Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001180707
Ethics application status
Approved
Date submitted
26/08/2022
Date registered
1/09/2022
Date last updated
1/09/2022
Date data sharing statement initially provided
1/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of the clinical and cost effectiveness of consultations with remotely situated expert wound nurses for healing of pressure injuries (bed sores) among residential aged care patients.
Scientific title
The clinical and cost effectiveness of remote expert wound nurse consultation for healing of pressure injuries among residential aged care patients: a protocol for a prospective pilot parallel cluster randomised controlled trial.
Secondary ID [1] 307841 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injuries (bed sores) 327451 0
Condition category
Condition code
Skin 324577 324577 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consultation with a remote expert wound nurse.

The intervention is “consultation” which involves the provision of expert clinical advice, education and support to patients (in the case of this trial, specifically aged care residents), nurses, personal care workers and family members.

The intervention includes the development, facilitation, implementation and evaluation of care plans for residents. The speciality associated with the consultation is wound management and specifically, as applies to the trial, with a focus on the clinical issue of pressure injury. The content and outcomes of the consultation are based on the evidence and recommendations in the International Guideline (prevention and treatment of pressure ulcers/injuries in clinical practice https://www.internationalguideline.com) and are tailored according to the individual needs of the resident, local processes, and the resources, skills and abilities of the nurses in the aged care settings who provide the direct care (wound management) to residents.

Recommendations that will be made by the Wound Management Clinical Nurse Consultants include wound dressing selection, pressure redistributing strategies (repositioning schedules and equipment to facilitate), skin care, activity and nutrition advice and referrals to allied health. Tailoring could include for example, education to residents who have capacity to understand (this education not provided to residents who do not have capacity), care planning for residents to reposition their body themselves if physically able (care planning for health care providers to reposition if the resident is unable to reposition their body themselves), support of family members if engaged in the consultations (not provided if not engaged), wound dressing selection in line with individual resident characteristics including for example consideration of skin allergies.

The expected time commitment required by the participant to follow recommendations in between consultations will vary in line with the complexity of the pressure injury and the characterises of the resident. Wound treatment (cleaning and redressing the pressure injury) can take between 20 and 60 minutes. This time is time that the resident would usually spend having the dressing attended and is therefore not in addition to use care time.

The “expert wound nurse” is one or more Wound Management Clinical Nurse Consultants (CNCs). These nurses usually have relevant post graduate qualifications (or are working toward) and/or relevant experience working in the field of wound management. In Victoria, these nurses are typical employed in a Grade 4 position.

“Remote” refers to the location of the CNC. The CNCs provides consultation from outside the residents aged care facility (referred to as their Home) in the trial.

The consultations occur via videoconferencing supplemented by the provision of pressure injury images. Images are taken by the treating nurse with an iPad or digital camera (facility owned and operated) immediately prior to the consultation and uploaded to a secure folder for access by project staff and the CNC. These images are then uploaded by the CNCs to an application that automatically calculates wound size and quantifies healing rate.

Participation in the consultations occurs over 12 weeks and in the study 24 weeks. The consultations occur at baseline, 4, 8, and 12 weeks. For residents who have complex wounds (more severe pressure injuries) an additional consultation is provided at week 1 to provide for additional monitoring and reinforcement of wound management policies and procedures and trial processes. After the 12 week consultation the consultations cease and status of the residents pressure injury is checked at 24 weeks.

Consultations take between 30 and 60 minutes.

Nurses are provided with a clinical intervention manual (pdf file) to guide the consultation process. This manual was purposed designed for the study.

The intervention is personalised to the individual needs of the participants of the consultation.

No adaptation of the intervention is planned as the intervention was evaluated and was refined in a feasibility study prior to the commencement of the trial.

Intervention adherence is monitored via fidelity checking of the CNC consultation process and outcomes (trial CNCs independently consulting and comparisons made by a different CNC) as well as checking of the similarity of intended care plans for the pressure injuries and the actual/applied care plan (via unannounced on site checking of the dressings in use by the research team) in the participating Homes.
Intervention code [1] 324319 0
Treatment: Other
Comparator / control treatment
Usual care. The participating Homes do employ in-house CNCs. Nurses engage with external CNCs (via consultancy) as they deem necessary for individual residents.
Control group
Active

Outcomes
Primary outcome [1] 332411 0
Number of wounds healed (complete wound closure). Complete wound closure is defined as “skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart” (U.S. Department of Health and Human Services Food and Drug Administration, 2006, p. 12).

Wound images (as described previously) are taken by nurses in the Homes. Verbal report from nurses in the Homes and checking of the electronic medical record will confirm that healing has occurred and wound images will be taken 2 weeks following the date assessed as healed (fully epithelialised).
Timepoint [1] 332411 0
12 weeks post-intervention commencement (end of CNC consultations) and 2 weeks post-intervention completion as per above definition of complete wound closure
Secondary outcome [1] 413399 0
Wound healing rate. As this is a pilot study wound healing rate will be calculated utilising a number of methods that will enhance confidence in study findings and address debate about the most appropriate algorithm to use. These methods will include percentage wound size reduction, percentage area change , percentage volume reduction, linear advancement/healing of wound margins mean adjusted healing rate based on linear advancement of the wound edge and wound area-over-time integral of wound margins. Pressure injury images (taken weekly) will be analysed in an application that automatically calculates wound size.
Timepoint [1] 413399 0
Weekly for 12 weeks post-intervention commencement
Secondary outcome [2] 413400 0
Wound infection. Wound infection is a clinical decision based on the presence of signs and symptoms of infection, including the classic cardinal signs of heat, pain, swelling, suppuration, erythema and fever. The CNC and the treating nurses will assess for infection and agree on whether present or not. Suspected infection will be confirmed or refuted by the residents general practitioner. As microbiological results are used to provide information on the presence or absence of microorganisms and to identify the organisms and their sensitivities, swabs are not being used to diagnose infection in the trial.
Timepoint [2] 413400 0
Weekly for 12 weeks post-intervention commencement
Secondary outcome [3] 413401 0
Satisfaction. Patient Satisfaction with nursing care quality (PSNCQ) survey and purpose designed questionnaire.
Timepoint [3] 413401 0
Baseline and 12 weeks post-intervention commencement
Secondary outcome [4] 413402 0
Quality of life. EQ5D 5L. Completed by resident if able or by treating nurse as proxy
Timepoint [4] 413402 0
Baseline and 12 weeks post-intervention commencement
Secondary outcome [5] 413403 0
Cost of treatment and care. Cost of resource use by participant for pressure injury care (log of resources used recorded by treating nurses). Cost of healthcare provider services (log of time spent by nurses and other healthcare workers used recorded by treating nurses)
Timepoint [5] 413403 0
Weekly for 12 weeks post-intervention commencement
Secondary outcome [6] 413404 0
Hospitalisations. By accessing the residential aged care facility electronic medical record system
Timepoint [6] 413404 0
Weekly for 12 weeks post-intervention commencement
Secondary outcome [7] 413405 0
Deaths. By accessing the residential aged care facility electronic medical record system
Timepoint [7] 413405 0
24 weeks post-intervention commencement
Secondary outcome [8] 413431 0
Time to healing. Calculation of days between pressure injury start date and healed date. The start date will be determined according to the documentation of this date in the residential aged care facility electronic medical health record. This may be documentation made by the Nurse (if the nurse identified the pressure injury) or may be documentation added to the electronic medical health record for example a hospital discharge summary. The Wound CNC will audit the electronic medical health record for this date. The healed date will be as advised by the nurses at the residential aged care facility and the status of the skin will be confirmed by the Wound CNC via provision of a digital image of the previously affected area of the skin on this date. An image taken two weeks after the date assessed by the nurse as healed will also be checked by the Wound CNC (as per the earlier definition of complete wound closure).
Timepoint [8] 413431 0
Weekly for 24 weeks post-intervention commencement

Eligibility
Key inclusion criteria
• Equal to or greater than 18 years of age;
• Has one or more pressure injury;
• Is a resident of participating Home;
• Is expected to be living in the Home for the 12 week intervention period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Receiving palliative care and/or whose passing (death) is expected to be imminent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster. 3 Homes (one each in a metropolitan Melbourne, regional Victorian and Mornington Peninsula region) were randomly allocated to be intervention sites and 3 sites (one each in a metropolitan Melbourne, regional Victorian and Mornington Peninsula region) to be control sites. We used simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) this completed by a statistician independent of the trial
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
As this is a pilot study no sample size calculation was undertaken. The sample size was informed by published guidelines (Eldridge, S., Costelloe, C., Kahan, B., Lancaster, G., & Kerry, S. (2016). How big should the pilot study for my cluster randomised trial be? Statistical Methods in Medical Research, 25(3), 1039–1056. doi:10.1177/0962280215588242)

Change in wound measurements will be examined utilising paired samples t-tests and one way repeated measures Analysis of Variance (ANOVA). Parametric and non-parametric measures will be used to compare the intervention and control groups at baseline to assess the effectiveness of randomisation to achieve comparable groups. Examination of the number of healed wounds in addition to days to healing will be analyzed using a Cox’s Proportional Hazard model. Analysis of wound healing rate will also be analyzed using a two-way repeated measures analysis of variance tests will also be used to test for wound healing rate. Analysis will be in accordance with intention-to-treat with additional consideration of a “complete case” analysis. Cases lost to follow up shall be assumed to have nil change to wound size. Average wound size change shall be imputed between time points for missed data. Cost analysis will follow a micro-costing approach including analysis of expenditure (actual clinician time and product costs); quantity and value of resources.

A “modified intention-to-treat” analysis will also be conducted to indicate of the effects associated with the treatment. The person conducting the analysis will not be aware which Homes were intervention and control sites.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2022
Actual
Date of last participant enrolment
Anticipated
16/12/2022
Actual
Date of last data collection
Anticipated
2/06/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23054 0
Regis Aged Care Blackburn - Blackburn
Recruitment hospital [2] 23055 0
Regis Aged Care Inala - Blackburn South
Recruitment hospital [3] 23057 0
Regis Aged Care Frankston - Frankston
Recruitment hospital [4] 23061 0
Regis Aged Care Ontario - Mildura
Recruitment hospital [5] 23062 0
Regis Aged Care Sunraysia - Mildura
Recruitment hospital [6] 23085 0
Regis Aged Care Rosebud - Capel Sound
Recruitment postcode(s) [1] 38410 0
3130 - Blackburn
Recruitment postcode(s) [2] 38411 0
3130 - Blackburn South
Recruitment postcode(s) [3] 38412 0
3199 - Frankston
Recruitment postcode(s) [4] 38418 0
3500 - Mildura
Recruitment postcode(s) [5] 38438 0
3940 - Capel Sound

Funding & Sponsors
Funding source category [1] 312116 0
Government body
Name [1] 312116 0
Victorian Medical Resarch Acceleration Fund (administered by the Victorian Department of Jobs, Precincts and Regions)
Country [1] 312116 0
Australia
Primary sponsor type
University
Name
University of Melbounre
Address
Building 104, Alan Gilbert Building.
University of Melbourne.
161 Barry Street Parkville 3010 Victoria Australia
Country
Australia
Secondary sponsor category [1] 313639 0
None
Name [1] 313639 0
Address [1] 313639 0
Country [1] 313639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311516 0
University of Melbourne - Responsible Human Ethics Committee - STEMM 2
Ethics committee address [1] 311516 0
Ethics committee country [1] 311516 0
Australia
Date submitted for ethics approval [1] 311516 0
16/08/2022
Approval date [1] 311516 0
22/08/2022
Ethics approval number [1] 311516 0
2022-22205-31646-5

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121374 0
Dr Suzanne Kapp
Address 121374 0
Building 104, Alan Gilbert Building. University of Melbourne. 161 Barry Street Parkville, 3053 Victoria Australia
Country 121374 0
Australia
Phone 121374 0
+61 3 90354413
Fax 121374 0
Email 121374 0
[email protected]
Contact person for public queries
Name 121375 0
Suzanne Kapp
Address 121375 0
Building 104, Alan Gilbert Building. University of Melbourne. 161 Barry Street Parkville, 3053 Victoria Australia
Country 121375 0
Australia
Phone 121375 0
+61 3 90354413
Fax 121375 0
Email 121375 0
[email protected]
Contact person for scientific queries
Name 121376 0
Suzanne Kapp
Address 121376 0
Building 104, Alan Gilbert Building. University of Melbourne.
161 Barry Street Parkville, 3053 Victoria Australia
Country 121376 0
Australia
Phone 121376 0
+61 3 90354413
Fax 121376 0
Email 121376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a pilot trial, data and documents will not be available as these are required to be kept confidential to inform our future definitive RCT trial design.


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
EmbaseThe clinical and cost effectiveness of remote expert wound nurse consultation for healing of pressure injuries among residential aged care patients: A protocol for a prospective pilot parallel cluster randomised controlled trial.2023https://dx.doi.org/10.1111/iwj.14121
N.B. These documents automatically identified may not have been verified by the study sponsor.