Background: The ALL ALS Consortium is a large-scale, nationwide NIH-funded, initiative designed to accelerate ALS research through standardized data and biospecimen collection and sharing as part of AMP-ALS. ALL ALS aims to enroll more than 2,000 participants by September 2026 across 36 U.S. Clinical Sites and offers a remote participation option to reduce barriers related to geography, mobility, and disease severity. However, this alone is insufficient to ensure broad awareness and participation. Achieving enrollment goals requires strategic and proactive outreach, community engagement, and trusted partnerships. Thus, ALL ALS established a centralized Outreach Team focused on expanding access to research participation through strategic collaboration and community engagement.
Objectives: To describe the roles and responsibilities of the ALL ALS Outreach Team, including Patient Navigator (PN) and Outreach Program Manager (OPM), and to illustrate how this model is effective in enhancing access, engagement, and recruitment in large, multi-site research studies.
Results: The ALL ALS Outreach Team functions as a centrally coordinated, consortium-wide resource. The PN provides individualized support to prospective and enrolled participants, manages the Participant Interest Form workflow, and facilitates connections with clinical sites. Together, the team implements coordinated outreach strategies – webinars, newsletters, social media campaigns, and community event – and maintains regular communication with Clinical Sites. The OPM leads engagement with external stakeholders, including ALS organizations, advocacy groups, clinical and private-sector partners, conducts site engagement visits, and supports local outreach efforts. As of December 2025, 498 Participant Interest Forms were submitted, generating 263 referrals to clinical sites; the OPM has collaborated with more than 20 external organizations across 42 states, and has distributed study materials to five Veterans Affairs facilities. Participants have been enrolled from 47 U.S. states and Puerto Rico.
Discussion: A centralized outreach model that integrates participant navigation with strategic partnerships can expand access to ALS research beyond traditional clinic populations. This approach supports broad geographic and demographic enrollment, strengthens community trust, and provides a scalable framework for recruitment and sustained engagement in large, multi-site research studies.