Navigating the Seas of Trial Management: My Journey with the PRONTO Trial

Introduction

As we mark World Sepsis Day, I find myself reflecting on a journey that has been both challenging and deeply rewarding – my role as a new trial manager for the PRONTO trial.

PRONTO, the largest clinical trial for sepsis in the UK, has been a monumental undertaking, and I joined the team during its final 18 months of operation. The pressure was palpable, but my determination to succeed was unwavering. This is the story of how I overcame that pressure, utilised my trial management skills, and set my sights on a higher end goal to lead the PRONTO trial towards a successful conclusion.

The PRONTO Trial: A Pioneering Endeavor

Sepsis is a life-threatening condition where every minute counts. The PRONTO trial team are responding to recommendations from the National Institute for Health and Care Excellence (NICE) for further research into Procalcitonin (PCT) testing in Emergency Departments (EDs), as a means of guiding clinical decision-making around antibiotic prescribing in patients with suspected sepsis. PCT is a blood test to identify bacterial infection which is currently not widely used in the NHS.

At the heart of PRONTO’s mission is the comparison of standard care with the addition of PCT testing versus standard care alone in managing suspected sepsis in adults presenting to the ED. The potential implications are significant—not only could it lead to improved patient outcomes but also result in more precise care and a reduction in inappropriate antibiotic prescriptions.

My Arrival: Facing and Overcoming Pressure

When I joined the PRONTO team, I was acutely aware of the immense pressure that came with being the new trial manager. The study had already been in motion for over 3 years, and I was stepping in during its critical final phase. The weight of the project’s importance, coupled with the responsibility to deliver results, manage a large team, and oversee the complex logistics of a trial of this scale felt overwhelming at times.

However, I was determined to rise above the pressure, leveraging three key trial management strategies:

1. Communicate: With no prior involvement in the trial, I was starting from zero! Communication meant survival. I continued to cultivate open lines of communication with the team, fostering an environment where ideas and concerns could be freely shared. This enabled me to quickly learn about the trial and its history, and about my colleagues and how we could work supportively and in cohesion. This also created a united front and a shared sense of purpose. I was not alone.
2. Own it: I embraced the project as my own, investing in a deep sense of responsibility. This sense of ownership drove my determination to go above and beyond, ensuring that every aspect of the trial was carefully executed to the best of my abilities.
3. Adapt: The dynamic nature of the trial requires adaptability. I welcomed the change and uncertainty, recognizing that flexibility was essential to navigate unexpected challenges. This was especially essential in the early months when the history of the trial was largely unknown to me.

A Higher End Goal: Transforming Sepsis Management

Beyond my trial management strategies, what truly keeps me motivated is the larger goal of what PRONTO can contribute to sepsis management. I am focused on the potential impact of our work—reducing antibiotic prescriptions without compromising patient outcomes. This overarching mission has transcended my initial lack of expert knowledge about sepsis, motivating me to rise above my own perceived limitations and doubts, and propels me forward with unwavering determination.

Furthermore, I’ve also been inspired by Julie, a sepsis survivor and UK Sepsis Trust (UKST) volunteer, who has played a pivotal role in the PRONTO trial.

A Special Contribution: Julie’s Perspective

Julie’s lived experience with sepsis brings invaluable insights to the project, contributing to every aspect of the trial proposal. On World Sepsis Day, it is crucial to recognize the importance of patient perspectives. Julie’s perspective on using lived experience to improve health outcomes can be found in this blog post, where she shares her journey and her invaluable contributions to our mission.

Conclusion

As the PRONTO trial approaches its conclusion, I look back on this journey with immense pride and gratitude. The pressure was significant, but it served as a catalyst for growth. PRONTO’s mission to improve sepsis management remains my driving force, and I am optimistic about the potential impact our work may have on patients’ lives.

On this World Sepsis Day, let us remember the significance of collaboration, innovation, and the invaluable contributions of individuals like Julie, who enrich our understanding and drive us closer to a future where sepsis is managed with greater precision and care. Together, we can make a difference.