- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640426
Messaging Intervention to Increase Medicare Annual Wellness Visits -- The NUDGE AWV Clinical Trial
Messaging Intervention to Increase Medicare Annual Wellness Visits: The MIMA Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63134
- Ascension Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
This is a group will serve as usual care and have no intervention during the study period
|
|
|
Experimental: Two Messages
This group will receive two messages as part of the study -- one email and one text message.
|
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
|
|
Experimental: Up To Five Messages
This group will receive up to five messages as part o the study -- two emails and three text messages.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Annual Wellness Visit scheduling
Time Frame: 14 days
|
Percentage of patients who schedule an AWV
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completed Annual Wellness Visit
Time Frame: 90 Days
|
Percentage of patients who have completed an AWV
|
90 Days
|
|
Days to Annual Wellness Visit Completion
Time Frame: 90 days
|
Number of days to AWV appointment completion
|
90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breast cancer screening
Time Frame: 180 days
|
Completion of breast cancer screening post intervention
|
180 days
|
|
Colon Cancer Screening
Time Frame: 180 days
|
Completion colon cancer screening post intervention
|
180 days
|
|
Ordering of tests for breast cancer screening
Time Frame: 90 days
|
Ordering of tests for breast cancer screening
|
90 days
|
|
Ordering of tests for colon cancer screening
Time Frame: 90 days
|
Ordering of tests for colon cancer screening
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAS20240013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.