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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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 dressin CONDITION: Pressure injuries (bed sores); ; Pressure injuries (bed sores) Skin ‐ Other skin conditions PRIMARY OUTCOME: 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). [12 weeks post‐intervention commencement (end of CNC consultations) and 2 weeks post‐intervention completion as per above definition of complete wound closure] 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. SECONDARY OUTCOME: 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)[Weekly for 12 weeks post‐intervention commencement] Deaths. By accessing the residential aged care facility electronic medical record system[24 weeks post‐intervention commencement] Hospitalisations. By accessing the residential aged care facility electronic medical record system[Weekly for 12 weeks post‐intervention commencement] Quality of life. EQ5D 5L. Completed by resident if able or by treating nurse as proxy[Baseline and 12 weeks post‐intervention commencement] Satisfaction. Patient Satisfaction with nursing care quality (PSNCQ) survey and purpose designed questionnaire. [Baseline and 12 weeks post‐intervention commencement] 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). [Weekly for 24 weeks post‐intervention commencement] 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. [Weekly for 12 weeks post‐intervention commencement] 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. [Weekly for 12 weeks post‐intervention commencement]
Epistemonikos ID: 13c041b57dbb3adfbbe9231c225ff291208065b9
First added on: Aug 26, 2024