ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1133-2422

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vascular surgery

Condition category

Condition code

Surgery

Other surgery

Cardiovascular

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

Delirium (Confusion Assessment Method, CAM)

Timepoint [2]

Delirium is assessed at multiple time points (3 times per week) during hospitalisation and will be converted to a binary variable

Primary outcome [3]

Length of stay (date of admission to date of actual discharge) using hospital information system data

Timepoint [3]

Discharge from first hospitalisation in study period

Secondary outcome [1]

Medical complications extracted by medical/surgical registrar from review of clinical notes and categorised using the Accordion classification system

Timepoint [1]

Discharge from first hospitalisation in the study period

Secondary outcome [2]

Discharge destination (died, discharged home, discharged to residential aged care)

Timepoint [2]

Discharge from hospital

Secondary outcome [3]

Cost-utility analysis (EQ5D Australian telephone version)

Timepoint [3]

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?

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)

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]

Other Collaborative groups

Name [1]

Australian Centre for Health Services Innovation

Address [1]

Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Avenue
Kelvin Grove
Queensland 4059

Country [1]

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]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Butterfield St
Herston
Qld 4029

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of Queensland School of Medicine

Address [1]

Health Sciences Building
Royal Brisbane and Women's Hospital
Butterfiled St
Herston
Queensland 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital

Ethics committee address [1]

Butterfield St
Herston
Queensland 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/05/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof Alison Mudge

Address

Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston 4029 Queensland

Country

Australia

Phone

61 7 36468111

Fax

61 7 36467800

Alison_Mudge@health.qld.gov.au

Contact person for scientific queries

Name

Prof Alison Mudge

Address

Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston 4029 Queensland

Country

Australia

Phone

61 7 3646 8111

Fax

61 7 36467800

Alison_Mudge@health.qld.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Frailty and Geriatric Syndromes in Vascular Surgical Ward Patients.	2016	https://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.

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Documents added manually

Documents added automatically