Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake

NCT06996366 | Completed

• 2 other identifiers: STU00219825R21AG081895-01A1
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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. At two clinics, researchers will randomize clinicians (and their associated, eligible patients) to early or delayed outreach.

Conditions

Annual Wellness Visit

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

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.

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.

Other: Outreach to encourage Annual Wellness Visit completion

Interventions

Outreach to encourage Annual Wellness Visit completion OTHER

Mailed and telephone outreach to patient.

Delayed outreach; Early outreach

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• Patients will be excluded if they are receiving palliative care or if their clinician feels that outreach for preventive care is inappropriate.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: April 22, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: March 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)