Annual Wellness VisitNCT06996366
Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake
A study testing Outreach to encourage Annual Wellness Visit completion in people with Annual Wellness Visit, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this randomized pilot study is to learn the impact of a primary care outreach intervention on the proportion of patients with Medicare insurance who are up-to-date on Medicare Annual Wellness Visit completion. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Annual Wellness Visit
- What is being tested?
- Outreach to encourage Annual Wellness Visit completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 21 Oct 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥1 in-person primary care visit during 18-month lookback period AND
- Medicare or Medicare Advantage insurance AND
- ≥1 risk factor shown to be associated with being overdue for Medicare Annual Wellness Visits (identified in preparatory analysis prior to pilot trial): Black/African American race or Latino/Hispanic ethnicity OR Not up-to-date for social needs screening OR Positive social need in past 18 months OR Medicaid insurance OR No use of scheduling features within patient portal in past 18 months
- Preferred language English AND
- Attributed primary care clinic is 1 of the participating clinics in the pilot trial AND
- No AWV completion (CPT G0402, G0438, G0439, G0468) during 10-month lookback period AND
- No appointment scheduled for upcoming AWV
Who cannot join
- Patients will be excluded if they are receiving palliative care or if their clinician feels that outreach for preventive care is inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized pilot study is to learn the impact of a primary care outreach intervention on the proportion of patients with Medicare insurance who are up-to-date on Medicare Annual Wellness Visit completion. At two clinics, researchers will randomize clinicians (and their associated, eligible patients) to early or delayed outreach.
- Conditions
- Annual Wellness Visit
- Being tested
- Outreach to encourage Annual Wellness Visit completion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach to encourage Annual Wellness Visit completionOther
Mailed and telephone outreach to patient.
| Study group | Role | What they receive |
|---|---|---|
| Early outreach | Experimental | Patients assigned to early outreach will receive mailed letter and telephone outreach encouraging them to schedule an Annual Wellness Visit with a primary care clinician. Social determinants of health screening and resource provision if applicable will be included in telephone outreach by health navigator. Receives: Other: Outreach to encourage Annual Wellness Visit completion |
| Delayed outreach | Other | Patients assigned to delayed outreach will receive no outreach for 6 months after study start and then will receive the same outreach intervention as early outreach arm. Receives: Other: Outreach to encourage Annual Wellness Visit completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Annual Wellness Visit
Binary (0/1) patient-level measure, based on presence of any CPT (Current Procedural Terminology) codes for Medicare preventive visits during follow-up period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start22 Apr 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 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.
- More trials run by Northwestern UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, David Liss, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996366
- Sponsor's protocol ID
- STU00219825
- Other IDs
- R21AG081895-01A1
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake
- ClinicalTrials.gov ID
- NCT06996366
- Acronym / sponsor ID
- STU00219825
- Conditions
- Annual Wellness Visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 30 May 2025 (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 randomized pilot study is to learn the impact of a primary care outreach intervention on the proportion of patients with Medicare insurance who are up-to-date on Medicare Annual Wellness Visit completion. At two clinics, researchers will randomize clinicians (and their associated, eligible patients) to early or delayed outreach.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early outreach | Experimental | Other: Outreach to encourage Annual Wellness Visit completionPatients assigned to early outreach will receive mailed letter and telephone outreach encouraging them to schedule an Annual Wellness Visit with a primary care clinician. Social determinants of health screening and resource provision if applicable will be included in telephone outreach by health navigator. |
| Delayed outreach | Other | Other: Outreach to encourage Annual Wellness Visit completionPatients assigned to delayed outreach will receive no outreach for 6 months after study start and then will receive the same outreach intervention as early outreach arm. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥1 in-person primary care visit during 18-month lookback period AND
- Medicare or Medicare Advantage insurance AND
- ≥1 risk factor shown to be associated with being overdue for Medicare Annual Wellness Visits (identified in preparatory analysis prior to pilot trial): Black/African American race or Latino/Hispanic ethnicity OR Not up-to-date for social needs screening OR Positive social need in past 18 months OR Medicaid insurance OR No use of scheduling features within patient portal in past 18 months
- Preferred language English AND
- Attributed primary care clinic is 1 of the participating clinics in the pilot trial AND
Key exclusion criteria (1 listed)
- Patients will be excluded if they are receiving palliative care or if their clinician feels that outreach for preventive care is inappropriate.
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 |
|---|---|---|
| Outreach to encourage Annual Wellness Visit completionMailed and telephone outreach to patient. | Other | Delayed outreach, Early outreach |
Primary outcome
Completion of Annual Wellness Visit
Time frame: 6 months
Binary (0/1) patient-level measure, based on presence of any CPT (Current Procedural Terminology) codes for Medicare preventive visits during follow-up period
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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 Outreach to encourage Annual Wellness Visit completion in people with Annual Wellness Visit, run by Northwestern University 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 7 inclusion and 1 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 23 Mar 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?
Completion of Annual Wellness Visit (time frame: 6 months). 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 23 Mar 2026.