Involving end-users in the design of a digital opioid safety intervention for adolescents and young adults (AYA) with inflammatory bowel diseases (IBD): A qualitative analysis of patient and clinician perspectives (Preprint)

BACKGROUND Chronic opioid use, a key predictor of opioid overdose, is common among adolescents and young adults (AYA) with inflammatory bowel diseases (IBD), underscoring a need for tailored interventions to monitor opioid exposure and risk for opioid-related harm. Prior research also highlights the need to engage both AYA IBD patients and IBD-focused clinicians in development of pain management and opioid safety interventions. Human-centered design (HCD) offers a promising approach to address this gap by directly engaging patients and clinicians in co-creating solutions. OBJECTIVE As a foundational effort, we leveraged HCD to identify and define AYA patient and clinician perspectives to inform the design and development of a digital opioid safety intervention. METHODS We conducted semi-structured interviews with AYA IBD patients and IBD-focused clinicians (gastroenterologists, surgeons, and nurses). Interviews explored patient experiences with pain management, opioid use, and transitions to adult care, as well as clinician experiences in monitoring pain and prescribing opioids. A co-design workshop, following the interviews, brought patient and clinician participants together to reflect as a group on the unique challenges of managing pain in IBD care and consider potential creative solutions to enhance pain management safety. Data were audio recorded, transcribed, and thematically analyzed using an inductive approach to identify themes. RESULTS A total of 17 participants (four AYA patients and 13 clinicians) contributed to the study. Thematic analysis generated three domains of needs that an opioid safety intervention should address: (1) Intersecting Needs (i.e. relevant at the patient and clinician and/or health system levels), (2) Patient-Level Needs (i.e. relevant at the patient level only), and (3) Clinician- and Health System-Level Needs (i.e. relevant at the clinician and/or health system levels only). Intersecting needs included integrating opioid safety interventions into multidisciplinary chronic care, supporting AYA transitions to independence, and acknowledging individual patient differences. Patient-level needs included assessing lived experiences of pain routinely, setting clear expectations about pain management, and connecting patients with safe non-opioid alternatives. Clinician- and system-level needs included accounting for pain management received outside the IBD clinic; addressing gaps in information, education, and resources regarding opioid risk or pain management; and coordinating safety efforts across clinical teams. CONCLUSIONS AYA patients with IBD and IBD-focused clinicians identified multiple needs, including integrating routine pain assessments, connecting patients with safe pain management strategies, and facilitating smooth AYA transitions to adult care. Incorporating these insights into the development of a digital opioid safety intervention may enhance alignment between patient and clinician expectations regarding safe pain management and opioid use. This study underscores the value of HCD in developing digital opioid safety tools that are practical, patient-focused, and effectively integrated into clinical workflows. Findings can guide future intervention design, prototyping, and testing with continued engagement of AYA IBD patients and clinicians.