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Trial registered on ANZCTR


Registration number
ACTRN12618001947291p
Ethics application status
Not yet submitted
Date submitted
25/11/2018
Date registered
30/11/2018
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Pressure Injury Clinical Judgment RIsk-Screening tool and Prevention Plan to reduce Pressure Injuries
Scientific title
Effectiveness of a Pressure Injury Clinical Judgment RIsk-screening tool and prevention plan: A Cluster Randomized Control Trial (EmPiRIC RCT)
Secondary ID [1] 296685 0
Nil Known
Universal Trial Number (UTN)
U1111-1224-4377
Trial acronym
EmPiRIC RCT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Prevention of pressure injuries 310531 0
Pressure injuries 310532 0
Condition category
Condition code
Skin 309242 309242 0 0
Other skin conditions
Public Health 309286 309286 0 0
Health service research
Injuries and Accidents 309287 309287 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will provide nurses with an alternative to the standard risk screening tool (Waterlow) and will involve them using their professional clinical judgement to assess pressure injury risk, and include a pressure injury prevention care plan with intervention checklist to prompt nurses in implementing preventative interventions. The plan is as per the New South Wales Pressure Injury Prevention and Management Policy. The screening tool comprises one question on risk and prompts nurses to interventions to prevent pressure injuries such as equipment, skin protection, devices and nutrition. Procedure and mode of delivery

Procedure
The intervention will be delivered by bedside nurses working on the study intervention wards.
1. All patients on the study wards will receive information from the bedside nurse regarding the study on admission to the ward. This will be in the form of a discussion lasting for approximately 5 minutes.
2. All nursing staff on the intervention wards will receive formal education by associate investigators of each facility on the study procedure, the pressure injury clinical judgment risk-screening tool and prevention plan prior to the commencement of the study. Formal education comprises two x 30 minute education sessions as follows: One x 30min lecture session on the study purpose, procedure and the clinical judgment risk-screening tool and prevention plan and one x 30 minute tutorial demonstration on using the tool in practice immediately after the lecture session.
3. The pressure injury clinical judgment risk-screening tool and prevention plan will be embedded in the electronic medical record for use by the ward bedside nurse.
4. Bedside ward nurses on the intervention ward will complete the tool on patients admitted to the unit. If a patient is identified as at risk, appropriate interventions will be implemented as per New South Wales pressure injury prevention and management policy.
5. Patients identified at risk of developing a pressure injury will be observed and monitored weekly for preventative interventions implemented.



ARM 2 Control group
The control group will have a standard pressure injury risk screening which involves nurses using the Waterlow risk tool to determine a patient's level of risk of developing a pressure injury as per the New South Wales Pressure Injury Prevention and Management Policy (https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2014_007.pdf.). Currently, New South Wales health use the Waterlow screening tool to determine a patient's level of risk for PI development. What the Waterlow does not have is a checklist of preventative interventions to prompt nurses to implement these interventions once a patient is identified at risk (the intervention tool has a checklist of preventative interventions).

Intervention fidelity and adherence will be monitored by a researcher-developed checklist comprising all elements of the intervention. This will be completed by ward nurses on the study intervention wards three times a week.

Intervention code [1] 312998 0
Prevention
Comparator / control treatment
The control group will have a standard nursing pressure injury risk screening which involves nurses using the Waterlow risk tool to determine a patient's level of risk of developing a pressure injury as per the New South Wales Pressure Injury Prevention and Management Policy (https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2014_007.pdf.). Currently, New South Wales health use the Waterlow screening tool to determine a patient's level of risk for PI development. What the Waterlow does not have is a checklist of preventative interventions to prompt nurses to implement these interventions once a patient is identified at risk (the intervention tool has a checklist of preventative interventions).
Control group
Active

Outcomes
Primary outcome [1] 308210 0
The development of the first new pressure injury, of any stage, in patients without pre-existing pressure injuries, as defined by the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel (2014) international staging system. Outcomes are assessed from patient data collection instrument (patient study-specific questionnaire instrument).
The patient study-specific questionnaire instrument is a study specific questionnaire which was developed for a previous study by the researchers to reduce pressure injuries. This instrument was developed in consultation with registered nurses and reviewed for face validity by senior researchers and senior registered nurses. The instrument captures information on patient demographics, time and date of data collection, diagnosis and comorbidities, skin assessment data for example erythema, blanching response, location and pressure injury information including, stage size, depth, location, exudate. The instrument was tested on ten patients by three senior nurses; a minor amendment was made to the instrument to include operational definitions of skin assessments.

Timepoint [1] 308210 0
Hospital-acquired pressure injury occurrence within a 30-day period
Secondary outcome [1] 354245 0
The severity of the new pressure injury (outcomes assessed from patient study-specific questionnaire instrument) .
Timepoint [1] 354245 0
30 days from admission
Secondary outcome [2] 354445 0
Time to pressure injury development (outcomes assessed from patient study-specific questionnaire instrument)
Timepoint [2] 354445 0
30 days from admission
Secondary outcome [3] 354446 0
Length of hospital stay (outcome assessed from medical records).
Timepoint [3] 354446 0
On discharge or transfer from ward

Eligibility
Key inclusion criteria
All patients who do not have any pre-existing pressure injuries on admission, who are admitted to the selected wards during the study period will be eligible to participate. Participants will remain in the study until discharge.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with pre-existing pressure injuries
Patients whose baseline assessment data could not be collected (for example the patient is admitted on a Friday and discharged by Monday)

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)
Full allocation concealment cannot be implemented at the ward level, as we wish to ensure that each arm of the trial will comprise similar wards, which will be achieved through block randomisation with blocks of size 2. The initial ward allocation in each pair will, however, be conducted using allocation concealment by an independent researcher with sealed envelopes as an allocation mechanism. Allocation concealment cannot be implemented at the patient level: as a cluster RCT is proposed, all patients in the same ward will receive the same allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Wards will be allocated to either the intervention or control group by an independent statistician using a computer-generated random list.The sequence will be revealed to the researchers after the wards have been allocated. No masking will be incorporated in the study.
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
The sample will be summarized descriptively. Exploratory analyses will be conducted on the data to check for data distributions, patterns and extent of any missing data, outliers and influential points. Data transformations will be considered if data is skewed or shows other gross violations from normality. The nature of data missingness will be assessed by methods such as separate variance t-tests and Little’s chi-squared tests, and appropriate strategies utilized accordingly (e.g. complete case analysis, deletion of variables, imputation by expectation maximization etc.)
The analysis of the primary outcome will be conducted using hierarchical regression models, in which patients represent the lower level and wards the upper level of the analysis. Random intercept models will be conducted with appropriate adjustments made to standard errors and confidence intervals due to clustering. Data will be transformed using the logistic transformation. The intra-class correlation will be evaluated using a simulation method to evaluate level-1 variance. Group balance across key covariates will be assessed and any covariate for which a substantive imbalance exists will be included in the model as a control variable alongside the key treatment variable, which will be forced into all models. P-values, odds ratios and associated 95% confidence intervals will be reported for all parameters.
The secondary analysis of time to HAPI occurrence within a 30-day period will be analysed using fully parametric time-to-event methods using interval censoring where the precise time of occurrence of a HAPI is not known. The model will use the same 2-level hierarchy, with the same corrections for data clustering, as described for the analysis of the primary outcome. Any variable included in the final multilevel logistic regression model above will also be fitted into the time-to-event model. Several candidate modelling distributions will be assessed for goodness-of-fit to data (e.g. exponential, Weibull, log-logistic etc.) with the best fitting distribution chosen by consideration of AIC statistics. P-values, hazard ratios or acceleration factors, with associated 95% confidence intervals, will be reported for all parameters and survival curves of individuals discriminated by variables of substantive importance will also be presented.
The secondary analysis of length of patient stay will be analysed using regression modelling under the same 2-level hierarchy, with the same corrections for data clustering, as described for the analysis of the primary outcome. P-values and parameter estimates with associated 95% confidence intervals, will be reported for all parameters.
Supplementary ward-level analyses will also be undertaken, to determine cumulative incidence and/or incidence rates in each type of ward in both groups.
Data will be analysed using Stata statistical software and MLwiN multilevel modelling software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12492 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 12493 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 12494 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 24872 0
2050 - Camperdown
Recruitment postcode(s) [2] 24873 0
2139 - Concord
Recruitment postcode(s) [3] 24874 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 301262 0
Hospital
Name [1] 301262 0
Royal Prince Alfred Hospital, Sydney Local Health District
Address [1] 301262 0
Level 7 KGV Building RPAH, Missenden Road Camperdown, Sydney New South Wales 2050
Country [1] 301262 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital, Sydney Local Health District
Address
Level 11 KGV Building RPAH, Missenden Road Camperdown, Sydney New South Wales 2050
Country
Australia
Secondary sponsor category [1] 300963 0
None
Name [1] 300963 0
Address [1] 300963 0
Country [1] 300963 0
Other collaborator category [1] 280446 0
University
Name [1] 280446 0
Faculty of Medicine and Health, University of Sydney
Address [1] 280446 0
Mallet Street Camperdown, Sydney, New South Wales, 2050
Country [1] 280446 0
Australia
Other collaborator category [2] 280447 0
University
Name [2] 280447 0
School of Nursing, Queensland University of Technology
Address [2] 280447 0
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Butterfield St., Herston, QLD 4029.
Country [2] 280447 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302005 0
'Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302005 0
Research Ethics and Governance Office (REGO)
Suite 210A, RPAH Medical Centre
100 Carillon Ave
NEWTOWN NSW 2042
Ethics committee country [1] 302005 0
Australia
Date submitted for ethics approval [1] 302005 0
30/11/2018
Approval date [1] 302005 0
Ethics approval number [1] 302005 0

Summary
Brief summary
This is a multisite cluster randomized clinical trial of 300 patients across six clinical units in three tertiary acute hospitals to evaluate the clinical effectiveness of a pressure injury clinical judgement risk-screening and care planning tool in reducing pressure injuries.

Standard care involves using the Waterlow pressure injury risk screening tool to determine a patient’s level of risk to develop a pressure injury.

The intervention involves removing the Waterlow tool and using the pressure injury clinical judgement risk-screening and care planning tool.

Our hypothesis is patients who receive the intervention have a lower incidence of HAPI compared to those patients who receive standard of care.

The planned duration of this study is 12 months.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88826 0
Ms Michelle Barakat-Johnson
Address 88826 0
Patient Safety and Quality, Level 7 KGV RPAH, Missenden Road Camperdown, Sydney, New South Wales, 2050
Country 88826 0
Australia
Phone 88826 0
+61 434899098
Fax 88826 0
Email 88826 0
michelle.barakatjohnson@health.nsw.gov.au
Contact person for public queries
Name 88827 0
Ms Michelle Barakat-Johnson
Address 88827 0
Patient Safety and Quality, Level 7 KGV RPAH, Missenden Road Camperdown, Sydney, New South Wales, 2050
Country 88827 0
Australia
Phone 88827 0
+61 434899098
Fax 88827 0
Email 88827 0
michelle.barakatjohnson@health.nsw.gov.au
Contact person for scientific queries
Name 88828 0
Ms Michelle Barakat-Johnson
Address 88828 0
Patient Safety and Quality, Level 7 KGV RPAH, Missenden Road Camperdown, Sydney, New South Wales, 2050
Country 88828 0
Australia
Phone 88828 0
+61 434899098
Fax 88828 0
Email 88828 0
michelle.barakatjohnson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Consent for de-identified individual participant data sharing will be sought from participants and the HREC. Once sought, the study data dictionary will be available.
What supporting documents are/will be available?
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 475 0
Statistical analysis plan
Citation [1] 475 0
Link [1] 475 0
Email [1] 475 0
Other [1] 475 0
Summary results
No Results