Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-27 @ 6:30 PM
Study NCT ID:
NCT06996366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of Annual Wellness Visit', 'timeFrame': '6 months', 'description': 'Binary (0/1) patient-level measure, based on presence of any CPT (Current Procedural Terminology) codes for Medicare preventive visits during follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Annual Wellness Visit']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥1 in-person primary care visit during 18-month lookback period AND\n* Medicare or Medicare Advantage insurance AND\n* ≥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\n* Preferred language English AND\n* Attributed primary care clinic is 1 of the participating clinics in the pilot trial AND\n* No AWV completion (CPT G0402, G0438, G0439, G0468) during 10-month lookback period AND\n* No appointment scheduled for upcoming AWV\n\nExclusion Criteria:\n\n* Patients will be excluded if they are receiving palliative care or if their clinician feels that outreach for preventive care is inappropriate.'}, 'identificationModule': {'nctId': 'NCT06996366', 'briefTitle': 'Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Reducing Racial and Ethnic Disparities in Medicare Annual Wellness Visit Uptake', 'orgStudyIdInfo': {'id': 'STU00219825'}, 'secondaryIdInfos': [{'id': 'R21AG081895-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AG081895-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early outreach', 'description': '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.', 'interventionNames': ['Other: Outreach to encourage Annual Wellness Visit completion']}, {'type': 'OTHER', 'label': 'Delayed outreach', 'description': '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.', 'interventionNames': ['Other: Outreach to encourage Annual Wellness Visit completion']}], 'interventions': [{'name': 'Outreach to encourage Annual Wellness Visit completion', 'type': 'OTHER', 'description': 'Mailed and telephone outreach to patient.', 'armGroupLabels': ['Delayed outreach', 'Early outreach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'David Liss', 'investigatorAffiliation': 'Northwestern University'}}}}