HIPPOCRATES: Health Inequalities in PerioPerative Outcomes - CReATing and Evaluating targeted Support interventions

Research question: Can interventions which are co-developed with patients experiencing socioeconomic deprivation improve outcome and reduce health inequalities after major non-cardiac surgery? Background: Reducing health inequalities, including those arising from socioeconomic position (SEP), is a priority for the NHS. Over 1 million NHS patients undergo elective major non-cardiac surgery annually, with >15% experiencing major complications which prolong hospitalisation and are associated with reduced survival and health-related quality of life. Patients from deprived backgrounds are at higher risk of these adverse outcomes. The perioperative pathway offers an opportunity to implement targeted interventions which improve both surgical outcome and longer-term inequalities. Objectives: Using existing data, evaluate the epidemiology of how SEP is associated with adverse postoperative outcomes Using systematic reviews and expert consensus, define the key characteristics of three approaches to improving outcome after major non-cardiac surgery: preoperative optimisation (including "prehabilitation" and behavioural support); financial support enhanced monitoring/surveillance Working with health professionals, scientists, and patients and public from deprived backgrounds, develop these characteristics into three interventions which could be clinically and cost-effective, feasible for the NHS, and acceptable to patients from deprived SEPs Evaluate these interventions using mixed methods in a multi-arm pilot randomised controlled trial (RCT) against standard-of-care Evaluate the most promising intervention in a fully-powered RCT and embedded process evaluation Develop funding applications for the other two interventions if deemed potentially beneficial and feasible Methods: Work Package (WP) 1: analyse the epidemiology of how individual and area-based measures of SEP are associated with adverse outcomes after major surgery, to generate hypotheses about which perioperative interventions may have most clinical benefit in patients from deprived groups. WP2: Using the Double Diamond method, co-design three interventions (based on preoperative optimisation, financial support and enhanced monitoring after hospital discharge) aimed at improving perioperative outcomes focusing on feasibility and acceptability in patients from deprived SEPs. Co-design workshops will involve patients and public, specifically recruiting participants from deprived SEPs, and also clinicians, scientists, service leaders and VCSEs. Outputs will include detailed implementation support. WP3: develop an online RCT platform from the Perioperative Quality Improvement Programme (PQIP: www.pqip.org.uk) dataset and database; develop master protocol and ethics/regulatory permissions for WP4 and 5 WP4: deliver pilot RCT evaluating three interventions against a single control group, recruiting 105 patients per arm in 12 hospitals. Use mixed methods to evaluate feasibility and potential for clinical and cost-effectiveness; select the most promising intervention for definitive evaluation WP5: in a data-enabled RCT in 40 hospitals, evaluate clinical and cost-effectiveness of a single intervention, randomising a further 2390 participants from deprived SEPs 1:1 against standard-of-care. Concurrent mixed-methods evaluation of implementation at scale. Primary outcome: days alive and out of hospital at 30-days; secondary outcomes include longer-term mortality, hospitalisation and health-related behaviours. WP6: develop further funding applications for other promising intervention(s) piloted in WP4, to be evaluated in an ongoing multi-arm, potentially multi-stage platform trial Timelines: 72-month programme. Impact: co-design approach has potential for wider impact and adoption; effective interventions may have generalisability outside perioperative pathways, and longer-term impact on health outcomes and inequalities.