**Transcript of Cyberseminar**

**QUERI Implementation Practice Seminar**

**QUERI Implementation Studies to Improve Quality and Safety in the Cath Lab**

**Presenters: Thomas T. Tsai, MD, MSc; Christopher L. Bryson, MD, MS; Christian Helfrich, PhD, MPH**

**April 22, 2013**

**QUERI Implementation Studies to Improve Quality and Safety in the Cath Lab**

**April 22, 2013**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at http://www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact:**christopher.bryson@va.gov*

Moderator:Well, I'll go ahead and introduce both our speakers.

So, presenting first we have D. Thomas Tsai. He is an Investigator at the VA Ischemic Heart Disease Quality Enhancement Research Initiative, known as QUERI, and a Director of the Interventional Cardiology at Denver VA Medical Center and an Assistant Professor of Medicine in the Division of Cardiology at the University of Colorado in Denver. 

Dr. Christian Helfrich is joining him. He's the Implementation Research Coordinator for the Ischemic Heart Disease QUERI and Core Investigator for VA Puget Sound Health Services, Research and Development and a Research Assistant Professor for the University of Washington and the Department of Health Services.

So, I'd like to thank them both for joining us. And at this time, I would like to turn it over to Dr. Tsai.

Dr. Tsai:Thank you, Molly for this opportunity to speak to the group today and for Christian for standing in for Chris. I hope Chris feels better.

My goal over the next 20 minutes is to give you a little sliver of an introduction to what we're doing here at the Denver VA and in our cath lab as one of the implementation of studies. This specifically is Veteran exposure to radiation and the cardiac cath lab.

So, I probably don't need to remind any of you on the phone but for myself, I've been working with QUERI now for the last five years. And I understand it to be the Quality Enhancement Research Initiatives that we launched in 1998 as part of a system-wide transformation aimed at improving quality of care.

And certainly, I embraced that aspect of working here at the VA and designed our study to speak to some of these QUERI processes that you see here that most of you are probably very familiar with. In terms of identifying a problem, identifying best practices. And then in the VA, trying to see what the practice patterns are here and then trying to improve and implement an intervention to improve or promote best practices.

Just because I've not done a QUERI Cyber Seminar before I thought we would do a poll question. They encourage us to this. So I’ll see if she’ll do this for us. Just to get an idea of who's out there in terms of who has interest in this area. So, I don't know Molly, if you're able to do that.

Molly:Yes. Thank you. Not a problem, thank you, Dr. Tsai.

 So, we have launched the poll question to our attendees. You should see that on your screen now, who is in the audience. And you can select all that apply to you. The first answer choice MDs, PhDs, support staff, nurses or health services researchers. So, please select just click next to the box of any of those answers that apply to you. 

And it looks like we've had about two thirds of our audience answer. So, we'll give people just another second or two to get those in. 

All right. And it looks like about three-fourths of our audience have replied so far. And the answers have stopped streaming in so I'm going to go ahead and close that and I'll show you the results.

Dr. Tsai, you should be able to see those on your screen now if you want to talk through them real quick.

Dr. Tsai: Well, it looks like 42 percent are nurses. A third are health services researchers. And looks like about a third are PACs and support staff and a quarter MD. So, that's informative. I appreciate that. So, I will hope that I can make this educational for all involved here.

She's going to hand it back to me. 

And so I need to explain the CART program mission. CART is a program of the VA and its idea was to develop and implement a single, national VA data repository, reporting system and quality improvement program for procedures performed in the VA cardiac cath labs. 

So, if you look at that map there, there are 77 cath labs in the United States that are VA and this is one software application that essentially is a repository for any data regarding that procedure as well as generation of the report for the medical records. 

So, it's a pretty innovative program in the sense that you are able to essentially do two things at once and that is to create the report from the medical record of a cardiac cath or a stent procedure, for example. At the same time, it's discrete data element based so you're also generating some data as well as to support quality improvement efforts.

And this clinical model is actually launched directly out of CPRS at all 77 sites. It was designed by the users so it's very intuitive an there are data definition standards that I used. And it clearly is faster than dictation so if you imagine a case coming to the cath lab. 

You sit with the fellows after the procedure is done. You talk about the coronary angiogram and as you're doing that, you're putting in this data, comorbidities of the patient, the LAD, does it have stenosis? What work you did on the artery. And then you complete that report and you generate something for CPRS at the same time you essentially populate discrete data elements for quality support as well. 

And so it's a very nice use for work flow issues and efficiency. And so the QUERI step number one is to identify high-risk, high-volume disease problem. And in this situation, as many of you have heard, with the increasing use of CT scans, nuclear medicine scans, cardiac procedures, there is exposure to radiation. And it certainly has hit the popular press over the last five to 10 years. 

And there is quite variability in the use of different radiation and exposures for patients. And we looked at the cardiac cath lab as an area where patients are a captive audience to receive different degrees of radiation.

And the risk that patients receive is a determination risk -- deterministic risk, which is really a serious injury to the skin that occurs once a threshold has been obtained. So, it's like burning your toast in the oven. If you leave it in there long enough at a high enough degree you're going to burn that toast. And start the analogy it's lunchtime.

You can see these pictures that there is a risk, albeit small, of causing skin injuries to the patient. These are tough because they're not immediate. They usually occur anywhere between four to 12 weeks after the procedure.

So often times these patients will have these and won't recollect or connect the dots that it was related to a procedure that they had. And of course, we're familiar with the fact that the more radiation we receive you do have an increased statistical risk of getting a cancer of some sort. 

And so we know that even if you're not given to kill skin cells and cause an ulcer, there may be some damage to the DNA, which thereby can put you at risk for cancer in the future. 

And just some numbers, if you look at a major interventional procedure that can develop about 100 mSv. Don't worry about the units. But it does increase your lifetime attributable risk of cancer by about 0.41 to 0.42 percent.

And if you look at these procedures like coronary angiographies where you're merely going in there to look at the plumbing to the heart to see if there's blockages, there is a range of radiation exposure between 3 and 23 mSv. And then if we fix something, a procedure like a stent to one of your coronary arteries, it takes more.

And there is increasingly complex procedures that we perform including EP procedures whether it's ablating, a pathway or an ITD implantation, that increases the radiation dose to five to 10 fold. So those are some numbers to think about.

And when we think about the stochastic risk, no patients are created equal. So, if you go on this X axis and you look at this dos of 10 mSv, the problem is we don't know what patient we are when we go to the cath lab. Whether we're below that diagonal line in green where you have low risk patient or you don't have a pre-existing hit to put you at risk for cancer where 10 mSv is probably not a big deal. 

However, if you happen to be a patient above that diagonal line then you have an increasing risk of getting cancer if you've had multiple hits. Let's say you have altered DNA repair genes. So, the idea here is that there's a risk that is not consistent across patients. 

So this brings me to poll question number two. So Molly, I'll let you take it away here.

Molly:Thank you, Dr. Tsai. 

I'll go ahead and launch that second poll question now. Okay. And the audience have it on their screens. So, the question is do you think diagnostic procedures that emit ionizing radiation contributes to ones' risk of cancer to be? The answer options are: No contribution, Miniscule contribution, Low contribution, Moderate contribution or High contribution.

And it looks like our audience is taking a little time to think about this one. We've had about a third of them vote so far. So, we'll give everybody a few more seconds.

Okay. It looks like about 70 percent of our audience has voted at this time and the answers are still streaming in. Okay. 

And I'm going to go ahead and close it at this time. And you should be able to see the results on your screen now.

I'm sorry. I did not do that right. There you go. Now you should be able to see the results.

Dr. Tsai:Great. So, it looks like clearly low to moderate and you know, true to QUERI this is a qualitative question, obviously. There's not a right answer. But it's good to see that it's anywhere between low, moderate and high. And if you give it back to me the correct answer is it really varies.

And also it's a matter of perspective. And this to me is the best analogy that if you take -- this is a linear no-threshold model meaning that there is an increasing risk with the increasing exposure that's variable but if you imagine two groups of patients, 10,000 people in each arm. And half of the group gets 10 mSv of exposure. If you look at the lifetime of 10,000 it's humbling to know that 30 percent of us will develop cancer of one sort or another.

So, that's 3,000 of the 10,000. And so with one 10 mSv exposure, that's like a diagnostic cardiocath, a nuclear stress test, that increases that 3,000 out of 10,000 in 3,005. That's you can get five additional cancers from that one 10 mSv exposure. And that is a predicted value but it's pretty well accepted. And the problem is you don't know which person that's going to be. 

So I think whatever your perspective may be, certainly for me, five additional cancers is a significant number of cancers. Thereby, the goal of our project is to minimize the risk of radiation exposure. 

So, in medicine every day we make these risk/benefit analyses and the idea here that was published in 1994 by the FDA is that the risk of an adverse radiation effect originating from a medically necessary procedure is almost always offset by the benefit received by the patient.

Now, that's giving us a huge benefit of the doubt that that's the case. But there's no question that if you give that first bullet point that we're doing it because there is some potential benefit, the order to improve the benefit/risk tradeoff ideally that we need to minimize the exposure of radiation per procedure.

And this is a -- you can think about it yourself. But I am sure many of you have had x-rays, CT scans, and if you can recall ever really being explicitly told of the increased risk of cancer, I think it would be the minority of you. Because often times, we look at these procedures as not being a significant increased risk of a malignancy.

So now that we've defined the problem, it would behoove us to see what the pattern of radiation use is within the VA And that is the power of the CART system that I described is that we wrote this RRP first to define the distribution of fluoroscopy time and radiation dose or procedure types.

And because we have CART that is stratified by just taking a picture of the plumbing versus putting a stent as a procedure, and we recorded this as a discrete data element. We could look back in CART and look at the distribution of fluoroscopy time and radiation per procedure.

And then in Ain two there you can see that we can try to look at different variables that increase the risk of getting more radiation for a particular procedure.

And if we looked at our aggregate VA CART data that we had around 90,000 procedures. And this is coronary angiography, which is again, just looking at the plumbing for the heart. Bypass grafts for those patients who had bypass surgery and PCI just refers to as a stenting procedure for a blocked artery.

You can see many operators within the VA system -- 58 facilities from '07 to 2010 were included in this cut of data.

And you can look at here -- if you look at the fluoroscopy time, you can see that the average -- this is the median fluoroscopy time was 4.7 minutes with an IQR of three to eight. And you can see there's a range around bypasses because that takes more time as well as stenting procedures.

And you can see there in the lower left, you'll see that there's predictors. That makes sense. So, for example PAD stands for peripheral arterial disease. So, if you have that it makes the procedure more challenging. Access getting up to the heart arteries takes more time. 

Some of the hospital factors like a teaching hospital. Obviously, if you need to teach a fellow how to do a procedure, I mean for us it takes double the time to do a procedure if you're working with a fellow versus doing it by yourself. And so that's something to take into consideration.

And then operator volume have issues as well. It seems with the more procedures an operator performs, there seems to be less fluoroscopy time needed. Now, that could be an effect of the operator but also if you're a high-volume stenter or your wheels are very well greased for getting patients in and out of the lab, you can imagine how also fluro time could be decreased.

And then also there seems to be an experience level. Just to give you an idea that there's ,you know, provider, patient and institutional factors related to radiation. 

So, once we saw that indeed there is variability in the distribution that is relatively broad, we sought to try and see if we couldn't decrease the variability in radiation exposure for patients by implementing some interventions.

And so the third aim was after getting this descriptive data out of CART is if we could basically create a safety tool kit, we chose two sites of Denver VA and the Ann Arbor VA as my training facility. So I figure it's easier to get things done at a place where you have contact and relationships already. The Ann Arbor VA was a gracious site in this as well.

And we focused on three things. One is education, you'll see on the left there. So, just like any procedure, if you could be more efficient with the processes and pay attention to some things just like trying to decrease your heating bill. There are some things you could do with temperature or turning off things at different hours. This is the idea that if you educate operators about how to reduce radiation exposure to the patient.

And this is a double benefit because you also reduce radiation exposure to yourself and the staff when you do these things, for the most part.

And the second was an in-lab radiation monitoring protocol. So, at a certain level of radiation exposure that staff in the cath lab basically alerts you like an alarm to say you know, Dr. Tsai you've exceeded this much radiation. And so it keeps it in the back of your mind and keeps you very concerned and keeps your eye on the ball about trying to make sure you reduce radiation exposure.

And then the idea of monthly provider report cards that we could give the operators their median and IQR doses of radiation by procedure compared to their colleagues at their institution. And compare the institution to other institutions at the VA of whether or not that would precipitate greater attention to radiation and decrease radiation exposure.

The educational intervention, I won't go into too much detail. Suffice it to say there are some reduction tips that are pretty common. It would be like putting your hand on the correct positions on your steering wheel that we all know that we should do to increase safety but we don't just because we've been driving for a long time. It's those types of things that these reminders that are pretty rudimentary for us who work in the cath lab but actually do reduce radiation time. And this has been shown. It followed that you can reduce radiation exposure by 15 or 20 percent.

So, we went to Ann Arbor. I went -- I stayed here at Denver VA and I gave in services and educated the staff and the docs about these radiation reduction tips. And that was the educational component of our three-pronged approach.

In the in-lab monitoring protocol suffice it to say there was a number. Here it's 3 Gy. And when you're doing a procedure you get feedback on the screen about how much radiation you're using. And once you meet that threshold you essentially get a reminder. Hey you know, you used 3 Gy so just want to let you know. 

And then at 5 Gy, which is a substantial amount of radiation, we actually do a time out and that is just in-lab monitoring protocol to say to yourself are you going to continue with the procedure? Or are you going to stop if it is a procedure in which you can't stop.

So clearly, everything here is superseded by what's needed by the patient. And you're going to do what's required. But this is a concept of -- as low as reasonably achievable, ALARA where you do the least that you can without compromising patient care.

And then finally, the monthly provider report card. On the bottom here is a screen shot in the CART application. Again, launched out of CPRS where the fellow, the docs put in this information of Total Contrast, Fluoroscopy Time, Radiation Dose. So, we have granular, quantitative data about how much radiation is being used per procedure. So, it's very easy by provider and by site to feed back this information to the site to see whether or not under the watchful eye that impacts your attention to radiation use.

Just as an example of the report card for Ann Arbor. I show it because it's very complimentary. If you look at their median fluoroscopy time, you know, it is less than the national average. If you look at 279, this is for a month. Actually, this is for September to February where they did 280 diagnostic caths compared to the rest of the VA system.

You can see that their median was 5.5 versus 6. And if you look at radiation dose, it was 60 versus 101. So you can see that overall, compare it to the average, they had less radiation exposure to the patient and others. This would be a particular provider. You can compare providers to their colleagues to see how they're doing versus their colleagues to get feedback that way. 

You can also see that the granular data is there. The idea here was for a three-month period to measure what the radiation and fluro-time was before the intervention. And then I flew out and gave the education intervention. And we also implemented an in-lab protocol at their site and then began giving monthly provider feedback. And then re-measured their radiation after three months hoping that that would lead to radiation safety. 

And you can see here this abstract we're presenting at Q-Core [PH] in Baltimore. Dr. Vali [PH] is one of our fellows. He wrote this abstract looking at our multimodal radiation intervention for intra-procedure radiation exposure in the VA

And you can see that if you look here at site one, you can see that the before is in blue and the after is in red. And there does not seem to be a significant difference just as in radiation exposure. But overall, as you saw in Ann Arbor, the site radiation doses were relatively low.

If you looked at the other site where there's a little higher overall use of radiation exposure, you can see that there was a significant decrease in the use of radiation per patient per procedure compared to pre versus post. 

And to look at temporal trends you can see the national average did not change in any significant way.

So our conclusion was a three-tiered multi-modal radiation reduction intervention was associated with reduced radiation exposure in a lab with high baseline radiation utilization. And that similar reductions were not observed in the lab with low baseline radiation utilization. And that perhaps, this suggests that a radiation reduction program like ours targeting higher radiation use centers may result in a meaningful decrease in patient radiation exposure.

So, just to summarize our RRP, I think this was a great mechanism to test this hypothesis and actually test an intervention albeit only at two sites. But we identified radiation at the cath lab as our problem. The literature for best practice is to try and decrease variability.

And then we looked at within the VA to verify that there indeed is some variation and this also exists without of VA cath labs as well as NCDR has shown us.

And then we created a multi-modal intervention and did this at the two sites. And we showed that at least it suggested that a high utilization site that perhaps this intervention can be effective at reducing radiation exposure.

The idea here is to confirm this data and to disperse this to other sites. And so the next step, quickly is really an SDP here is the hybrid effect in this implementation study of a multi-faceted intervention to reduce radiation dose for patients undergoing cath lab. 

So our mechanism from this RRP is now to pursue an SDP. This has sort of been the initial phases of evaluation. But the idea here is really to assess the current programs that have higher radiation use, so targeting those sites. Looking at readiness to change and potential barriers for implementing the radiation reduction tool kit. Not all sites are the same. 

And initially we're going to do different roll-outs here but he feedback was that why don't we just do a control arm and an intervention arm and try to do it over a shorter period of time. So we heeded to those suggestions and will do so in our rebuttal back to the SDP in the initial letter here.

And then to try to assess the barriers and facilitators to try and optimize the impact. And so we did do a qualitative component and I won't share with you at this time at the different sites and providers to see what they liked, what they didn't like, what they thought was effective to tailor this next intervention for the SDP.

And so with that, that is our introduction to our RRP. That was supported by QUERI and our next steps to pursue an SDP. And I would like to thank the QUERI, the National CART Program, our CVOR, which is our research operations here at Denver and Seattle and Dr. Ho, in particular who is at the VA in Denver. And then Denver and Ann Arbor Cath Labs. Thank you.

Molly:Great. Thank you very much, Dr. Tsai. And at this time, I would like to turn it over to Dr. Helfrich.

Dr. Helfrich:Okay. And just real quickly, Tom, are you able to hang on until the end of the call? Or are you...

Dr. Tsai:No, I'll be here.

Dr. Helfrich:Okay. Fantastic. Just wanted to make sure folks had a chance to ask any questions. But we can hold on until the end of the call, then. And Tom, that was great. Thanks so much for presenting that.

So, folks my name is Christian Helfrich and I'm presenting on behalf of Dr. Bryson like Molly said. Unfortunately, Chris came down with a really nasty cold and his throat is -- he's hacking a bunch.

What I'm presenting on is another -- well, I'm going to give just a little bit of background about IHD-QUERI and our mission, which both Tom's radiation safety study fits into and this study that I'm going to talk about briefly that deals with trying to increase the utilization of radial access cardiac interventions.

So, with the QUERI program, as many of you know, we've -- QUERI teams are set up usually in two different geographic sites with a range of investigators. Ours were based in Denver where Tom is and in Seattle. We've got critical investigators, such as Tom. We've also got investigators with nine clinical backgrounds such as myself. I'm an implementation science researcher. 

We work collaboratively on interventions -- on implementation interventions. We've got 22 investigators nationally who are affiliated with IHD-QUERI and we've been -- we've had a wide range of studies and projects. Our last one only a few years ago -- at that point we had 20 studies that we conducted in the previous three years for a total of $7.5 million in research funding.

Our mission is to improve the quality of care and clinical outcomes for Veterans with ischemic heart disease and are at risk for ischemic heart disease and doing that by assessing and promoting evidence based implementation of evidenced based best practices. And what Tom just presented was a great example of that, looking to the literature for how to -- evidence for how to change practices. In that case, around radiation exposure and then coming up with a way of delivering and testing a way of delivering it.

With IHD-QUERI unlike many of the QUERI centers our strategic goals actually have to do more with how we do things rather than clinical strategic goals. We have two primary strategic goals.

One is to leverage information systems, existing and new information systems to improve quality and safety. And again, the CART program, which Tom talked about and I'll talk about a little bit more, is a great example of that.

So, getting the information both clinical and in terms of implementation, organizational change, getting the right information to the right people at the right moment at the point where they can make decisions on it. And in particular within that goal one, we're interested in developing implementation tools and interventions. 

And again, that's really what both of these projects we're talking to day about address, implementation tools and interventions that can be implemented at a programmatic level.

And then our second goal is to improve cardiovascular risk factor management by integrating new programs into evolving systems of care. That really has to do with the patient and line care team initiative and primary care and specialty care transformation. So, we really got an eye to developing intervention programs that can fit within this incredibly, quickly-evolving system of care in the VA.

So, Tom already talked about the importance of minimizing radiation exposure. I'm going to talk about a second study dealing with cath lab safety that has to do with interventional cardiology. And interventional cardiac procedures are important first and foremost because they are part of evidence-based, guideline-based comprehensive care for ischemic heart disease.

There are over 1,200 cardiac interventions every year in VA cath labs. And these are procedures while very safe are significant. And they also bear significant cost. They are about $30,000 in DSS, estimated cost per case -- annual cost.

And there's a fairly wide variation in cost, in observed cost in the VA Cath lab safety is also important because -- because of the CART system that Tom talked about, we have an excellent platform for tracking quality, safety and outcomes and also CART provides a platform for intervening. And Tom gave a great example with feedback reports that can be built into this reporting system.

With cardiac interventions in particular, there, again, while they are very, very safe, there are some dangers, primarily bleeding complications. Approximately 2 percent of all cases have significant bleeding complication. 

In general, it's a really awful experience for the patient. It's costly for the system. It increases hospital stays. It might require a blood transfusion. It also is primarily -- the majority of bleeding complications appear to be related to the access site. Going in through the radial artery in the wrist versus the femoral artery in the groin. Radial access intervention, going through the radial artery is associated with a 50 to 70 percent lower rate of bleeding complications. And that benefit appears to be greater for women who are at a higher risk of bleeding complications. 

But in spite of that difference, that lower risk of bleeding complications from radial access procedures, they're only used in about 15 percent of cases in the VA I think it's up there about 16 percent in the latest figures.

This is just a quick picture of the radial and ulnar arteries from a radial case. The question is why isn't radial access used in a higher proportion of cases? There actually is no published research on determinates. You know, why? What factors are driving a lack of use of radial access? There are a number of authors who have hypothesized why that might be. 

And certainly one of the biggest is that the majority of cardiac fellows in the U.S. are trained to do femoral access. Radial access training is not heavily sponsored by the major professional societies. It does take a while to learn. One estimate is that it takes about 50 cases before you become proficient and can do it relatively quickly.

There may be some doubt about the benefits of that, whether or not there truly is that significant of bleeding complication associated with femoral access procedures.

So, Chris and Tom Tsai, who was also a co-investigator on the study and a number of colleagues from Chicago and Durham put together a proposal to test a trained radial access training program that currently is being conducted in the private sector. It's used in the private sector to support use of radial access procedures and also to assess barriers to current use and perceptions of radial PCI among VA interventionists.

So, we conducted a mixed-method study to try to understand why radial access procedures are not being used in higher rates and to test the pilot test training intervention that's been developed in the private sector and used in the private sector for training.

This intervention, there are a few important things about this intervention. It involved a reverse-site visit and a site visit. And it was a team-based intervention. So, the idea with this training is that it was not just the cardiologist, the interventionist who was going to get trained but also one or more members of their team. Either the cardiac catheterization lab nurse or cardiac cath technician would join the interventionist to get trained alongside them.

And again, the training involved two major components. One, what we called a reverse-site visit training, which is the main training program. That was a day-long visit to the cath lab in Chicago, a place where they have operators who do primarily radial access procedures who are experienced. Our cath teams are experienced. 

And during the day-long reverse-site visit, there was a morning of didactic sessions going over the evidence for radial access and providing some basic overviews of the procedure. And then in the afternoon, there was the opportunity to practice on a simulator. And then the interventionist and their team actually scrubbed in to observe and assist on cases in the afternoon.

Subsequently, after that reverse-site visit training, the teams went back to their sites. Three to six months later, members of the training team, an interventionist and an experienced cath nurse conducted a site visit to see how things were going and help troubleshoot, to observe and just provide support.

To assess the implementation and outcomes of the training program and also to assess barriers and perception, barriers to implementing radial access procedures and perceptions of radial versus femoral. We conducted semi-structured interviews with participants in the program before and after the intervention. And then also fielded a structured survey -- the structured survey went just interventionists because that's who were able to identify nationally and that structured survey went out after the reverse-site visit.

We also had some notes from the site visit team when the training interventionist and cath nurse went out to visit the sites. When they came back we had de-brief calls and also have some notes from those calls. 

In terms of barriers to radial access use, if you remember, this lower item, learning curve, that was something that was already discussed in the literature. Folks are not trained in their fellowships in radial access procedures and that it's challenging to subsequently learn to do the procedure in a different way.

What we heard from folks was that there was also concern about getting into trouble. And we heard that a few times. If the case didn't have any complications, that they were fairly comfortable going in through the radial artery. But if they did have any problems, they felt less certain about how they would handle those problems through the radial artery.

We also heard that operator safety and the cath team safety in terms of radiation exposure, which Tom just talked about a few minutes ago. That was a significant concern. And that it was particularly concerned in terms of the learning curve, that early on before operators felt proficient that it could take significantly longer to do a radial access case than a femoral access case. And that longer case time ended up to equating to increased radiation exposure.

We also heard from a minority of folks that there was some perception that while the evidence of bleeding complications might favor radial access procedures that there was some concerns that other complications such as radial occlusions, the radial artery occluding after the procedure -- that those were under-reported or unreported. And that in fact, that evidence was also taken into account that there may not be such a compelling case for radial access procedures.

We did hear, the folks were -- the participants in our study were generally aware of and agreed with the supposition that patient preferences favored radial access procedures because with a radial access procedure, patients are able to sit up right away. They are able to be released earlier. And generally it's a more favorable experience for the patient.

They also recognized that they had distinct advantages for the catheter nurses and techs, in particular in terms of holding pressure. With a femoral access case, there's a need to hold pressure on the access site for a sustained period to ensure that there is no bleeding and also a requirement to monitor the patients more carefully.

And because of the anatomy and because of this advantage of the radial cases that that was not necessary. And that was a huge advantage to the nurses and techs. It also allowed them to discharge the patients faster and actually be more efficient in the cath lab.

So, based on those interview findings we developed a structured survey that we fielded to cardiologist interventionists who were in the CART system. So, we used CART to identify the interventionist and sent out a structured survey. It included items based on perceptions of radial versus femoral PCI, barriers to using radial access procedures or PCI. And then their self-report current use of radial access procedures and experience on training on radial access.

We identified a total of 235 interventionists and received completed surveys from 79 of them. So, a 33.6 percent response rate exactly. You know, just over a third. And we received responses from 48 interventionists out of the 66 cath labs with interventionists represented in CART at that point in time.

In terms of perceptions of radial access versus femoral access we had seven questions related to the ease of monitoring patients after the procedure, having fewer vascular access site complications, fewer bleeding complications. The superior technical results in terms of being able to resolve the arterial blockage, time to complete the procedure, allowing patients to go home sooner and then comfort for the patients.

And what you can see the dark blue is where the proportion of respondents who rated radial much better. The middle blue is radial better. And the light blue is radial somewhat better. And inversely for femoral. The black is femoral is much better. The dark grey is femoral is better. And the light grey is femoral is somewhat better. And then the white in the middle is neutral. Neither radial nor femoral better. 

And for five of the seven, it clearly favors radial. You know, ease of monitoring patients, complications, patients going home more comfortable all favor radial. It's really with the technical results somewhat and then the faster completion time. So this perception that femoral access procedures are much faster. 

In terms of barriers, we asked a range of structured questions about barriers. And I'm not going to go through all of them. I'll draw your attention to three of them.

The two highest are increased radiation exposure to the cath team and increased exposure to the operator. And these are rated on a three-point scale. Is it a major barrier? A minor barrier? Or not a barrier?

So, the dark blue is a major barrier. The light blue, a minor barrier and then the white is not a barrier. On the very small spaces on the far right hand side, the black, those are where we were missing observations, the non-respondents to that question.

So you can see that the only two barriers that were cited by a majority of respondents were the radiation exposure to the operator and the cath lab team. So, those appear to be more salient factors for interventionists than anything else.

The other thing I'll draw your attention to is the long-wearing curve for radial access, which was not a surprise. That's the fourth from the bottom. Again, just under half of respondents said that was a major barrier but it was a lower percentage than those, as you can see, who said that radiation exposure was a major barrier.

So, with the site visit debrief, the teams that actually -- and Tom can chime in -- Tom was one of the trainers and conducted site visits. But what we heard from the interviews after the Chicago training, what we called the reverse-site visit, from before the Chicago training to after, we heard that the training was effective at addressing concerns over the evidence for radial access PCI. So, for example again, that issue about complications being under-reported, that appeared to be really well addressed by the Chicago training.

And also the cath lab team members, not so much the interventionists but the cath lab team members expressed -- a big theme was increased confidence among the cath team members in going to you know, a predominately radial access lab. 

From the site visits that were conducted three to six months later, what we subsequently heard was that it appears that those site visits were important for identifying what I would call unrecognized barriers. Things that if you'd asked the teams beforehand, they may not have recognized as a potential problem.

And just as an example, one of the things we heard, again on the radiation safety front, but there was a great deal of concern about radiation exposure. And after the site visit, one of the cath techs had reported in an interview that the arm board placement was a major issue. The way that the arm board had previously been placed prior to the site visit, placed the arm closer to the operator and the team and increased their radiation exposure. After the site visit, the training team was able to show them how to better place the board and reduce that radiation exposure. And the cath tech felt like that was a really important change.

There are also some examples of radial access-specific equipment. One lab had equipment that they thought was radial specific and it wasn't. The training team was able to point that out and help them identify appropriate equipment.

Currently, we're analyzing data from the participating sites. It is not clear if practices changed. It is not clear if the proportion of radial access cases has increased. There is clearly a modest temporal trend in increasing radial access cases. But it's very slow.

Our next step is to conduct a larger, multi-site trial that's powered to detect a change in the proportion of radial access cases. 

So just to review the findings from this rapid response project, operator safety and equipment issues are significant barriers to radial access procedures. Operator safety really being radiation exposure. The reverse site visit training program that we piloted is effective at influencing attitudes. Having those teams go to an experience site from the interviews we see evidence that that changes attitudes about radial access procedures.

Doing the subsequent site visits by the trainers to the participating sites also looks like it's important for troubleshooting and helping sites overcome barriers. So, once they go back to their sites and try to become a predominately radial access lab. But again, it's not clear if this training program has actually succeeded in increasing radial access rates. But that's really something we see as a next step with a service-directed project where we could have enough sites where we'd be powered to detect a difference.

So, I will stop there and see if there are questions for me or Tom.

Molly: Great. Thank you so much, Christian.

I just want to let our attendees know for those that showed up after the top of the hour to submit a question or a comment for our presenters to simply write it in to the write-in section on the control panel. It's located on that Go-go-webinar dashboard on the right hand side of your screen.

We don't have any questions pending at this time. While we wait for any to come in, would either of you like to give any concluding comments?

Unidentified Male: Tom, any?

Dr. Tsai:Yes. I guess I would say you know, what strikes me about both of these projects is that you know, if you would as sort of as prospective research investigators out there looking for funding these mechanisms. I was surprised at the types of projects the QUERI would consider with respect to -- if you think about both these projects, they're both interventions. They both require traveling to sites. They seem to be relatively robust with regards to the funding stream.

But at the same time, I think it's encouraging to know that these innovative ideas and programs that they're willing to support. The idea of a non-industry funded mechanism to train VA operators to perform radial PCIs, I think is a great idea. Not because I’m a core investigator, it wasn't my idea but I participate. But the idea that there needs to be some mechanism to disperse training with new techniques.

And just like laparoscopic gallbladder surgery, initially people thought it was crazy. Why would we ever do something like that? I think the point here is that there is increased safety from the radial approach. And clearly there are barriers to it because it's not the routine way things are done.

And just like the gallbladder approach as well, not every case is suited for a radial approach. There are some cases that are clearly better suited from coming from the leg. But I'm just struck initially you know, I've been with QUERI for five years. I was pleasantly surprised that they would fund projects like these for people out there who might have projects that they're like well I don't think this is a QUERI type project. I would not count them out. 

Molly. Thank you. Christian, do you have any concluding comments?

Christian Helfrich:Yes. Thank you.

Like Tom said, I think the QUERI program is a really excellent opportunity for folks who are interested in research that really is that next step along for clinical research trying to apply evidence based practice in real world settings -- that's what we're trying to do.

And I think that although we didn't have a lot of time to go into detail about the CART program. One of the things I think we are very cognizant of is this issue of trying to fit our work within the existing clinical operational system and using the tools that are there and trying to make data collection for quality improvement purposes not something that is independent and it takes time and effort independent of the clinical work. And I think that's been one of the tremendous successes with the CART program. It's something that is a clinical tool that builds the quality improvement data collection piece into the existing process. It's something that's made both of these pilot programs much more feasible. 

Molly:Thank you. We do have one question that came in for Tom. First they wanted to comment on a great talk from you both. Have you looked at radiation lowering techniques for peripheral procedures? For example, we did an -- I'm sorry, I'm going to completely butcher this. We did an ileac lesion today with a large patient and clearly the radiation dose was higher. Is CART controlling for when operators proceed or type when they are looking at radiation dose per operator?

Dr. Tsai:Thank you for that question. That's a great question. 

Certainly there are factors that are not controllable. So when we look at the factors we try and find modifiable risk factors that can be controlled in things such as procedure type, you can't control. You can't change the fact that if a patient is morbidly obese most of you will know that radiation is sort of a self-exposure mechanism. And so they will get you a good picture regardless of the size of the patient. They just will use more radiation to do so.

So, in larger patients, the radiation use goes up tremendously. But at least in our study, we have tried to control for the controllables with regards to specific procedure type, patient type, access point. And despite all of those things, controlling for those factors, there is still quite a bit of variability.

So I think a lot of these radiation techniques, education, in-lab monitoring protocol can really span the gamut of different procedures in patients. So we're hopeful that this will extend to peripheral patients, EP in particular and any radiologic procedure.

Molly:Thank you for that reply.

Well, that was our last question. Both of our presenters have left their contact information on the handouts. So, if something comes to you later, feel free to make contact with us.

Once again, I'd like to thank Christian and Tom for presenting for us. I'd like to thank our attendees for joining us and for our attendees, as you exit today's session, please do wait just a moment while a feedback survey populates on your screen. It is your input. That guides our program.

So, thank you once again to everyone. And have a good rest of the day.

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