Patients approaching major surgery Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Stage 1: Patient participants: 1. Adult patients (=18 years of age) 2. Within 3 months of having undergone major surgery or preparing for major surgery 3. Discharged from hospital to their own home Healthcare professional participants: 1. Perioperative team members currently caring for patients approaching major surgical intervention in the preoperative period. 2. Employed at South Tees Hospitals NHS Foundation Trust or York Hospital 3. A medical, nursing or allied healthcare professional background or a wider stakeholder in perioperative care e.g. an individual with management or commissioning responsibility for perioperative services. Stage 2: Patient participants: 1. Adult patients (aged >18 years) listed for a major surgical procedure. 2. A minimum of 4 weeks available prior to planned surgery. 3. ASA (American Society of Anaesthesiology) fitness for surgery grade >2 4. At least one health risk behaviour amenable to remotely supervised prehabilitation via the developed intervention. 5. Access to and willingness to utilise a smartphone and integrated wearable device. 6. Able to access and utilise the internet at home. Healthcare professional participants: 1. Perioperative team members currently caring for patients approaching major surgical intervention in the preoperative period. 2. Employed at South Tees Hospitals NHS Foundation Trust or York Teaching hospital NHS Foundation Trust
Exclusion criteria
Exclusion criteria: Stage 1: Patient participants: 1. Unable to provide informed written consent 2. Currently receiving end-of-life care 3. Unable to understand and communicate in written and spoken English Stage 2: Patient participants: 1. Unable to provide informed written consent 2. Pregnancy 3. History of severe mental illness requiring active investigation or treatment by mental health services or compromising the informed consent process 4. Unable to understand spoken and written English 5. Already undergoing prehabilitation or a preference for an alternative mode of support e.g. a face-to-face service 6. Safety concerns around remotely supervised exercise training based on American College of Sports Medicine (ACSM) criteria for clinical exercise testing and prescription
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Intervention feasibility 2. Intervention acceptability to patients and HCPs 3. Intervention fidelity Measured using a combination of qualitative participant feedback (semi-structured interviews) and programme usage data including e.g. logins, time spent and completion rates of programme components at exit from the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical data: 1. Alive at hospital discharge based on review of electronic records at hospital discharge 2. 30-day mortality measured based on review of electronic records at day postoperative day 30 3. 90-day mortality measured based on review of electronic records at postoperative day 90 4. Postoperative morbidity assessed using the Comprehensive complication Index (CCI) at hospital discharge 5. Days at home post-surgery (DAH30) measured based on review of electronic records at 3-month postoperative assessment 6. Length of hospital stay (days) based on review of electronic records at 3-month postoperative assessment 7. Length of critical care stay (days) based on review of electronic records at 3-month postoperative assessment Behavioural risk factor assessment: Smoking: 1. Smoking status (number of cigarettes) at baseline assessment, preoperative assessment and 3-month postoperative assessment 2. Nicotine dependence assessed using Fagerstrom score (if smokes) at baseline assessment Alcohol: 1. Consumption (units of alcohol) at baseline assessment, preoperative assessment and 3-month postoperative assessment 2. Alcohol dependence assessed using AUDIT (if >14 units per week) at baseline assessment Exercise and activity: 1. Functional capacity assessed using Duke Activity Status Index (DASI) at baseline assessment, preoperative assessment and 3-month postoperative assessment 2. Physical activity assessed using International Physical Activity Questionnaire (IPAQ) Short form at baseline assessment, pre-operative assessment and 3-month postoperative a | — |
Countries
England, United Kingdom