Increasing the Feasibility, Impact, and Equity of the Medicare Annual Wellness Visit (AWV)

NCT ID: NCT05910736

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2028-08-31

Brief Summary

The goal of this study is to improve the use of preventive health services by implementing a multilevel intervention to stimulate Annual Wellness Visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 24 primary care practices over 24 months. Every 3 months, 6 practices will receive the intervention. Electronic health record (EHR) data extractions will be used to collect outcomes in a population cohort of patients. Semi-structured interviews will be conducted with clinicians/staff and patients to assess intervention implementation. The investigators hypothesize that the implementation will increase AWV visit use and consequently, use of preventive health services.

Detailed Description

Older adults vastly underutilize evidence-based preventive health services that are proven to reduce serious illness, morbidity and mortality. In fact, fewer than half of adults aged 65 and older are up-to-date on evidence-based cancer screenings and vaccinations recommended by expert committees (e.g., the USPSTF and CDC/ACIP). Those at greatest risk for receiving poor preventive care include racial and ethnic minority groups and persons of low socioeconomic status. Yet interventions to remedy this underutilization in older adults have mostly targeted individual preventive health services, rather than the totality of services needed by patients. The 2011 Medicare establishment of the Annual Wellness Visit (AWV) is a great and underused opportunity to respond to the National Cancer Institute's calls for multilevel interventions that address both the supply and demand for vastly underutilized preventive health services. This free-to-the-patient AWV visit gives providers dedicated time to focus on preventive health services.

The investigators developed a multilevel intervention to increase AWV use that successfully increased AWV utilization in 3 small (2-5 provider) pilot practices. The intervention addresses the complexities of increasing AWVs at patient (demand for services), provider (supply of services), and practice levels. It combines electronic health record (EHR)-generated information and tools with practice redesign tools and approaches to inform providers and patients about the preventive health services needed by individual patients. This proposal's goal is to conduct a pragmatic trial to evaluate the effect of the intervention on increasing AWV and preventive health services utilization. The investigators will implement the intervention in geographically and racially/ethnically diverse community-based practices, Federally Qualified Health Centers, and academic health system practices. Practices include small to mid-size primary care practices (including solo practices), which typically are under-represented in research. Specific aims of this study are to: 1) Evaluate the effect of the intervention on use of a) AWVs and b) USPSTF and CDC/ACIP-recommended preventive services in 3 different types of practice settings; 2) Evaluate the effect of the intervention on reducing racial/ethnic disparities in AWV utilization; and 3) Evaluate factors affecting implementation and sustainability of the intervention tools and approaches, implementation strategies, and intervention effect in diverse patient settings. Implemented via video conferencing and remote deployment of EHR tools, this low-cost intervention could easily be disseminated to small and solo practices across the country. The anticipated increase in patient use of preventive health services will improve population health and lower mortality, particularly in at-risk racial/ethnic minority patients.

The intervention will be carried out sequentially in 24 primary care practices across the United States over 24 months. Every 3 months, 6 practices will receive the intervention. Many of the practices expected to participate in the study care for predominantly minority patients. Primary endpoints to be measured include: 1) rates of AWV use, and 2) completion of preventive health services recommended by the United States Preventive Services Task Force (USPSTF), CDC, and ACIP. The investigators hypothesize that the intervention will increase rates of AWV use, and in turn will result in greater completion of recommended preventive health services. The investigators also expect it to decrease racial/ethnic disparities in AWV utilization.

Conditions

Preventive Health Services

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Medicare AWV Toolkit

Practice-tailored intervention combining EHR tools with practice redesign workflows and templates for completing AWVs

Group Type: EXPERIMENTAL

Medicare AWV Practice Redesign Toolkit

Intervention Type: BEHAVIORAL

Electronic health record-based tools coupled with practice redesign strategies and approaches

Interventions

Medicare AWV Practice Redesign Toolkit

Electronic health record-based tools coupled with practice redesign strategies and approaches

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• have Medicare coverage
• aged 50 or older
• has at least one visit to the practice in the past 12 months
• not deceased

Practice eligibility criteria:

• care for patients with Medicare insurance

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DARTNet

UNKNOWN

Sponsor Role: collaborator

American Academy of Family Physicians National Research Network

NETWORK

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

MetroHealth System, Ohio

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Derjung Tarn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derjung M Tarn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Banner Health

Phoenix, Arizona, United States

UCLA Health

Los Angeles, California, United States

MetroHealth

Cleveland, Ohio, United States

Countries

United States

References

Tarn DM, Pace WD, Stange KC, Tseng CH, Wenger NS. 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. PLoS One. 2025 Aug 8;20(8):e0329004. doi: 10.1371/journal.pone.0329004. eCollection 2025.

Reference Type: DERIVED

PMID: 40779597 (View on PubMed)

Other Identifiers

R01AG081996-01

Identifier Type: NIH

Identifier Source: org_study_id

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