Enhancing Clinical Access to Pediatric Celiac Disease Care at UCSF Health using a Human-Centered Design Framework
PROPOSAL TITLE: Enhancing Clinical Access to Pediatric Celiac Disease Care at UCSF Health using a Human-Centered Design Framework
PROJECT LEAD(S): Telly Cheung, MD; Mala Setty, MD; Patrika Tsai, MD, MPH
EXECUTIVE SPONSOR(S): Sue Rhee, MD; Amy Lu, MD
ABSTRACT
Clinical access to pediatric celiac care at UCSF remains inadequate, as >90% of kids are estimated to be undiagnosed or unknown to the institution. This represents a significant missed opportunity to screen, diagnose, and manage a growing population of children with celiac disease. No qualitative initiatives to date have engaged caregivers and practitioners to 1) identify these barriers to patient access and 2) co-design patient-centered interventions to enhance care delivery. As therapeutics rapidly emerge, we need to improve care gaps that are limiting individuals from seeking celiac expertise. We propose a novel human-centered design project to increase access to celiac care by streamlining scheduling workflows, engaging in patient-centered outreach, standardizing nutritional resources, and developing practitioner-driven modifications to the electronic health records. Using structured design methods, we will pilot this work in the Type 1 diabetes clinics at UCSF. We aim to boost referral volumes and improve care efficiency by 25% at UCSF. A 3% increase in patient volume during FY2026 would generate an estimated return of investment of $353,478 from initial evaluation, screening, and diagnostic endoscopies, and up to $4.6 million from endoscopies if we evaluated all missing cases.
TEAM
- Telly Cheung, MD (Project Lead), 3rd Year Pediatric GI Fellow, Rising Assistant Professor of Pediatrics
- Mala Setty, MD (Project Co-Lead), Professor of Pediatrics
- Patrika Tsai, MD, MPH (Project Co-Lead), Professor of Pediatrics
- Sharad Wadhwani, MD, MPH (Project Mentor), Assistant Professor of Pediatrics
- Namrata Patel-Sanchez, MD, MPH (Quality Improvement Mentor), Assistant Professor of Pediatrics
- UCSF School of Medicine Technology team (Project Collaborator), Human-Centered Designers
- Jennifer Olson, MD (Project Collaborator), Professor of Pediatrics
- Sharon Chui, MPH (Project Collaborator), Digestive Disease Administrative Director
- Sue Rhee, MD (Executive Sponsor), Division Chief of Pediatric Gastroenterology
- Amy Lu, MD (Executive Sponsor), Chief Quality Officer, UCSF Health
PROBLEM
Celiac disease is a chronic, small-intestinal immune-mediated enteropathy estimated to affect over 100 million individuals worldwide.1,2 Among the 7.7 million people living across 9 counties in the Bay Area, an estimated 22,000 children likely have celiac disease. This estimate is based on the 1.4% global prevalence of celiac disease and approximation that 20% of the Bay Area population is under 18 years old.2,3 From 2013-2023, about 2,000 children screened for celiac seropositivity at UCSF, which accounts for <10% of potential cases. Thus, >90% of kids remain undiagnosed or unknown to UCSF, leading to missed opportunities for early diagnosis, timely intervention, and effective reduction of morbidity and mortality in a growing celiac population.4
Celiac disease imposes a burden on children, society, and the healthcare system through high dietary costs, nutritional deficits, barriers to reimbursement, loss in school performance, and greater healthcare utilization.5 These challenges disproportionately affect low-income families with limited access to care, and may worsen existing health inequities.6,7 No quality improvement initiatives to date have engaged caregivers and practitioners in designing targeted interventions to bridge these care gaps. Across studies, models for improvement in chronic pediatric illnesses have leveraged patient-centered strategies to transform healthcare systems.8–15 They lay the groundwork for advancing celiac care by underscoring the value of accessibility.
Despite these critical gaps, therapeutics are rapidly emerging with >20 celiac drugs currently under investigation, and Phase 3 trials for adults beginning in early 2025.16–18 Building a model of care at UCSF that integrates the needs of caregivers and practitioners will be essential to serving the millions anticipated to seek gastroenterology expertise over time.19 By utilizing human-centered design methods, we will directly engage stakeholders in developing best-practices tailored to their needs. Piloting structured design work in type 1 diabetes, a high-risk condition with >5-fold higher prevalence of celiac disease, will inform decision-making and enable a strategic, scalable approach to improve clinical access for pediatrics and adults.20–22
The UCSF Division of Pediatric Gastroenterology is committed to advancing quality initiatives that address gaps, meet rising demand, and enhance celiac care. This project builds upon our Division’s investment in the professional growth of the celiac team. Support from Caring Wisely would accelerate key milestones needed to develop stakeholder-driven improvements, positioning UCSF to offer high-quality and accessible celiac care.
TARGET
Our target goal is to use human-centered design methods to establish an integrated care model for celiac disease that improves clinical access to screen, diagnose, and manage all children with concomitant type 1 diabetes by 25% across UCSF Health centers between 2025-2026. We will use structured design incorporating stakeholder values and preferences to achieve these qualitative and quantitative benefits:
Qualitative |
| Quantitative |
Improve clinical access for children with celiac disease | → | Increase celiac referral volume by 25% |
Design educational material for caregivers and pediatricians that manage chronic conditions associated with celiac disease | → | Increase celiac serology testing by 25% |
Develop standardized gluten-free diet resources | → | Reduce time to dietician education by 25% |
Establish an APeX-based Smartform to streamline celiac screening, diagnosis, and management | → | Improve standardized documentation by 25% |
Enhance framework to transition children to adult care | → | Increase transition-of-care for patients ≥21 years old to Adult Gastroenterology by 25% |
GAPS
Several gaps at UCSF detract from screening, diagnosing, and managing the >90% of potential diagnoses.
System issues:
- Lack of systematic infrastructure to efficiently identify at-risk individuals from primary care and subspecialties, refer to Pediatric Gastroenterology, and timely schedule with the celiac team
- Fragmented care prohibits multi-disciplinary and team-based management of celiac disease
Educational gaps:
- Inadequate outreach to engage with caregivers and educate pediatricians on the referral of at-risk kids
- Non-standardized dietary education reduces the effectiveness and quality of dietary counseling
Technological gaps:
- Lack of standardized documentation to chart the disease course of celiac disease
- Gaps in clinical documentation limit effective transition-of-care from Pediatric to Adult Gastroenterology
INTERVENTION
Human-centered design is a novel participatory-based approach used in public health, medicine, and industry to solve problems.23 This structured process elicits the perspectives and values of stakeholders, allowing for the co-design of interventions specific to the end-users’ needs. By integrating inclusive and equitable strategies, human-centered design is ideal for addressing the systematic, educational, and technological disparities in celiac care. We will apply human-centered design principles to inform the following interventions aimed to improve clinical access to celiac care:
| Intervention | Description | Rationale | Equity-Driven |
System | Re-design efficient referral and appointment scheduling workflows | Understand the barriers patients face in accessing celiac care and identify practitioner needs for improving scheduling | Streamlining referrals will enhance accessibility, reduce delays, and improve care transition from teens to adult care | Enroll caregivers who screen positive for ≥1 social need(s) (i.e., financial strain, food insecurity, housing instability, and/or transportation issues) |
Education | Develop a patient-centered outreach campaign | Raise awareness among the community and referring pediatricians | Minimizing educational gaps among caregivers and practitioners will improve recruitment | Create an outreach intervention in multiple languages |
Education | Create standardized gluten-free diet nutritional resources for dissemination | Define high-value gluten-free diet resources and preferred modality to disseminate education | Decreasing inconsistency in dietary counseling will improve adherence and disease control | Provide culturally appropriate gluten-free education that aligns with the diverse dietary practices of families |
Technology | Practitioner-driven modifications to the electronic health records | Incorporate practitioner-driven modifications to the electronic health records to enhance documentation of celiac disease courses | Standardized documentation will facilitate more efficient monitoring of at-risk kids, resource allocation for refractory cases, and support transition-of-care | Ensure the values and preferences of all team members (i.e., clinicians, dieticians, social workers, and medical staff) are recognized |
Practice Setting: We will focus on outpatient clinics for celiac disease and type 1 diabetes through the Department of Pediatrics that spans UCSF Mission Bay and Benioff Children’s Hospital Oakland.
Target Population: We will assemble a team of caregivers (N=12) and practitioners (N=8). To ensure equity, we will enroll caregivers with ≥1 social need(s) (i.e., financial strain, food insecurity, housing instability, and/or transportation issues) based on UCSF’s Social Determinants of Health tracker. We will recruit racially and ethnically minoritized caregivers to promote diverse representation. Practitioner teams will include: 2 gastroenterologists, 2 pediatricians, 1 advanced practice provider, 1 dietician, 1 social worker, and 1 practice administrator.
Approach: We will use design tools (e.g., brainstorming, sorting, categorizing, sketching, theming, synthesis, ideation, role-playing, storyboarding, and prototyping) to identify the high-value barriers to accessing and improving celiac care. The Double-Diamond model for human-centered design provides a framework to first broaden our understanding of the problems in the current celiac model of care (Discovery), distill these problems into design principles (Define), again expand on potential solutions (Develop), and finally narrow design solutions (Deliver) based on iterative feedback from stakeholders. We will achieve these aims by engaging stakeholders in a series of 8 virtual focus groups.
| Focus Group # | Focus Group Agenda |
Discover | 1 – Caregivers 2 – Practitioners | Identify gaps in care Brainstorming |
Define | 3 – Caregivers 4 – All | Define design principles Problem sorting and categorizing |
Develop | 5 – Caregivers 6 – Practitioners 7 – Caregivers 8 – All | Ideation and role-playing Visual storyboarding Prototype iterations |
Focus Group Content: In focus groups 1-2 (Discovery), we will ask caregivers and practitioners to share their experiences in receiving and providing care, respectively. In semi-structured interviews, we will ask about their experiences managing celiac disease, barriers to dietary adherence, scheduling and APeX workflow issues, and challenges accessing or providing care. In focus groups 3-4 (Define), we will design concept maps using data captured in Discovery. We will sort and prioritize problems as elicited by stakeholders (e.g., ranking and voting). We will map the path that children and their caregivers go from symptom onset to diagnosis and treatment (i.e., obtaining referrals, getting blood work, identifying gluten-free options, and scheduling follow-up). For practitioners, we will map their experience scheduling, evaluating patients, helping caregivers navigate dietary changes, and documenting clinical data. We will distill the findings into design principles to guide our interventions to address these problems. In focus groups 5-6 (Develop), we will evoke ideation and role-playing among caregivers and practitioners to develop patient-centered healthcare interventions. We will facilitate ideation and storyboarding to allow stakeholders to react, respond, and discuss their ideas. By brainstorming and sorting solutions with stakeholders, we will prioritize the most important interventions in our celiac model of care. In focus groups 7-8, we will develop a prototype iteration for these ideal targets. We will support structured feedback to ensure that storyboards reflect stakeholders’ perspectives.
Potential barriers to implementation: We may have insufficient representation of diverse social needs from caregivers. We will purposely enroll caregivers with social adversities screened at UCSF to ensure equitable inclusion. We may also have difficulty scheduling focus groups with stakeholders. We will budget extra time to schedule focus groups up to every 2-4 weeks. Moreover, we bring our: (1) experience applying human-centered design methods to now published work, (2) formal training in human-centered design through UCSF’s Department of Epidemiology and Statistics, (3) existing relationships with design team consultants who will directly support this proposal, (4) success in recruiting diverse participants, and (5) planned advanced training in the Improvement Science Series at Cincinnati Children’s that lines up with the start-up of this award period.24,25 Together, this ensures our proposal can feasibly be conducted within the 1-year award period.
Potential adverse outcomes of proposed interventions: Practice changes (i.e., standardization of gluten-free resources and documentation) may initially be challenging to adopt. Our human-centered design approach will integrate the values and preferences of stakeholders into interventions, thus helping to streamline implementation. As clinical access increases, we expect that higher patient volumes will require adjustments in practitioners’ schedules. Our focus on optimizing scheduling workflow will preemptively address these issues.
PROPOSED EHR MODIFICATIONS
Due to gaps in standardizing the identification of all at-risk individuals, we will implement an APeX Smartform initiative to improve documentation. Currently, our non-standardized approach to documenting disease courses detracts from monitoring the most at-risk individuals. By building a celiac-focused Smartform into patients’ “Problem List”, this unified documentation will facilitate quality improvement efforts and strengthen future research opportunities. We will develop a template to track disease severity, symptom profile, diagnostic criteria, associated conditions, serologic and nutritional markers, anthropometrics, and dietary adherence.
RETURN ON INVESTMENT (ROI)
By establishing a systematic, educational, and technological framework to improve our screening of celiac disease among high-risk children with type 1 diabetes, we will increase clinical access and reduce the widening gap in equitable care. By conservative estimates using Medi-Cal reimbursement rates, if we increased our screening to capture even 3% of the 20,000 children with potential celiac disease in the Bay Area, a comprehensive evaluation (i.e., laboratory screening, diagnostic endoscopies, and referrals) would generate an estimated return of investment of $353,478 in revenue.26 Moreover, the billing of outpatient follow-up and celiac screening required for 1st degree family members would further enhance revenue.1,27,28 Our estimates would represent the recruitment of approximately 40% of children with type 1 diabetes currently followed at UCSF. The market share for the estimated 20,000 and growing number of children in the Bay Area with celiac disease remains substantial. These initiatives lay the groundwork for generating up to $4.6million from diagnostic endoscopies alone of all undiagnosed children, with adult cases bringing an additional $20 million.2,3,26 Investing to improve the model of care for celiac disease will capture the projected >$10 billion market for gluten-free products and services (by 2032), leveraging near limitless growth potential for UCSF.29
Tests and Referrals | Procedural Code (CPT) | Cost (Medi-Cal rates)26 |
Complete blood count with differential | 85025 | $6.75 |
Complete metabolic panel | 80053 | $9.19 |
Tissue transglutaminase IgA | 86364 | $11.53 |
Deamidated gliadin peptides IgA and IgG | 86258 | $11.53 |
Endomysial antibody | 86231 | $12.09 |
Total serum IgA | 82784 | $6.08 |
Total serum IgG | 82784 | $6.08 |
Thyroid stimulating hormone | 84443 | $14.76 |
Free thyroxine (T4) | 84439 | $7.91 |
Iron panel | 83540 | $5.72 |
Ferritin | 82728 | $12.07 |
Vitamin D | 82306 | $20.72 |
HLA celiac typing | 81382 | $109.94 |
Upper endoscopy with biopsies | 43239 | $234.18 |
Complex new outpatient visit | 99205 | $90.23 |
Dietician referral | 97802 | $30.35 |
SUSTAINABILITY
If successful, this foundational work will identify gaps to accessing celiac care and help develop patient-centered solutions, setting the stage for a Cross-Bay Celiac Disease Program at UCSF. Once implemented, our interventions (i.e., scheduling workflow updates, nutritional resources, and APeX modifications) should require minimal maintenance from personnel. Moreover, by creating a robust referral network, generating revenue, and gaining recognition as a world-renown institution, we position UCSF to garner support from the Department of Pediatrics, Division of Pediatric Gastroenterology, and philanthropy from donors. Philanthropy remains a key driver of success in other Celiac Disease Centers nationally. Philanthropic efforts will be one instrumental component to ensure the Center's long-term impact and outreach. Ultimately, implementation of our quality initiatives will inform a scalable model that may advance health equity in other chronic diseases.
BUDGET
Budget Item | Description | Amount |
UCSF SOM Tech Team | The UCSF SOM Tech team provides expertise in human-centered design and will be responsible for facilitating semi-structured interviews, focus groups, and applying human-centered design principles for this project. | $19,800 ($132 hourly rate, 150 hours of effort) |
Salary Support for Dr. Cheung | Lead all aspects of project ideation, design, development, management, implementation, and analysis. | $20,000 (0.15 FTE) |
Participant Incentives | We will give participants $50 for each focus group that they participate in. | $8000 |
Transcription Services | We will transcribe recorded focus groups using a professional transcription service (TranscriptionWing). | $1500 |
Data Network and IT Support | We will budget for data networking and IT support (i.e., for data storage, software, hardware, and/or internet security). | $500 |
REFERENCES
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Comments
What a wonderful proposal to
What a wonderful proposal to improve our patient efficiency, satisfaction, and revenue! Way to go Aimee!
This project will increase
This project will increase access to many patients waiting to for a test, while keeping them informed on what to expect. Thank you for working on this Aimee and Bill!
Such a great idea to educate
Such a great idea to educate our patient population that can result in our team meeting and exceeding patient expectations, and ultimately improving patient outcomes.