RecruitingACTRN12619001778178

Perioperative Enhancement of Cognitive Trajectory (The PROTECT trial)

Perioperative Enhancement to improve the Cognitive Trajectory of older patients undergoing cardiac and non-cardiac surgery (The PROTECT trial)

Sponsor

The University of Melbourne

Enrollment

692 participants

Start Date

Apr 19, 2021

Study Type

Interventional

Conditions

Postoperative Neurocognitive Disorder Mild Neurocognitive Disorder Delirium Major Neurocognitive Disorder

Summary

Cognitive decline including delirium is known to follow anaesthesia and surgery in the elderly and may have long term consequences including increased risk of dementia. There is evidence that lifestyle interventions may reduce the risk of delirium and slow the progression of cognitive decline. This study will implement a care program to reduce the incidence of perioperative delirium and in turn, reduce postoperative neurocognitive disorder. To achieve these aims participants randomised to our specialised care group will receive perioperative optimisation strategies (e.g. medications, pain management) in accordance with the expert opinion for delirium prevention in Australia (ACSQHC, 2016). In addition, these patients will receive lifestyle interventions targeting modifiable cardiovascular risk factors (e.g. diabetes, inactivity, smoking). Our control group will receive current standard of care. Primary outcomes include mild or major neurocognitive disorder at 3 and 12 months, assessed with a battery of neuropsychological tests. Secondary outcomes include days alive and out of hospital, QoL and functional independence.

Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

After surgery, many older adults experience confusion (called delirium) or a decline in memory and thinking — sometimes lasting months. This is sometimes called postoperative cognitive disorder, and it can have serious long-term consequences including increased dementia risk. This trial is testing whether a specialised care program — combining careful medication management, pain relief strategies, and lifestyle changes targeting risk factors like inactivity and diabetes — can reduce these problems in older surgical patients. Participants are randomly assigned to either the specialised care program or standard hospital care. Their thinking and memory are tested before surgery and again at three and twelve months afterwards, using a battery of neuropsychological tests. Researchers will also track quality of life, independence, and how many days participants spend outside of hospital. You may be eligible if you are 65 or older and are scheduled for cardiac or non-cardiac surgery that requires at least one night in hospital, and you live close enough to St Vincent's Hospital Melbourne to attend follow-up appointments. People with prior significant brain injury, hearing or vision problems that would interfere with testing, or who lack capacity to consent independently are not eligible.

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Interventions

Participants randomised to the intervention group will receive postoperative optimisation strategies that closely mirror the validated 'enhanced recovery after surgery - ERAS' principles. This includes effective medical management directed by site anaesthetists and pain specialists (e.g. example reducing the use of benzodiazepines post operatively and facilitating passive emergence from anaesthesia). Nutritional support will be provided by research staff and overseen by site dieticians, ensuring that nutrition and hydration goals are established with the participant throughout the perioperative period. Site physiotherapists will ensure participants in the intervention arm are mobilised as early and frequently as possible postoperatively. Research staff will ensure participants have the required devices for sensory orientation (hearing aids, glasses etc. and liaise with participants’ families to ensure required items are available from home). In addition, participants randomised to the intervention arm will receive a thorough education session (30 to 60 minutes duration) prior to hospital admission, tailored to their surgery and individual risk factors (e.g. sensory impairments, recent infections). This education will focus on ways to prevent delirium throughout the surgical period and additionally the role of modifiable lifestyle factors for physical and cognitive health (e.g. diet, exercise, stress management, cognitive stimulation, social engagement). To this end, participants will be supported in a number of ways throughout the perioperative period to make healthy lifestyle changes. These supports include activity tracking devices, which will be worn in the week prior to surgery and 30 days post discharge. In additional participants will receive 1-4 text message prompts up to 6 months post discharge, a monthly phone call up to 12 months post discharge and be provided with the opportunity to attend up to six education sessions of two hours duration. All interventions will be overseen by a case manager. Although the intervention will transpire over 12 months, support will be reduced in a graded fashion over the course of the year.