Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 12:55 AM
Study NCT ID:
NCT02468869
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Discharge Communication in the Emergency Department Through Information Structuring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' recall of the information provided during discharge communication", 'timeFrame': '3 times: immediately after discharge, one week after discharge, one month after discharge'}], 'secondaryOutcomes': [{'measure': 'Adherence to recommendations', 'timeFrame': '2 times: one week and one month after discharge'}, {'measure': 'Patient satisfaction in four dimensions', 'timeFrame': 'Immediately after discharge', 'description': '(1) comprehension, (2) structuredness (3) recommendation of the physician to family and friends (4) informativeness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Recall', 'Discharge communication', 'Satisfaction', 'Adherence', 'Information structuring', 'Empathy skills'], 'conditions': ['Information Structuring Skills', 'Empathy Skills']}, 'descriptionModule': {'briefSummary': "The goal of the proposed study is to assess the potential of information structuring for improving discharge communication. Specifically, the investigators aim to examine the advantages of an information-structuring skills training for physicians (compared to an empathy skills training) on discharge communication and associated patient outcomes, such as patients' information recall and adherence to physician recommendations. The investigators hypothesize that patients receiving structured discharge information from their trained physicians will be able to recall more information and show higher adherence to recommendations relative to controls (i.e., patients receiving discharge information from doctors trained in empathy skills)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with chest pain\n* Outpatients with abdominal pain\n\nExclusion criteria:\n\n* Patients younger than 18 years of age (limited ability to provide informed consent)\n* Patients with limited ability to communicate in German, the default language at the hospital (confounder related to language proficiency)\n* Patients with dementia (confounder arising from pathological memory deficits)'}, 'identificationModule': {'nctId': 'NCT02468869', 'briefTitle': 'Improving Discharge Communication in the Emergency Department Through Information Structuring', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Improving Discharge Communication in the Emergency Department Through Information Structuring: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BACOP2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Information structuring skills training', 'description': 'Physicians received a communication skills training focusing on information structuring with the so-called book metaphor for a structured discharge communication with the patient.', 'interventionNames': ['Behavioral: Communication skills training "information structuring skills"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empathy skills training', 'description': 'Physicians received a communication skills training focusing on empathy skills with the acronym NURSE for an empathetic discharge communication with the patient.', 'interventionNames': ['Behavioral: Communication skills training "empathy skills"']}], 'interventions': [{'name': 'Communication skills training "empathy skills"', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Empathy skills training']}, {'name': 'Communication skills training "information structuring skills"', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Information structuring skills training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Emergency Department', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Roland Bingisser, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Max Planck Institute for Human Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}