Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-01 @ 2:43 PM
Study NCT ID:
NCT00988000
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Initial Specialist Telephone Consultation With New Patients in Secondary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.partridge@imperial.ac.uk', 'phone': '+44 (0)20 7594 7959', 'title': 'Professor Martyn Partridge', 'organization': 'Imperial College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 month', 'eventGroups': [{'id': 'EG000', 'title': 'Agree to Alternative Study Invitation', 'description': 'Patients agree to alternative study invitation', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Declined the Alternative Study Invitation', 'description': 'Patients who declined/ non-responders to alternative study invitation', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comparator', 'description': 'Patients - choose and book', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Satisfaction of the Alternative Consultation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Agree to the Alternative Consultation', 'description': 'Patients respond to study invitation and agree'}, {'id': 'OG001', 'title': 'Declined the Alternative Study Invitation', 'description': 'Declined/non-responders for the invitation'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Patients choose and book'}], 'classes': [{'title': 'first clinic appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.85', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '5.26', 'spread': '0.70', 'groupId': 'OG002'}]}]}, {'title': 'follow-up appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.47', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '5.36', 'spread': '0.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First clinic appointment (Month 0) and Follow-up appointment (6 months', 'description': 'Patient Satisfaction assessed by MISS scale, Medical interview satisfaction score. The score 0-7, 0 means dissatisfaction, higher scores indicate higher satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete data and those that had an alternative consultation did not need a follow up appointment'}, {'type': 'SECONDARY', 'title': 'Number of Required Investigations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Agree to the Alternative Study Invitation', 'description': 'Patients respond to study invitation and agree'}, {'id': 'OG001', 'title': 'Declined the Alternative Study Invitation', 'description': 'Declined/ non-responders to the alternative study invitation'}, {'id': 'OG002', 'title': 'Comparator', 'description': 'Patients choose and book'}], 'classes': [{'title': 'Planned investigations', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}]}, {'title': 'Completed investigations', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-6 months', 'description': 'reduction in number of required investigations', 'unitOfMeasure': 'number of investigation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Agree to Alternative Study Invitation', 'description': 'Patients Respond to study invitation - agree to alternative consultation'}, {'id': 'FG001', 'title': 'Declined the Alternative Study Invitation', 'description': 'Patients respond to study invitation - declined/ non-responders for the invitation'}, {'id': 'FG002', 'title': 'Comparator', 'description': 'Patients - choose and book'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Patients' who attending respiratory outpatient clinics"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Respond to Study Invitation - Agree to Alternative Consultatio', 'description': 'participants agreed to have an alternative consultation i.e. telephone consultation for their first hospital appointment'}, {'id': 'BG001', 'title': 'Respond to Study Invitation - Declined/ Non-responders', 'description': 'Participants declined or did not respond to the invitation to participate in the study'}, {'id': 'BG002', 'title': 'Comparator - Choose and Book', 'description': 'participants in this group booked their appointment through the choose and book system'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '17.0', 'groupId': 'BG002'}, {'value': '56.7', 'spread': '15.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2009-09-30', 'resultsFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-23', 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction of the Alternative Consultation', 'timeFrame': 'First clinic appointment (Month 0) and Follow-up appointment (6 months', 'description': 'Patient Satisfaction assessed by MISS scale, Medical interview satisfaction score. The score 0-7, 0 means dissatisfaction, higher scores indicate higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Number of Required Investigations', 'timeFrame': '0-6 months', 'description': 'reduction in number of required investigations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outpatients'], 'conditions': ['Respiratory Diseases']}, 'descriptionModule': {'briefSummary': "Consultations with patients by hospital consultants are organised today in a manner which is barely dissimilar from that offered 30 or 40 years ago. Whilst some attempts to improve this process, such as Choose and Book, shorter waiting times and patients' receiving a copy of the correspondence sent to their general practitioner (GP) have improved the situation, there has been little radical change and little thought given to the patient experience.\n\nThe investigators wish to investigate whether patients' experience of attending respiratory outpatient clinics can be improved by a pre-clinic telephone call with a specialist thereby reducing the number of attendances at the hospital for appointments and investigations and improving overall patient satisfaction.", 'detailedDescription': "This study will investigate whether taking a new patient's history over the telephone permits better selection and arrangement of investigations prior to or synchronous with the first face to face consultation, with the potential to reduce the number of visits the patient has to make to the hospital.\n\nPatients will be offered an initial telephone consultation by post and may opt-in or out of the study. Those having a telephone consultation would have this booked for a specific time and date and the patient would be sent an appropriate information leaflet regarding this. After the telephone consultation patients receive a summary of the consultation and details of any investigations and appointments booked by the research nurse. Patients who did not respond to the initial invitation letter within seven days or who declined to participate would be sent a routine appointment. All patients would asked to complete the MISS-21 questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All new adult general respiratory referrals from primary care\n\nExclusion Criteria:\n\n* Follow-up patients'}, 'identificationModule': {'nctId': 'NCT00988000', 'briefTitle': 'Initial Specialist Telephone Consultation With New Patients in Secondary Care', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Telephone Consultations for New Patients Being Referred to a Specialist Respiratory Outpatient Clinic', 'orgStudyIdInfo': {'id': 'NHLICX07Q060519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Agree to the alternative study invitation', 'description': 'Agree with alternative of telephone consultation (instead of face to face) offered as an initial consultation to new referrals', 'interventionNames': ['Other: telephone consultation']}, {'type': 'OTHER', 'label': 'Decline the alternative study invitation', 'description': 'Decline, no respond to the alternative of telephone consultation', 'interventionNames': ['Other: No intervention']}, {'type': 'OTHER', 'label': 'Comparator', 'description': 'Choose and book', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'telephone consultation', 'type': 'OTHER', 'description': 'alternative to face to face consultation for new referrals', 'armGroupLabels': ['Agree to the alternative study invitation']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'no alternative to face to face consultation', 'armGroupLabels': ['Comparator', 'Decline the alternative study invitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College at Charing Cross campus', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Professor MR Partridge, MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Dunhill Medical Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}