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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Geriatric co-management of older vascular surgical patients in hospital
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
Secondary ID [1] 299117 0
None
Universal Trial Number (UTN)
U1111-1239-2899
Trial acronym
GeriCO-V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vascular surgery 314186 0
age and ageing 314187 0
Condition category
Condition code
Public Health 312544 312544 0 0
Health service research
Surgery 312545 312545 0 0
Other surgery
Cardiovascular 312682 312682 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315396 0
Treatment: Other
Intervention code [2] 315517 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 321192 0
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..
Timepoint [1] 321192 0
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.
Primary outcome [2] 321193 0
Acute hospital length of stay (days)
Timepoint [2] 321193 0
Acute hospital stay measured from admission under vascular surgery to discharge from vascular surgery
Secondary outcome [1] 374264 0
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.
Timepoint [1] 374264 0
From admission to discharge under vascular sugery
Secondary outcome [2] 374265 0
In-hospital mortality
Timepoint [2] 374265 0
From admission to discharge under vascular surgery
Secondary outcome [3] 374266 0
14-day readmission rates
Timepoint [3] 374266 0
At 14 days post discharge from hospital
Based on data linkage to patient medical records.
Secondary outcome [4] 374267 0
Proportion of long-stay admissions (defined as admission duration of greater than 14 days)
Timepoint [4] 374267 0
Day 14 of admission
Secondary outcome [5] 374268 0
Consultations to other medical specialties.

Based on documentation in patient medical records.
Timepoint [5] 374268 0
From admission to discharge under vascular surgery
Secondary outcome [6] 374269 0
Proportion of patients newly discharged to a residential aged care facilit.

Based on documentation in patient medical records.
Timepoint [6] 374269 0
At discharge
Secondary outcome [7] 374270 0
Proportion of patients discharged home with increased community services.

Based on documentation in patient medical records.
Timepoint [7] 374270 0
At discharge
Secondary outcome [8] 374271 0
Mobility status at discharge

Based on documentation in patient medical records. Assessed as either independent or assisted with or without an aid/wheelchair.
Timepoint [8] 374271 0
At discharge
Secondary outcome [9] 374272 0
Potentially inappropriate medications on discharge

Based on documentation in patient medical records using DBI and Beer's criteria.
Timepoint [9] 374272 0
At discharge
Secondary outcome [10] 374273 0
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.
Timepoint [10] 374273 0
From admission to discharge under vascular surgery
Secondary outcome [11] 374687 0
28-day readmission rates
Timepoint [11] 374687 0
At 28 days post discharge from hospital
Based on data linkage to patient medical records.

Eligibility
Key inclusion criteria
All individuals aged 65 years and over admitted under vascular surgery with an expected LOS > 2 days
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients consulted by vascular surgery but admitted under another team.
2. Day only admissions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Prospective before and after study comparing the pre-intervention and post-intervention cohorts
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/02/2019
Date of last participant enrolment
Anticipated
17/07/2020
Actual
17/12/2020
Date of last data collection
Anticipated
16/10/2020
Actual
31/01/2021
Sample size
Target
300
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14650 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 27675 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 303660 0
University
Name [1] 303660 0
Centre for Education and Research on Ageing, University of Sydney
Country [1] 303660 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 303766 0
None
Name [1] 303766 0
Address [1] 303766 0
Country [1] 303766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304180 0
Sydney Local Health District HREC - Concord Repatriation General Hospital
Ethics committee address [1] 304180 0
Ethics committee country [1] 304180 0
Australia
Date submitted for ethics approval [1] 304180 0
08/10/2018
Approval date [1] 304180 0
05/12/2018
Ethics approval number [1] 304180 0
LNR/18/CRGH/244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96058 0
Dr Janani Thillainadesan
Address 96058 0
Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
Country 96058 0
Australia
Phone 96058 0
+61 2 9767 6931
Fax 96058 0
+61297677289
Email 96058 0
Janani.Thillainadesan@health.nsw.gov.au
Contact person for public queries
Name 96059 0
Janani Thillainadesan
Address 96059 0
Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
Country 96059 0
Australia
Phone 96059 0
+61 2 9767 6931
Fax 96059 0
+61 2 9767 7289
Email 96059 0
Janani.Thillainadesan@health.nsw.gov.au
Contact person for scientific queries
Name 96060 0
Janani Thillainadesan
Address 96060 0
Department of Geriatric Medicine; Concord Hospital
Building 12, Concord Hospital, Hospital Road, Concord NSW 2139
Country 96060 0
Australia
Phone 96060 0
+61 2 9767 6931
Fax 96060 0
+61 2 97677289
Email 96060 0
Janani.Thillainadesan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results will be available on request and by agreement of investigators.
When will data be available (start and end dates)?
From publication of results in a peer-reviewed journal.
No end date determined.
Available to whom?
Case by case basis at discretion of investigators
Available for what types of analyses?
Case by case basis at discretion of investigators
How or where can data be obtained?
Subject to approvals by Principal Investigator, Dr Janani Thillainadesan.
Email: Janani.Thillainadesan@health.nsw.gov.au


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
SourceTitleYear of PublicationDOI
EmbaseThe Prognostic Performance of Frailty for Delirium and Functional Decline in Vascular Surgery Patients.2021https://dx.doi.org/10.1111/jgs.16907
EmbaseUnderstanding the Role and Value of Process Quality Indicators in Older Vascular Surgery Inpatients.2021https://dx.doi.org/10.1016/j.jss.2021.05.003
EmbaseGeriatric Comanagement of Older Vascular Surgery Inpatients Reduces Hospital-Acquired Geriatric Syndromes.2022https://dx.doi.org/10.1016/j.jamda.2021.09.037
N.B. These documents automatically identified may not have been verified by the study sponsor.