Clinical trial NCT05910736: Increasing the Feasibility, Impact, and Equity of the Medicare Annual Wellness Visit (AWV)
Official title: Increasing the Feasibility, Impact, and Equity of the Medicare Annual Wellness Visit (AWV)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preventive Health Services
Keywords: older patients
Medicare Annual Wellness Visits
preventive health care
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: DARTNet
name: American Academy of Family Physicians National Research Network
name: Case Western Reserve University
name: MetroHealth System, Ohio
First posted: 2023-06-20
Enrollment: 22485
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge
Primary purpose: PREVENTION

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.

Eligibility criteria: There are no inclusion or exclusion criteria based on sex/gender, race, and/or ethnicity.

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

Primary outcomes:
measure: AWV utilization
timeFrame: 12 months after intervention implementation in all practices
measure: AWV utilization
timeFrame: 24 months after intervention implementation in all practices
measure: Composite preventive health services score
timeFrame: 12 months after intervention implementation in all practices
measure: Composite preventive health services score
timeFrame: 24 months after intervention implementation in all practices
Secondary outcomes:
measure: Utilization of recommended preventive health services
timeFrame: 12 months after intervention implementation in all practices
measure: Utilization of recommended preventive health services
timeFrame: 24 months after intervention implementation in all practices
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
Study officials:
affiliation: University of California, Los Angeles
name: Derjung M Tarn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: