Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000541303
Ethics application status
Approved
Date submitted
10/09/2008
Date registered
27/10/2008
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
PressUre uLCers: Effectiveness of Risk assessment tools. A randomised controlled trial (the ULCER Trial)
Scientific title
Among internal medical patients does screening with pressure ulcer risk assessment tools, compared with no screening, reduce the incidence of pressure ulcers.
Secondary ID [1] 284288 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The ULCER study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure ulcers 3879 0
Condition category
Condition code
Skin 4080 4080 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two interventions which will be compared with standard practice. The first is not using any instrument to assess pressure ulcer risk. Patients in this group will not be screened and there will be no pressure ulcer screening instrument in their medical record. The second group will be screened on admission and weekly thereafter until hospital discharge using the Ramstatius tool, which contains only one question related to the patients ability to turn independently. Nurses will receive information about the instrument and advised to follow instructions on the form for frequency of re-screening.
The study will be conducted over a 12-month period
Intervention code [1] 3607 0
Prevention
Comparator / control treatment
The Waterlow scale (standard practice) will be used for the initial screening to assess pressure ulcer risk. As this is a pragmatic trial, we will not screen again but it is possible that patients will be screened again during the course of their hospital stay (routine practice).
Control group
Active

Outcomes
Primary outcome [1] 4978 0
Patients will be reviewed at least second daily for the presence of any pressure ulcers. This will be undertaken by study nurses who will have received specific training in pressure ulcer grading.
Timepoint [1] 4978 0
Patients will be reviewed at least second daily for the presence of any pressure ulcers. Development of a pressure ulcer at any time during an in-patient episode of care will be recorded.
Secondary outcome [1] 8396 0
Length of hospital stay
Timepoint [1] 8396 0
Time from admission to discharge will be recorded at patient hospital discharge.

Eligibility
Key inclusion criteria
- Newly admitted to an Internal Medicine
ward
- Anticipated length of stay of at least 3
days
- Not having darkly pigmented skin
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Must be free of pressure ulcers on admission

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients expected to remain in hospital for at least three days will be randomly assigned, within 24 hours of admission, to be screened with the Waterlow screening tool, the Ramstadius tool, or not screened at all. Following eligibility assessment, patients will be allocated to the Waterlow, Ramstadius, or clinical judgement group using a phone randomisation method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomized list will be produced to ensure allocation is unpredictable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2009
Actual
15/04/2009
Date of last participant enrolment
Anticipated
Actual
15/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
1070
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3846 0
Other Collaborative groups
Name [1] 3846 0
Royal Brisbane and Women's Hospital (RBWH) Private Practice Trust
Country [1] 3846 0
Australia
Funding source category [2] 4070 0
Charities/Societies/Foundations
Name [2] 4070 0
Royal Brisbane and Women's Hospital Research Foundation
Country [2] 4070 0
Australia
Primary sponsor type
Individual
Name
Joan Webster
Address
Level 2, Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 3664 0
Hospital
Name [1] 3664 0
RBWH
Address [1] 3664 0
RBWH
Butterfirld Street
Herston 4029
Country [1] 3664 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6141 0
RBWH Human Research Ethics Committee
Ethics committee address [1] 6141 0
RBWH
Butterfirld Street
Herston 4029
Ethics committee country [1] 6141 0
Australia
Date submitted for ethics approval [1] 6141 0
28/09/2008
Approval date [1] 6141 0
Ethics approval number [1] 6141 0
RBWH 2008/143

Summary
Brief summary
Pressure ulcer development is a significant risk for hospitalised patients and health care facilities. Pressure ulcer related costs in Australia have been estimated at $285 M per annum. Preventative measures are generally based on estimating the patient’s risk, using screening tools such as the Waterlow scale. Despite the widespread use of the Waterlow scale as an intervention to prevent pressure ulcers, its effectiveness has never been tested using rigorous methods. We propose to conduct a three group, single centred randomised controlled trial to compare the Waterlow Scale, with a simpler, one item measure; and with clinical judgement. We will also investigate risk factors for pressure ulcer development in an acute hospital setting.
Trial website
Trial related presentations / publications
Webster J, Coleman K, Gardner G, Mudge A, Stankiewicz M, Kirby J, Vellacott C, Horton-Beshers M, McClymont A. PressUre uLCers: Effectiveness of Risk assessment tools. A randomised controlled trial (the ULCER Trial). BMJ Quality & Safety in Health Care 2011; 20(4):297-306
Public notes

Contacts
Principal investigator
Name 28916 0
Prof Joan Webster
Address 28916 0
Level 2, Bld 34
RBWH
Butterfield St
Herston QLD 4029
Country 28916 0
Australia
Phone 28916 0
+ 61 7 3646 8590
Fax 28916 0
Email 28916 0
joan_webster@health.qld.gov.au
Contact person for public queries
Name 12073 0
Joan Webster
Address 12073 0
Level 2, Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 12073 0
Australia
Phone 12073 0
(07) 3636 8590
Fax 12073 0
Email 12073 0
joan_webster@health.qld.gov.au
Contact person for scientific queries
Name 3001 0
Joan Webster
Address 3001 0
Level 2, Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 3001 0
Australia
Phone 3001 0
(07) 3636 8590
Fax 3001 0
Email 3001 0
joan_webster@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
SourceTitleYear of PublicationDOI
EmbasePressure ulcers: Effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).2011https://dx.doi.org/10.1136/bmjqs.2010.043109
N.B. These documents automatically identified may not have been verified by the study sponsor.