The NIH Health Care Systems Research Collaboratory program is welcoming new embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing as part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). At the same time, many of the Collaboratory’s early Demonstration Projects are completed and now publishing results. At a recent Collaboratory Steering Committee meeting, we spoke with four of the principal investigators (PIs) of completed trials to glean advice for new trials.
What words of advice do you have for investigators conducting their first embedded PCT?
Dr. Laura Dember, PI of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial (NCT02019225).
Dr. Dember: “An important message is that progress in making big changes to how trials are conducted is going to be incremental. We need to be aspirational, but we also need to recognize that we’re not going to solve all of the problems with one try. We should not be discouraged by the things that don’t work, but rather keep moving forward by building on what we’ve learned.”
Dr. Lynn Debar, PI of the Collaborative Care for Chronic Pain in Primary Care (PPACT) trial (NCT02113592).
Dr. DeBar: “Regarding stakeholder engagement, recognize that these are really complex adaptive systems, and sometimes, more resources and harder pushing is not the way to accomplish your goal. You have to really think through how to communicate: where and how you push requires thinking about all the stakeholders involved.”
Dr. Beverly Green, Co-PI of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) trial (NCT01742065).
Dr. Green: “The collaboration part of bringing the investigators together to figure out the pieces of the puzzle has really been valuable to me. Really try to understand stakeholder engagement, the values of the people involved, and work to align them. This way, when you get it right, embedded pragmatic research can save money, improve health, and be a better experience for staff and patients. It’s a win-win.”
Dr. Huang: “Communication is so important because if you have stakeholders at the table, not all of them will have the exact vantage point as you, and you will learn by communicating. And, if you’re learning different things and reaching different forks in the road that require decision-making and troubleshooting, it’s only by talking about them that you get everybody to really understand what the goal is. And in this way, you come up with better solutions than you could come up with yourself.”
What was the biggest lesson learned in conducting your trial?
Dr. Dember: “It’s important to effectively engage with people on the ground. The extent to which this is possible depends on the setting, but, at least for some interventions, being able to engage with the people who are actually implementing the trial procedures is critical.”
Dr. Huang: “The biggest lesson is the critical nature of the partnership and the investment involved in maintaining it. The strength of our trial, and our ability to conduct it, was dependent on a strong partnership.”
Dr. Debar: “Vertical integration is important: you need high level buy-in, but you also need buy-in from people on the ground who are providing care.”
Dr. Green: “Someone in NIH did the math regarding how much an implementation study costs per participant, and he said, ‘That has to be cheaper.’ This prompted me to think about what things could be answered with embedded research. As a clinician, day to day, I am always making decisions that I don’t really know the answer because there isn’t enough evidence. There are so many questions that need to be answered, and embedded pragmatic research is a great starting point for getting more answers. We’ll never get there by doing this one trial at a time with traditional research.”
Congratulations to all four investigators for their groundbreaking work on their Demonstration Projects!