Preventive Health ServicesNCT05910736
Increasing the Feasibility, Impact, and Equity of the Medicare Annual Wellness Visit (AWV)
A study testing Medicare AWV Practice Redesign Toolkit in people with Preventive Health Services, run by University of California, Los Angeles at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Preventive Health Services
- What is being tested?
- Medicare AWV Practice Redesign Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,485 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MetroHealth
Cleveland, Ohio, 44109
UCLA Health
Los Angeles, California, 90024
Banner Health
Phoenix, Arizona, 85006
About this study
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.
Read the 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
- Being tested
- Medicare AWV Practice Redesign Toolkit
- Keywords
- older patients, Medicare Annual Wellness Visits, preventive health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicare AWV Practice Redesign ToolkitBehavioural
Electronic health record-based tools coupled with practice redesign strategies and approaches
| Study group | Role | What they receive |
|---|---|---|
| Medicare AWV Toolkit | Experimental | Practice-tailored intervention combining EHR tools with practice redesign workflows and templates for completing AWVs Receives: Behavioral: Medicare AWV Practice Redesign Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
AWV utilization
% of eligible patients completing an AWV (CPT codes G0438 or G0439) or Initial Preventive Physical Examination (IPPE) (CPT code G0422) in the past 12 months
Measured: 12 months after intervention implementation in all practices
AWV utilization
% of eligible patients up to date on their AWV (CPT codes G0438 or G0439) or Initial Preventive Physical Examination (IPPE) (CPT code G0422)
Measured: 24 months after intervention implementation in all practices
Composite preventive health services score
composite score representing % of all recommended preventive health services that a patient has fulfilled
Measured: 12 months after intervention implementation in all practices
Composite preventive health services score
composite score representing % of all recommended preventive health services that a patient has fulfilled
Measured: 24 months after intervention implementation in all practices
Secondary outcomes (2)
Utilization of recommended preventive health services
% of patients up to date on each of the preventive health services listed below.
Vaccinations
- Influenza vaccine
- Herpes zoster vaccine
- Pneumococcal vaccine
- Tetanus vaccine
Cancer screening
- Colorectal cancer screening
- Mammogram
- Pap smear
Other screening / counseling
- Osteoporosis screening
- Hepatitis C screening
- Alcohol misuse screening
- Depression screening
- Tobacco use screening
- Advance care planning
Measured: 12 months after intervention implementation in all practices
Utilization of recommended preventive health services
% of patients up to date on each of the preventive health services listed below.
Vaccinations
- Influenza vaccine
- Herpes zoster vaccine
- Pneumococcal vaccine
- Tetanus vaccine
Cancer screening
- Colorectal cancer screening
- Mammogram
- Pap smear
Other screening / counseling
- Osteoporosis screening
- Hepatitis C screening
- Alcohol misuse screening
- Depression screening
- Tobacco use screening
- Advance care planning
Measured: 24 months after intervention implementation in all practices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 May 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive Health ServicesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Stepped wedge
- Masking
- None (open label)
- Enrolment
- 22,485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- DARTNet, American Academy of Family Physicians National Research Network, Case Western Reserve University, MetroHealth System, Ohio
- Responsible party
- Principal investigator, Derjung Tarn, University of California, Los Angeles
- Investigators
- Derjung M Tarn, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910736
- Sponsor's protocol ID
- R01AG081996-01
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will engage the University of California Curation Center (UC3) to serve as the data repository for all components of the project. The research team will work with UC3 to curate and deliver to the curation center definition of data elements extracted from EHR and source data in a standardized, de-identified format. We also will include statistical codes for analyses in the form of R, SAS or STATA files. The DRYAD system within the UC3 provides a platform to publish the metadata concerning the project that researchers globally can access. This system will serve as the data repository in which we will house the data management plan for the source data as well as metadata that describes the source data and code books of the underlying data elements, with record counts such that outside researchers can have a full understanding of what is housed in the system.
Publications
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.
PubMed 40779597
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Feasibility, Impact, and Equity of the Medicare Annual Wellness Visit (AWV)
- ClinicalTrials.gov ID
- NCT05910736
- Acronym / sponsor ID
- R01AG081996-01
- Conditions
- Preventive Health Services
- Keywords
- older patients, Medicare Annual Wellness Visits, preventive health care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,485 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- DARTNet, American Academy of Family Physicians National Research Network, Case Western Reserve University, MetroHealth System, Ohio
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Medicare AWV Toolkit | Experimental | Behavioral: Medicare AWV Practice Redesign ToolkitPractice-tailored intervention combining EHR tools with practice redesign workflows and templates for completing AWVs |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have Medicare coverage
- aged 50 or older
- has at least one visit to the practice in the past 12 months
- not deceased
- care for patients with Medicare insurance
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicare AWV Practice Redesign ToolkitElectronic health record-based tools coupled with practice redesign strategies and approaches | Behavioural | Medicare AWV Toolkit |
Primary outcome
AWV utilization
Time frame: 12 months after intervention implementation in all practices
% of eligible patients completing an AWV (CPT codes G0438 or G0439) or Initial Preventive Physical Examination (IPPE) (CPT code G0422) in the past 12 months
AWV utilization
Time frame: 24 months after intervention implementation in all practices
% of eligible patients up to date on their AWV (CPT codes G0438 or G0439) or Initial Preventive Physical Examination (IPPE) (CPT code G0422)
Composite preventive health services score
Time frame: 12 months after intervention implementation in all practices
composite score representing % of all recommended preventive health services that a patient has fulfilled
Composite preventive health services score
Time frame: 24 months after intervention implementation in all practices
composite score representing % of all recommended preventive health services that a patient has fulfilled
2 secondary outcomes
Utilization of recommended preventive health services
Time frame: 12 months after intervention implementation in all practices
Utilization of recommended preventive health services
Time frame: 24 months after intervention implementation in all practices
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 40779597Tarn 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.
- Individual participant dataSharing planned: Yes. The research team will engage the University of California Curation Center (UC3) to serve as the data repository for all components of the project. The research team will work with UC3 to curate and deliver to the curation center definition of data elements extracted from EHR and source data in a standardized, de-identified format. We also will include statistical codes for analyses in the form of R, SAS or STATA files. The DRYAD system within the UC3 provides a platform to publish the metadata concerning the project that researchers globally can access. This system will serve as the data repository in which we will house the data management plan for the source data as well as metadata that describes the source data and code books of the underlying data elements, with record counts such that outside researchers can have a full understanding of what is housed in the system.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derjung M Tarn, MD, PhD principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicare AWV Practice Redesign Toolkit in people with Preventive Health Services, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AWV utilization (time frame: 12 months after intervention implementation in all practices). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.