prompts, order sets, and best practice alerts for infants with eczema or egg allergy had better guideline adherence rates than clinics without these tools.20
Baseline documentation of EPI guidance and caregiver-reported peanut ingestion in our clinic were 13.9% and 0%, respectively. We aimed to increase the documentation of clinically appropriate EPI to 50% and caregiver-reported peanut ingestion to 50% at 6 and 9-month WCC encounters from the project’s launch through sustainability.
Methods
Context
This quality improvement (QI) initiative targeted all infants seen for routine care at 4, 6, and 9-month WCC encounters. The intervention occurred in an off-site, academic, residency continuity clinic at UNC serving several counties in North Carolina. The clinic serves a large population of patients on Medicaid or self-pay (66%) and patients experiencing food insecurity. Spanish is the preferred language for approximately a quarter of the population.
Baseline Data
During the baseline period, the clinic conducted 134 WCC encounters for 4, 6, and 9-month-old infants between January 1, 2022, and March 31, 2022. The average in-room time for patients was 63 minutes, and diphtheria-tetanus-acellular pertussis (DTaP) vaccination rates for the 6-month WCC encounters were 100%. Providers documented EPI guidance during 13.9% of these visits. Home peanut introduction handouts and smart lists were unavailable during baseline data collection. There was no documentation of reported peanut consumption in any patients’ EMR during chart review at baseline.
Interventions
This QI initiative lasted from April 2022 to August 2022, when a leadership handoff occurred. The project leader collected sustainability data through December 2022. Using QI methodology, the QI team developed a standardized work protocol and CDS tools within the EMR, including smart lists (a predefined list of text choices), visit templates, and patient education handouts for home peanut in English and Spanish. The team executed modifications through plan-do-study-act (PDSA) cycles to improve guideline adherence.
Stakeholder Engagement
The project lead identified a firm commitment from the clinic director regarding the importance of EPI and standardizing an approach to implement the guidelines. Other stakeholders for the project included the clinic staff, pediatric residents, and other clinical faculty in practice.
Practice Facilitation
Primary care practices often lack the resources to invest in infrastructure and training. Practice facilitation increases the likelihood of success in QI initiatives, increases provider adherence to evidence-based guidelines, and improves care quality metrics in many clinical settings.24 The project lead served as the practice facilitator and engaged in QI activities, such as kickoff meetings, goal setting, maintaining momentum, and planning for leadership handoff.
Standard Work Protocol
The team streamlined and standardized eczema classification based on physical exam findings, body surface area affected, and topical steroid use. Thereafter, we directed the provider to follow the work protocol for the appropriate EPI guidance. The eczema classification and the EPI guidance resulted in 1 unified standard work protocol for providers (Fig 1).
Home Peanut Introduction Handout
The QI team determined that the instructions in the addendum guidelines, as written, were complex and might deter caregivers. The addendum guidelines offer 3 different types of peanut-containing foods.1 The team felt using peanut butter was most practical and accessible to families, and thus we removed other forms of peanut-containing foods from our handout. PORCH, a community organization collecting food donations, supplies the clinic with food, including peanut butter, ensuring access to those families with food insecurity.
Given the site-specific needs assessment, the project lead simplified the instructions for home introduction of peanuts. The new handout captures similar safety guidance and simplifies feeding directions (Fig 2). Providers electronically inserted the handout in the patients’ after-visit summary. The clinic used UNC translation services for a Spanish-translated version of the handout to serve the clinic’s Spanish-speaking families.
EMR Changes
There were 3 changes to the clinic’s provider templates for 4, 6, and 9-month WCC encounters. Members of the QI team adapted the note templates for these WCC encounters in the EMR to remove redundant elements in the existing note templates. The sections of the note template addressing peanut introduction were designed to be easy and quick to use.
Second, the QI lead included an anticipatory guidance section for EPI screening for each 4, 6, and 9-month WCC visit template for the associated visit. The EPI screening tool involved multiselect drop-down lists for solid food introduction, peanut introduction, and assessment of other risk factors for the development of peanut allergy. The template then prompted the provider to select a low or high-risk level for the infant related to the development of peanut allergy. Based on the risk stratification, the provider chose from another drop-down list to guide the family toward home introduction or direct the provider to order a serum immunoglobulin E to peanut. In rare cases, the work protocol prompted the provider to recommend peanut avoidance when there is a history of allergic reactions consistent with the diagnosis of peanut allergy. At 6 and 9-month WCC visits, the templates prompted providers to ask about peanut consumption since the infant’s last visit.
Third, we modified the physical skin exam findings on the EMR template to a specific detailed skin assessment drop-down list detailing the presence or absence of typical morphologic features of eczema on specified areas of the infant’s body. This focus on standardizing and improving eczema classification is essential to adequately stratify infants into the correct risk category for the development of peanut allergy. Screenshots of EMR changes appear in Fig 3.
Study of the Interventions
Using tailored EMR reports and manual chart reviews, the project lead compiled data from baseline through 6 PDSA cycles (Table 1) and 5 months of sustainability after the project for all 4, 6, and 9-month WCCs in the clinic.
Date . | PDSA Cycle . | Changes to Improve Outcomes . |
---|---|---|
4/1/22–4/28/22 | #1 | Clinic residents and faculty piloted the EMR templates and smart lists or phrases for user and logic errors. Minor adjustments to smart phrase logic and usability in response to piloting feedback. |
4/29/22–5/19/22 | #2 | Project lead provided education to residents and faculty on the background of peanut allergy, LEAP guidelines, and QI project CDS toolkit and aims. |
5/20/22–6/2/22 | #3 | Project lead launched the approved EMR templates and CDS tools for 2 uninterrupted weeks to allow interface with the smart lists or phrases, home peanut introduction handout, and standard work protocol by multiple providers in the clinic. |
6/3/22–6/16/22 | #4 | UNC interpreter services translated the home peanut introduction handout into Spanish for AVS. Modified work protocol to tighten classification of ‘severe’ eczema to exclude recurrent hydrocortisone use after feedback from faculty providers. Expanded EMR accessibility to home peanut introduction handout through the EMR permissions feature. |
6/17/22–7/7/22 | #5 | Project lead visited the clinic weekly to answer questions and boost engagement with the project by providing candy and printed peanut allergy comic strips. Laminated computer tags with visual text reminders of smart phrases for the English and Spanish home peanut introduction handout to increase distribution in AVS. |
7/8/22–8/11/22 | #6 | Placed in-text reminder embedded in the LEAP risk smart phrase or list section reminding provider to put home peanut introduction handout in the patient AVS for low to moderate-risk infants. |
Date . | PDSA Cycle . | Changes to Improve Outcomes . |
---|---|---|
4/1/22–4/28/22 | #1 | Clinic residents and faculty piloted the EMR templates and smart lists or phrases for user and logic errors. Minor adjustments to smart phrase logic and usability in response to piloting feedback. |
4/29/22–5/19/22 | #2 | Project lead provided education to residents and faculty on the background of peanut allergy, LEAP guidelines, and QI project CDS toolkit and aims. |
5/20/22–6/2/22 | #3 | Project lead launched the approved EMR templates and CDS tools for 2 uninterrupted weeks to allow interface with the smart lists or phrases, home peanut introduction handout, and standard work protocol by multiple providers in the clinic. |
6/3/22–6/16/22 | #4 | UNC interpreter services translated the home peanut introduction handout into Spanish for AVS. Modified work protocol to tighten classification of ‘severe’ eczema to exclude recurrent hydrocortisone use after feedback from faculty providers. Expanded EMR accessibility to home peanut introduction handout through the EMR permissions feature. |
6/17/22–7/7/22 | #5 | Project lead visited the clinic weekly to answer questions and boost engagement with the project by providing candy and printed peanut allergy comic strips. Laminated computer tags with visual text reminders of smart phrases for the English and Spanish home peanut introduction handout to increase distribution in AVS. |
7/8/22–8/11/22 | #6 | Placed in-text reminder embedded in the LEAP risk smart phrase or list section reminding provider to put home peanut introduction handout in the patient AVS for low to moderate-risk infants. |
Measures and Analysis
This project included 2 primary outcome measures, 1 focused on EPI documentation and the other on caregiver-reported peanut ingestion. An additional outcome and single process measure targeted provider behaviors in response to our QI initiative. Two balancing measures tracked the project’s impact on vaccination rates and patient in-room time. The QI team used control charts for the measures analyses, observing the Shewhart Rules in determining clinical and statistical significance (Table 2). The project lead used QI macros for Excel (KnowWare International Inc., Denver, Colorado; Version 2018) to generate statistical process control charts (SPCCs) and analyze data. We collected and reported data for all infants seen for their routine 4, 6, and 9-month WCC encounters over a period of 12 consecutive months.
Measure Type . | Description . | Measure . | Significance . | Analysis . |
---|---|---|---|---|
Outcome | EPI guidance from providers to patient caregivers | Documentation of clinically appropriate EPI guidance at 4, 6, and 9-mo WCCs in patient EMR | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Outcome | Caregiver-reported peanut consumption by infants | Reported consumption of peanut by caregivers at 6 and 9-mo WCCs | Measurement of QI initiative on caregiver behavior in response to provider guidance | SPCC with statistical significance using Shewart rule for Significance |
Outcome | Distribution of home peanut introduction handout | Percentage of expected home peanut introduction handout inserted in AVS for infants with no eczema or mild to moderate eczema | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Process | Provider adoption of revised 4, 6, and 9-mo WCC templates and smart lists | Percentage of provider use of templates, smart lists, and documentation features as intended without deletions or substitutions at 4, 6, and 9-mo WCCs | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Balancing | Patients receiving 6-mo DTaP vaccine (expected) | Rate of vaccination for DTaP at 6 mo of age (EPIC dashboard data) | Measurement of QI impact on immunization compliance | Descriptive statistics |
Balancing | Average visit length (min) for 4, 6, and 9-mo WCCs | Patient time in-room (min) | Measurement of QI impact on length of provider-parent interaction | SPCC with statistical significance using Shewart rule for Significance |
Measure Type . | Description . | Measure . | Significance . | Analysis . |
---|---|---|---|---|
Outcome | EPI guidance from providers to patient caregivers | Documentation of clinically appropriate EPI guidance at 4, 6, and 9-mo WCCs in patient EMR | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Outcome | Caregiver-reported peanut consumption by infants | Reported consumption of peanut by caregivers at 6 and 9-mo WCCs | Measurement of QI initiative on caregiver behavior in response to provider guidance | SPCC with statistical significance using Shewart rule for Significance |
Outcome | Distribution of home peanut introduction handout | Percentage of expected home peanut introduction handout inserted in AVS for infants with no eczema or mild to moderate eczema | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Process | Provider adoption of revised 4, 6, and 9-mo WCC templates and smart lists | Percentage of provider use of templates, smart lists, and documentation features as intended without deletions or substitutions at 4, 6, and 9-mo WCCs | Measurement of QI initiative on provider behavior | SPCC with statistical significance using Shewart rule for Significance |
Balancing | Patients receiving 6-mo DTaP vaccine (expected) | Rate of vaccination for DTaP at 6 mo of age (EPIC dashboard data) | Measurement of QI impact on immunization compliance | Descriptive statistics |
Balancing | Average visit length (min) for 4, 6, and 9-mo WCCs | Patient time in-room (min) | Measurement of QI impact on length of provider-parent interaction | SPCC with statistical significance using Shewart rule for Significance |
Ethical Considerations
The UNC institutional review board (IRB) found this QI initiative was an internal improvement project and exempt from IRB oversight. IRB #22-0559.
Results
The average number of 4, 6, and 9-month infant visits in each biweekly period was 19 (ranging from 8 to 28). The workflow prompted providers to insert the home peanut introduction handout for infants with no or mild-moderate eczema at 4, 6, and 9-month WCCs. The home introduction handout was not expected for infants not yet developmentally ready for solids or infants already eating peanuts. The distribution rate of the home peanut introduction handout into the patients’ after-visit summary (AVS) increased from 5.2% at baseline to 54.1% during sustainability (Fig 4).
The EPI guidance documentation increased from 13.9% at baseline to 83.5% during sustainability (Fig 5). Reported peanut consumption by caregivers during 6 and 9-month WCCs increased from 0% at baseline to 34.6% during sustainability (Fig 6).
The adoption rate of the EMR templates, smart lists, and phrases increased from 2% at baseline to 73% during sustainability (Fig 7).
There were no significant changes to balancing measures during the project. DTaP vaccination rates remained at 100%. There was no significant shift in the patient time in-room of 65 minutes during the project (Fig 8).
Discussion
We significantly improved measures to increase early peanut introduction in infants using QI methodology and interprofessional collaboration. Using a standardized EMR bundle of CDS tools, engagement, facilitation, and feedback to providers conducting the targeted WCC encounters helped achieve project aims.
Before this project, discussing EPI guidance between providers and caregivers under the 2017 and updated 2019 guidelines was a reasonable expectation in the primary care setting. Given the rationale for our project was that implementation of these guidelines was low, this particular outcome measure’s improvement from 13.9% to 83.5% throughout the project and, into 5 months of sustainability, shows the powerful impact of our intervention.
For the other measures analyzed with SPCCs, we exceeded our goals of 50% for the documentation of EPI guidance and distribution of the handout in the AVS. We fell just short of our goal for provider adoption of the templates and smart lists, but the measure improved from baseline with a statistically significant shift in the mean.
We tracked caregiver-reported peanut consumption at 6 and 9-month WCC visits through all project phases. We observed shifts in the percentage of reported ingestion between baseline, implementation, and sustainability as template use gained momentum. Most infants had not yet introduced solids by 4 months, but EPI guidance is still important during these early infant WCCs. We did not find any documentation of reported peanut consumption during our baseline review of charts. Though we did not reach our goal of 50% peanut consumption at 6 and 9-month WCCs during the project, 34.6% reported consumption in this age group by the end of sustainability speaks to the efficacy of our CDS bundle on patient-centered outcomes. Caregivers who reported no peanut consumption at the 6 and 9-month WCC visits allowed providers to reinforce EPI guidance.
Identifying and tracking balancing measures remain essential parts of QI work. Overall, we made significant changes to the context of these WCC visits with minimal disruption to these other visit aspects. Although in-room time did not significantly change throughout the project, we observed the beginnings of a data shift above the average in-room time during early sustainability, which coincided with the start of a new academic year and a surge of influenza, coronavirus disease 2019, and respiratory syncytial virus in the Fall of 2022. The clinic experienced increased visits during this time and had challenges with staffing because of illness. In addition, we suspect that many new resident providers forget to document when the patient visit is complete, which alters the recorded in-room time.
The availability of the coronavirus disease 2019 vaccine for infants in our target population, new residents starting with the academic year, and surges of respiratory illness coincided with a decrease in our measures tracked with SPCCs. These findings were not unexpected, but revamping toward education, engagement, and facilitation showed these measures rebounded quickly, and during the second half of sustainability, in-room time showed recovery, evidenced by consecutive decreases in the final 3 months of the project.
A particular strength of this QI project was the use of the EMR to make counseling about EPI easier for providers. The prompt in the note template reminded providers to counsel about this topic in our clinic, where many resident physicians rotate through without consistent presence to learn new processes. In addition, the patient education materials were easily inserted into the after-visit materials for patients, allowing a tool to guide a conversation with families and materials for the family to take home. Lastly, our process-driven CDS tools captured reported peanut consumption by caregivers at 6 and 9-month WCCs.
Other published QI work aiming to improve EPI guideline adherence discusses projects that used education sessions and pre and postassessments but did not incorporate CDS tools.13,25 Although these projects documented increased provider awareness and knowledge about EPI guidelines, the projects lacked supporting data that increased knowledge translated into practice changes during WCC encounters. One QI project used emails to providers, small group education sessions, reminder cards at workstations, home introduction sheets, and onsite assistance by an allergist to improve guideline adherence.26 Guideline adherence did not exceed 17% during the intervention cycles. Although these interventions represent CDS tools, they were neither standardized nor inclusive of EMR templates or smart phrases.
The most similar effort to improve EPI guideline adherence is the iREACH program, a CDS bundle utilizing EMR features and handouts to aid providers in EPI in primary care settings. In a sample of 143 WCC encounters at 4 and 6 months, results showed better adherence to guidelines (52.4%) with the use of the iREACH bundle compared with the control clinic (14.1%) without the bundle (P < .001).20
Koplin et al showed that guideline adherence might only prevent up to 44% of peanut allergy diagnoses if providers restrict interventions to high-risk infants.11 Therefore, continuing to use the home peanut introduction handout in infants with no eczema may be beneficial in preventing unnecessary peanut avoidance. PCPs are most likely to interface with otherwise healthy infants, and assessing infants for early atopy offers a unique opportunity to practice primary and secondary prevention. Most infants observed during this QI project met the criteria for immediate home introduction of peanuts and were able to avoid unnecessary allergy referrals. PCPs should confidently promote broad EPI and diet diversification in patients showing developmental readiness for solid food introduction.
Although this project at a single site showed improvements in early peanut introduction, the goal of generalizability of this QI initiative to the broader population remains an unmet need. Moving the needle on this initiative will require working with more primary care clinics. One barrier to generalizability is that some offices do not use EMR systems, making the reproducibility of these interventions more challenging. However, the handouts can serve as stand-alone documents for printing and distribution to families. Additionally, CDS tools could include modifying prompts about EPI guidance on paper charting systems in place of EMR accessibility.
Another limitation of our study is that there are significant anticipatory guidance recommendations for WCCs. Our study examined several balancing measures but could not capture the full complexity of WCCs and aspects of the visit that may have been lost because of adding in this counseling. Future projects should assess caregiver understanding and knowledge of EPI guidelines after visits, as this was beyond the scope of our project.
Conclusions
Peanut allergy in children is a population health problem affecting families and healthcare systems. Research shows EPI can reduce the incidence of peanut allergy, but adoption of this practice remains low in primary care settings. QI methodology improved documentation of EPI guidance at routine WCC encounters and reported rates of peanut consumption without impacting other measures at our site. Broader PCP use of CDS tools and EMR standardization could improve guideline adherence to prevent peanut allergy in infants.
Acknowledgments
Thank you to the providers and staff at the UNC Children’s Primary and Specialty Care Clinic for engaging with this project. Thank you also to Dr. Edwin Kim for his mentorship.
Dr Herlihy conceptualized and designed the project, designed the data collection instruments, collected data, conducted the initial analyses, and drafted the initial manuscript; Dr Walters advised Dr Herlihy throughout the project design and implementation and aided in data analyses; Dr D’Auria advised Dr Herlihy throughout the project design and implementation; Dr Orgel collaborated on the standard work protocol’s design and rollout; Dr Jordan oversaw project implementation and sustainability efforts and aided in data analysis; and all authors critically reviewed and revised the manuscript, approved the final manuscript as submitted, and agree to be accountable for all aspects of the work.
FUNDING: No external funding.
CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest to disclose.
- AAP
American Academy of Pediatrics
- AVS
after visit summary
- CDS
clinical decision support
- EMR
electronic medical record
- EPI
early peanut introduction
- IRB
Institutional Review Board
- LEAP
Learning Early About Peanuts
- PCP
primary care provider
- PDSA
Plan Do Study Act
- QI
quality improvement
- SPCC
statistical process control chart
- UNC
University of North Carolina
- WCC
well child check
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