The HCD research process typically involves defining the problem and empathizing with end user needs, followed by brainstorming and ideation, prototyping, and testing potential solutions [24]. In this study, we focused on early formative phases of HCD: defining and empathizing with end user needs through collaborative exploration of perspectives and discussion of experiences among all participants. To that end, we first conducted a semistructured individual interview with AYA patients with IBD and IBD clinicians (including gastroenterologists, surgeons, and nurses). The primary goal of the interviews was to elucidate experiences with managing pain, current practices related to using or prescribing opioid medications, and potential gaps in the care pathways for AYA patients with IBD that could be contributing to higher rates of opioid use in this patient population.

To further clarify end user needs and begin brainstorming solutions, we conducted a co-design workshop, a well-established application within the HCD approach [34]. Bringing together patient and clinician interview participants, our goal for the co-design workshop was to gain insight, based on participants’ discussions and reflections as a group, into the challenges of managing pain in IBD care and potential solutions to enhance safety in pain management. Together, the interview and workshop findings establish a foundation for future development of a digital opioid safety tool tailored for AYA with IBD. The study design and reporting adhered to the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines (Checklist 1) [35].

Our multidisciplinary team brought together a variety of experiences and expertise to the process of data collection and analysis. For example, 3 research team members are clinicians who see young patients with IBD (LC, SBH, and MVR), 2 research team members are patients with IBD (AA and SNB), and another team member is the father of a child with a complex GI condition (ABLB). Additionally, 2 team members have extensive design training and expertise (AA and ABLB), 4 team members are trained in community health research (MY, LC, DD, and NSB), and 3 team members have expertise in health services and outcomes research (MY, MVR, and SNB). Given prior literature describing power imbalances between patients and clinicians and/or researchers, we ensured that our team was intentionally multidisciplinary (ie, including patient, clinician, and researcher viewpoints) so that we could consider and balance those perspectives throughout the study [36,37]. To this end, we took several steps, particularly during the co-design workshop, to mitigate potential power imbalances between patient and clinician participants. These steps included abandoning formal professional titles in favor of first names, using interactive techniques such as structured “round robin” turns to equalize participation, and holding the sessions in a neutral, easily accessible space rather than a clinical boardroom, office, or hospital space [36,37]. Throughout the study planning, data collection (interviews and workshop), and analytic phases, team members acknowledged how their clinical knowledge and lived experiences (as researchers, patients, and/or clinicians) may have influenced their interpretation of the findings and emerging themes in the data. To ensure reflexivity, team members engaged in regular team discussions and memo writing to document analytic decisions.

Semistructured interviews and the co-design workshop were conducted with AYA patients with IBD and IBD clinicians at Ann & Robert H. Lurie Children’s Hospital of Chicago and the Digestive Health Center at Northwestern Memorial Hospital.

We used Malterud and colleagues’ [38] model of information power to help inform the total number of study participants, indicating a narrow study aim: participants with experiences in living with IBD or caring for others who live with IBD; a strong dialogue during interviews and the co-design workshop, guided by prior relevant knowledge; and an appropriate thematic analysis. For patients, we focused on their experiences with pain management, opioid use, and the transition to adult care. We used a convenience sampling approach. Eligibility criteria for patients included (1) patients aged 15‐29 years and (2) previously diagnosed with IBD with a clinic visit record. The IBD clinics at both Northwestern’s Digestive Health Center and Lurie Children’s Hospital provided our team with a list of AYA patients, with their email contact information, who received IBD care from that facility and met our eligibility criteria. Eligible patients who met inclusion were invited to participate by email. In the summer of 2023, we informed these patients about the study by email and invited them to participate in the study. We then sent a weekly reminder via email to all eligible patients who had not responded. Interested eligible patients received an information sheet outlining our study aims, procedures, potential risks and benefits, privacy protections, and the voluntary nature of their participation. We scheduled the interview at participants’ convenience between June and August 2023 either in-person or by video-based conferencing. At the beginning of each interview, we included time to answer any questions the participant may have had about the study and to obtain informed consent for participation in the study.

For clinicians, the objective was to explore their perspectives on, and practices for, monitoring pain, prescribing opioids, and managing pain in AYA patients with IBD. All IBD-focused clinicians (16 in total) at the Digestive Health Center and the Lurie Children’s Hospital, including gastroenterologists, surgeons, nurses, and nurse practitioners, were invited to participate by email invitation. As in the patient interviews, we scheduled clinician interviews according to their convenience between July and August 2023 either in-person or by video-based conferencing. At the beginning of each interview, we included time to answer any questions the clinician participant may have had about the study and obtained informed consent for participation in the study.

All interviews and the workshop session were audio recorded and transcribed verbatim. The interviews and workshop sessions were analyzed concurrently using thematic analysis [43]. Two research team members (SNB and LC) independently coded the transcripts using an inductive coding approach and the constant comparison method to compare data from an initial group of transcripts and generate a preliminary codebook. The 2 coders then collaboratively compared and refined codes, code applications, and code definitions to produce a final codebook (Multimedia Appendix 4), which was then applied to all transcripts. Discrepancies in code applications were reconciled through consensus [43,44]. Coded transcripts were analyzed within and across cases to develop themes, all of which represented needs and ideal attributes for the design of a digital opioid safety tool in this clinical setting. While interview and workshop data shared some overlap, they were distinct in that the interview data focused more on challenges experienced or needs expressed by participants. By contrast, the co-design workshop generated unique insights, building on the interviews, by inviting participants to consider innovative solutions related to opioid safety while engaging them in the workshop activities together. For both the interviews and workshop session, we again reflected on Malterud and colleagues’ [38] model of information power as a guide during our analysis meetings. In this context, development of our final themes and their categories continued until agreement was reached. MAXQDA (version 2022; VERBI Software GmbH) was used for data storage, coding, and thematic analysis.

The study was approved by the institutional review board at Northwestern University and all participants provided verbal consent (institutional review board number STU00216695). All study data were deidentified prior to analysis to protect participant confidentiality. Data were stored on encrypted, password-protected systems, and any Protected Health Information used for recruitment was securely maintained in a separate Health Insurance Portability and Accountability Act–compliant location with access limited to the study team. For their participation, all participants received a US $50 virtual gift card following each activity.

Of 20 patients approached, 7 (35%) participants were recruited. The remaining patients (n=13) reported that they could not participate due to other competing responsibilities, time constraints, or scheduling conflicts related to summer travel. After 1 weekly recruitment reminder, 4 of the 20 eligible patients had replied that they were willing to participate, which resulted in 4 interviews. After 2 additional weekly reminders via email, 3 additional patients expressed their interest in participating, resulting in a total of 7 interviews. Of the 16 clinicians approached, 13 (81%) were recruited; the remaining clinicians cited lack of time or scheduling conflicts as the reason why they could not participate or did not respond to our invitation. Therefore, overall, 7 patients and 13 clinicians participated in the study. Table 1 summarizes participant characteristics. Clinicians included 8 physicians (including gastroenterologists and surgeons), 3 nurse practitioners, 1 nurse, and 1 psychologist. All clinicians focused on IBD clinical care.

We organized the resultant themes into three broad categories: (1) Intersecting Needs (ie, relevant at the patient and clinician and/or health system level), (2) Patient-Level Needs (ie, relevant at the patient level only), and (3) Clinician- and/or Health System–Level Needs (ie, relevant at the clinician and/or health system levels only) to inform the design and development of a digital opioid safety tool. These categories helped to organize the insights shared by AYA patients and their clinicians, including needs for future interventions based on their experiences and roles. Our rationale for organizing themes in this way was to distinguish the unique needs of each group while still bringing their viewpoints together, particularly because the safety tool is intended to be used by both clinicians and patients. Therefore, our themes delineate these viewpoints by stakeholder group, although they may include viewpoints of participants representing a different group. Figure 1 demonstrates these themes by category. Themes are denoted in italicized text throughout this section.

We derived key themes, collectively categorized as “Intersecting Needs,” based on data reported by clinicians and patients. These themes are outlined in Table 2 alongside representative quotes. A primary need emphasized by both groups is the integration of safety interventions across multidisciplinary, chronic care settings. Clinicians emphasized that effective management of AYA patients with IBD requires comprehensive coordination across clinicians from multiple specialties beyond gastroenterology (eg, psychiatry or primary care), necessitating interventions that streamline care and access to a patient’s history. Patients frequently reported the burden of consolidating records from various clinicians to ensure comprehensive information exchange during appointments. For example, 1 AYA patient described getting procedures done with 1 clinician yet discussing results and future management with a different clinician, complicating continuity of care and putting the onus of coordination across clinical specialties on the patient (Table 2). Clinicians and patients both highlighted that, while this may be relatively typical of the siloed infrastructure of health care in the United States, in a setting specific to AYA with IBD or other chronic conditions, it is important to consider that many of these young patients also face the burden of additional chronic comorbidities, such as mental health illnesses. Seamlessly coordinating care and coordination of management is necessary for a positive, safe, and healthy experience for the patients, while also minimizing gaps in care management. This extended to clinician and patient perceptions surrounding the design of a digital opioid safety tool, which they believed must address co-occurring comorbidities and the reality of which AYA patients with IBD need to seek care from multiple specialties beyond gastroenterology.

Supporting AYA with IBD as they transition to independent care is another critical theme. The ages of 15‐29 years are marked by significant life transitions, including entering new academic or professional settings, relocating away from caregivers, and assuming primary responsibility for health management. Due to their positioning in terms of age and developmental stages, it is imperative to acknowledge the impact of a chronic disease and potential chronic opioid use for AYA with IBD and frame conversations and management plans, respectively. AYA patients expressed a desire for support during this transitional phase of life, such as continued support from caregivers during decision-making processes or even returning home for health care visits to maintain that support. Clinicians noted that many AYA may lack a full understanding of their diagnosis or treatment history, having only recently taken over care management responsibilities. Programs such as those at Ann & Robert H. Lurie Children’s Hospital of Chicago and the Crohn’s & Colitis Foundation were cited as existing resources designed to support AYA during this transitional phase through training sessions or support groups. However, both patients and clinicians emphasized the need for individualized approaches, recognizing the heterogeneity of experiences of AYA. All patients, especially AYA whose circumstances vary and who may rely on caregivers more than adult populations, require unique approaches and care. Variations in pain thresholds, definitions of pain, and care priorities were also noted as key factors that influence each patient’s needs.

The chronic nature of IBD fosters ongoing relationships between clinicians and patients, allowing for a deeper understanding of individual care preferences. Patients stressed the importance of framing conversations around overall health and wellness, emphasizing the profound impact of physical pain on mental health and social functioning. Additionally, AYA patients expressed fear about long-term medication use, specifically anxiety about potential side effects and dependence. Therefore, addressing both the physical and psychological dimensions of IBD management requires open communication about pain management and medication use, supporting AYA patients as they navigate their evolving health care needs while navigating their overall development and life stages.

Table 3 highlights key themes reflecting patient concerns, needs, and experiences related to pain management in IBD care. Clinicians must actively acknowledge and assess AYA patients’ pain experiences and set clear expectations for pain management. One clinician noted that external factors such as sleep patterns and nutrition can significantly impact pain experiences, underscoring the need for a comprehensive understanding of each patient’s unique lifestyle and circumstances.

As emphasized in category 1, addressing information gaps regarding individual patient risk for chronic opioid use requires clinicians to fully understand the patient’s specific concerns, questions, and available resources. Both patients and clinicians emphasized the importance of connecting patients with safe and effective pain management strategies, including nonopioid and nonpharmacologic options. Several AYA patients reported limited awareness of pain management options beyond medication. For instance, 1 patient recalled being advised to try yoga and dietary adjustments, assuming that those were the only alternatives to long-term medication use. In contrast, other patients reported being offered medication as the sole pain management option. Clinicians advocated for a “toolbox” approach to care, integrating diverse strategies to manage pain effectively. During the co-design session, a clinician addressed the misconception that “surgery represents failure,” despite surgery being a viable treatment option, further emphasizing the need for balanced and comprehensive patient education. Education must be consistent and tailored to each patient’s needs, information level, and overall health goals. Clinicians also noted that parents of AYA patients may avoid opioid prescriptions based on perceived risks, misinformation, or negative experiences. Therefore, more education on the empirical understanding of nonopioid pain management alternatives and how to address the root issue of the patient, or their child’s pain, can help relieve patients and their caregivers’ concerns and strengthen their understanding.

Caregivers often hold valuable insights regarding medication history, treatment side effects, and patient preferences, which can be vital for effective pain management. Many AYA patients receive their diagnoses and begin their journey with IBD care from a young age, during which their caregivers are the primary decision makers and documentarians of their care. As AYA transition into adulthood, they assume responsibilities for themselves. AYA patients expressed a desire for continued caregiver input, particularly during decision-making about complex treatment options. Likewise, clinicians emphasized that caregiver perspectives should be actively considered to support well-rounded, patient-centered care. Ensuring that caregivers remain appropriately informed and engaged can strengthen the patient-caregiver-clinician triad, promoting more effective, cohesive care throughout the AYA care journey.

Enhancing caregiver education on evidence-based nonopioid pain management options can alleviate concerns and promote more informed decision-making. Effectively engaging and acknowledging caregivers in the care of AYA patients with IBD is crucial, particularly as patients transition from pediatric to adult care. Many AYA patients receive their diagnosis in childhood, with caregivers initially serving as primary decision makers and record-keepers. As patients assume responsibility for their own care—an overwhelming transition for anyone but especially for AYA with chronic diseases (ie, IBD)—they often encounter challenges navigating complex systems. For example, 1 patient shared that their parents typically handled insurance-related calls for them, but once they turned 18 years of age, insurance providers required that the patient be on the phone. This shift required a strong understanding of the processes which the patient may not have been involved in before turning 18 years of age. This transition underscores the importance of caregiver involvement to ensure continuity of care, to prevent critical information gaps, and to support AYA patients in managing new responsibilities, alongside their diagnoses, with confidence.

Multiple clinician- and health system–level themes emerged from discussions with AYA IBD-focused clinicians, as outlined in Table 4. Clinicians emphasized the importance of accounting for care provided by other clinicians or institutions. For example, 1 nurse described using Epic (an electronic medical records software) to track patients’ pharmacy records and medication history, regardless of the prescribing clinician or institution. Comprehensive awareness of all care received is essential to ensure appropriate and coordinated treatment for AYA with IBD. A significant need identified by clinicians is addressing patient information gaps regarding individual risk for chronic opioid use. A nurse practitioner noted that patient education, including pain management, medications, and disease understanding, is a substantial component of their role. However, each patient presents with unique circumstances, including varying disease manifestations, social determinants of health, and support systems. Thus, clinicians emphasized the importance of tailored education and resources that address each patient’s specific risk profile within the context of their IBD and care. Additionally, clinicians highlighted the necessity of coordinated opioid safety efforts across care teams. Without such coordination, the risk of overprescribing, inadequate education, or inconsistent messaging may increase, leading to potential overdosing, suboptimal outcomes, or adverse health experiences. On a systemic level, clinicians reported lack of training in pain management specific to AYA with IBD, despite having high levels of expertise in other areas. They also noted that time constraints due to systemic factors and patient volume often limit their ability to thoroughly address pain management, further underscoring the need for streamlined, effective communication and educational strategies.

In this study, we used HCD principles [24] and qualitative research methods [45] to examine and identify end user perspectives to inform the future design of a digital opioid safety tool. We engaged AYA patients with IBD and IBD clinicians to understand their perspectives and needs as potential end users of such a tool. Our findings highlight, first, the importance of supporting collaborative relationships among patients, caregivers, and clinicians to promote safe opioid use; second, the need to contextualize and frame opioid- and pain-related discussions according to AYA patients’ age and developmental stage; and finally, the value of applying HCD methods in clarifying directions for digital safety tools tailored to the lived experiences of AYA with IBD, a population at high risk of opioid overdose and other serious harm. Taken together, these findings provide a foundation for the development and implementation of future efforts that aim to actively engage end users (ie, patients and clinicians) together in optimizing opioid safety for AYA with IBD, seamlessly fit into both patient care experiences and clinician workflows, and address their unique needs and perspectives. Based on the findings of this study, our team identified salient design recommendations for consideration as a digital opioid safety tool is developed for this population, presented in Table 5.

By centering the experiences and needs of both patients and clinicians, our findings contribute uniquely to the evidence-base at the intersection of IBD care, pain management, and opioid use. Pain management and opioid use among AYA with IBD are well-documented challenges [45-48]. AYA with IBD face distinct challenges due to their transitional life stage and evolving health care needs [49,50], increasing their risk for short-term or chronic opioid use [51]. In our study, clinician and patient needs intersected (category 1), highlighting a gap in consistent, accessible communication and education tailored to individual patient needs. Clinicians emphasized the importance of addressing patient knowledge gaps regarding opioid risks, aligning with patients’ expressed need for consistent, accessible education. For future prototyping and design, this suggests a need for methods capable of assessing individual patients’ educational needs and providing education tailored according to those needs. As highlighted in Table 5, recommendation 2, a digital opioid safety tool could include a library of educational materials with options for text, audio, and video, and a patient-friendly method of identifying the content needed and format desired.

Additionally, patients emphasized the value of caregiver engagement as part of their care team, while clinicians highlighted the necessity of coordinated, multidisciplinary approaches. Collaborative efforts among patients, caregivers, and clinicians are therefore essential for safe and effective opioid management and risk assessment among AYA patient populations. This finding underscores the need for digital opioid safety tool developers to focus on interoperability across care contexts to facilitate seamless information exchange (Table 5, recommendations 3 and 5). This raises potential design tensions, such as how informatics systems can mediate access to and disclosure of information in a nuanced manner (eg, between AYA and parental caregivers). Having the ability to access a comprehensive view of patient care through a digital tool can strengthen clinical care teams, reduce gaps in opioid safety management, and allow AYA to engage their caregivers as necessary.

Both patients and clinicians emphasized the importance of holistic care that acknowledges the distinctive challenges of AYA living with IBD. AYA often balance school, work, extracurriculars, and social transitions alongside new responsibilities for independently managing their chronic, fluctuating health, which can complicate engagement in care [49]. Furthermore, each patient’s individual circumstances, evolving disease trajectories, and unique developmental needs demand tailored and shared decision-making delivered through education and collaboration [52]. Participants noted that by consistently framing health discussions around holistic wellness rather than isolated symptoms, clinicians can provide more comprehensive, developmentally attuned care for AYA with IBD and help patients feel supported in managing the physical and psychosocial dimensions of their IBD. Future design work should consider how to best support clinicians and patients in identifying the unique patient circumstances that are relevant. Future digital tools could support previsit elicitation workflows that capture the patient’s broader life context and updates between appointments, which can allow clinicians to adequately monitor patient needs and address pertinent experiences (Table 5, recommendation 4).

Our study demonstrates that HCD can extend to the critical domain of opioid safety in IBD through careful and consistent engagement of clinicians, patients, and others involved in the IBD care continuum. Bringing these groups, and their naturally distinct but complementary perspectives, together begins to fill an important gap where few patient-centered digital tools currently exist. The interviews and co-design workshop that we conducted serve as a helpful first step in this direction to unpack patient and clinicians’ underlying perceptions influencing pain management practices. Additional design work will be useful to build on this and consider, for example, how to foster a sense of partnership between these groups to sustain longer-term opioid safety. As our research advances to design the process, formats, and tools needed to integrate a digital opioid safety tool into the care of AYA with other painful chronic digestive disorders, it will also be important to collaborate and consider the needs, from a design perspective, of other groups involved in care delivery for AYA with chronic digestive disorders, including clinicians beyond gastroenterology and GI surgery, electronic health record architects, and health system leaders to ensure interoperability and feasibility.

This study lays out an adaptable model for future research that seeks to characterize the unique needs and perspectives among AYA with IBD and their clinicians to develop targeted health care interventions in this care setting. As shown in many clinical areas beyond IBD [53-55], HCD presents an especially promising opportunity in addressing opioid safety in IBD because it moves beyond traditional patient education to cocreate solutions that reflect the lived realities of patients, caregivers, and clinicians. As we build on these findings to develop and integrate a digital opioid safety tool into the care of AYA with IBD, future research is needed to understand the extent to which HCD can help drive meaningful and sustainable reductions in opioid use in this vulnerable patient population.

This study has several limitations. Participants were recruited exclusively from Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital in Chicago, which may limit the generalizability of findings to other settings. The sample was predominantly female, and the recruitment population was largely White, potentially overlooking the broader racial and socioeconomic diversity present in the IBD community, although the findings provide important groundwork to guide more inclusive future research. Additionally, while existing studies address opioid use across broader GI populations, this study focused narrowly on a relatively small sample with IBD [15,45,46], potentially limiting applicability to other GI conditions. These limitations should be considered in the context of existing methodological literature establishing that the goal of qualitative research is, often, to investigate discrete in-depth phenomena (vs generalizing to larger populations) [56]. Smaller sample sizes, such as those in this study, can be justified with the appropriate information power generated through data analysis [38,57]. Therefore, the study provides a strong foundation, despite these limitations, for future work aimed at optimizing digital opioid safety interventions for AYA with IBD based on end user experiences and needs.

Future design processes and research must also account for socioeconomic and structural barriers that influence opioid risk and digital engagement among marginalized AYA populations [58]. Digital health interventions can unintentionally exacerbate health disparities if structural barriers such as digital literacy, device or internet access, and socioeconomic constraints are not considered during development [59,60]. User-centered and co-design approaches attempt to mitigate these risks by involving patients, caregivers, and clinicians throughout the design process to ensure that technologies reflect the needs of diverse users with consideration of potential constraints. Similarly, prior research on co-designed digital health interventions for AYA suggests that engaging end users during development can improve usability, accessibility, and relevance across varying socioeconomic contexts [61].

In this study, we used an HCD approach to qualitatively assess the needs and expectations of AYA patients with IBD and IBD clinicians regarding opioid safety. By directly engaging stakeholders, we identified overlapping priorities that extend beyond pain control to encompass education, communication, and coordinated care across the AYA care continuum. Our findings highlight critical insights for the foundation of using HCD to inform the design of sustainable interventions for AYA with IBD: first, the importance of building collaborative relationships to support safe opioid use; second, the need to frame pain discussions within a holistic, developmentally attuned approach to AYA wellness; and third, the potential of HCD to generate practical, scalable digital tools tailored to the lived experiences of this high-risk group.

Moving forward, our findings indicate that for digital health interventions to be effective in chronic disease management, they must move beyond passive symptom monitoring to facilitate active clinical coordination and shared decision-making. By integrating end user perspectives, our results lay the groundwork for co-designed digital tools that can improve opioid safety, strengthen multidisciplinary care, and ultimately enhance quality of life for AYA with IBD.