Comparing different forms of structured follow-up support in the treatment of multiple health risks for chronic disease: a randomized controlled trial protocol

Abstract Background Primary care clinics need effective, low-cost tools to screen for and address multiple health risks — and technology can provide important efficiencies. My Own Health Report (MOHR) is a web-based intervention with 3 core functions: (1) risk flagging; (2) goal-setting for patient-prioritized risks; and (3) providing resources. A prior randomized trial in primary care settings showed that MOHR was feasible and effective. However, we identified two key gaps : a need for a flexible menu of delivery options to adopt and sustain MOHR and a pragmatic way to provide structured follow-up. Methods/design We developed and pilot-tested two distinct primary implementation strategies to provide structured follow-up: the first primary strategy, termed “Reminder-Resource message ( R 2 message) ,” involves automated motivational text message nudges to remind patients of their MOHR goal and point to resources. The second, “R 2 navigation ,” involves personal support - community health worker phone calls to deliver reminders and resources. Each primary strategy is paired with additional secondary strategies that together address the contextual determinants of successful implementation and sustainment identified using our Pragmatic Robust Implementation and Sustainability Model (PRISM). We engaged clinic staff, patients, and community partners to finalize the R 2 message and R 2 navigation strategies and secondary strategies. This individually randomized, type 2 hybrid effectiveness-implementation trial will enroll 1,000 adult patients with at least two cancer risks (including both insufficient physical activity and fruit/vegetable intake). We will evaluate the outcomes and cost-effectiveness of R 2 message and R 2 navigation alone or in combination in 12 primary care clinics including both (a) large metropolitan health system and (b) rural-serving clinics. Expected outcomes include: (1) improvement in behavioral risk factors; (2) implementation outcomes – including representative engagement with R 2 message and R 2 navigation, and cost; and (3) improvement in practice value outcomes, including patient experience ratings. Based on the trial findings, we will co-develop an implementation, adaptation and sustainment guide for the most cost-effective implementation strategy. Conclusions We expect the implementation strategies compared will produce different levels of representative engagement, behavior change, cost, and practice value. These findings will inform pragmatic ways to improve outcomes important to patients, primary care, and society. Trial Registration# at ClinicalTrials.gov NCT07569224 (Registration date: 04/29/2026).