Primary Palliative Care for Emergency Medicine (PRIM-ER), an NIH Collaboratory Trial, received approval this month to enter its implementation phase. PRIM-ER is a pragmatic, cluster randomized trial of a multidisciplinary primary palliative care education and decision support intervention in a diverse sample of emergency departments that differ in their specialty geriatric and palliative care capacity, geographic region, payer mix, and patient demographic characteristics.

We spoke with the principal investigator of PRIM-ER, Dr. Corita Grudzen, at the NIH Collaboratory Steering Committee meeting in May about the completion of the study’s planning phase.

What is the status of your study?

PRIM-ER is currently transitioning from a 1-year UG3 planning phase to the UH3 implementation phase, where the intervention will be tested at full scale across 33 sites in a stepped-wedge trial. Our program manager is conducting training sessions in preparation for implementing the intervention at study sites.

Were there surprises during the planning phase of the study?

There weren’t surprises so much as confirmation of what we already knew, which was that enthusiasm can go a long way. Having a detail-oriented, responsive site principal investigator is also key. When you have a well-organized team on the ground, the distance doesn’t matter as much, and all the things you think are going to get in the way don’t get in the way. Things go smoothly when you have someone who is incredibly enthusiastic, loves the content, understands the content, and is infectious about sharing the training and information with others. I think that can overcome a lot of potential barriers.

What is an example of a challenge that you were able to overcome with the help of the NIH Collaboratory Core Working Groups?

Working with the Cores was reassuring, in that they showed us we weren’t alone. We were all struggling with the same issues, and it was okay not to be perfect in the way we were attacking all the problems. We were all planning pragmatic trials, and it was okay if we showed our warts and all.

What other challenges have you faced?

Having a good team at the primary organization is really important. It’s important to have a good administrative team—a program manager, project director—who can hold down the fort, especially with pragmatic trials, when you’re traveling to a lot of sites.

What advice do you have for investigators conducting their first embedded pragmatic clinical trial?

Give yourself a break. There are a ton of imperfections in conducting embedded pragmatic trials. It’s all about the people. Pick great site principal investigators. That’s more important than anything else about the institutions. You want to have enough eligible patients that you’re going to have an impact or whatever else is involved in picking your sites. Enthusiasm and organizational savvy go a long way. Be patient and flexible and open to new iterations of what you’re doing. It feels scary at first, but I think it will serve you to be open to change.

PRIM-ER is supported within the NIH Collaboratory by cooperative agreements from NCCIH and the National Institute on Aging and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about PRIM-ER and the NIH Collaboratory Trials.