Annual Wellness VisitNCT06640426
Messaging Intervention to Increase Medicare Annual Wellness Visits -- The NUDGE AWV Clinical Trial
A study testing Two Messaging Nudges and Five messaging nudges in people with Annual Wellness Visit and Breast Cancer Screening, run by Laura Feemster at 1 site in United States.
Trial summary
Medicare Annual Wellness Visits (AWVs) are critical for addressing preventive care needs among older adults, yet the most recent estimates from the Center for Medicare Services suggest less than 50% of eligible patients take advantage of this free healthcare benefit. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Annual Wellness Visit, Breast Cancer Screening, Colon Cancer Screening
- What is being tested?
- Two Messaging Nudges and Five messaging nudges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,842 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to 27 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 or older
- Have either a mobile phone number or an email address on file with the health system
- Included in and non-compliant on the Ascension AWV Clinical Priority Goal measure
- Have consented to receive electronic communications from the health system
Who cannot join
- Patients whose primary care providers are exempted from the campaign by the health system
- Completed MAWV appointment in previous 30 days
- Has an upcoming AWV appointment scheduled
- Have received a nudge campaign from the Clinical Transformation team in the past 90 days
- Patients who have previously opted out of receiving electronic communications from the health system in our message delivery platform (Salesforce)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Messaging Intervention to Increase Medicare Annual Wellness Visits: The MIMA Randomized Clinical Trial
Medicare Annual Wellness Visits (AWVs) are critical for addressing preventive care needs among older adults, yet the most recent estimates from the Center for Medicare Services suggest less than 50% of eligible patients take advantage of this free healthcare benefit. Behavioral science-informed messaging interventions offer a promising strategy to increase AWV participation by guiding patient behavior. In this study, investigators will evaluate a health system initiative that utilizes personalized email and text messages to encourage Medicare beneficiaries to schedule and attend their AWVs. This approach aims to boost patient engagement in preventive health services, ultimately improving care outcomes for older adult populations
Read the detailed description
The Centers for Medicare \& Medicaid Services (CMS) recommends Annual Wellness Visits (AWVs) to encourage preventive care and improve long-term health outcomes for Medicare beneficiaries. These visits are designed to provide a proactive approach to healthcare by focusing on identifying risk factors, updating medical histories, and developing personalized prevention plans that promote early detection of diseases. By prioritizing prevention over treatment, AWVs help reduce the overall cost burden on the healthcare system while enhancing patient engagement and empowering individuals to take a more active role in managing their health. Yet despite these benefits, most Medicare members who are eligible for an AWV - at no cost to them - do not complete one.
Behavioral science research suggests that personalized messages, designed to facilitate action, can have significant impacts on health behavior. Studies have found these messaging interventions can increase vaccination rates, cancer screening rates, and other care gap closure.
- Being tested
- Two Messaging Nudges, Five messaging nudges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Messaging NudgesBehavioural
This intervention involves receiving one personalized email and one personalized text message, which include the provider's name, the patient's name, and a phone number to schedule an Annual Wellness Visit
Five messaging nudgesBehavioural
This intervention involves patients receiving up to five personalized email and text messages, which include the provider's name, the patient's name, and a phone number to schedule an Annual Wellness Visit
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | This is a group will serve as usual care and have no intervention during the study period |
| Two Messages | Experimental | This group will receive two messages as part of the study -- one email and one text message. Receives: Behavioral: Two Messaging Nudges |
| Up To Five Messages | Experimental | This group will receive up to five messages as part o the study -- two emails and three text messages. Receives: Behavioral: Five messaging nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Wellness Visit scheduling
Percentage of patients who schedule an AWV
Measured: 14 days
Secondary outcomes (2)
Completed Annual Wellness Visit
Percentage of patients who have completed an AWV
Measured: 90 Days
Days to Annual Wellness Visit Completion
Number of days to AWV appointment completion
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Oct 2024
- Primary completion12 Nov 2024
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Annual Wellness VisitStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a randomized controlled trial to evaluate a health system initiative to improve Medicare Annual Wellness Visit (AWV) completion. Investigators will randomly assign Ascension Health patients who are eligible for an AWV to one of three conditions. Patients in Treatment Condition #1 will receive a set of up to five email and text messages over the course of eight days, while also receiving usual care which could include messaging from their practice or the electronic health record. Patients in Treatment Condition #2 will receive a set of two email and text messages on a single day. Patients in the Control Condition will receive no messages as part of this campaign, but will be receiving usual care, which could include messages related to AWV's from their primary care practice or from the electronic health record.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Feemster
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Laura Feemster, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640426
- Sponsor's protocol ID
- RAS20240013
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Has patient information that we are not approved to share
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messaging Intervention to Increase Medicare Annual Wellness Visits: The MIMA Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06640426
- Acronym / sponsor ID
- RAS20240013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29,842 participants (actual)
- Lead sponsor
- Laura FeemsterIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 15 Oct 2024 (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.
Medicare Annual Wellness Visits (AWVs) are critical for addressing preventive care needs among older adults, yet the most recent estimates from the Center for Medicare Services suggest less than 50% of eligible patients take advantage of this free healthcare benefit. Behavioral science-informed messaging interventions offer a promising strategy to increase AWV participation by guiding patient behavior. In this study, investigators will evaluate a health system initiative that utilizes personalized email and text messages to encourage Medicare beneficiaries to schedule and attend their AWVs. This approach aims to boost patient engagement in preventive health services, ultimately improving care outcomes for older adult populations
Detailed description
The Centers for Medicare \& Medicaid Services (CMS) recommends Annual Wellness Visits (AWVs) to encourage preventive care and improve long-term health outcomes for Medicare beneficiaries. These visits are designed to provide a proactive approach to healthcare by focusing on identifying risk factors, updating medical histories, and developing personalized prevention plans that promote early detection of diseases. By prioritizing prevention over treatment, AWVs help reduce the overall cost burden on the healthcare system while enhancing patient engagement and empowering individuals to take a more active role in managing their health. Yet despite these benefits, most Medicare members who are eligible for an AWV - at no cost to them - do not complete one.
Behavioral science research suggests that personalized messages, designed to facilitate action, can have significant impacts on health behavior. Studies have found these messaging interventions can increase vaccination rates, cancer screening rates, and other care gap closure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study will use a randomized controlled trial to evaluate a health system initiative to improve Medicare Annual Wellness Visit (AWV) completion. Investigators will randomly assign Ascension Health patients who are eligible for an AWV to one of three conditions. Patients in Treatment Condition #1 will receive a set of up to five email and text messages over the course of eight days, while also receiving usual care which could include messaging from their practice or the electronic health record. Patients in Treatment Condition #2 will receive a set of two email and text messages on a single day. Patients in the Control Condition will receive no messages as part of this campaign, but will be receiving usual care, which could include messages related to AWV's from their primary care practice or from the electronic health record.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –This is a group will serve as usual care and have no intervention during the study period |
| Two Messages | Experimental | Behavioral: Two Messaging NudgesThis group will receive two messages as part of the study -- one email and one text message. |
| Up To Five Messages | Experimental | Behavioral: Five messaging nudgesThis group will receive up to five messages as part o the study -- two emails and three text messages. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 or older
- Have either a mobile phone number or an email address on file with the health system
- Included in and non-compliant on the Ascension AWV Clinical Priority Goal measure
- Have consented to receive electronic communications from the health system
Key exclusion criteria (5 listed)
- Patients whose primary care providers are exempted from the campaign by the health system
- Completed MAWV appointment in previous 30 days
- Has an upcoming AWV appointment scheduled
- Have received a nudge campaign from the Clinical Transformation team in the past 90 days
- Patients who have previously opted out of receiving electronic communications from the health system in our message delivery platform (Salesforce)
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 |
|---|---|---|
| Two Messaging NudgesThis intervention involves receiving one personalized email and one personalized text message, which include the provider's name, the patient's name, and a phone number to schedule an Annual Wellness Visit | Behavioural | Two Messages |
| Five messaging nudgesThis intervention involves patients receiving up to five personalized email and text messages, which include the provider's name, the patient's name, and a phone number to schedule an Annual Wellness Visit | Behavioural | Up To Five Messages |
Primary outcome
Annual Wellness Visit scheduling
Time frame: 14 days
Percentage of patients who schedule an AWV
2 secondary outcomes
Completed Annual Wellness Visit
Time frame: 90 Days
Days to Annual Wellness Visit Completion
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. Has patient information that we are not approved to share
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Messaging Nudges and Five messaging nudges in people with Annual Wellness Visit and Breast Cancer Screening, run by Laura Feemster at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Annual Wellness Visit scheduling (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.