Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT01017627
Status:
UNKNOWN
Last Update Posted:
2010-04-02
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-01', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization', 'timeFrame': 'one year to accumulate 1500 hospitalizations'}], 'secondaryOutcomes': [{'measure': 'hemoglobin, transferrin saturation, albumin, white blood cell count, and C-reactive protein* levels measured in the period following hospitalization and change relative to values measured prior to hospitalization (where available).', 'timeFrame': 'one year to accumulate 1500 hospitalizations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ESRD', 'Anemia', 'Hospitalizations', 'Mortality'], 'conditions': ['Anemia', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '17942761', 'type': 'BACKGROUND', 'citation': 'Wingard RL, Pupim LB, Krishnan M, Shintani A, Ikizler TA, Hakim RM. Early intervention improves mortality and hospitalization rates in incident hemodialysis patients: RightStart program. Clin J Am Soc Nephrol. 2007 Nov;2(6):1170-5. doi: 10.2215/CJN.04261206. Epub 2007 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.', 'detailedDescription': 'The post-hospitalization quality improvement project will be piloted across 30 Fresenius clinics. Targeted enrollment of 1500 episodes of hospitalization in which the patient returns after discharge to resume outpatient dialysis.\n\nPatient outcomes will be followed for up to 30 days from the time of discharge from hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18\n* resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission\n* enrolled in a facility-based anemia management program\n\nExclusion Criteria:\n\n* enrolled in hospice\n* previous hospitalization within the past 30 days (ie. patients discharged from a repeat hospitalization)\n* anticipated discharge from the outpatient dialysis facility within 30 days (ie anticipated transfer to another facility or hospice)'}, 'identificationModule': {'nctId': 'NCT01017627', 'briefTitle': 'Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care North America'}, 'officialTitle': 'A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD', 'orgStudyIdInfo': {'id': '20090068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Early anemia management', 'description': "Upon return to the dialysis unit following hospitalization, patients will be immediately identified and have immediate implementation of the unit anemia protocol rather than waiting for the next regularly scheduled unit labs and regular follow-up. Thus, labs will be obtained within the first 3-7 days following hospitalization and appropriate titration of Epo and iron medications within the 7 days after discharge from hospital and under the direction of the pre-specified algorithm used in the patient's facility; all drug dosing will comply with package insert instructions", 'interventionNames': ['Other: Early anemia diagnosis and treatment']}, {'type': 'OTHER', 'label': 'case control', 'description': 'Each case will be "data-matched" to an intra-facility (primary control), and then an inter-facility (validation control) control patient. Matching criteria will be by age, gender, diabetic status, attending nephrologist, length of hospitalization stay, and hospital discharge date (to minimize the difference in the date between the case and control). These patients did not have early intervention but followed the usual practice of waiting for the next regularly scheduled dialysis unit labs with anemia management to follow using the regular unit algorithm.', 'interventionNames': ['Other: No change from normal routine']}], 'interventions': [{'name': 'Early anemia diagnosis and treatment', 'type': 'OTHER', 'description': 'Patients returning to the unit are immediately assessed and treated for anemia', 'armGroupLabels': ['Early anemia management']}, {'name': 'No change from normal routine', 'type': 'OTHER', 'description': 'Normal unit policy for labs and anemia treatment', 'armGroupLabels': ['case control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Central', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32246', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "St. John's", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32250', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'JAX Beach', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46733', 'city': 'Decatur', 'state': 'Indiana', 'country': 'United States', 'facility': 'Tri Counties', 'geoPoint': {'lat': 40.8306, 'lon': -84.92913}}, {'zip': '46750', 'city': 'Huntington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Huntington', 'geoPoint': {'lat': 40.8831, 'lon': -85.49748}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Floyd County', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '40216', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'South Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70517', 'city': 'Breaux Bridge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Breaux Bridge', 'geoPoint': {'lat': 30.27353, 'lon': -91.89928}}, {'zip': '71233', 'city': 'Delta', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delta', 'geoPoint': {'lat': 32.3257, 'lon': -90.92705}}, {'zip': '70501', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'East Lafayette', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '01844', 'city': 'Methuen', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Methuen', 'geoPoint': {'lat': 42.7262, 'lon': -71.19089}}, {'zip': '02119', 'city': 'Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Roxbury', 'geoPoint': {'lat': 42.3251, 'lon': -71.09533}}, {'zip': '49014', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Battle Creek', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '48823', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'East Lansing', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oshtemo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48911', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lansing', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saganaw Riverside', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saginaw', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '39744', 'city': 'Eupora', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Eupora', 'geoPoint': {'lat': 33.54068, 'lon': -89.26701}}, {'zip': '39301', 'city': 'Meridian', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Meridian', 'geoPoint': {'lat': 32.36431, 'lon': -88.70366}}, {'zip': '38655', 'city': 'Oxford', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Yokna River', 'geoPoint': {'lat': 34.3665, 'lon': -89.51925}}, {'zip': '64057', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Independence Centerpoint', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Desert Inn', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89120', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'South Pecos', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Briggs Ave', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Freedom Lake', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44512', 'city': 'Boardman', 'state': 'Ohio', 'country': 'United States', 'facility': 'Boardman', 'geoPoint': {'lat': 41.02423, 'lon': -80.66285}}, {'zip': '44410', 'city': 'Cortland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cortland', 'geoPoint': {'lat': 41.33033, 'lon': -80.72536}}, {'zip': '44035', 'city': 'Elyria', 'state': 'Ohio', 'country': 'United States', 'facility': 'Elyria', 'geoPoint': {'lat': 41.36838, 'lon': -82.10765}}, {'zip': '44128', 'city': 'North Randall', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Randall', 'geoPoint': {'lat': 41.43478, 'lon': -81.52568}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Westlake', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '44094', 'city': 'Willoughby', 'state': 'Ohio', 'country': 'United States', 'facility': 'Willoughby', 'geoPoint': {'lat': 41.63977, 'lon': -81.4065}}, {'zip': '97006', 'city': 'Beaverton', 'state': 'Oregon', 'country': 'United States', 'facility': 'Twin Oaks', 'geoPoint': {'lat': 45.48706, 'lon': -122.80371}}, {'zip': '97015', 'city': 'Clackamas', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clackamas', 'geoPoint': {'lat': 45.40762, 'lon': -122.57037}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Fresenius Medical Services', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Smyrna', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '37209', 'city': 'West Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Nashville', 'geoPoint': {'lat': 36.15895, 'lon': -86.84639}}, {'zip': '76119', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'North Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76119', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Tarrant County', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76708', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Waco', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Waco West', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Raymond Hakim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fresenius Medical Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Raymond Hakim, M.D., Ph.D.', 'oldOrganization': 'Fresenius Medical Care North America'}}}}