Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 7:57 AM
Study NCT ID:
NCT05014256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 1168}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health system reported completion of transplant evaluation', 'timeFrame': '18 months', 'description': 'Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports'}], 'secondaryOutcomes': [{'measure': 'Live donor inquires to transplant center', 'timeFrame': '6 months, 12 months, 18 months', 'description': 'the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire'}, {'measure': 'Live kidney donor transplants', 'timeFrame': '6 months, 12 months, 18 months', 'description': 'The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire'}, {'measure': 'Placement on deceased kidney donor waitlist', 'timeFrame': '6 months, 12 months, 18 months', 'description': 'The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS'}, {'measure': 'Deceased kidney donor transplants', 'timeFrame': '6 months, 12 months, 18 months', 'description': 'The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS'}, {'measure': 'Health system reported initiation of transplant evaluation', 'timeFrame': '18 months', 'description': 'Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports'}, {'measure': 'Patient reported physician discussions', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire'}, {'measure': 'Patient reported family discussions', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire'}, {'measure': 'Patient reported initiation of transplant evaluation', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire'}, {'measure': 'Patient reported completion of transplant evaluation', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire'}, {'measure': 'Patient reported identification of a living donor', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire'}, {'measure': 'Patient reported kidney transplant knowledge', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'Number of questions patients correctly answer measured by patient report in questionnaire'}, {'measure': 'Patient reported empowerment', 'timeFrame': 'baseline, 6 months, 12 months, 18 months', 'description': 'Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplant', 'Living donor kidney transplant'], 'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '40199386', 'type': 'DERIVED', 'citation': 'Boulware LE, Ephraim PL, Shafi T, Green JA, Browne T, Strigo TS, Peskoe S, Wilson J, Lokhnygina Y, Alkon A, Jackson GL, Ellis MJ, Sudan D, Cameron B, Vaitla PK, Cabacungan A, Brubaker L, Obermiller EL, Diamantidis CJ. System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial. Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6.'}]}, 'descriptionModule': {'briefSummary': "This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide oral informed consent\n* Male or female, aged 18 to \\<=75 years\n* Presence of CKD (2 eGFRs \\<60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%\n* English speaking with adequate ability to hear and understand questions over the phone\n* Willing to comply with all study procedures and be available for the duration of the study\n\nExclusion Criteria:\n\n* Male or female, aged \\<18 or \\> 75 years\n* Non-English speaking\n* Lack of ability to hear and comprehend verbal communication.\n* Patients on dialysis\n* Deceased\n* Hospice/palliative care\n* Prior kidney transplant\n* Currently waitlisted at any transplant center\n* Self-reported terminal illness or receipt of hospice services'}, 'identificationModule': {'nctId': 'NCT05014256', 'briefTitle': 'System Interventions to Achieve Early and Equitable Transplants (STEPS) Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'System Interventions to Achieve Early and Equitable Transplants (STEPS) Study', 'orgStudyIdInfo': {'id': 'IRB00097407'}, 'secondaryIdInfos': [{'id': '7U01DK127918-02', 'link': 'https://reporter.nih.gov/quickSearch/7U01DK127918-02', 'type': 'NIH'}, {'id': 'IHS-2020C1-19350-IC', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEPS Health System Surveillance and Outreach intervention', 'interventionNames': ['Behavioral: STEPS Health System Outreach intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Kidney Care'}], 'interventions': [{'name': 'STEPS Health System Outreach intervention', 'type': 'BEHAVIORAL', 'description': 'STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach', 'armGroupLabels': ['STEPS Health System Surveillance and Outreach intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Ebony Boulware, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwell Health', 'class': 'OTHER'}, {'name': 'Geisinger Clinic', 'class': 'OTHER'}, {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}