Operationalizing patient and stakeholder engagement in high-acuity trials: Lessons from IMPROVE-AD.

Patient and stakeholder engagement is increasingly emphasized in clinical research, yet practical guidance on how to operationalize engagement in high-acuity, multicenter surgical trials remains limited. We describe the design and early implementation of a structured engagement strategy within the IMPROVE-AD (Improving Outcomes in Vascular Disease-Aortic Dissection) trial. IMPROVE-AD is a pragmatic, multicenter randomized trial comparing optimal medical therapy alone with optimal medical therapy plus thoracic endovascular aortic repair for uncomplicated type B aortic dissection. A formal patient engagement committee, supported by a stakeholder engagement core, was established to integrate patient perspectives into trial design and conduct. Engagement activities included inputs on trial design, recruitment strategies, participant-facing materials, and communication approaches. Observations were derived from the early implementation of these activities. Stakeholder engagement informed several aspects of trial development and implementation. Early engagement contributed to the refinement of trial design elements, including the prioritization of clinical endpoints over surrogate measures. During trial implementation, patient engagement committee input supported the revision of informed consent language, development of public-facing materials, and refinement of recruitment messaging, with an emphasis on clarity, transparency, and clinical equipoise. Access to aggregated screening and enrollment data enabled the identification of potential barriers to recruitment and underrepresentation. These observations are descriptive. A formal evaluation of the impact of engagement on enrollment, retention, or other trial outcomes has not yet been conducted. Structured stakeholder engagement can be incorporated into the design and conduct of a high-acuity, multicenter randomized trial and may inform communication, recruitment, and implementation strategies. Although the full model described here is resource intensive, selected elements may be adaptable across diverse research settings. Further work is needed to evaluate the impact of engagement and to identify scalable approaches.