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Trial registered on ANZCTR


Registration number
ACTRN12612001201864
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
14/11/2012
Date last updated
14/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An interdisciplinary model to enhance care of older patients undergoing vascular surgery
Scientific title
Do vascular surgical patients aged 65 and older managed with a model of care including proactive medical consultation and early functional and cognitive rehabilitation have a reduction in functional decline, delirium, medical complications and hospital length of stay compared to usual surgical ward care?
Secondary ID [1] 281272 0
Nil
Universal Trial Number (UTN)
U1111-1133-2422
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular surgery 287470 0
Condition category
Condition code
Surgery 287802 287802 0 0
Other surgery
Cardiovascular 288108 288108 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-intervention cohort receives care from vascular surgical team, including referral to allied health and medical services as required, according to usual practice.
Intervention is a complex system change which directly engages team members of the intervention ward in an evolving redesign of care processes to meet the following broad goals:
1. Proactive medical consultation: consistent medical registrar supervised by a general physician will review older patients pre-operatively where feasible and throughout the post-operative course in collaboration with the surgical team to optimise management of comorbidities, until the time of discharge
2. Enhanced multidisciplinary care team focus to support implementation of cognitive orientation/stimulation, feeding assistance and exercise/ambulation, achieved using holistic facilitation based on the PARIHS framework
3. Staff and patient education regarding delirium, functional decline and malnutrition and strategies designed to minimise them, using small group interactive staff teaching (initally 30 minutes per week for 5 weeks, repeated every 10-12 weeks based on staff rotations) and staff and patient brochures
Post-intervention cohort data will be collected after 6 months (August-December 2013) or when intervention is considered mature. Intervention will continue throughout the post-intervention data collection period.
Intervention code [1] 285741 0
Treatment: Other
Intervention code [2] 285742 0
Rehabilitation
Comparator / control treatment
Pre-implementation (usual) care provided by vascular surgical team and ward staff, assessed August-December 2012
Control group
Active

Outcomes
Primary outcome [1] 288021 0
Functional decline, defined as increase in number of basic activites of daily living (based on Katz scale) for which the patient requires human assistance (patient report supplemented as necessary by nurse report)
Timepoint [1] 288021 0
Functional status measured at multiple time points (3 times per week) during hospitalisation will be compared to pre-admission functional status using trajectory modelling
Primary outcome [2] 288022 0
Delirium (Confusion Assessment Method, CAM)
Timepoint [2] 288022 0
Delirium is assessed at multiple time points (3 times per week) during hospitalisation and will be converted to a binary variable
Primary outcome [3] 288023 0
Length of stay (date of admission to date of actual discharge) using hospital information system data
Timepoint [3] 288023 0
Discharge from first hospitalisation in study period
Secondary outcome [1] 299295 0
Medical complications extracted by medical/surgical registrar from review of clinical notes and categorised using the Accordion classification system
Timepoint [1] 299295 0
Discharge from first hospitalisation in the study period
Secondary outcome [2] 299296 0
Discharge destination (died, discharged home, discharged to residential aged care)
Timepoint [2] 299296 0
Discharge from hospital
Secondary outcome [3] 299297 0
Cost-utility analysis (EQ5D Australian telephone version)
Timepoint [3] 299297 0
28 days from discharge

Eligibility
Key inclusion criteria
Aged 65 or older, admitted to vascular surgical unit with anticipated length of stay at least 3 days
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to be reviewed within 4 days of admission
Unable to consent and no statutory health authority available

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)
Pre-intervention cohort enrolled August-December 2012 under usual care conditions; post-intervention cohort enrolled August-December 2013 under new conditions following implementation of new model of care
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
Post-intervention cohort compared to pre-intervention cohort
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286038 0
Other Collaborative groups
Name [1] 286038 0
Australian Centre for Health Services Innovation
Country [1] 286038 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Centre for Health Services Innovation
Address
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove
Queensland 4059
Country
Australia
Secondary sponsor category [1] 284851 0
Hospital
Name [1] 284851 0
Royal Brisbane and Women's Hospital
Address [1] 284851 0
Butterfield St
Herston
Qld 4029
Country [1] 284851 0
Australia
Other collaborator category [1] 277082 0
University
Name [1] 277082 0
University of Queensland School of Medicine
Address [1] 277082 0
Health Sciences Building
Royal Brisbane and Women's Hospital
Butterfiled St
Herston
Queensland 4029
Country [1] 277082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288085 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 288085 0
Butterfield St
Herston
Queensland 4029
Ethics committee country [1] 288085 0
Australia
Date submitted for ethics approval [1] 288085 0
Approval date [1] 288085 0
29/05/2012
Ethics approval number [1] 288085 0
HREC/12/QRBW/101

Summary
Brief summary
In this study, the research group will work with staff on a vascular surgical ward to design and introduce changes to care which are more elder-friendly, to ensure that older patients regain their usual function faster after surgery. This will include prompt input from a physician to prevent early medical complications, early input from allied health professionals such as physiotherapists and nutritionists to reduce the risks of muscle loss, and resular encouragement from all staff members to keep their body and mind as active as possible. The changes in care will be made by working closely with ward staff using an evidence-based framework for implementing complex changes in health care settings.
The investigators hope to show that the new model of care improves the rate of return to independence, reduces complications and reduces length of stay in this high risk patient group, compared to the usual way of organising care. They will also assess whether these improvements justify the additional intensity (and therefore cost) of staffing which would be necessary to provide this enhanced care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34740 0
Address 34740 0
Country 34740 0
Phone 34740 0
Fax 34740 0
Email 34740 0
Contact person for public queries
Name 17987 0
Prof Alison Mudge
Address 17987 0
Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston 4029 Queensland
Country 17987 0
Australia
Phone 17987 0
61 7 36468111
Fax 17987 0
61 7 36467800
Email 17987 0
[email protected]
Contact person for scientific queries
Name 8915 0
Prof Alison Mudge
Address 8915 0
Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston 4029 Queensland
Country 8915 0
Australia
Phone 8915 0
61 7 3646 8111
Fax 8915 0
61 7 36467800
Email 8915 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseFrailty and Geriatric Syndromes in Vascular Surgical Ward Patients.2016https://dx.doi.org/10.1016/j.avsg.2016.01.033
N.B. These documents automatically identified may not have been verified by the study sponsor.