RAPID driven Treatment of Pleural Infection (feasibility study)RAPTOR-f

Research question: Is it feasible to deliver a definitive randomised trial comparing usual care to RAPID driven care in patients with pleural infection?

Background: Pleural infection is characterised by the collection of infected fluid within the pleural cavity, which is the membrane between the lung and chest wall. The incidence of pleural infection is rising, particularly in the elderly.

Patients are treated by admission to the hospital, drainage of infected fluid (via a chest tube inserted between the ribs) and antibiotics.

However, a significant proportion fail initial treatment and require either invasive surgery (Video Assisted Thoracoscopic Surgery, VATS) or medications given through the chest drain (intrapleural enzyme therapy, IET). Clinical outcomes in pleural infection remain poor.

There is a 20% mortality at 12 months, an average hospital length of stay of 14 days and this results in significant costs to the NHS, estimated at £58 million / year.

Currently, all patients with pleural infection are treated in a stepwise manner with initial chest tube drainage and antibiotics, and only those not showing a good response after 3 to 5 days going on to have more aggressive therapy (VATS or IET). This non-specific approach is generic and inefficient.

There is now a validated risk stratification tool (the RAPID score) which accurately predicts 3 and 12-month mortality using 5 routinely collected baseline factors.

However, as with many risk stratification tools, its ability to alter treatment for clinical benefit has not been proven.

Aims and Objectives: This research will address the feasibility of delivering a randomised controlled trial of usual care versus RAPID driven care aiming to measure recruitment rate, recruitment proportion (number eligible versus number randomised) and completeness of key outcomes.

Methods: We will conduct two related work streams (WS) to address the research aims: WS1: RAPTOR-f (RAPID driven Treatment of Pleural Infection versus standard care feasibility) is a feasibility randomised trial of RAPID score driven treatment versus standard care (according to British Thoracic Society Guidelines 2023) in pleural infection.

We will recruit 30 patients from 3 UK centres, randomising 1:1 between standard care and RAPID driven treatment. The primary outcome is feasibility (randomisation rate).

Secondary outcomes include length of hospital stay, need for readmission and repeat intervention, proportion requiring IET and surgery, and patient-centred outcomes with validated pain/breathlessness scores (100mm VAS) and quality of life questionnaires (EORTC QLQ-LC13).

WS2: Embedded qualitative study; we will conduct semi-structured interviews with participants and health professionals, focusing on experiences of participating in the trial, to inform the feasibility of a full-scale trial in the future. Timelines for delivery: Study starts November 2024, 22 months total duration.

Anticipated Impact and Dissemination: Successful completion of our proposed work will lead to a funding application (via NIHR RFPB or HTA) to conduct a definitive trial comparing RAPID score driven treatment to standard care, with the potential to alter the current treatment pathway and inform treatment guidelines.

The feasibility study and qualitative work will be presented at conferences and published in peer-reviewed journals and patient-facing newsletters.