Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT05240105
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2022-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the "Platform Model" for Staffing in Psychiatric and Psychosomatic Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5961}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Administered Treatments', 'timeFrame': 'Week one of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week two of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week three of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week four of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week five of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week six of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week seven of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}, {'measure': 'Administered Treatments', 'timeFrame': 'Week eight of treatment: assessment of administered treatment units', 'description': 'units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists'}], 'secondaryOutcomes': [{'measure': 'HONOS - Health of the Nation Outcome Scales', 'timeFrame': 'administered once per patient at week one of treatment', 'description': 'measure of severity of mental illness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosomatic Medicine']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy.', 'detailedDescription': 'The aim of the study is to test the suitability of a structural model (so-called platform model) developed by a working group of various scientific societies and professional associations for staffing in psychosomatic medicine and psychotherapy. For this purpose, in three steps (1.) the four treatment clusters developed in the platform model will be quantified and empirically validated on the basis of the therapeutic services provided in health care practice; (2.) the current staffing for the four treatment clusters will be described ("as-is analysis"); and (3.) prototypical therapy plans will be developed as a basis for estimating the target staffing requirements. On this basis, a target staffing estimate will be made for all professional groups.\n\nFor the study, a total of 80 psychosomatic clinics from Germany will be randomly selected, belonging in equal parts to the groups of psychosomatic university clinics, psychosomatic specialist hospitals, and psychosomatic departments in somatic or in psychiatric hospitals. In addition, 20 day clinics are included. In these clinics, the structural framework conditions including staffing will be surveyed and the routine documentation of therapy units will be evaluated by cluster analysis in order to empirically validate the presumed treatment clusters and to describe the necessary staffing requirements.\n\nThe empirical examination and validation of the platform model, including the four assumed treatment clusters, has the potential to positively influence care practice in the long term by adjusting staffing levels in psychosomatic clinics to actual care requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'nationwide German population of psychosomatic specialist clinics and departments at University hospitals, general hospitals, or psychiatric hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Clinics:\n\n* belong to the predefined nationwide population of psychosomatic specialist clinics and departments\n* randomly selected for inclusion in the study,\n* the clinic management (head physician or comparable) agrees to participation in the study\n* possibility of electronic recording of the qualified therapy units for all treating professional groups.\n\nInclusion Criteria for Patients:\n\n* patient treated in one of the selected clinics on the corresponding ward or day clinic\n* at least 18 years old\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05240105', 'acronym': 'EPPIK', 'briefTitle': 'Evaluation of the "Platform Model" for Staffing in Psychiatric and Psychosomatic Clinics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Evaluation of the Suitability of the "Platform Model" as an Instrument for Staffing in Psychiatric and Psychosomatic Clinics (EPPIK) - Subproject Psychosomatics', 'orgStudyIdInfo': {'id': 'EPPIK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Departments for Psychosomatic Medicine at University Clinics', 'description': 'no study interventions, observational group', 'interventionNames': ['Other: no intervention, purely observational']}, {'label': 'Clinics specialized in Psychosomatic Medicine', 'description': 'no study interventions, observational group', 'interventionNames': ['Other: no intervention, purely observational']}, {'label': 'Departments for Psychosomatic Medicine at general hospitals', 'description': 'no study interventions, observational group', 'interventionNames': ['Other: no intervention, purely observational']}, {'label': 'Departments for Psychosomatic Medicine at psychiatric hospitals', 'description': 'no study interventions, observational group', 'interventionNames': ['Other: no intervention, purely observational']}], 'interventions': [{'name': 'no intervention, purely observational', 'type': 'OTHER', 'description': 'There will be no interventions. The study is purely observational and investigates differences in naturally occuring treatments at these four types of departments for Psychosomatic Medicine.', 'armGroupLabels': ['Clinics specialized in Psychosomatic Medicine', 'Departments for Psychosomatic Medicine at University Clinics', 'Departments for Psychosomatic Medicine at general hospitals', 'Departments for Psychosomatic Medicine at psychiatric hospitals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Simone U Jennissen, PhD', 'role': 'CONTACT', 'email': 'simone.jennissen@med.uni-heidelberg.de', 'phone': '+4962215634620'}, {'name': 'Hans-Christoph Friederich, Prof.', 'role': 'CONTACT'}], 'facility': 'Simone University Jennissen', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Simone U Jennissen, PhD', 'role': 'CONTACT', 'email': 'simone.jennissen@med.uni-heidelberg.de', 'phone': '004962215634620'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsches Krankenhausinstitut', 'class': 'UNKNOWN'}, {'name': 'DGPPN', 'class': 'UNKNOWN'}, {'name': 'DGKJP', 'class': 'UNKNOWN'}, {'name': 'DGPM', 'class': 'UNKNOWN'}, {'name': 'Forum für Gesundheitswirtschaft gGmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study coordinator', 'investigatorFullName': 'Simone Jennissen', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}