**Transcript of Cyberseminar**

**Evidence-based Synthethis program**

**Effects of Nurse-Managed Protocols in the Outpatient Management of Adults with Chronic Conditions**

**Presented by Ryan J. Shaw, PhD, RN**

**January 28, 2014**

*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 www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact ryan.shaw@duke.edu*

Facilitator:It looks like we are just at the top of the hour here. I would like to introduce today's presenter, Ryan Shaw. Dr. Shaw is an assistant professor in the School of Nursing with Interdisciplinary Training in Nursing Health Informatics and Computer Science. He is affiliated with the Duke Center for Health Informatics, and has a secondary appointment in the Center for Health Service Research in Primary Care at the Durham's Veterans' Affairs Medical Center. With that, I would like to turn things over to Dr. Shaw. 

Dr. Shaw:Okay great! Thanks very much. Can you guys hear me?

Facilitator:We can hear you yes. 

Dr. Shaw:Okay, great! Sorry. I had just gotten disconnected, but now I'm back. Alright. Well, thanks very much for having me. Today, I'm going to talk about a recent report that we did on a nurse-managed protocols in the outpatient management of adults with chronic conditions. 

So, I would first like to acknowledge our investigative team including: Jennifer McDuffy, Cristina Hendrix, and Linda Davis and also Alison Edie and also John Williams who is the Durham ESP Center Director and also Liz Wing and Avishek Nagi. So [I should make] just a quick disclosure that this report is based on research conducted by the Evidence-Based Synthesis Program at the Durham VA. It was funded by the Department of Veterans Affairs. The findings and the conclusions here are those of the authors and do not necessarily represent the views of the VA, or the US Government. [This is] just some necessary stuff to go through. [Let me give you] just a quick overview of the VA Evidence-Based Synthesis Program. 

This is sponsored by the VA, and it was established to provide timely and accurate syntheses of Healthcare topics that are identified by VA clinicians and managers and policy makers to improve the health and healthcare of veterans. It builds on staff and expertise already in place at the evidence-based practice centers. These are located across the nation. It also provides evidence syntheses on important clinical practice topics that are relevant to veterans to help to develop clinical policies to implement effective services and to also guide the direction of future research. 

These topics are nominated through a nomination process. You can find more information here through that link. Essentially a steering committee essentially represents research and operations and also provided oversight and guides the program direction. There's a technical advisory panel for each topic including this one to provide content expertise and to also to guide topic development and to go over the draft reports. Then, we have external peer review that. They give comments on the draft reports before they are submitted back to the VA. The final reports are posted on the VA HSR&D website. They're currently on the intranet. They will soon be available on the extranet. 

So the current report, I do apologize that the background is actually it's supposed to be more faded. But, the current report is on the effects of nurse-minute protocols in the outpatient management of adults with chronic conditions. Medical management of a chronic illness consumes 75% of every healthcare dollar spent in the U.S. Thus the provision of economical yet high-quality care is a major concern. Diabetes, hypertension, hyperlipidemia, and also CHF are prime examples of chronic disease that cause substantial mortality and also require long-term medical management. For each of these chronic diseases, the majority of care occurs in outpatient settings where well established clinical practice guidelines are available. 

Despite the availability of these guidelines, there are important gaps between the care recommended, and the care that is actually delivered. The shortage of primary care clinicians has been identified as one barrier to the provision of comprehensive chronic disease care. It provides an impetus to develop strategies for expanding the roles and the responsibilities of other interdisciplinary team members to help meet this increasing need. 

In an effort to serve more people and to improve chronic disease care, the VA established the Patient-Aligned Care Team known as PACT, which is in adaptation of the Patient-Centered Medical Home, which is based up the Chronic-Care Model, which has the following core principles: team-based care, also patient centered care, and also coordinated care across the healthcare system in the community, enhanced access to care, and assistance based approach to quality and safety. 

The Institute of Medicine also known as the IOM also recommended the expansion of nurses roles to allow them to practice to the full extent of their training. There is robust evidence supporting the effectiveness of nurses in providing patient education about chronic disease as well as secondary prevention strategies. Nurses are ideally suited to collaborate with other professionals to meet increasing demands for chronic care. Nurses are accustomed to working in multidisciplinary teams and, with clearly defined protocols and training, may well be able to order relevant diagnostic tests, adjust routine medications, and appropriately refer patients for medical evaluation. With that being said, the purpose of this review was to synthesize the current literature describing the effects of nurse-managed protocols for the outpatient management of adults with common chronic conditions such as diabetes, hypertension, hyperlipidemia, and CHF.

So, just to give you a quick definition of what is a nurse-managed protocol. A protocol includes a series of actions set by current clinical guidelines or standards of practice that are implemented by nurses to manage a patient's condition.

So, to do this synthesis, we followed a standard protocol for all steps of this review where we did the topic development. Then we did a systematic search for the literature. Then we did study selection, data abstraction, quality assessment, data synthesis, and then we sent it out for peer review. I'll be going through most of these steps through the reset of the webinar. 

So here were our following three key questions for this report. Key question one: For adults with a chronic medical condition do nurse-managed protocols compared with usual care improve the following outcomes: nurse-staff experience such as satisfaction, treatment adherence and quality measures such as biophysical markers, process-of-care measures, and also resource utilization? That was our first question. And then, the next two were: In studies in nurse-managed protocols, how well do participating nurses adhere to the protocol? And then, the key question three was: Are there adverse effects associated with the use of nurse-managed protocol. 

To guide our process, we use this analytic framework where we first had looked at adults with diabetes, hypertension, hyperlipidemia, and CHF. And then, we looked at the nurse-based protocol from them to look at the scope of it, and to look at the nurse training. And then, we also looked at: was it a primary or a speciality care or usual care? And then, we looked at the intermediate outcome such as: nurse experience, treatment adherence, and other quality measures such as biophysical markers. We then looked to see if there were adverse effects from that, and we looked at: were there any modifiers that did impact those intermediate outcomes? And then, we looked at final outcomes, which include health-related quality of life and healthcare utilization.

So for our search strategy, we searched multiple databases for English language publications in Medline, in Bigpsych and Postinal and also Cochrane from 1982, December 2012. Our search terms included terms for RN protocols, nurse protocols, and also RCTs and in additions for the various biophysical markers and so forth. I just didn't want to list the entire search terms here because there were quite a few. 

We also did supplemental searches in bibliographies, individual papers in systematic reviews, and we also looked in clinicaltrials.gov to look at on the trials that may not have been published. So for study eligibility criteria, we looked at intervention that used nurse-minute protocols compared with usual care in the outpatient setting. Now, the didn't necessarily have to be RCT, but they did have to have a usual care comparison. The population had to be adults at least 18 years old with diabetes, hypertension, hyperlipidemia, a CHF, or a combination of those.

For the intervention itself, and this is really important, it had to involve a registered nurse, an LPN, or an equivalent to that, who is functioning beyond their usual scope of practice. So, we're not talking about nurse practitioners. That is something important to note because we are looking at a registered nurse or an LPN who are functioning beyond their normal scope of practice and to create some criteria for this, they had to have the ability to adjust a patient's medications, and it had to be based on a written protocol. The comparator, it could have been a usual outpatient care or another quality improvement group. 

So for the outcomes for each of the key questions and for the first one, they either had to report on at least one of the following: either the nursing staff experience treatment adherence, a lab or physiological marker such as hemoglobin A1C, or a blood pressure, or a performance metric, or utilization of medical resources. For Key Question Two they needed to look at the fidelity of the nurse-managed protocol. And for the third one, we looked for articles on adverse. The setting had to primarily be in an outpatient setting. The patients could have been in a hospital at the beginning of the study, but most of the care had to be delivered in an outpatient setting. That could have been either face-to-face, or a phone call where a nurse was talking to the patient. 

For the quality assessment of the research articles, we assessed risk of bias by applying quality criteria described by ARC, and I'm not going to go into to too much detail there. And for the RCTs we abstracted several data elements to perform this quality assessment as shown. And, we assigned a quality score of good fair or poor. Furthermore when we rated the body of evidence, we either ranked it as high, moderate, low, or insufficient. And, this would help inform us, and also inform you if further research is likely to change the confidence in the potential effects of the nurse-managed protocol that we found in the literature. 

So, to do the literature search, we found over 2,600 references. We excluded most of them that at the title and abstract level. Then we had 340 to review at the full text level, which is quite a few. Then we excluded 309 for various reasons, and we ended up including 29 studies. Two of those had a companion article. So our final sample size was the 29 studies to assess the effects of nurse-managed protocols on various chronic conditions in the outpatient settings. 

So again, we had 29 studies. Eighteen of those focused on the management of elevated cardiovascular risk including diabetes, hypertension, and also hyperlipidemia. Ten of these studies were on CHF. One of them was on resource utilization of older adults with various chronic conditions. Twenty-six of those studies were RCTs. The risk of bias is as follows: 10 were low, 16 were moderate, and 3 were high. It's important to note that none of these studies were actually conducted in VA settings. 

So the overall study characteristics. I'm going to walk you through this. I do realize that this is a busy slide, but we broke these studies down into two sections. Those that were on a cardiovascular risk, and those that were on CHF. So, for the cardiovascular risk studies, again, they were 18 with a total of 23,000 patients and 16 of those were RCTs. The settings where the nurses did the nurse managed protocols were mostly in a general medical setting. Only one of them was a telephone-base delivered care. Of these 18 studies, 12 of them were focused on diabetes management for glucose. Fifteen were on hypertension, and fourteen were on hyperlipidemia. They could have been a combination of these. Fifteen of them were a clinic visit, and three were telephone based.

So, for the nurse training out of the 18 studies here, in three of them, the nurse had to have a clinical certification such as being a diabetes nurse educator. In ten of them, the nurse received study-specific training to be able to use the nurse-based protocol. In four of them, it was not described what the training of the nurse to be able to do this intervention was. Out of these 18 studies, in 12 of them, the nurse was given the autonomy to independently initiative a new medication. 

Furthermore, this is just the breakdown of the patient demographics, which I’m not going to go into too much right now just in the interest of time, but I am going to just show you down here under the disease severity. The mean hemoglobin A1C for the populations targeted here were 8.1. The systolic blood pressure was about 149. This is just to give you an understand standing of the disease severity of the patients who were targeted here for the nurse-based interventions. For the CHF studies, there were 10 of them with a total of about 2,800 patients throughout them all. They were all RCTs. These occurred in a medical specialty. The six of them were a telephone and clinic delivered care. In four of them, the nurse-based protocol was through a clinic visit. In five of them it was from a primarily telephone based. 

For the nurse-based training of the studies in four out of the ten the nurse had to have a clinical certification. In five of them, the nurse only had gone through study-specific training. In eight out of the ten of these, the nurse was given the autonomy to independently initiate a new medication. 

Just a few more study characteristics. Just going to look down here at the disease severity of the CHF studies, let's see, 50% of the patients had a heart failure classification of one to two and another 50%, yes, right had a heart failure classification between three and four. This slide is off a bit, but you should get the general idea that there was a good mix between a patient who had a more severe condition versus perhaps a less severe one.

So for the Key Question One, just to remind you, for adults with medical conditions, do nurse-managed protocols compared with usual care improve the following outcomes? So the results for the cardiovascular risk were as follow: There was a positive effect of the nurse-based protocols on improving hemoglobin A1C by 0.4%. Systolic blood pressure and diastolic blood pressure, 4 mm Hg and 2 mm Hg. Total cholesterol improved by nine and LDL improved by 12. Also, more patients were shown to reach target goals in total cholesterol and blood pressure. For blood pressure, our risk analysis estimated that 16 patients per 1,000 were more likely to reach their target blood pressure goal, and 106/1,000 patients were more likely to reach their total cholesterol goal. 

In the studies on CHF, there was lower all-cause mortality. We estimated this at approximately 36 fewer deaths per 1,000 patients. More patients were also proscribe ACE or ARBs in the management of CHF. That was approximately 18/1,000 patients. We also found that there was a decrease in CHF hospitalizations at 32 patients per 1,000. 

Unfortunately, the effects on the nursing staff satisfaction were not reported at all. 

Treatment adherence was infrequently reported, but there was a pattern adherence to lifestyle goals among the patients here. The educational preparation to assume this expanded nurse role was not well reported. I also forgot to mention that all of the nurses from these studies were either a registered nurse or an RN equivalent. There were no LPNs who were used in these studies. Also many of these studies were a combination between U.S. based and also Western European based or from Australia or New Zealand or Canada. 

For the Key Question Two, in studies of nurse-managed protocols, how well do participating nurses adhere to the protocol? There was indirect of evidence through improved outcomes, which suggested that nurses adhered to the protocols, however direct evidence was insufficient to establish how well the nurses actually adhere to the protocols when engaged in delivering nurse-managed care. Only two of the 29 studies reported increase nurse adherence to treatment protocols. The other just did not report it. Thus for Key Question Two, there was insufficient data in terms of how well a nurse actually adhered to the nurse-managed protocols. Either the data was just not collected, or the data was not reported. 

For Key Question Three, are there adverse effects associated with the use of nurse-managed protocols, which is an important question for all of us. Unfortunately adverse events were reported in only one study. Thus the evidence was insufficient to establish if there are adverse effects associated with the use of nurse-managed protocols. 

So, this is also a somewhat busy slide, but it's the overall summary. I highlighted on the right side what was the strength of evidence in terms of the effects of the nurse-managed protocols. So, if we start with the nurse-managed protocols on the cardiovascular risk studies, we see that the strength of evidence on improving hemoglobin A1C was moderate. On blood pressure, it was also moderate. And, on helping patients to reach their target blood pressure goals, there was moderate evidence. On, cholesterol, the evidence was low. For helping patients to reach their target cholesterol at goal their was a moderate strength. 

For those studies on congestive heart failure on decreasing mortality, there was moderate evidence of the effects of the nurse-managed protocols. There was low evidence on decreasing total hospitalizations. However for CHF specific hospitalizations, there was high evidence. And, on increasing the number of medications that the patients were prescribed, there was moderate evidence on the strength of these nurse-based interventions.

So, [there are] some conclusions. With the implementation of PACT, the VA will play a critical role in reconfiguring team-based care models to expand the responsibilities of team members. Nurses are in an ideal position to collaborate with other team members in the deliver of more accessible and effective medical care for veterans with chronic disease. Results suggest that nurse-managed protocols have positive effects on the outpatient management with stable common chronic conditions such as type II diabetes, hypertension, hyperlipidemia, and CHF. 

There are limitations though. There was a lack of detailed description of the actual protocols. There was limited reporting of the intervention intensity treatment adherence by patients, protocol adherence by the nurses, health-related quality of life, resource utilization, staff satisfaction, and the educational level and the supervision that is needed of the nurses. Also, only RNs were used here. So I cannot comment on the use of LPNs at least from the literature that we had searched. Outcomes also varied across studies, and contributed to unexplained variability. 

There were strengths though. This was a highly structured and systematic review of the existing evidence. There was a multidisciplinary team , which included expertise in internal medicine -- sorry this slide was actually supposed to be changed, but I'll just say it out loud -- in nursing, in health services research, and so forth. Sorry as this is difficult to read. 

So, the recommendation for future research is that patients with a complex disease or multiple chronic diseases, we need to do additional studies on the effects of nurse-based protocols. We also need to look at those studies, which are narrowly focused, which are only for example on blood pressure or diabetes because most of the studies were a combination. 

We also need to look specifically at multi-target interventions. We need to look at the effects of patient and staff satisfaction. Are nurses satisfied with this? Do they actually want to take on this expanded role? Would patients enjoy that? Would it actually help them? What is the effect on physician satisfaction to and also other members of the care team? What is the fidelity to the intervention protocol? 

So, I tried to keep this short to leave plenty of time for questions. There are definitely more details in the report, which I would be happy to answer. I actually finished a lot sooner than I thought, so yes. I would like to open up the floor to questions on the report. 

Facilitator:Fantastic! That gives us a lot of time for questions, so not a problem. For the audience, we are taking questions. Please use the Q&A screen at the lower-right-hand corner of your monitor. Please try to keep the questions to the report. We will not be taking questions on individual patients. 

The first question that we have here: "What were the legal issues involved in working beyond usual scope of practice? I have worked in settings where protocols were widely used, and then severely curtailed because of scope of practice concerns. For example, the legal department advised that the protocols amounted to nurses prescribing medications without a license." 

Dr. Shaw:That is a really good question. We actually didn't bring that up in the report. From my recollection of going through the 29 studies that we had, I don't really remember anything about the legal aspect of that. So that is definitely an important area for future research. So I really don't know. That is a really good question actually, so yes. That's my answer. We're not sure. 

Facilitator:Okay, and to be honest, we get a lot of questions that come up during sessions where hey that would be a great research study, so that's a fantastic one! Great! Okay. The next question here: "What are RCTs?"

Dr. Shaw:Sure that is a Randomized Control Trial where you have different intervention groups where, for example, if we were doing the nursing interventions, and we have a patient come in, we would randomly assign them to either the nursing intervention or to a usual care group. You can do that random assignment though various ways. You could just role a dice or flip a coin, but there are also computer programs to do that. 

Facilitator:Great! Thank you. The next question: "Were there any malpractice suits against these nurses especially with protocols?"

Dr. Shaw:So that is a good question too since we did a review of the peer-reviewed literature, which was not reported. That's a good question though. That is something that we would have to go back to all of the authors and ask them. I don't know if they would actually release that information or not. Part of the reason why we include clinicaltrials.gov in our database search is to see if there were studies similar to this that were conducted, and they were not published on. As far as I know, we did not find anybody. But information like that is usually, is not often actually published in peer-reviewed journals, at least, not what I have read much, so good question. I'm not sure. 

Those are certainly important things to consider from a policy and implementation standpoint. If we think about how nurses deliver care in the inpatient setting, we already have these types of protocols If you think back to working in the ICU for those clinicians here. In many setting, a nurse is given that autonomy by either the hospital or the prescribing physician to for example make adjustments to an insulin drip and based upon an algorithm, and limits that are already prescribed, but the nurse makes those decisions autonomously based upon the patients blood sugar values such as a sliding scale. That's what I'm trying to say.

So I imagine that the implications would be somewhat similar to that. So if they're available in a hospital-based setting, I don't see why they couldn’t be translated to an outpatient setting. Hopefully that answers the question. 

Facilitator:If not they'll probably send in a clarifying question, so that's okay. The next question here; somebody just wants to clarify. "Were only non nurse practitioners included?"

Dr. Shaw:To our knowledge we only included studies that had looked at a registered nurse or an LPN practicing beyond their scope of practice. The reason is that a nurse practitioner can already prescribe medications right. What we don't know is if in the individual studies, if nurse practitioners were practicing in the role of a registered nurse. That's certainly a limitation. My hunch is that probably not that many, so I don't know that for sure. But, we did send out an inquiry letter to many of the authors from these studies because we had to make sure that it was a registered nurse and not a nurse practitioner, and so all of these studies that were here, the study author said that these were registered nurses or something that would be equivalent to that. 

So back to answering your question as far as I know, these were all non nurse practitioners. 

Facilitator:Great! Thank you. The next question: "Is it possible to get the protocols?"

Dr. Shaw:I'm trying to think what protocols we have. One of the limitations was that many of the protocols were not published. However, we do have a list of the study authors that we could share, so that if someone is interested in getting them, they could send out inquiry emails from them. But, those are certainly next steps for future research in terms of actually getting the protocols because they often were not published. There are some of them, but you are welcome to send me an email, and we could talk about that further. 

Facilitator:Great! Thank you. The next question here: "How do the results compare to non-nurse protocols or physician NP protocols?"

Dr. Shaw:How did we report? Good question. We didn't assess that. Those weren't our key questions. That is certainly a really good thing for future research. That would require another literature review. Back to the beginning, we had over 3,000 articles. So we had to limitation to be able to actually get to our key questions, and to answer those at hand. But, how they compared to other protocols is important to know. Beyond just a physician protocol, there are also thoughts about what about a pharmacist-based protocol, too. Those are all things to consider in terms of expanding, not only the role of nurses, but perhaps of other team member, so I don't know from the results of this study. But, those would be important things to ask for the next research step especially implementation and making changes in care teams and policies. 

Facilitator:Great! Thank you. The next question here says, "Only five studies were conducted in the U.S., and none were in the VA. How applicable is this review to our Healthcare System?"

Dr. Shaw:Great question! So this is also why we had to send out emails to most of the study authors to ask if the registered nurses, or I should say the nurses who were being used, if they're were equivalent to a registered nurse in the U.S. We came together as a team. We put together a document, so that people in other countries could compare their nurse interventionist to what would be a registered nurse here. That is definitely a limitation to this in that only five studies were conducted in the U.S. 

None of them were in the VA. My hope would be that that may serve an impetus to invest into a trial that would either attest a nurse-managed protocol in a VA setting or something similar to that. But, that is an important limitation. These were questions that the VA had. There unfortunately has not been that much done in this country. So if there's anyone on the line, and you might be thinking, oh, perhaps we should fund this in the VA, well there you go.

Facilitator:Great! Thank you. We have someone here who is just sending a comment. "Different states have variation in nurse practice acts. It is state dependent." 

Dr. Shaw:Right. That probably goes back to the comment that I made early about nurses having perhaps different roles in inpatient setting, but yes. That's also something to consider. If we were to implement an expanded nursing role, there are definitely policy and legal implications beyond just the hospital itself. Those are things that I can't really speak to, but for those who are policy makers, who are on this webinar or hospital administrators and so forth, are certainly things that we're going to look into more detail on. That information we don't have from this specific report. But, that's also good to know that we don't have that information. 

Facilitator:Great! Thank you. The next question here: "My understanding about protocols is that a standing order has to be in place for nurses to be able to work per protocol." 

Dr. Shaw:That is my understanding. Those specific details were not actually reported in most of the studies. They might have been in one or two. But, that is my understanding also of a nurse-based protocol, sorry, of the protocols from these studies in the sense that a physician had to prescribe the protocol. And then, the nurse carried out the protocol having the autonomous decision to adjust medications or to prescribe new ones, but only based upon that protocol. Right, so those would be individual protocols prescribed by a physician. I don't know if they were prescribed by a nurse practitioner or a PA, however, considering that only five of the studies were conducted in the U.S. that would something that would have to be looked at in each individual country in terms of their scopes of practice in their healthcare teams.

Facilitator:Alright, thank you. The next question: "The scope of practice for LPNs and LVNs varies state-by-state. In some states LPNs and LVNs cannot assess a patient. They can only observe and report to an RN or physician. Wouldn't this limited scope of practice make the LPN and LVN ineligible to follow a protocol since an assessment of the patient is required?"

Dr. Shaw:Very good point. So, we went into this having that as an open question just examining if LPNs or LVNs were used, and they weren't. I think that that certainly brings up that perhaps, at this point in time, using an LPN or an LVN may not be the best approach right now, but that would be up to policy decision makers and healthcare administrators. From this report, I can only speak to the registered nurse or its equivalent. I imagine that it's likely that an LPN or an LVN would not have this expanded scope of practice in part because of the required training that is needed, which is somewhat inconclusive from this report. Some of the nurses did have additional certifications like being a diabetes nurse educator and so forth. Those are other things that would have to be teased out. Can you just have? I don't know if we can just have any nurse do this, or if this was to move forward whether it should be mandated that a nurse to have this expanded role, needs to have a specific certification. So, I would likely agree with that commentator that at this probably this would not trickle down to the LPN or the LVN level. 

Facilitator:Great! Thank you. The next question here: "Did these studies mention who developed the protocols?"

Dr. Shaw:They did. Part of that I'll have to go by what's on top of my head. Yes. The study protocols were, for the most part, developed by physicians, and for the most part, in a care team. Some of them were developed by teams including nurses. The details on that are scant. I would honestly have to go through each study to get more detail on that, but it was usually by either a group of physician or a team-based approach that did include nurses. But that is a good question, though. 

Facilitator:Great! Thank you. Next question: "How would the Pact Module work in the specialty clinic setting?"

Dr. Shaw:Ooh, good point. So, that's something that I would in part have to defer back to those who are working the Pact setting right now. But how this would work in PACT is, since it's a team-based approach, the nurse essentially work in-team with the other care members including a physician nurse practitioner PA. And so, policies and protocols would have to be developed to examine exactly what is that expanded scope of the nurse, and the specific medications that they would be able to manage. Perhaps that would be through a nurse doing a telephone-based triaging to patients or delivering care via the telephone if they worked in the outpatient clinic. 

If the patients were prescribed a protocol, the nurse could make those decisions to change those medications or so forth and so on. But specifically how that would have to be done is something that the VA, if they do want to move forward with this, something that they would have to essentially develop to change procedures and how the team could work together because, as I had mentioned earlier, I might not just be nurses. It could be other team members. Perhaps a pharmacist and so forth too. Those are all things for future research for us to examine. 

Facilitator:Okay, great! Thank you. The next questioner sent in two separately. I think that they are kind of supposed to go together, so I'm going to put these together here. "The presenter keeps saying, practicing beyond scope of practice, but assessed it as within scope of practice for an RN to determine medications based on protocol. I believe that is within the scope of license. I think that this is setting up for the questions coming from the audience about legal implications, right? Please clarify what exactly is meant by beyond scope of license. And isn't that why you made the reference to algorithms in the ICU?"

Dr. Shaw:Correct. So, I'll try to specify that more. By talking about beyond scope of practice, I'm talking about having a nurse autonomously change a patients' medication levels, either changing the actual prescription, or initiating a new one. So by practicing beyond the scope of practice, the nurse makes those decisions on her of his own to adjust a medication without having to refer back to another provider that that is the correct to do so to speak. So, it would be quite similar to your physician or nurse practitioner, and you decide to change a dose or to initiate a new medication. However, the nurse would have to go by a specified protocol that would be give to them. Hopefully that clarifies it, but if not, please ask again.

Facilitator:"Yep, you got it. Great! Thanks," [came] back from that one, so good. Okay the next question here: "Were the protocols standardized for this study so everyone was using the same protocols?"

Dr. Shaw:As far as I know, the protocols were standardized for those patients who were enrolled in the study. I won't be able to comment on for each study wether or not how much of the patient load that each nurse had that those patients were part of the intervention. That I don't know. That's something that we would have ask probably each individual author on the studies. But, as far as I know, for each study, it was a standard protocol for each of them. We didn't find that there were any subsequent research studies at least reported where they were doing, for example, two side-by-side protocols. That's about as much as what's reported. Unfortunately, we are overall limited by what actually gets published. 

Facilitator:Okay. Thank you. The next question: "Have these findings been shared with the PACT Program Office, and what recommendations do you have for implementing these findings in PACT.

Dr. Shaw:Sure. We haven't necessarily spoken with PACT just yet. We just finalized the report back in the fall. And now, we are moving towards have this published in a peer-review journal. So, those are some of the next steps including also doing this webinar. So, we haven’t quite gotten that far yet, but that is a really good question. In terms of implementation, I would say that before this move to actual implementation there is more research that definitely needs to be done because there were a lot. So, while there were positive effects on the patient outcomes, there was not that much information given on the process measures. 

So how do we actually implement this? How do we change team-based care? What are the policies that we need to develop? Do nurses actually want this? Do patients want this? Do physicians want this? How do we change the dynamics of a clinic? Those are larger questions that perhaps the PACT Team in the VA will have to sit as a group and discuss how to reconfigure these, and what resources need to be invested to answer additional research questions. So for an implementation standpoint, there is a lot unknown. And there are also those legal questions too that people had asked before too. 

Really this report showed, or at least in my opinion that his is worth moving forward because it did show improved patient outcomes, which is what all of us want. I believe that it is certainly worth looking into. If we ever get to the point of implementation, that would be great, but that's certainly a larger discussion to have. 

Facilitator:Okay, great! Thank you. The next question: "Could you give an example of an RN equivalent?"

Dr. Shaw:Sure. So an RN equivalent would be someone in another country either Canada or the U.K. or Australia. I wish that I had this document up in front of me. Essentially what we did is we looked at the scope of a practice of the registered nurse across several states to make sure that we had a good understanding, for the most part, with the overall scope of a practice of nurses in terms of providing patient education, providing care, and so forth and so on. 

And, we credit a document that listed that out. We had the study authors just check off if the nurses in those studies met those criteria, which were very similar to each state's scope of practice. What we really wanted to know that the nurses were not nurse practitioners. So, there was also that criteria too where we did want to know that a scope of a practice in that country that the nurse could not independently adjust medications in their usual scope of practice outside of the research study. 

So, that's essentially how we had formulated that. We didn't ask too much more detail. Per each country, so we just had to rely on those study authors to give us a nod, either a yea or a nay that the interventionists were equivalent to the U.S. version. We did end up having to drop some studies because we found out that some of them were similar to a nurse practitioner here, in that that they could already prescribe meds on their own, outside of the study and so forth.

Facilitator:Okay, great! Thank you. For the audience we are getting close to the top of the hour. The session is scheduled to go for about another 15 minutes, but I know that many of you are only able to stay here for the hour. We are recording this call. We will send out the archives. If you do need to leave now, we will send that archive out, so that you can catch the last few questions on that recording. 

The next question that we have here: "How do you motivate the nurses to want to expand their scope?"

Dr. Shaw:That is a really good question. Wow! Yes, so that's another thing that we need to ask the nursing community, and the nurses who work at VA. Do they want to take on this responsibility of having an expanded role? How do we motivate people? That information I don't have from this report, but just kind of thinking out loud. We can present to nurses that this can help them to practice to the fullest extent of their training. They can help to improve their patient outcomes. We would need to put together a task force to discuss [the question]: What is the best way to motivate a nurse to want to take on this?  That is a good question. I don't completely know, but that is definitely worth brainstorming in terms of increasing motivation to do this. I can definitely imagine that some nurses will not want to take on this expanded role and responsibility. 

Facilitator:We did a couple of comment in from the audience. [Crosstalk]

Dr. Shaw:Yes. Please.

Facilitator:Money and certifications.

Dr. Shaw:Good ones, yes. Okay. Yes. I would say that money is always certainly a good way to go. Yes, and certification would be good. Just kind of my opinion; this is not from this report is that if we are going to have nurses take on this expanded role. I think that it would be important for them to have a certification just to kind of show their competency in this role. Those are just my personal thoughts. Money is great, yes.

Facilitator:Okay. Thank you. The next one here is a comment. "Not only state dependent, but same facility dependent. Some facilities seem to restrict focus of nursing practice compared while others seemed to expand roles. We've also seen difference between providers and what level autonomy they extend to team nurse."

Dr. Shaw:Right, yes absolutely good point, sure. Right because I can imagine that some teams may not want to have a nurse have this expanded role, or there might levels of that expansion because this expanded role is based upon a protocol, and it may be that a team only wants the nurse to have a protocol certain medications or certain diseases perhaps only on diabetics or perhaps only on people who have hypertension etc. Yes, that is a really good point also that it is not just a state-based thing, but it's also facility based. 

Facilitator:Great! Thank you. The next question here: "In screening the various studies, did you run across studies related to nurse initiated home PT, OT, or nursing?"

Dr. Shaw:Good question, too. Not that I recall. There were some studies where. So, all of these studies had to primarily outpatient based where the nurse is based out of a clinic. So, we didn't focus on public-health nurses so to speak, but in some of them, the nurse did make home visits. We don't have more details in terms of where the protocols were actually used in terms of the making a medication adjustment or ordering diagnostic tests etc. But, only some of them did include home-based visits. For the CHF studies, some of them were nurse-based CHF clinics. If that helps to answer that question too. 

Facilitator:Okay, great! Thank you. This one also is another comment. "The CA has been using RN care managers for some time. They really enjoy it, and have had great success."

Dr. Shaw:Okay, using an RN care manager could potentially bet he way to go towards this type of expanded role. Yes. 

Facilitator:Great! That actually does conclude all of the questions that we have received in. Ryan did you want to make any final remarks before we wrap things up here?Dr. Shaw:I just wanted to thank everyone who was able to come today. And thank you for the many questions. Again, you can contact me at ryan.shaw@duke.edu. I would be glad to answer further questions or to discuss future research steps etc. So alright, thanks again. 

Facilitator:Great! Thank you so much Ryan for taking the time to pull this together and present this today. We all very much appreciate it. For the audience, if you all can hold on for just another minute, I'm going to put a feedback form up when I close the meeting out. We really do read through all of your feedback, and we really do take that into consideration with our current and upcoming session. Thank you everyone for joining us for today's: HSR&D Cyber Seminar, and we hope to see you at a future session. Thank you.

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