Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake

NCT ID: NCT06996366

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Early outreach

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.

Group Type: EXPERIMENTAL

Outreach to encourage Annual Wellness Visit completion

Intervention Type: OTHER

Mailed and telephone outreach to patient.

Delayed outreach

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.

Group Type: OTHER

Outreach to encourage Annual Wellness Visit completion

Intervention Type: OTHER

Mailed and telephone outreach to patient.

Interventions

Outreach to encourage Annual Wellness Visit completion

Mailed and telephone outreach to patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥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

Exclusion Criteria

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

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Liss

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R21AG081895-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00219825

Identifier Type: -

Identifier Source: org_study_id