Table 3.

Barriers to referrals, access and equity of monoclonal antibodies for COVID-19 infection, organized by diffusion of innovation domains.

Attributes of mAbs as an innovation
Relative disadvantage (mAb infusion)	The mode of administration is a concern: “Gosh, it’s an infusion. That sounds complicated and hard. And if they don’t know about the subcutaneous piece…And it’s, I understand, uncomfortable – to have that much medication delivered into your subcutaneous tissue. By the fourth injection, people are getting a little tired of it.” (physician, rural, health system affiliated) Infusions are complex to implement: “It’s the time, and increased burden to both the patient, and to my ER, and the patients that are able to do it. I guess I have yet to see the solid evidence to say, ‘Yes. We need to really do this for you.’ If a person is willing to do it, I’m happy to give it to them. But I’m not going to try and strongly persuade them. Because I just – like I said, it’s just that all of those seem like big barriers where I’m not really convinced that the adverse sides outweigh the benefits.” (physician, rural, health system affiliated) Receiving mAbs may delay vaccination and boosters: “The concern is, you know, if you’re giving them the antibody externally… how much will that delay if they need a third dose… a booster dose of the vaccine? Because if I – the booster dose and they have antibodies circulating at high levels, it may not be that effective, right? So now I’m saying, “Okay, well you got this. You probably should wait for your booster for 90 days. Let the antibodies go away and then get the booster.” “ (physician, urban, health system affiliated) Safety risks are rare, but not negligible: “One patient that we had, she came in with an anaphylactic reaction after receiving the antibody therapy… She came in probably every, about every other day over the course of a little over a week needing epinephrine. It was one of the things that – it really opened up my eyes to it… maybe just think a little bit more… These antibodies are still in the body for so long. It’s not metabolized or broken down as quickly as medication is, and so if you do develop an anaphylactic reaction, it’s gonna stick around for quite some time.” (physician, urban, health system affiliated)
Relative disadvantage (societal costs)	Resources may be better spent elsewhere: “I don’t know how much the monoclonal antibodies cost. Well, I don’t know how much is the cost to the patient; how much our charge is; if it’s being paid for by the state. I honestly have no idea about any of that information. But from an overall societal standpoint, I guess I assume that [mAbs are] relatively expensive, and it does concern me a little bit that we’re spending money on them for not a huge gain. Whereas there are other things that we could spend that money on that may be more helpful. I mean, the vaccines, I think, are even more efficacious than the antibody treatment…So it almost makes sense, you know, a zero-sum situation to say, ‘Well, if we’re gonna spend a dollar either on monoclonal antibody treatments or on vaccine outreach, it seems like it would be a better use of the money to get people vaccinated.’” (physician, urban, independent)
Systems of communication and influence about mAbs
Diffusion and dissemination (communication channels)	Finding relevant and timely information is still a challenge: “It’s one of those things that it’s sort of similar to, like when HIV and-and AIDS came about, and we just didn’t know a whole lot about it. So things just got deferred to the high-level specialists who were handling that. Right? The family practice just sort of said, ‘We don’t really know a whole lot, so we’re just going to not touch this.’ And that’s-that’s sort of where are we – I think that’s sort of what’s happened with COVID. It’s just sort of been, like, we don’t know enough. And it’s a lot to navigate.” (PA, urban, independent)
Leadership	Leadership may need more support to promote mAbs: "And I could imagine that if our leadership had the right, like, contacts and information and felt motivated to do it, and felt like it was important, we could do, like mass text message campaigns and update our Instagram and Facebook accounts to be like, “"We have treatment for COVID. FYI, call us.” (physician, urban, FQHC)
Characteristics of the implementation process for mAb referral and treatment
Centralization	Centralized systems may not be trusted: “Saying wow...we can make this easier by just having, Joe Smith from Denver call Betty Sue in rural Colorado and say, “Hey, I’m Joe Smith, I see that your COVID test is positive.” Betty Smith is gonna go, “What? How do you know my test is positive?” That’s the first response. And then, “Who are you?...and you’re now telling me that I should go to this location to get some test or some treatment that I’ve never heard about? Okay, goodbye...I’m gonna go call my primary care physician. So you know, even though I hear that system is maybe being slick and simple, it is not patient-centric....Their language is, ‘How do I feel? Do I trust you? I don’t even know what questions to ask, so I need to go to my trusted person...’” (physician, rural, independent) Centralized systems may not benefit all equally: “We probably had three or four patients that did qualify, none of them wanted to travel to the hospital. So, the system probably was not unreasonable, it was too onerous for us and our patient population” (physician, rural, independent)
Complexity and compatibility of mAbs referrals	The referral process is too complex: “Getting a patient enrolled as a candidate has been too difficult to do. It takes a lot of additional time for myself in addition to obviously the time we spend at the office visit. If the staff is involved in doing it, they don’t all of the sudden have the technical knowledge to be able to do that themselves. And so, sometimes if they’re asking us questions. So, it kind of bogs us down a little bit in terms of trying to get that set up.” (physician, urban, independent)
Linkage to testing	Being unaware of test results can delay access to treatment: “I think the first barrier is just getting people tested.” (nurse practitioner, urban, FQHC) “I try to get ‘em to [my health system]...as opposed to-to these days going to, you know, the Walmart and getting a rapid COVID test that they take at home. And so the – whether they’re positive or negative, we’ll never know.” (physicians, urban, health system affiliated) “….in [northern Colorado city] where they would get tested, or they’d be in Walgreens or something or – that was probably the - the hardest part to try and get the results of that test.” (physician, rural, independent)
Practice setting characteristics
Structure of care (i.e., health system affiliation)	Large systems can sometimes be slow: “I often feel frustrated that things are slow – they’re really slow to change in these big systems, and I have no idea how to improve that… There’s also just other stuff with government regulations and how hospitals are supposed to approve new ideas that it’s just a slow, lengthy process. If you have a new idea or a new drug that you want to use, it has to go through multiple committees for approval. I’m not super familiar with how all that works, but I just know it takes a long time.” (physician, urban, health system affiliated) Rural systems may not have capacity to support new processes: “So yeah. I think the barriers to bringing [mAbs] to a rural place like [RURAL LOCATION], Colorado would be, do we have the numbers to make it reasonable to bring that into our hospital, and how does insurance cover it? Will patients be receptive to another, like, new, scary – essentially a thing that they’re unsure of. So I don’t know.” (physician assistant, rural, independent)
Readiness for implementation	On the frontlines, it can be difficult to incorporate new tasks: “I think a big barrier is figuring out how to incorporate these infusions in with the regular flow of the clinic now that the volume is picking up… trying to figure out how to get all your other work done – how to get all your other patients seen and still be doing these infusions at the same time… It’s a barrier.” (nurse practitioner, urban, health system affiliated) A lack of interoperable systems can be a barrier: “[To get access to mAbs] I asked my medical assistant to fax over the enrollment form, and then I received a phone call from the pharmacist, I think, from the infusion center who essentially said, ‘I can’t accept this order by fax, but if you sign-in to [EHR] and you open’ – I’ll make a chart for this patient. Like, I’ll open a chart for this patient… ‘cause they didn’t exist in the [EHR] before…” (physician, urban, FQHC)