Investigation of an artificial intelligence module to prioritise review of non-healing cardiac surgical wounds in adults Surgery
Conditions
Interventions
This project is a two-centre, unblinded parallel-group randomised feasibility study with safety and acceptability outcomes comparing the wound prioritisation module with standard care. A total of 120
out-patient appointments, advised to contact GP, or no follow-up.
Intervention Group: The intervention group will use the artificial intelligence enabled platform with the new wound prioritisation m
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients having first/redo CABG surgeries with or without adjunct cardiac procedures such as valve replacement, or chest reopening during same admission as index surgery, and either no infection, or an existing non-infected wound complication, or any other infection except surgical site. 2. Patients without a smartphone/with physical disability/with visual impairment will be eligible if they are willing to use a smartphone or internet provided by the study, or their next of kin or carer is able-bodied or has a smartphone.
Exclusion criteria
Exclusion criteria: 1. Patients having CABG requiring ventricular assist device (VAD) or 2. Extracorporeal membrane oxygenation (ECMO), or 3. Ventilated or unconscious patients, or 4. Pre-existing surgical site infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety outcomes: quality of images received, assessed by clinicians at 30 days. A quality image is one that can be used to make a clinical decision. 2. Acceptability outcomes: clinician and patient satisfaction using surveys and interviews at day 30. Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. 3. Feasibility outcomes: recruitment rate, adherence with the module (intervention group only), loss to follow-up. Adherence will be reported as the number and percentage of adherent patients in the intervention group. To be adherent a patient needs to submit 1 photo within the 30 day period. This will be compared with the progression criteria defined in the protocol. The definitive study will proceed (or not) based on these outcomes. 4. Economic modelling outcomes: Will include number and severity of wound problems/infections, wound-related hospital readmission, prescribed antibiotics time to review images, further surgery to treat wounds, prescribed wound treatments, clinic visits, GP visits, patient travel time, and quality of life SF 6Dv2 (added 25/07/2024) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety outcomes. More detailed discussion about reasons for compliance/non-compliance will be explored in the staff surveys and interviews and the patient intervention group surveys and interviews. Survey data will be analysed using descriptive statistics and qualitative data from the interviews will analysed using thematic analysis. 2. Feasibility outcomes: access/barriers to participation and willingness of participants to be randomised, and attrition rates and suitability of assessment procedures and outcome measures, including time and resources required to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data. To contribute to sample sizes for a definitive trial - number and severity of wound problems/infections, wound-related hospital readmission, further surgery to treat wounds, prescribed wound treatments, prescribed antibiotics, clinic visits, GP visits. 3. Other secondary outcomes: number of photos received (per patient), number of requests (for images) complied with -intervention group only, number photos initiated by patients (intervention group only), number of follow-up requests. | — |
Countries
England, United Kingdom
Contacts
Public ContactMelissa;Judith Rochon;Tanner
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Outcome results
None listed