Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-04-01 @ 5:54 PM
Study NCT ID:
NCT07109427
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PSA screening completion rates in the BJC East Health System', 'timeFrame': 'Through 5 years', 'description': 'The overall PSA screening rate will be calculated as the number of PSA screening tests that are ordered by PCPs who will receive the alert and completed by patients within a year of the ordering date, divided by the total number of eligible patients.'}], 'secondaryOutcomes': [{'measure': 'Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7)', 'timeFrame': 'Through 5 years'}, {'measure': 'Incidence of advanced and metastatic disease at diagnosis of prostate cancer', 'timeFrame': 'Through 5 years'}, {'measure': 'Incidence of early-stage prostate cancer', 'timeFrame': 'Through 5 years'}, {'measure': 'Stage distribution of prostate cancer diagnoses', 'timeFrame': 'Through 5 years'}, {'measure': 'Biopsy rates', 'timeFrame': 'Through 5 years'}, {'measure': 'Percent of PSA screening ordered but not completed', 'timeFrame': 'Through 5 years'}, {'measure': 'Median PSA at time of diagnosis', 'timeFrame': 'Through 5 years'}, {'measure': 'Evaluate the agreement between 3T MRI and biomarker test results', 'timeFrame': 'Through 5 years', 'description': 'The 3T MRI and biomarker tests are used to help determine whether a biopsy is necessary. The investigators will categorize the results as positive versus negative and the agreement will be gauged based on Kappa coefficient.'}, {'measure': 'PSA screening rate by age group', 'timeFrame': 'Through 5 years', 'description': 'Age groups will include 40-49, 50-70, and 70-75'}, {'measure': 'PSA screening rate by race', 'timeFrame': 'Through 5 years'}, {'measure': 'PSA screening rate by comorbidity burden', 'timeFrame': 'Through 5 years'}, {'measure': 'PSA screening rate by insurance coverage', 'timeFrame': 'Through 5 years'}, {'measure': 'PSA screening rate by provider', 'timeFrame': 'Through 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSA Screening', 'Clinically Significant Prostate Cancer', 'African American men', 'Electronic Health Record'], 'conditions': ['Prostate Cancer', 'Cancer of the Prostate']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': '\\- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care:\n\n* Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines.\n* Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices.\n* The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria:\n\n* Receive care within the BJC Health System\n* Have had at least one primary care physician appointment in the calendar year of PSA screening (primary care)\n* Be male\n* Not have a history of prostate cancer\n* Meet one of the following risk criteria:\n\n * High Risk for Prostate Cancer\n\n * African American, between the ages of 40 and 75 (inclusive), or\n * Family history of prostate, breast, ovarian, and/or pancreatic cancer, or\n * Known familial germline mutation OR\n * Average Risk for Prostate Cancer\n\n * Between the ages of 50 and 75 (inclusive)'}, 'identificationModule': {'nctId': 'NCT07109427', 'briefTitle': 'Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System', 'orgStudyIdInfo': {'id': '202507064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Annual PSA Health Maintenance Reminder', 'description': 'An annual health maintenance reminder will be implemented for all men who meet the American Cancer Society guidelines for average- and high-risk eligibility criteria. The goal is to encourage their primary care provider (PCP) to engage in a shared decision-making discussion with the patient about the benefits and risks of prostate cancer screening.\n\nThis alert will appear in the health maintenance reminder section of the electronic health record (EHR).\n\nAlthough all providers with access to EPIC can view the alert, it is typically the PCPs who review and take action on alerts in the health maintenance reminder section.', 'interventionNames': ['Other: Annual PSA Health Maintenance Reminder']}], 'interventions': [{'name': 'Annual PSA Health Maintenance Reminder', 'type': 'OTHER', 'description': 'The annual health maintenance reminder does not mandate PSA screening for eligible patients. Instead, it recommends that primary care providers (PCPs) initiate a shared decision-making discussion with their patients. As part of this conversation, patients will be informed of their individual risk factors-including race, family history, and germline mutations-and can then make an informed choice about whether to proceed with PSA screening.', 'armGroupLabels': ['Annual PSA Health Maintenance Reminder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lannis Hall, M.D., MPH', 'role': 'CONTACT', 'email': 'lannishall@wustl.edu', 'phone': '636-916-9947'}, {'name': 'Lannis Hall, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Saira Khan, Ph.D., MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arnold Bullock, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Timothy Eberlein, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kristina Williams', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cliff Robinson, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jingqin (Rosy) Luo, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Abraham, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Johnson, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Lannis Hall, M.D., MPH', 'role': 'CONTACT', 'email': 'lannishall@wustl.edu', 'phone': '636-916-9947'}], 'overallOfficials': [{'name': 'Lannis Hall, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}