Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-06 @ 6:08 AM
Study NCT ID:
NCT03393351
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2017-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Shared Decision-Making in Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A stepped wedge design, a variant of the cluster randomized controlled trial feasible to evaluate interventions in routine implementation, will be used. Participating clinics will receive the multifaceted implementation program in a randomized sequence.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in uptake of shared decision-making from the patients' perspective", 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)'}], 'secondaryOutcomes': [{'measure': "Change in uptake of shared decision-making from external observers' perspective", 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'Action to employ shared decision-making as measured by the German version of the Observer OPTION 5 scale using audio-recorded medical encounters. The Observer OPTION 5 scale measures the extent to which clinicians involve patients in decision-making. Each of the 5 items is assessed on a scale ranging from 0 to 4 with higher values indicating more involvement of patients in decision-making. A sum score is calculated (ranging from 0 to 20) and rescaled to be between 0 to 100, for ease of interpretation.'}, {'measure': "Acceptability of shared decision-making from the health care providers' perspective", 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'Perception that shared decision-making is agreeable, palatable, or satisfactory as measured by an adapted version of the acceptability survey developed by McColl et al.'}, {'measure': "Readiness for implementing change from the health care professionals' perspective", 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure'}, {'measure': "Appropriateness of shared decision-making from the health care professionals' perspective", 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure'}, {'measure': 'Change in penetration of shared decision-making at the clinic level', 'timeFrame': 'baseline, 3 years', 'description': 'Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics'}, {'measure': 'Change in penetration of shared decision-making in multidisciplinary team meetings', 'timeFrame': 'All clinics: baseline, 8 months, 16 months, 24 months', 'description': 'Integration of shared decision-making within a setting and its subsystems as measured by an adapted version of the Metric for the Observation of Decision Making in Multidisciplinary Team Meetings (MDT-MODe)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shared Decision-Making', 'Decision Making', 'Patient Participation', 'Patient Centeredness', 'Health Services Research', 'Implementation Research', 'Oncology', 'Stepped Wedge Design', 'Mixed Methods'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '29580249', 'type': 'BACKGROUND', 'citation': 'Scholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Muller V, Smeets R, Witzel I, Kriston L, Harter M. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y.'}, {'pmid': '37553560', 'type': 'DERIVED', 'citation': 'Hahlweg P, Lindig A, Frerichs W, Zill J, Hanken H, Muller V, Peters MC, Scholl I. Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial. BMC Health Serv Res. 2023 Aug 8;23(1):840. doi: 10.1186/s12913-023-09778-w.'}, {'pmid': '34965881', 'type': 'DERIVED', 'citation': 'Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Harter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for participating patients:\n\n* diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)\n* admitted for inpatient or outpatient treatment at the participating clinics\n* age \\> 18 years\n* German-speaking\n\nExclusion Criteria for participating patients:\n\n* severe cognitive impairment\n\nInclusion Criteria for participating health care professionals:\n\n* physician or nurse working at the participating clinics\n\nExclusion Criteria for participating health care professionals:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03393351', 'acronym': 'PREPARED', 'briefTitle': 'Implementation of Shared Decision-Making in Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'SCHO 1551/1-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shared decision-making program', 'interventionNames': ['Other: Shared decision-making program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Shared decision-making program', 'type': 'OTHER', 'description': 'The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components:\n\n1. shared decision-making trainings for health care professionals,\n2. individual coaching for physicians,\n3. patient activation strategy,\n4. provision of patient information material and decision aids,\n5. revision of the clinics quality management documents, and\n6. critical reflection of current organization of multidisciplinary team meetings.\n\nImplementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.', 'armGroupLabels': ['Shared decision-making program']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Isabelle Scholl, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research Group, Prinicipal Investigator', 'investigatorFullName': 'Isabelle Scholl', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}