Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03893968
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2018-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Are Doctors and Assistant Nurses Equally Good at Informing Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The investigator is blinded to group allocation.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are assigned to either a group informed by doctors or assistance nurses in parallel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Information recall', 'timeFrame': '1 week after surgery', 'description': "A telephone-interviews were performed seven days after the surgery using a structured questionnaire. For the main objective, seven questions were asked testing patients recall/knowledge of their postoperative self-care. Each question evaluated the patients' knowledge of a unique aspect of postoperative self-care. The questionnaire is designed based on the postoperative info sheet received by patients after hand surgery."}], 'secondaryOutcomes': [{'measure': 'Stress and satisfaction', 'timeFrame': '1 week after surgery', 'description': 'During the telephone interview the patients could rate on a 1-10 scale their level of "feeling of understood the information", stress, and satisfaction. "Feeling of having understood the information" means the patients perception of having fully understood all the information and knowing fully what to do when leaving the hospital. For assessing "stress", the interviewer asked about the level of stress that the patient had experienced during the week following the surgery. Regarding "satisfaction", the interviewer asked and assessed how satisfied the patients were with the way the personnel had informed the patient (e.g. not used difficult or confusing language, had given the patient time to ask questions etc).'}, {'measure': 'Additional healthcare contacts', 'timeFrame': '30 days after surgery', 'description': 'Compare differences in the number of healthcare contacts due to not being able to recall or having understood information.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Care']}, 'descriptionModule': {'briefSummary': "Objectives: to compare patients' recall of information regarding postoperative self-care when being informed by either doctors or assistant nurses.\n\nMethods: a non-blinded randomized single-center controlled trial being conducted at a hand-surgical unit in Northern Sweden. Included are adult ambulatory patients about to undergo surgery in local anesthesia. Patients are randomized into two parallel groups, with the control-group being informed by doctors and the intervention-group by assistant nurses. Patients will be telephoned one week after surgery for assessment of information recall via a structured telephone-interview.", 'detailedDescription': "The study was conducted within the hand-surgical unit at Norrland's University Hospital in Umeå, county of Västerbotten, in Sweden. There are three hospitals in this sparsely populated county of 55432〖km〗\\^2 with about 268000 in population. The hand-surgery unit serves both the local population and is a tertiary referral center.\n\nAs the healthcare in Sweden is funded by taxpayers, the healthcare for patients is free, apart from a small nominal fee. There was a total of seven doctors and seven assistant nurses participating in the study, all having several years of experience working with hand-surgical care. Prior to the study, doctors had the formal responsibility of informing patients about their postoperative care. However, despite it being the surgeons' responsibility, the task of informing patients was at times performed by assistant nurses. After receiving the information, patients were discharged and left the clinic. Normally patients receive a complementary written information after being informed verbally. Patients included in the study did not receive the written information, since it might have been a confounding factor in understanding of information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* about to undergo elective hand surgical procedure in local anaesthesia\n* 18 years or older.\n\nExclusion Criteria:\n\n* does not speak Swedish\n* dementia or other form av cognitive impairment'}, 'identificationModule': {'nctId': 'NCT03893968', 'briefTitle': 'Are Doctors and Assistant Nurses Equally Good at Informing Patients', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Are Doctors and Assistant Nurses Equally Good at Informing Patients: A Randomized Controlled Trial Comparing Information Recall Regarding Postoperative Self-care', 'orgStudyIdInfo': {'id': '2017/446-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Informed by a doctor', 'description': 'Information by a doctor', 'interventionNames': ['Behavioral: Information by a doctor']}, {'type': 'EXPERIMENTAL', 'label': 'Informed by an assistant nurse', 'description': 'Information by an assistant nurse', 'interventionNames': ['Behavioral: Information by an assistant nurse']}], 'interventions': [{'name': 'Information by an assistant nurse', 'type': 'BEHAVIORAL', 'description': 'Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse.', 'armGroupLabels': ['Informed by an assistant nurse']}, {'name': 'Information by a doctor', 'type': 'BEHAVIORAL', 'description': 'Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor.', 'armGroupLabels': ['Informed by a doctor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90956', 'city': 'Umeå', 'state': 'Sverige', 'country': 'Sweden', 'facility': "Norrland's University Hospital", 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Martin Fahlström', 'role': 'STUDY_CHAIR', 'affiliation': 'Umea University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Aleksandra McGrath', 'investigatorAffiliation': 'Umeå University'}}}}