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Trial registered on ANZCTR
Registration number
ACTRN12619001332112
Ethics application status
Approved
Date submitted
29/08/2019
Date registered
30/09/2019
Date last updated
12/02/2021
Date data sharing statement initially provided
30/09/2019
Date results information initially provided
12/02/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Geriatric co-management of older vascular surgical patients in hospital
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Scientific title
Geriatric co-management of older vascular surgical patients in hospital to reduce geriatric syndromes and length of stay - a prospective before and after study
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Secondary ID [1]
299117
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None
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Universal Trial Number (UTN)
U1111-1239-2899
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Trial acronym
GeriCO-V
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
vascular surgery
314186
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age and ageing
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Condition category
Condition code
Public Health
312544
312544
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0
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Health service research
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Surgery
312545
312545
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0
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Other surgery
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Cardiovascular
312682
312682
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Delivery of proactive comprehensive geriatric assessment and management (CGA) of patients aged 65 years and over admitted under the vascular surgery service with an expected length of stay > 2 days. The geriatrician and senior vascular nurse will work as a team to undertake CGA at admission, make management recommendations, and follow-through till hospital discharge (i.e. the intervention is delivered from admission up until hospital discharge). The geriatrician will round twice weekly and will liaise with the vascular CNC on other weekdays to implement CGA. There will be no service provision on weekends. A multidisciplinary team meeting will occur weekly with attendance by the geriatrician that focuses on discharge planning. Provision of education and training in CGA and delirium for nursing staff as part of in-service education on the ward; this will be delivered by the geriatrician, vascular clinical nurse consultant, vascular clinical nurse educator, and falls and delirium clinical nurse consultant. Patient and carer education regarding delirium and falls, and strategies to prevent these with distribution of consumer information pamphlets which are available from the Agency for Clinical Innovation.
This is anticipated to be an ongoing service.
Patient recruitment in the post-implementation phase will conclude after 8 months.
Intervention fidelity will be assessed as the proportion of patients who received comprehensive geriatric assessment and management by the geriatrician and/or vascular CNC.
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Intervention code [1]
315396
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Treatment: Other
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Intervention code [2]
315517
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Prevention
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Comparator / control treatment
Pre-implementation (usual) care provided by vascular surgical team and ward staff, with geriatrician consultation available if requested (traditional reactive model of care).
Pre-implementation data will be collected for 8 months pre-intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of participants who experience at least one of the following geriatric syndromes during admission: delirium, functional decline at discharge, constipation, pressure injury or falls Delirium assessment based on face to face CAM and baseline cognitive screen. As well as based on notes and nursing staff observation. Functional decline will be assessed as an increase in ADL by 1 point or more between admission and discharge from the vascular surgery team as assessed using the KATZ ADL scale. Falls, constipation and pressure injury incidence will be sourced from patient medical records using predefined criteria developed by the study investigators based on a literature review and expert opinion. Delirium is the geriatric syndrome of most interest as has been associated with multiple adverse long-term consequences..
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Assessment method [1]
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Timepoint [1]
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Occurrence of delirium, constipation, pressure injury or falls will be measured from hospital admission to discharge while under the vascular surgery team.
Functional status will be measured at admission and discharge.
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Primary outcome [2]
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Acute hospital length of stay (days)
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Assessment method [2]
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Timepoint [2]
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Acute hospital stay measured from admission under vascular surgery to discharge from vascular surgery
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Secondary outcome [1]
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Medical and surgical complications including hospital-acquired complications.
Complications will be assessed based on patient medical records using pre-defined criteria. Complications to be assessed: vascular, surgical site/wound, respiratory, renal, neurological, cardiac, haematological, falls, pressure injuries, pain, constipation, sepsis.
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Assessment method [1]
374264
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Timepoint [1]
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From admission to discharge under vascular sugery
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Secondary outcome [2]
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In-hospital mortality
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Assessment method [2]
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Timepoint [2]
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From admission to discharge under vascular surgery
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Secondary outcome [3]
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14-day readmission rates
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Assessment method [3]
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Timepoint [3]
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At 14 days post discharge from hospital
Based on data linkage to patient medical records.
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Secondary outcome [4]
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Proportion of long-stay admissions (defined as admission duration of greater than 14 days)
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Assessment method [4]
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Timepoint [4]
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Day 14 of admission
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Secondary outcome [5]
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Consultations to other medical specialties.
Based on documentation in patient medical records.
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Assessment method [5]
374268
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Timepoint [5]
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From admission to discharge under vascular surgery
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Secondary outcome [6]
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Proportion of patients newly discharged to a residential aged care facilit.
Based on documentation in patient medical records.
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Assessment method [6]
374269
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Timepoint [6]
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At discharge
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Secondary outcome [7]
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Proportion of patients discharged home with increased community services.
Based on documentation in patient medical records.
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Assessment method [7]
374270
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Timepoint [7]
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At discharge
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Secondary outcome [8]
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Mobility status at discharge
Based on documentation in patient medical records. Assessed as either independent or assisted with or without an aid/wheelchair.
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Assessment method [8]
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Timepoint [8]
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At discharge
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Secondary outcome [9]
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Potentially inappropriate medications on discharge
Based on documentation in patient medical records using DBI and Beer's criteria.
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Assessment method [9]
374272
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Timepoint [9]
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At discharge
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Secondary outcome [10]
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Care processes
Based on documentation in patient medical records using a predefined list of care processes developed by the study investigators based on the ACOVE criteria. Examples: documentation of indication for a new urinary catheter, documentation of treatment preferences.
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Assessment method [10]
374273
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Timepoint [10]
374273
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From admission to discharge under vascular surgery
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Secondary outcome [11]
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28-day readmission rates
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Assessment method [11]
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Timepoint [11]
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At 28 days post discharge from hospital
Based on data linkage to patient medical records.
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Eligibility
Key inclusion criteria
All individuals aged 65 years and over admitted under vascular surgery with an expected LOS > 2 days
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients consulted by vascular surgery but admitted under another team.
2. Day only admissions.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Prospective before and after study comparing the pre-intervention and post-intervention cohorts
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/02/2019
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Date of last participant enrolment
Anticipated
17/07/2020
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Actual
17/12/2020
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Date of last data collection
Anticipated
16/10/2020
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Actual
31/01/2021
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Sample size
Target
300
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Concord Repatriation Hospital - Concord
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Recruitment postcode(s) [1]
27675
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2139 - Concord
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Centre for Education and Research on Ageing, University of Sydney
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Address [1]
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Centre for Education and Research on Ageing
Building 18, Concord Hospital, Hospital Road, Concord NSW 2139
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Country [1]
303660
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
303766
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Address [1]
303766
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Country [1]
303766
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District HREC - Concord Repatriation General Hospital
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Ethics committee address [1]
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Concord Hospital Research Office
Building 20, Ground Floor, Hospital Road, Concord NSW 2139
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Ethics committee country [1]
304180
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Australia
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Date submitted for ethics approval [1]
304180
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08/10/2018
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Approval date [1]
304180
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05/12/2018
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Ethics approval number [1]
304180
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LNR/18/CRGH/244
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Summary
Brief summary
Older patients undergoing surgery are at an increased risk of post-operative complications including geriatric syndromes such as delirium, functional decline and falls.. The Aged Care Department at Concord Hospital will introduce a novel co-management model of care for older adults admitted under the vascular surgery service. As part of the new service proactive comprehensive geriatric assessment and management will be undertaken by the geriatrician who will work collaboratively with the vascular surgery nursing staff and team. Using a prospective before and after study design, this research will evaluate the impact of this innovative, interdisciplinary and patient-centred model of care on important health outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
96058
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Dr Janani Thillainadesan
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Address
96058
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Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
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Country
96058
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Australia
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Phone
96058
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+61 2 9767 6931
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Fax
96058
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+61297677289
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Email
96058
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[email protected]
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Contact person for public queries
Name
96059
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Dr Janani Thillainadesan
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Address
96059
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Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
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Country
96059
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Australia
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Phone
96059
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+61 2 9767 6931
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Fax
96059
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+61 2 9767 7289
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Email
96059
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[email protected]
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Contact person for scientific queries
Name
96060
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Dr Janani Thillainadesan
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Address
96060
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Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
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Country
96060
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Australia
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Phone
96060
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+61 2 9767 6931
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Fax
96060
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+61 2 97677289
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Email
96060
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified data underlying published results will be available on request and by agreement of investigators.
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When will data be available (start and end dates)?
From publication of results in a peer-reviewed journal.
No end date determined.
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Available to whom?
Case by case basis at discretion of investigators
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Available for what types of analyses?
Case by case basis at discretion of investigators
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How or where can data be obtained?
Subject to approvals by Principal Investigator, Dr Janani Thillainadesan.
Email:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Geriatric Comanagement of Older Vascular Surgery Inpatients Reduces Hospital-Acquired Geriatric Syndromes.
2022
https://dx.doi.org/10.1016/j.jamda.2021.09.037
Embase
Understanding the Role and Value of Process Quality Indicators in Older Vascular Surgery Inpatients.
2021
https://dx.doi.org/10.1016/j.jss.2021.05.003
Embase
The Prognostic Performance of Frailty for Delirium and Functional Decline in Vascular Surgery Patients.
2021
https://dx.doi.org/10.1111/jgs.16907
N.B. These documents automatically identified may not have been verified by the study sponsor.
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