Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT04726202
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2021-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-24', 'size': 660392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-22T08:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reimbursement per day at hospital', 'timeFrame': '8 months', 'description': 'total reimbursement per arm divided by the total stay of the patients in the arm in days'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '8 months', 'description': 'length of hopital stay in full days including entry and discharge day'}, {'measure': 'Total reimbursement per case', 'timeFrame': '8 months', 'description': 'reimbursement in Swiss Francs per case'}, {'measure': 'case mix index per case', 'timeFrame': '8 months', 'description': 'Financial department will provide the cost weight/case mix index per case'}, {'measure': 'Severity of perioperative complications', 'timeFrame': '8 months', 'description': 'complications during hospitalisation will be graded according to the Clavian-Dindo scale. In case of multiple complications the highest grade will be taken.'}, {'measure': 'readmission rate', 'timeFrame': '8 months', 'description': 'Rate of case related readmissions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DRG', 'Diagnosis-Related Groups', 'ICD', 'reimbursement'], 'conditions': ['Diagnosis-Related Groups', 'Healthcare Common Procedure Coding System']}, 'referencesModule': {'references': [{'pmid': '12410910', 'type': 'BACKGROUND', 'citation': "Fillit H, Geldmacher DS, Welter RT, Maslow K, Fraser M. Optimizing coding and reimbursement to improve management of Alzheimer's disease and related dementias. J Am Geriatr Soc. 2002 Nov;50(11):1871-8. doi: 10.1046/j.1532-5415.2002.50519.x."}, {'pmid': '10311457', 'type': 'BACKGROUND', 'citation': 'Fetter RB, Freeman JL. Diagnosis related groups: product line management within hospitals. Acad Manage Rev. 1986 Jan;11(1):41-54.'}, {'pmid': '1288673', 'type': 'BACKGROUND', 'citation': 'Fetter RB. Hospital payment based on diagnosis-related groups. J Soc Health Syst. 1992;3(4):4-15.'}, {'pmid': '7637403', 'type': 'BACKGROUND', 'citation': 'Freeman JL, Fetter RB, Park H, Schneider KC, Lichtenstein JL, Hughes JS, Bauman WA, Duncan CC, Freeman DH Jr, Palmer GR. Diagnosis-related group refinement with diagnosis- and procedure-specific comorbidities and complications. Med Care. 1995 Aug;33(8):806-27. doi: 10.1097/00005650-199508000-00006.'}, {'pmid': '10113461', 'type': 'BACKGROUND', 'citation': 'Hughes JS, Lichtenstein J, Fetter RB. Procedure codes: potential modifiers of diagnosis-related groups. Health Care Financ Rev. 1990 Fall;12(1):39-46.'}, {'pmid': '29188352', 'type': 'BACKGROUND', 'citation': 'Geuss S, Jungmeister A, Baumgart A, Seelos R, Ockert S. [Prospective DRG coding : Improvement in cost-effectiveness and documentation quality of in-patient hospital care]. Chirurg. 2018 Feb;89(2):138-145. doi: 10.1007/s00104-017-0555-4. German.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '19638912', 'type': 'BACKGROUND', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}], 'seeAlsoLinks': [{'url': 'https://grouper.swissdrg.org/swissdrg/single', 'label': 'OnlineGrouper'}, {'url': 'https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf', 'label': 'Common Terminology Criteria for Adverse Events (CTCAE)'}, {'url': 'https://www.admin.ch/opc/en/classified-compilation/19920153/index.html', 'label': 'Federal Act on Data Protection (FADP)'}, {'url': 'https://www.admin.ch/opc/de/classified-compilation/20061313/index.html', 'label': 'Human Research Act (HRA)'}, {'url': 'https://www.admin.ch/opc/de/classified-compilation/20121176/index.html', 'label': 'Ordinance on Clinical Trials in Human Research (ClinO)'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of present study is that the daily monitoring and optimization of DRG coding is associated with higher reimbursement. Therefore, the primary objective is to determine if the daily monitoring and optimization of DRG coding of individual cases leads to better proceeds per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing inpatient surgery in the fields of General, Visceral, Endocrine or Transplantation Surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing surgery as inpatients (at least one night stay)\n* treated at the Kantonsspital St. Gallen, St. Gallen site\n\nExclusion Criteria:\n\n* surgery as outpatients\n* surgery at the Rorschach and Flawil sites\n* patients operated on by the Department of Surgery, but hospitalized at another department of the hospital'}, 'identificationModule': {'nctId': 'NCT04726202', 'briefTitle': 'Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Impact of Semi-automated Proposal and Optimization of Diagnoses and Surgical Procedures for Precoding: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Chir201902'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control arm', 'description': 'standard procedure of coding at hospital', 'interventionNames': ['Other: Standard procedure']}, {'label': 'Precoding arm', 'description': 'Coding of the standard procedure will be reviewed and corrected', 'interventionNames': ['Other: precoding']}], 'interventions': [{'name': 'Standard procedure', 'type': 'OTHER', 'description': 'Coding of cases follows the standard procedures established at the hospital', 'armGroupLabels': ['Control arm']}, {'name': 'precoding', 'type': 'OTHER', 'description': 'Standard coding will be reviewed by dedicated physicians and corrected or extended if necessary.\n\nCoding will compared to the written OP report for consistency. Dedicated physician visits patients daily (in addition to routine visits). Dedicated physicians review discharge report and will make changes and additions. DRG coding will be adapted to results from visits and discharge report.', 'armGroupLabels': ['Precoding arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Department of Surgery, Cantonal Hospital of St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Thomas Steffen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital St. Gallen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Steffen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of Department', 'investigatorFullName': 'Thomas Steffen', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}