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Trial registered on ANZCTR


Registration number
ACTRN12619000238178
Ethics application status
Approved
Date submitted
11/02/2019
Date registered
18/02/2019
Date last updated
15/05/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a heel off-loading boot in reducing heel pressure injuries in intensive care patients: a single-blinded randomised controlled trial.
Scientific title
Efficacy of a heel off-loading boot in reducing heel pressure injuries in intensive care patients: a single-blinded randomised controlled trial (REsPIRE RCT).
Secondary ID [1] 297358 0
nil known
Universal Trial Number (UTN)
Trial acronym
REsPIRE RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pressure injury 311484 0
critical care 311558 0
Condition category
Condition code
Skin 310124 310124 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of the application of the PrevalonTM heel protector boot; Skin inspection to the heels every 8 hours; Shift by shift assessment of the PrevalonTM heel protector boot position; Documentation of all assessment and prevention strategies at each shift. The boot will remain insitu for the duration of the patient’s intensive care unit stay or until the patient is no longer bed-bound and no longer deemed at risk of developing a heel pressure injury.

The PrevalonTM boot is a heel protector device that supports the foot and ankle and elevates the heel to provide complete off-loading at the heel. The PrevalonTM boot also holds the foot in position to avoid foot and leg rotation to prevent foot contractures.



Following ethical and governance approvals, Clinical Nurse Educators, Clinical Nurse Specialists and bedside RNs will be trained in the application of the PrevalonTM heel protector boot and data collection. This training will be provided by the investigators who are all recognised clinical experts. Training comprises one x 30 minute education session on theory, demonstration, procedures and benefits of the PrevalonTM and a 2 minute video on the application of the PrevalonTM. All training will be provided face to face to nurses, either at the bedside at an appropriate time that will be arranged with the nursing unit manager and the clinical nurse educators. The video link is as follows: https://sageproducts.com/videos/heel-protector3/training/. Further, general project information sessions will be provided at each participating hospital site for all ICU clinicians.
For patients randomised to the intervention group, a PrevalonTM heel protector boot information brochure (a readily available resource https://sageproducts.com/wp-content/uploads/2015/08/Prevalon-Heel-Protector-Wedge_21433C.pdf) will be left at the bedside for nurses and interested family members.

Fidelity and adherence to the intervention and control will be monitored by measurement of processes of care for both groups via a checklist. RNs will complete a checklist to monitor adherence to each group’s protocol (paper or electronic) three times a week.
Intervention code [1] 313606 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will receive standard routine pressure injury prevention care to the heels:
1. Heels off loaded by standard care as per hospital protocol (heel elevation on pillows or other heel elevation measures)
2. Skin inspection to the heels every 8 hours
3. Shift by shift assessment of the positioning of pillows
4. Documentation of all assessment and prevention strategies at each shift
Control group
Active

Outcomes
Primary outcome [1] 319015 0
Proportion of pressure injuries developed in heels of ICU patients within 28 days. A skin assessment tool will be used to record skin assessment as per current staging international guidelines (National Pressure Ulcer Advisory Panel [NPUAP]/ European Pressure Ulcer Advisory Panel [EPUAP]/Pan Pacific Pressure Injury Alliance [PPPIA], 2014) and includes the following: Patient name, MRN, date and time of data collection, SOFA score, skin assessment descriptors such as erythema, blanching response, moisture, oedema, induration, skin breakdown, pressure injury size, depth, location, exudate. The pressure injury international guideline on assessment and staging of pressure injuries https://www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-16Oct2014.pdf)
Timepoint [1] 319015 0
28 days from admission
Secondary outcome [1] 366720 0
• Length of time to heel pressure injury occurrence;
Data will be collected on daily skin assessment daily (Monday to Friday) and recorded on a skin assessment tool for both the intervention and control groups. A skin assessment tool will be used to record skin assessment as per current staging international guidelines (National Pressure Ulcer Advisory Panel [NPUAP]/ European Pressure Ulcer Advisory Panel [EPUAP]/Pan Pacific Pressure Injury Alliance [PPPIA], 2014) and includes the following: Patient name, MRN, date and time of data collection, SOFA score, skin assessment descriptors such as erythema, blanching response, moisture, oedema, induration, skin breakdown, PI size, depth, location, exudate.

Timepoint [1] 366720 0
28 days from admission
Secondary outcome [2] 366727 0
Severity of staging of heel pressure injury/s; Data will be collected on daily skin assessment daily (Monday to Friday) and recorded on a skin assessment tool for both the intervention and control groups. A skin assessment tool will be used to record skin assessment as per current staging international guidelines and includes the following: Patient name, MRN, date and time of data collection, SOFA score, skin assessment descriptors such as erythema, blanching response, moisture, oedema, induration, skin breakdown, pressure injury size, depth, location, exudate.
Timepoint [2] 366727 0
28 days from admission
Secondary outcome [3] 366728 0

Proportion of plantar contractures (patients who have a > 5 degrees change in ankle dorsiflexion) within 28 days. For all patients in the study, at day 1 (when the patient has been enrolled in the study) and at 28 day (or earlier if the patient in the intervention no longer requires the PrevalonTM boot or is being transferred or dicgharged) plantar flexion contractures will be measured by a trained nurse or physiotherapist for change in ankle dorsiflexion using goniometer. Using consistent landmarks, the goniometer will be placed at the 5th metartarsal and at head of fibula, and the head of 5th metatarsal to the head of fibula axis to measure dorsifelxion. This will be collected on a specific data collection form for this study.
Timepoint [3] 366728 0
28 days of admission

Eligibility
Key inclusion criteria
• All ICU patients >18years with who have been assessed as high risk of developing a pressure injury (Waterlow > 15, Braden <10).
• Patients who are expected to remain in ICU > 72 hours
• Patients who are expected to be bed bound for at least three days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with a community or hospital-acquired PI on both heels diagnosed within 24 hours of admission to the ICU.

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)
It will not be possible for clinical staff administering the intervention, or patients, to be blinded to group allocation. Eligible participants in each arm will be randomised at the patient level either into the intervention or the control arm using block randomisation with randomly sized blocks of size 2, 4, 6 or 8 via a web-based randomization in Redcap (REDCap is a secure, web-based application designed to support data capture for research studies, to build and manage online surveys and data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants in each arm will be randomised at the patient level either into the intervention or the control arm using block randomisation with randomly sized blocks of size 2, 4, 6 or 8 via a web-based computerised randomization system in Redcap (REDCap is a secure, web-based application designed to support data capture for research studies, to build and manage online surveys and data). Staff assessing outcomes will be blinded to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample will be summarised at baseline by allocation and as a complete cohort. The data will be examined to assess the extent and pattern of any missing data and an appropriate strategy utilised to deal with any missing data (e.g. complete case analysis, multiple imputation). Any substantive imbalances in key predictors resulting from the randomisation process will be noted and controlled for in subsequent analyses if necessary. The unit of assessment will be the heel. The extent of data clustering (heels within patients) will be assessed and if necessary a hierarchical model structure comprising heels at the lower analysis level and patients at the upper analysis level will be constructed. The primary outcome (proportion of heels without pre-existing PIs which develop a HAPI during the analysis period) will be assessed using the uncorrected chi-squared test or logistic regression (models with controlling variables), in either a single-level or multilevel framework as appropriate.
The secondary outcome of time to PI occurrence will be assessed using Kaplan-Meier survival methods with significance of group differences assessed using the log-rank procedure. Survival curves will also be provided to facilitate a visual comparison of group survival. The occurrence of any event will be treated as a censored observation. The secondary outcome of severity of pressure ulceration will be assessed using the chi-squared test for trend. The secondary outcome of plantar flexion contractures will be assessed using the chi-squared test for association. Corrections for multiple comparisons across secondary outcomes will be applied informally.
Statistical significance, effect sizes and associated 95% confidence intervals will be reported as appropriate for all outcomes.

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] 13083 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13084 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 25592 0
2050 - Camperdown
Recruitment postcode(s) [2] 25593 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 301924 0
Hospital
Name [1] 301924 0
Royal Prince Alfred Hospital
Address [1] 301924 0
Missenden Road Camperdown, NSW 2050
Country [1] 301924 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital, Level 7 KGV Missenden Road Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 301681 0
Individual
Name [1] 301681 0
Ms Ivanka Komusanac
Address [1] 301681 0
Level 11, Nursing and Midwifery Executive, Level 11,KGV Missenden Road Camperdown, NSW 2050
Country [1] 301681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302608 0
'Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302608 0
Research Ethics and Governance Office (REGO)
Suite 210A, Level 2,
RPAH Medical Centre
100 Carillon Ave
NEWTOWN NSW 2042
Ethics committee country [1] 302608 0
Australia
Date submitted for ethics approval [1] 302608 0
13/03/2019
Approval date [1] 302608 0
10/04/2019
Ethics approval number [1] 302608 0

Summary
Brief summary
This is a multisite single-blinded randomised controlled trial of 418 patients across three intensive care units in three acute hospitals to evaluate the clinical effectiveness of a heel off-loading boot (Prevalon TM) in reducing heel pressure injuries and preventing foot contractures in intensive care patients. Patients in ICU who meet the eligibility criteria will be allocated to one of two arms, either the intervention (PrevalonTM heel protector boot - https://sageproducts.com/prevalon-heel-protectors/) or the control (standard care - use of pillow/s for heel elevation). The trial design follows the Consolidated Standards of reporting Trials (CONSORT) protocol RCTs.

Our hypothesis is patients who receive the intervention have a lower incidence of heel PIs and plantar flexion contractures compared to those patients who have standard care.

The planned duration of this study is 18 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90806 0
Dr Michelle Barakat-Johnson
Address 90806 0
Level 7, Patient Safety and Quality, KGV Missenden Road Camperdown, NSW 20250
Country 90806 0
Australia
Phone 90806 0
+61 434899098
Fax 90806 0
Email 90806 0
michelle.barakatjohnson@health.nsw.gov.au
Contact person for public queries
Name 90807 0
Dr Michelle Barakat-Johnson
Address 90807 0
Level 7, Patient Safety and Quality, KGV Missenden Road Camperdown, NSW 20250
Country 90807 0
Australia
Phone 90807 0
+61 434899098
Fax 90807 0
Email 90807 0
michelle.barakatjohnson@health.nsw.gov.au
Contact person for scientific queries
Name 90808 0
Dr Michelle Barakat-Johnson
Address 90808 0
Level 7, Patient Safety and Quality, KGV Missenden Road Camperdown, NSW 20250
Country 90808 0
Australia
Phone 90808 0
+61 434899098
Fax 90808 0
Email 90808 0
michelle.barakatjohnson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for de-identified individual participant data sharing will be sought from participants and HREC. Once sought the data dictionary will be available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results