It’s been just over a year since the Limb Loss and Preservation Registry (LLPR) flipped its shingle from “Coming Soon” to “Open for Business.” Co-founded by the Mayo Clinic with funding from the National Institutes of Health, the LLPR is now receiving data about amputee care from more than a dozen clinical partners, and new affiliates are joining at a rate of roughly one a week. The potential benefits for people with limb loss can scarcely be overstated. Comprehensive data can open the door to better insurance coverage, smarter treatment approaches, more funding for amputee-oriented research, and new opportunities for service organizations that support amputees.,
“The goal of this registry is to provide us with numbers we can rely on,” says Danielle Melton, a PM&R doctor at UC Health (the University of Colorado School of Medicine’s clinical arm). A longtime expert in amputee care and rehabilitation, Melton guided UC Health to become the first hospital system in the country to officially join the registry. Four other hospital systems have jumped into the pool since then, putting the LLPR within sight of its goal to add 25 hospital systems in 2023.
As you might imagine, it’s not easy getting a healthcare behemoth to take action—even when said action will cut costs, improve patient outcomes, and empower caregivers. We spoke with Melton last month to learn what sort of effort it took to convince UC Health to go first; how joining the registry will get progressively easier as more hospital systems join the party; and what individual amputees can do to move the process along. “We want to be a resource and an example to motivate other systems to participate,” Melton says. “By working together, we advance the care of this patient population.”
Our conversation with Melton is edited for clarity and length. Scroll all the way down for more of Amplitude‘s coverage about the Limb Loss and Preservation Registry, and stay tuned for news about Amplitude‘s commitment to helping the LLPR succeed.
How did UC Health make the decision to jump in? Why is it a good move for your organization? And what had to happen behind the scenes for that to be possible?
I am a physical medicine and rehabilitation doctor, and I spent 20 years in practice in Houston, working primarily with amputees. When the Limb Loss Registry started, Ken [Kaufman, the project director] approached me about being on the advisory panel. So I’ve been involved with this for at least five years—even longer, frankly, because I was chair of the Amputee Coalition’s scientific medical advisory committee, and we had been pushing to create a registry for the patient population.
In May of 2022 I was recruited to the University of Colorado to build an amputee program similar to what I’ve done in Houston. As part of that, I requested that the hospital system sign on to be part of the registry. The UC system has a committee of registries, and that has been an education in and of itself. I started working with the registry committee to try to explain what the Limb Loss and Preservation Registry was, and why it was important for UC Health to participate. There’s a lot of hoops you have to jump through and lot of boxes that have to be checked. As I said, it’s been an education for me.
What other registries does the UC system participate in?
I can’t speak to all of them. I know for sure we participate in the joint replacement registry, which was also started at Mayo. Another registry they were interested in at the time I arrived was vascular surgery. There are registries for almost everything in healthcare. The committee decides whether they’re going to participate based on whether it’s cost effective—whether it benefits their patients and they see some value in it. The takeaway I got from the meetings about the Limb Loss Registry was that it’s kind of a no-brainer, because it’s relatively low cost for hospitals to participate, and the time commitment is negligible because Mayo has already identified what the data sets are. They’ve already identified what information needs to be collected, and where that information resides in the EHR [electronic health record]. That means there’s not a lot of IT support that needs to happen. A hospital system doesn’t have to re-create the wheel when they sign on. They don’t have to hire someone to input a lot of data or maintain the information. It’s a once-a-month push of information. It’s not manual entry.
By comparison, when I was at the University of Texas I was involved with the trauma registry, which has been around for years. But the commitment to belong is pretty intense. They actually have to hire people to maintain that registry at each of the sites. The Limb Loss Registry is nothing like that, so there’s comparatively limited commitment.
Is it overstating it to say that it’s almost a plug and play kind of situation?
The biggest challenge I’ve seen in this one is getting the legal department on board to sign the agreement. Everybody wants to make sure their best interests are protected, I guess. So they might change some phrases within the agreement, and my understanding is that Mayo has been pretty accommodating to doing that. But I’m not gonna lie. The biggest challenge has been getting those people to communicate and ultimately sign off on the agreement so we can move forward.
The second concern is that the cost structure is kind of nebulous. That’s a lesson learned from my role on the advisory panel. We should have been more specific. We’ve said that it’s “fairly negligible,” meaning that whereas it might cost $1,500 a month to participate for other registries, we knew this was going to be maybe $200 a month. Much less. But we didn’t have those solid numbers at the start. We should have had a clearer picture of what this is going to cost, so that when people ask the question, we could be more definitive about the answer. Going forward, hospitals will now have that information.
Do you have a sense of what the target is for how many hospital systems are expected to join this year? Does UC Health’s joining the registry lower the hurdles and make it easier for other systems to sign on?
Great question. I think one reason I was recruited to be on the panel is because of the connections I have within the field. I went through a list of academic institutions around the country, and we identified those institutions that have a limb-loss champion on site—meaning they have a PM&R doctor or a surgeon who specializes in limb loss and would find value in participating in the registry. That gave us a database of institutions to target. To answer your question: I do think our participation lowers the hurdles for other systems, because now we have some examples. Now there are colleagues that new institutions can call to ask, “What do I need to do? How did you do it?” I hope I can serve as a resource for these folks. It does take somebody who’s committed to making it happen.
As a practitioner who works with a lot with amputees, how does it benefit you to have this data set coming into formation? What kinds of questions will you be able to answer that you haven’t been able to answer before?
The information we have right now is somewhat unreliable. We just don’t have a place to get updated numbers to understand which patients are at risk for further amputation, what class of devices are most compatible for which types of patients, or what we can expect for recovery times or mobility levels or pain control within different groups of patients. We don’t have good numbers from a demographic standpoint to understand health disparity issues. So there’s a lot of information we hope to gain.
Ultimately, we have the responsibility to use that information to advocate for patients. We can take those numbers to insurance companies and prove to them, “If we provide prosthetic devices that will keep patients more active, it’s going to improve their quality of life and prolong their ability to do things. They’re going to be less likely to develop other comorbidities and experience fewer hospital admissions.” Over the long term, we want to be able to use the registry to help patients understand how they’re doing. That’s ultimately where we want to head. There are some things that have to happen before we get there, but the registry gets us moving in the right direction.
It’s regrettably common for people to butt heads with their insurer over prosthetic device coverage. Are there other health care services or technologies that might become more accessible to amputees because of this registry?
In an ideal situation, we’d identify centers of excellence that care for amputees very well and get outstanding outcomes, and then use their experience to develop standards of care across the board. These might include access to physical therapists and occupational therapists who have expertise in limb loss. It might include access to mobility devices other than prosthetics. One that comes to mind for people with bilateral lower extremity amputations would be a wheelchair with elevation capacity. Until very recently, amputees were excluded from that technology by Medicare. I spent probably 10 years telling Medicare officials, “This is a stupid rule, why are we not changing this?” but I didn’t have the data to back it up. Having a registry with real-time information will be very helpful.
The other thing I would say is access to psychological support after limb loss. If we provide the right tools and the right mental health followup care, they’re going to have better outcomes across the board for everything. Defining standards of care is really where this should go.
I know a direct patient portal is going to become part of this registry at some point. How important is it for individual patients to stay engaged with the registry over time? And how can that gigantic herd of cats be coaxed into staying engaged so that long-term outcomes data can really be meaningful?
We’ll learn some of this over time. The more hospital systems we get involved, the better, because that’s where the numbers are going to come from. The individual patient portal is more important to help people understand the issues they’re facing. This registry has the ability to define standards of care for individuals with limb loss, to benchmark centers that are doing it well, and then filter down to the individual so they can be better self-advocates. They can go to their provider and say, “Are you part of this registry? Are you tracking the stuff that’s going to help me get the best outcomes?” Patients will be able to connect the dots across the country, see where they stand from a population-level standpoint, and get access to the best care. That’s the big benefit of the individual patient portal. That’s what the registry can ultimately provide.