I-PASS: Should I have equipoise?

Author: Dr. Trey Coffey 

Staff Paediatrician, Medical Officer for Patient Safety, Hospital for Sick Children
Assistant Professor of Paediatrics, Associate Director, Centre for Patient Safety, University of Toronto


What to do when you have to implement something so that you can research the outcome? How can you possibly dedicate blood, sweat, tears, and change management muscle if you do not feel at your core that it is a worthwhile effort? I can’t. If I do not believe in something, I am not going to deploy the precious neurons I have left after years of sleep deprivation, nor will I find sufficient ‘attentional moments’ amidst the many flashing lights demanding the attention of a fledgling Safety Officer. So, fortunately, I have been given the opportunity to apply my full arsenal of energy and skills to an endeavor which is both hands-on, tangible improvement while also being a rigorously evaluated research study. How has this good fortune befallen me? Back in 2009, my office mate/mentor/friend Sanjay Mahant said to me, “Hey. There is this study happening on handoffs. We should join it since we are part of PRIS. You should lead our site since it’s a safety thing.” After many, many conference calls, grant applications, sales pitches, lectures, and occasional moments of wanting to kill Sanjay, I am happy to report that, as usual, he was right – this is a journey that I am happy to be a part of.


Under the watchful eye of our intrepid leaders Chris Landrigan and Amy Starmer, a small army of educators, researchers, and safety people have joined forces in an ever-expanding project called I-PASS, the IIPE-PRIS Accelerating Safe Signout Study. We created a curriculum, delivered it to hundreds of faculty and residents throughout North America, and continue to have opportunities to share our work. But, you ask, wasn’t this a research study? Didn’t she say something about rigorous evaluation? Indeed, we are measuring the effect of the intervention on important outcomes like medical errors, efficiency and quality of handoff, and user satisfaction.


Which brings me to the dilemma at hand. Shouldn’t I have equipoise? Should I be suggesting that my colleagues adopt this handoff improvement strategy when we don’t have data beyond our promising pilot? And, conversely, should I be working to collect these outcome data if we are already doing this and plan to keep doing it?


This is not just my little dilemma. Anyone working in safety is familiar with the tension between expediency and rigor: “Just do it, or wait for data?” To compound this dilemma, what about that paucity of data and relative lack of funding for safety research? To answer this I am going to bear in mind the advice of an incredibly sensible person I had the good fortune to meet recently, Dr. Harvey Fineberg, President of the Institute of Medicine. When asked about expediency vs. rigor, Dr. Fineberg was pretty clear that waiting for more data is most definitely not a reason to resist proceeding full steam ahead with trying to improve safety (Okay, he was more erudite than that, I am paraphrasing). At the same time, another wise voice resonates in my head: Kaveh Shojania, head of our University of Toronto Centre for Patient Safety, who might say that there is an opportunity cost to embarking on improvement efforts not grounded in evidence and this behooves us to do methodologically sound safety and quality research.


I don’t disagree with that assertion. But, I can tell you with certainty that handoff in my clinical area is better since we implemented I-PASS. Many of the residents have no idea just how problematic it was before, but I remember. It is not perfect, but it is substantially and yes, anecdotally, better. After all, all that counts cannot be counted and uptake by individuals is driven by face validity and directly experienced benefit (and not by altruism nor data, unfortunately). 

What will finally transform healthcare into a safe and reliable industry, and will I be fortunate enough to see that happen in my lifetime? Will it be the traditional research-to-knowledge-translation-to-implementation cycle of academic medicine? I have my doubts. While I continue to seek the answer to this question, I will gladly promote I-PASS to anyone willing to listen, as I believe in its value and have seen real world results first hand. But for the purpose of spreading beyond our own institutions, data regarding the efficacy will be essential. So I guess I have an answer to my little dilemma. What we need are interventions which offer immediate tangible benefits to users and are also backed by outcome data. Given this tall order, I hope to support the kind of pragmatic, end-user-driven studies like I-PASS that might stand a chance of getting us where we need to go. 


For more information on the I-PASS Study, please visit: http://www.ipasshandoffstudy.com/