Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.
The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.
Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.
ClinicalTrials.gov Registry NCT04889417.
People without access to recognised and understood speech and/or written communication methods can experience exceptional disadvantage in health settings. This can result in poor health outcomes, lengthier hospital admissions and adverse events, including preventable deaths. Despite numerous attempts to integrate augmentative and alternative communication into health settings, the first-person ‘voice’ of the patient is often not accessible or prioritised, deferring instead to others, such as parents or carers, or the ‘best guess’ by healthcare professionals. The Talking Scrubs project aims to form a bridge to augmentative and alternative communication by locating key communication icons on scrubs (and scrubs/vest) to be used with patients (in and of themselves) and/or to prompt the use of patient individualised communication methods. The paper describes the methodological process for Stage 4 of the project. Prior stages involved investigating the concept, developing and validating instrument measures and co-designing and feasibility pilot testing the scrubs/vests. Stage 4 (this protocol) aligns with the diagnostic process, to test the feasibility and effectiveness of the scrubs intervention at two large, metropolitan medical centres with 5–10 general practitioners, approximately 30 patients and up to 10 flow-on diagnostic screening clinicians such as nurses and phlebotomists. Stage 4 is the first time the instrument measures will be applied and re-tested post-validation.
Using mixed methods, Stage 4 will apply the communication self-efficacy instruments co-designed in Stage 2 and validated in Stage 3 to measure effectiveness of the scrubs intervention by comparing pre-intervention and post-intervention changes in both clinician and patient population groups. Qualitative interviews, agency recorded data and participant journal recordings (optional) will be used to identify feasibility. SPSS V.29 (IBM, Chicago, Illinois, USA) will be applied to analyse participant communication self-efficacy measures and NVIVO V.10 (Lumiverso, Denver, Colorado, USA) to the retrieved qualitative data.
Stages 3 and 4 have ethics approval from the University of South Australia Ethics Committee identification number 206 930 and are registered as a clinical trial with Australia and New Zealand Clinical Research Trials (ANZCRT) with registration number 12625000490471p. Stage 1 (national survey) and Stage 2 (stakeholder focus groups) received ethics approval from Flinders University. Findings will be disseminated through national and international health translation platforms, publications, media and on the Talking Scrubs website.
ANZCRT with the registration number ACTRN12625000490471p.