Increasing the feasibility, impact, and equity of the Medicare Annual Wellness Visit (AWV) with a practice tailored AWV intervention: A stepped wedge clinical trial protocol

Background: Older adults vastly underutilize evidence-based preventive health services and screenings that reduce illness, morbidity and mortality. The free-to-patient Medicare Annual Wellness Visit (AWV) is an opportunity to enhance preventive healthcare use, but also is underused. Objectives: To evaluate the effect of a practice-tailored intervention on the sustained use of Medicare AWVs and on guideline-recommended preventive services and racial/ethnic disparities in 3 types of practice settings. Methods: This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented at the practice level in 24 primary care practices across the country (8 community-based, 8 academic, and 8 serving medically underserved populations). Electronic health record data will be used to assess changes in AWV and preventive service delivery rates and racial, ethnic, and gender disparities. Semi-structured interviews will be conducted with clinicians/staff and patients, and clinicians will be surveyed to assess the process and acceptability of the intervention. The protocol is registered on clinicaltrials.gov (NCT05910736). Results: Analyses will determine the effect of the intervention on AWV visit and preventive health services use at 12- and 24-months post-intervention implementation. Additional analyses will evaluate the effect of the intervention on reducing racial/ethnic disparities. Conclusions: A practice-tailored intervention has the potential to increase use of AWVs and preventive health services, and reduce racial/ethnic disparities, in diverse practice settings.