David C. Aron, MD, MS

Paul Conlin, MD. Thank you all for joining us to talk about the recently released VA/DoD Clinical Practice Guideline for the Management of Type 2 Diabetes Mellitus in Primary Care (CPG). We’ve gathered together a group of experts who were part of the CPG development committee. We’re going to talk about some topics that were highlighted in the CPG that might provide additional detail to those in primary-care practices and help them in their management of patients with diabetes.

A unique feature of the VA/DoD CPG is that it emphasizes shared decision making as an important tool that clinicians should employ in their patient encounters. Dr. Watts, health care providers may wonder how they can make time for an intervention involving shared decision making using the SHARE approach, (ie, seek, help, assess, reach, and evaluate). Can you give us some advice on this?

Sharon Watts, DNP. Shared decision making is really crucial to success in diabetes. It’s been around for a while. We are trying to make an emphasis on this. The SHARE approach is from the Agency for Healthcare Research and Quality (AHRQ). The AHRQ has a wealth of information on its website. What AHRQ emphasizes is making it brief but conversational when you’re using the SHARE approach with your patient. Most importantly, the patient needs to be in the center of this dialogue, expressing his or her values and preferences of what’s most important to the whole team. This is a team effort. It’s not just with a provider. That’s where providers get overwhelmed. You can ask your nurse to advise the patient to write down 1 or 2 questions that are really important about diabetes before they come to see you, before the encounter. We can refer patients to diabetes classes where a lot of this information is given. The patient can talk to the dietitian or the pharmacist. There’s a whole team out there that will help in SHARE decision making. It’s crucial in the end for the provider to help the patient reach the decision and determine how best to treat the diabetes with them.

Dr. Conlin. Can you give a brief description of the key components of the SHARE approach?

Dr. Watts. Breaking it down simply, providers can start off by asking permission to go over the condition or treatment options because this immediately sets the stage as a signal to the patient that they are important in controlling the dialogue. It’s not the provider giving a discourse. You’re asking for permission. The next step would be to explore the benefits and risks of any course taken. Use decision aids if you have them. Keep in mind your patient’s current health literacy, numeracy, and other limitations.

Next ask about values, preferences, or barriers to whatever treatment you’re talking about. For instance, will this work with your work schedule?

Then the last thing would be ask what the patient wants to do next. Reach a decision on treatment, whatever it is, and make sure that you revisit that decision. Follow up later to see if it’s really working.

Dr. Conlin. If I’m a busy clinician and I have a limited amount of time with a patient, when are the appropriate times to employ the SHARE approach? Can I break it into components, where I address some elements during one visit and other elements in another visit?

Dr. Watts. Absolutely. It can be spread out. Your team is probably already providing information that will help in the SHARE approach. Just chart that you’ve done it. We know the SHARE approach is important because people
tend to be adherent if they came up with part of the plan.

Dr. Conlin. Where does diabetes self-management education and diabetes self-management support fall into this framework?

Dr. Watts. Diabetes is a complex disease for providers and for the team and even more so for our patients. Invite them to diabetes classes. There’s so much to understand. The classes go over medications and blood sugar ranges, though you still may have to review it with the patient in your office. It saves the provider time if you have an informed and activated patient. It’s the same with sending a patient to a dietitian. I do all of the above.

Dr. Conlin. Many providers may not be familiar with this type of approach. How can I tell whether or not I’m doing it correctly?

Dr. Watts. The AHRQ website has conversation starters (www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/tools/index.html). Then make sure when you are with the patient to use Teach-Back. Have that conversation and say, “I want to make sure I understood correctly what we decided would work best for you.” Ask patients to say in their own words what they understand. Then I think you’re off to a great start.

Dr. Conlin. Many patients tend to be deferential to their health care providers. They were brought up in an era where they needed to listen to and respect clinicians rather than participate in discussions about their ongoing care. How do you engage with these patients?

Dr. Watts. That is a tough one. Before the patient leaves the office, I ask them: Are there any barriers? Does this work for your schedule? Is this a preference and value that you have? Is there anything that might get in the way of this working when you go home? I try to pull out a little bit more, making sure to give them some decision aids and revisit it at the next visit to make sure it’s working.

Dr. Conlin. We’ll now turn to a discussion of using hemoglobin A1c (HbA_1c) measurements in clinical practice. Dr. Aron, what factors can impact the relationship between HbA_1c and blood glucose? How should we use HbA_1c in the treatment of patients who come from varied ethnic and racial backgrounds, where the relationship to average blood glucose may be different?

David C. Aron, MD, MS. The identification of HbA_1c has been a tremendous advance in our ability to manage patients with diabetes. It represents an average blood glucose over the preceding 3 months but like everything in this world, it has issues. One is the fact that there is a certain degree of inaccuracy in measurement, and that’s true of any measurement that you make of anything. Just as you allow a little bit of wiggle room when you’re driving down the New Jersey Turnpike and watching your speedometer, which is not 100% accurate. It says you are going 65 but it could, for example be 68 or 62. You don’t want to go too fast or you’ll get a speeding ticket. You don’t want to go too slowly or the person behind you will start honking at you. You want to be at the speed limit plus or minus. The first thing to think about in using HbA_1c is the issue of accuracy. Rather than choose a specific target number, health care providers should choose a range between this and that. There’ll be more detail on that later.

The second thing is that part of the degree to which HbA_1c represents the average blood glucose depends on a lot of factors, and some of these factors are things that we can do absolutely nothing about because we are born with them. African Americans tend to have higher HbA_1c levels than do whites for the same glucose. That difference is as much as 0.4. An HbA^_1c of 6.2 in African Americans gets you a 5.8 in whites for the same average blood glucose. Similarly, Native Americans have somewhat higher HbA_1c, although not quite as high as African Americans. Hispanics and Asians do as well, so you have to take your patient’s ethnicity into account.

The second has to do with the way that HbA_1c is measured and the fact that there are many things that can affect the measurement. An HbA_1c is dependent upon the lifespan of the red blood cell, so if there are alterations in red cell lifespan or if someone has anemia, that can affect HbA_1c. Certain hemoglobin variants, for example, hemoglobin F, which is typically elevated in someone with thalassemia, migrates with some assays in the same place as thalassemia, so the assay can’t tell the difference between thalassemia and hemoglobin F. There are drugs and other conditions that can also affect HbA_1c. You should think about HbA_1c as a guide, but no number should be considered to be written in stone.

Dr. Conlin. I can imagine that this would be particularly important if you were using HbA_1c as a criterion for diagnosing diabetes.

Dr. Aron. Quite right. The effects of race and ethnicity on HbA_1c account for one of the differences between the VA/DoD guidelines and those of the American Diabetes Association (ADA).

Dr. Conlin. Isn’t < 8% HbA_1c a national performance measure that people are asked to adhere to?

Dr. Aron. Not in the VA. In fact, the only performance measure that the VA has with a target is percent of patients with HbA_1c > 9%, and we don’t want any of those or very few of them anyway. We have specifically avoided targets like < 8% HbA_1c or < 7% HbA_1c, which was prevalent some years ago, because the choice of HbA_1c is very dependent upon the needs and desires of the individual patient. The VA has had stratified targets based on life expectancy and complications going back more than 15 years.

Dr. Conlin. Another issue that can confuse clinicians is when the HbA_1c is in the target range but actually reflects an average of glucose levels that are at times very high and very low. How do we address this problem clinically?

Dr. Aron. In managing patients, you use whatever data you can get. The HbA_1c gives you a general indication of average blood glucose, but particularly for those patients who are on insulin, it’s not a complete substitute for measuring blood glucose at appropriate times and taking the degree of glucose variability into account. We don’t want patients getting hypoglycemic, and particularly if they’re elderly, falling, or getting into a car accident. Similarly, we don’t want people to have very high blood sugars, even for limited periods of time, because they can lead to dehydration and other symptoms as well. We use a combination of both HbA_1c and individual measures of blood glucose, like finger-stick blood sugar testing, typically.

Dr. Conlin. The VA/DoD CPG differs from other published guidelines in that we proposed patients are treated to HbA_1c target ranges, whereas most other guidelines propose upper limits or threshold values, such as the HbA_1c should be < 7% or < 8% but without lower bounds. Dr. Colburn, what are the target ranges that are recommended in the CPG? How were they determined?

Maj. Jeffrey A. Colburn, MD. It may be helpful to pull up the Determination of Average Target HbA_1c Level Over Time table (page S17), which lays out risk for patients of treatment as well as the benefits of treatment. We first look at the patient’s state of health and whether they have a major comorbidity, a physiologic age that could be high risk, or advanced physiologic age with a diminished life expectancy. In controlling the levels of glucose, we’re often trying to benefit the microvascular health of the patient, realizing also that eventually poor management over time will lead to macrovascular disease as well. The main things that we see in child data is that the benefits of tight glucose control for younger patients with shorter duration of type 2 diabetes mellitus (T2DM) is the prevention of retinopathy, nephropathy, and peripheral neuropathy. Those patients that already have advanced microvascular disease are less likely to benefit from tight control. Trying to push glucose very low can harm the patient. It’s a delicate balance between the possible benefit vs the real harm.

The major trials are the ADVANCE, ACCORD, and the VADT trial, which was done in a VA population. To generalize the results, you are looking at an intensive control, which was trying to keep the HbA_1c in general down below the 7% threshold. The patients enrolled in those trials all had microvascular and macrovascular disease and typically longer durations of diabetes at the time of the study. The studies revealed that we were not preventing macrovascular disease, heart attacks, strokes, the types of things that kill patients with diabetes. Individuals at higher HbA_1c levels that went down to better HbA_1c levels saw some improvement in the microvascular risk. Individuals already at the lower end didn’t see as much improvement. What we saw though that was surprising and concerning was that hypoglycemia, particularly severe hypoglycemia in the VADT trial was a lot more frequent when you try and target the HbA_1c on the lower end. Because of these findings, we proposed the table with a set of ranges. As Dr. Aron noted, HbA_1c is not a perfect test. It does have some variance in the number it presents. The CPG proposed to give individuals target ranges. They should be individualized based upon physiologic age, comorbidities, and life expectancy.

A criticism of the table that I commonly hear is what’s the magic crystal ball for determining somebody’s life expectancy? We don’t have one. This is a clinician’s judgment. The findings might actually change over time with the patient. A target HbA_1c range is something that should be adapted and evolve along with the clinician and patient experience of the diabetes.

There are other important studies. For example, the UKPDS trials that included patients with shorter durations of diabetes and lesser disease to try and get their HbA_1c levels on the lower end. We included that in the chart. Another concept we put forward is the idea of relative risk (RR) vs absolute risk. The RR reduction doesn’t speak to what the actual beginning risk is lowered to for a patient. The UKPDS is often cited for RR reduction of microvascular disease as 37% when an HbA_1c of 7.9% is targeted down to 7.0%. The absolute risk reduction is actually 5 with the number needed to treat to do so is 20 patients. When we present the data, we give it a fair shake. We want individuals to guide therapy that is going to be both beneficial to preventing outcomes but also not harmful to the patient. I would highly recommend clinicians and patients look at this table together when making their decisions.

Dr. Conlin. In the VA/DoD CPG, the HbA_1c target range for individuals with limited life expectancy extends to 9%. That may seem high for some, since most other guidelines propose lower HbA_1c levels. How strong are the data that a person with limited life expectancy, say with end-stage renal disease or advanced complications, could be treated to a range of 8% to 9%? Shouldn’t lower levels actually improve life expectancy in such people?

Dr. Colburn. There’s much less data to support this level, which is why it’s cited in CPG as having weaker evidence. The reason it’s proposed is the experience of the workgroup and the evidence that is available of a high risk for patients with low life expectancy when they reduce their HbA_1c greatly. One of the concerns about being at that level might be the real issue of renal glycosuria for individuals when their blood glucose is reaching above 180 mg/dL, which correlates to the 8% to 9% HbA_1c range. You may have renal loss and risk of dehydration. It is an area where the clinician should be cautious in monitoring a patient in the 8% to 9% HbA_1c range. With that being said, a patient who is having a lot of challenges in their health and extremely advanced conditions could be in that range. We would not expect a reversing of a micro- or macrovascular disease with glycemia control. We’re not going to go back from that level of disease they have. The idea about keeping them there is to prevent the risks of overtreatment and harm to the patient.

Dr. Conlin. Since patients with diabetes can progress over their lifetime from no complications to mild-to-moderate complications to advanced complications, how does the HbA_1c target range evolve as a patient’s condition changes?

Dr. Colburn. As we check for evidence of microvascular disease or neuropathy signs, that evidence often is good for discussion between the clinician and patient to advise them that better control early on may help stem off or reverse some of that change. As those changes solidify, the patient is challenged by microvascular conditions. I would entertain allowing more relaxed HbA_1c ranges to prevent harm to the patient given that we’re not going back. But you have to be careful. We have to consider benefits to the patient and the challenges for controlling glucose.

I hope that this table doesn’t make providers throw up their hands and give up. It’s meant to start a conversation on safety and benefits. With newer agents coming out that can help us control glucose quite well, without as much hypoglycemia risk, clinicians and patients potentially can try and get that HbA_1c into a well-managed range.

Dr. Conlin. The CPG discusses various treatment options that might be available for patients who require pharmacologic therapy. The number of agents available is growing quite markedly. Dr. Colburn, can you describe how the CPG put together the pharmacologic therapy preferences.

Dr. Colburn. The CPG expressively stayed away from trying to promote specific regimens of medications. For example, other guidelines promote starting with certain agents followed by a second-line agent by a third-line agents. The concern that we had about that approach is that the medication landscape is rapidly evolving. The options available to clinicians and patients are really diverse at this moment, and the data are not concrete regarding what works best for a single patient.

Rather than trying to go from one agent to the next, we thought it best to discuss with patients using the SHARE decision-making model, the adverse effects (AEs) and relative benefits that are involved with each medication class to determine what might be best for the person. We have many new agents with evidence for possible reductions in cardiovascular outcomes outside of their glycemic control properties. As those evidences promote a potentially better option for a patient, we wanted to allow the room in management tomake a decision together. I will say the CPG as well as all of the other applicable diabetes guidelines for T2DM promote metformin as the first therapy to consider for somebody with newly diagnosed T2DM because of safety and availability and the benefit that’s seen with that medication class. We ask clinicians to access the AHRQ website for updates as the medicines evolve.

In a rapidly changing landscape with new drugs coming into the market, each agency has on their individual website information about individual agents and their formulary status, criteria for use, and prior authorization requirements. We refer clinicians to the appropriate website for more information.

Dr. Conlin. There are a series of new medications that have recently come to market that seem to mitigate risk for hypoglycemia. Dr. Lugo, which treatment options carry greater risk? Which treatment options seem to have lesser risk for hypoglycemia?

Amy M. Lugo, PharmD. Insulin and the sulfonylureas have the highest risk of hypoglycemia. The sulfonylureas have fallen out of favor somewhat. One reason is that there are many newer agents that do not cause weight gain or increase the risk of hypoglycemia. Some of the newer insulins may have a lower risk of hypoglycemia and nocturnal hypoglycemia, in particular; however, it is difficult to conclude emphatically that one basal insulin analog is less likely to cause clinically relevant severe or nocturnal hypoglycemia events. This is due to the differences in the definitions of hypoglycemia used in the individual clinical trials, the open label study designs, and the different primary endpoints.

Dr. Conlin. How much affect on HbA_1c might I expect to see using SGLT2 inhibitors or GLP-1 agonists? What would be some of the potential AEs I have to be aware of and therefore could counsel patients about?

Dr. Lugo. Let’s start with SGLT2 inhibitors. It depends on whether they are used as monotherapy or in combination. We prefer that patients start on metformin unless they have a contraindication. When used as monotherapy, the SGLT2s may decrease HbA_1c from 0.4% to 1% from baseline. When combined with additional agents, they can have > 1% improvement in HbA_1c from baseline. There are no head-to-head trials between any of the SGLT2 inhibitors. We cannot say that one is more efficacious than another in lowering HbA_1c. The most common AEs include genital mycotic infections and urinary tract infections. The SGLT2 inhibitors also should be avoided in renal impairment. There was a recent FDA safety alert for the class for risk of ketoacidosis. Additionally, the FDA warned that patients
with a history of bladder cancer should avoid dapagliflozin, and canagliflozin has a warning for increased risk of bone fractures, amputation, and decreased bone density.

Other actions of the SGLT2 inhibitors include a reduction in triglycerides and a modest increase in both low-density lipoprotein cholesterol and highdensity lipoprotein cholesterol. The SGLT2 inhibitors also slightly decrease systolic blood pressure (by 4 mm Hg to 6 mm Hg) and body weight (reduction of 1.8 kg)

The GLP-1s are likely to be more efficacious in reducing HbA_1c. Typically we see 1% or greater lowering in HbA_1c from baseline. As a class, the GLP-1 agonists have a lower risk of hypoglycemia; however, the risk increases when combined with sulfonylureas or insulin. The dose of insulin or sulfonylurea will likely need to be decreased when used concomitantly.

Patients are likely to experience weight loss when on a GLP-1 agonist, which is a great benefit. Gastrointestinal AEs such as nausea are common. Adverse effects may differ somewhat between the agents.

Dr. Conlin. Patients’ experience of care is integral to their engagement with treatment as well as their adherence. Ms. Decesare, what are patients looking for from their health care team?

Elaine M. Decesare. Patients are looking for a knowledgeable and compassionate health care team that has a consistent approach and a consistent message and that the team is updated on the knowledge of appropriate treatments and appropriate lifestyle modifications and targets for the care of diabetes.

Also, I think that the team needs to have some empathy for the challenges of living with diabetes. It’s a 24-hour-a-day disorder, 7 days a week. They can’t take vacation from it. They just can’t take a pill and forget about it. It’s a fairly demanding disorder, and sometimes just acknowledging that with the patient can help you with the dialog.

The second thing I think patients want is an effective treatment plan that’s tailored to their needs and lifestyles. That goes in with the shared decision-making approach, but the plan itself really has to be likely to achieve the targets and the goals that you’ve set up. Sometimes I see patients who are doing all they can with their lifestyle changes, but they can’t get to goal, because there isn’t enough medication in the plan. The plan has to be adequate so that the patient can manage their diabetes. In the shared approach, the patient has to buy in to the plan. With the shared decision making they’re more likely to take the plan on as their plan.

Dr. Conlin. How do you respond to patients who feel treatment burnout from having a new dietary plan, an exercise program, regular monitoring of glucose through finger sticks, and in many cases multiple medications and or injections, while potentially not achieving the goals that you and the patient have arrived at?

Ms. Decesare. First, I want to assess their mood. Sometimes patients are depressed, and they actually need help with that. If they have trouble with just the management, we do have behavioral health psychologists on our team that work with patients to get through some of the barriers and discuss some of the feelings that they have about diabetes and diabetes management.

Sometimes we look at the plan again and see if there’s something we can do to make the plan easier. Occasionally, something has happened in their life. Maybe they’re taking care of an elderly parent or they’ve had other health problems that have come about that we need to reassess the plan and make sure that it’s actually doable for them at this point in time.

Certainly diabetes self-management education can be helpful. Some of those approaches can be helpful for finding something that’s going to work for patients in the long run, because it can be a very difficult disorder to manage as time goes on.

Dr. Colburn. Type 2 DM disproportionately affects individuals who are ≥ 65 years compared with younger individuals. Such older patients also are more likely to have cognitive impairment or visual issues. How do we best manage such patients?

Ms. Decesare. When I’m looking at the care plan, social support is very important. If someone has social support and they have a spouse or a son or daughter or someone else that can help them with their diabetes, we oftentimes will get them involved with the plan, as long as it’s fine with the patient, to offer some help, especially with the patients with cognitive problems, because sometimes the patients just cognitively cannot manage diabetes on their own. Prandial insulin could be a really dangerous product for someone who has cognitive disease.

I think you have to look at all the resources that are available. Sometimes you have to change your HbA_1c target range to something that’s going to be manageable for that patient at that time. It might not be perfect, but it would be better to have no hypoglycemia rather than a real aggressive HbA_1c target or a target range, if that’s what’s going to keep the patient safe.

Dr. Conlin. We thank our discussants for sharing very practical advice on how to implement the CPG. We hope this information supports clinicians as they develop treatment plans based on each patient's unique characteristics and goals of care.

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Paul Conlin, MD. Thank you all for joining us to talk about the recently released VA/DoD Clinical Practice Guideline for the Management of Type 2 Diabetes Mellitus in Primary Care (CPG). We’ve gathered together a group of experts who were part of the CPG development committee. We’re going to talk about some topics that were highlighted in the CPG that might provide additional detail to those in primary-care practices and help them in their management of patients with diabetes.

A unique feature of the VA/DoD CPG is that it emphasizes shared decision making as an important tool that clinicians should employ in their patient encounters. Dr. Watts, health care providers may wonder how they can make time for an intervention involving shared decision making using the SHARE approach, (ie, seek, help, assess, reach, and evaluate). Can you give us some advice on this?

Sharon Watts, DNP. Shared decision making is really crucial to success in diabetes. It’s been around for a while. We are trying to make an emphasis on this. The SHARE approach is from the Agency for Healthcare Research and Quality (AHRQ). The AHRQ has a wealth of information on its website. What AHRQ emphasizes is making it brief but conversational when you’re using the SHARE approach with your patient. Most importantly, the patient needs to be in the center of this dialogue, expressing his or her values and preferences of what’s most important to the whole team. This is a team effort. It’s not just with a provider. That’s where providers get overwhelmed. You can ask your nurse to advise the patient to write down 1 or 2 questions that are really important about diabetes before they come to see you, before the encounter. We can refer patients to diabetes classes where a lot of this information is given. The patient can talk to the dietitian or the pharmacist. There’s a whole team out there that will help in SHARE decision making. It’s crucial in the end for the provider to help the patient reach the decision and determine how best to treat the diabetes with them.

Dr. Conlin. Can you give a brief description of the key components of the SHARE approach?

Dr. Watts. Breaking it down simply, providers can start off by asking permission to go over the condition or treatment options because this immediately sets the stage as a signal to the patient that they are important in controlling the dialogue. It’s not the provider giving a discourse. You’re asking for permission. The next step would be to explore the benefits and risks of any course taken. Use decision aids if you have them. Keep in mind your patient’s current health literacy, numeracy, and other limitations.

Next ask about values, preferences, or barriers to whatever treatment you’re talking about. For instance, will this work with your work schedule?

Then the last thing would be ask what the patient wants to do next. Reach a decision on treatment, whatever it is, and make sure that you revisit that decision. Follow up later to see if it’s really working.

Dr. Conlin. If I’m a busy clinician and I have a limited amount of time with a patient, when are the appropriate times to employ the SHARE approach? Can I break it into components, where I address some elements during one visit and other elements in another visit?

Dr. Watts. Absolutely. It can be spread out. Your team is probably already providing information that will help in the SHARE approach. Just chart that you’ve done it. We know the SHARE approach is important because people
tend to be adherent if they came up with part of the plan.

Dr. Conlin. Where does diabetes self-management education and diabetes self-management support fall into this framework?

Dr. Watts. Diabetes is a complex disease for providers and for the team and even more so for our patients. Invite them to diabetes classes. There’s so much to understand. The classes go over medications and blood sugar ranges, though you still may have to review it with the patient in your office. It saves the provider time if you have an informed and activated patient. It’s the same with sending a patient to a dietitian. I do all of the above.

Dr. Conlin. Many providers may not be familiar with this type of approach. How can I tell whether or not I’m doing it correctly?

Dr. Watts. The AHRQ website has conversation starters (www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/tools/index.html). Then make sure when you are with the patient to use Teach-Back. Have that conversation and say, “I want to make sure I understood correctly what we decided would work best for you.” Ask patients to say in their own words what they understand. Then I think you’re off to a great start.

Dr. Conlin. Many patients tend to be deferential to their health care providers. They were brought up in an era where they needed to listen to and respect clinicians rather than participate in discussions about their ongoing care. How do you engage with these patients?

Dr. Watts. That is a tough one. Before the patient leaves the office, I ask them: Are there any barriers? Does this work for your schedule? Is this a preference and value that you have? Is there anything that might get in the way of this working when you go home? I try to pull out a little bit more, making sure to give them some decision aids and revisit it at the next visit to make sure it’s working.

Dr. Conlin. We’ll now turn to a discussion of using hemoglobin A1c (HbA_1c) measurements in clinical practice. Dr. Aron, what factors can impact the relationship between HbA_1c and blood glucose? How should we use HbA_1c in the treatment of patients who come from varied ethnic and racial backgrounds, where the relationship to average blood glucose may be different?

David C. Aron, MD, MS. The identification of HbA_1c has been a tremendous advance in our ability to manage patients with diabetes. It represents an average blood glucose over the preceding 3 months but like everything in this world, it has issues. One is the fact that there is a certain degree of inaccuracy in measurement, and that’s true of any measurement that you make of anything. Just as you allow a little bit of wiggle room when you’re driving down the New Jersey Turnpike and watching your speedometer, which is not 100% accurate. It says you are going 65 but it could, for example be 68 or 62. You don’t want to go too fast or you’ll get a speeding ticket. You don’t want to go too slowly or the person behind you will start honking at you. You want to be at the speed limit plus or minus. The first thing to think about in using HbA_1c is the issue of accuracy. Rather than choose a specific target number, health care providers should choose a range between this and that. There’ll be more detail on that later.

The second thing is that part of the degree to which HbA_1c represents the average blood glucose depends on a lot of factors, and some of these factors are things that we can do absolutely nothing about because we are born with them. African Americans tend to have higher HbA_1c levels than do whites for the same glucose. That difference is as much as 0.4. An HbA^_1c of 6.2 in African Americans gets you a 5.8 in whites for the same average blood glucose. Similarly, Native Americans have somewhat higher HbA_1c, although not quite as high as African Americans. Hispanics and Asians do as well, so you have to take your patient’s ethnicity into account.

The second has to do with the way that HbA_1c is measured and the fact that there are many things that can affect the measurement. An HbA_1c is dependent upon the lifespan of the red blood cell, so if there are alterations in red cell lifespan or if someone has anemia, that can affect HbA_1c. Certain hemoglobin variants, for example, hemoglobin F, which is typically elevated in someone with thalassemia, migrates with some assays in the same place as thalassemia, so the assay can’t tell the difference between thalassemia and hemoglobin F. There are drugs and other conditions that can also affect HbA_1c. You should think about HbA_1c as a guide, but no number should be considered to be written in stone.

Dr. Conlin. I can imagine that this would be particularly important if you were using HbA_1c as a criterion for diagnosing diabetes.

Dr. Aron. Quite right. The effects of race and ethnicity on HbA_1c account for one of the differences between the VA/DoD guidelines and those of the American Diabetes Association (ADA).

Dr. Conlin. Isn’t < 8% HbA_1c a national performance measure that people are asked to adhere to?

Dr. Aron. Not in the VA. In fact, the only performance measure that the VA has with a target is percent of patients with HbA_1c > 9%, and we don’t want any of those or very few of them anyway. We have specifically avoided targets like < 8% HbA_1c or < 7% HbA_1c, which was prevalent some years ago, because the choice of HbA_1c is very dependent upon the needs and desires of the individual patient. The VA has had stratified targets based on life expectancy and complications going back more than 15 years.

Dr. Conlin. Another issue that can confuse clinicians is when the HbA_1c is in the target range but actually reflects an average of glucose levels that are at times very high and very low. How do we address this problem clinically?

Dr. Aron. In managing patients, you use whatever data you can get. The HbA_1c gives you a general indication of average blood glucose, but particularly for those patients who are on insulin, it’s not a complete substitute for measuring blood glucose at appropriate times and taking the degree of glucose variability into account. We don’t want patients getting hypoglycemic, and particularly if they’re elderly, falling, or getting into a car accident. Similarly, we don’t want people to have very high blood sugars, even for limited periods of time, because they can lead to dehydration and other symptoms as well. We use a combination of both HbA_1c and individual measures of blood glucose, like finger-stick blood sugar testing, typically.

Dr. Conlin. The VA/DoD CPG differs from other published guidelines in that we proposed patients are treated to HbA_1c target ranges, whereas most other guidelines propose upper limits or threshold values, such as the HbA_1c should be < 7% or < 8% but without lower bounds. Dr. Colburn, what are the target ranges that are recommended in the CPG? How were they determined?

Maj. Jeffrey A. Colburn, MD. It may be helpful to pull up the Determination of Average Target HbA_1c Level Over Time table (page S17), which lays out risk for patients of treatment as well as the benefits of treatment. We first look at the patient’s state of health and whether they have a major comorbidity, a physiologic age that could be high risk, or advanced physiologic age with a diminished life expectancy. In controlling the levels of glucose, we’re often trying to benefit the microvascular health of the patient, realizing also that eventually poor management over time will lead to macrovascular disease as well. The main things that we see in child data is that the benefits of tight glucose control for younger patients with shorter duration of type 2 diabetes mellitus (T2DM) is the prevention of retinopathy, nephropathy, and peripheral neuropathy. Those patients that already have advanced microvascular disease are less likely to benefit from tight control. Trying to push glucose very low can harm the patient. It’s a delicate balance between the possible benefit vs the real harm.

The major trials are the ADVANCE, ACCORD, and the VADT trial, which was done in a VA population. To generalize the results, you are looking at an intensive control, which was trying to keep the HbA_1c in general down below the 7% threshold. The patients enrolled in those trials all had microvascular and macrovascular disease and typically longer durations of diabetes at the time of the study. The studies revealed that we were not preventing macrovascular disease, heart attacks, strokes, the types of things that kill patients with diabetes. Individuals at higher HbA_1c levels that went down to better HbA_1c levels saw some improvement in the microvascular risk. Individuals already at the lower end didn’t see as much improvement. What we saw though that was surprising and concerning was that hypoglycemia, particularly severe hypoglycemia in the VADT trial was a lot more frequent when you try and target the HbA_1c on the lower end. Because of these findings, we proposed the table with a set of ranges. As Dr. Aron noted, HbA_1c is not a perfect test. It does have some variance in the number it presents. The CPG proposed to give individuals target ranges. They should be individualized based upon physiologic age, comorbidities, and life expectancy.

A criticism of the table that I commonly hear is what’s the magic crystal ball for determining somebody’s life expectancy? We don’t have one. This is a clinician’s judgment. The findings might actually change over time with the patient. A target HbA_1c range is something that should be adapted and evolve along with the clinician and patient experience of the diabetes.

There are other important studies. For example, the UKPDS trials that included patients with shorter durations of diabetes and lesser disease to try and get their HbA_1c levels on the lower end. We included that in the chart. Another concept we put forward is the idea of relative risk (RR) vs absolute risk. The RR reduction doesn’t speak to what the actual beginning risk is lowered to for a patient. The UKPDS is often cited for RR reduction of microvascular disease as 37% when an HbA_1c of 7.9% is targeted down to 7.0%. The absolute risk reduction is actually 5 with the number needed to treat to do so is 20 patients. When we present the data, we give it a fair shake. We want individuals to guide therapy that is going to be both beneficial to preventing outcomes but also not harmful to the patient. I would highly recommend clinicians and patients look at this table together when making their decisions.

Dr. Conlin. In the VA/DoD CPG, the HbA_1c target range for individuals with limited life expectancy extends to 9%. That may seem high for some, since most other guidelines propose lower HbA_1c levels. How strong are the data that a person with limited life expectancy, say with end-stage renal disease or advanced complications, could be treated to a range of 8% to 9%? Shouldn’t lower levels actually improve life expectancy in such people?

Dr. Colburn. There’s much less data to support this level, which is why it’s cited in CPG as having weaker evidence. The reason it’s proposed is the experience of the workgroup and the evidence that is available of a high risk for patients with low life expectancy when they reduce their HbA_1c greatly. One of the concerns about being at that level might be the real issue of renal glycosuria for individuals when their blood glucose is reaching above 180 mg/dL, which correlates to the 8% to 9% HbA_1c range. You may have renal loss and risk of dehydration. It is an area where the clinician should be cautious in monitoring a patient in the 8% to 9% HbA_1c range. With that being said, a patient who is having a lot of challenges in their health and extremely advanced conditions could be in that range. We would not expect a reversing of a micro- or macrovascular disease with glycemia control. We’re not going to go back from that level of disease they have. The idea about keeping them there is to prevent the risks of overtreatment and harm to the patient.

Dr. Conlin. Since patients with diabetes can progress over their lifetime from no complications to mild-to-moderate complications to advanced complications, how does the HbA_1c target range evolve as a patient’s condition changes?

Dr. Colburn. As we check for evidence of microvascular disease or neuropathy signs, that evidence often is good for discussion between the clinician and patient to advise them that better control early on may help stem off or reverse some of that change. As those changes solidify, the patient is challenged by microvascular conditions. I would entertain allowing more relaxed HbA_1c ranges to prevent harm to the patient given that we’re not going back. But you have to be careful. We have to consider benefits to the patient and the challenges for controlling glucose.

I hope that this table doesn’t make providers throw up their hands and give up. It’s meant to start a conversation on safety and benefits. With newer agents coming out that can help us control glucose quite well, without as much hypoglycemia risk, clinicians and patients potentially can try and get that HbA_1c into a well-managed range.

Dr. Conlin. The CPG discusses various treatment options that might be available for patients who require pharmacologic therapy. The number of agents available is growing quite markedly. Dr. Colburn, can you describe how the CPG put together the pharmacologic therapy preferences.

Dr. Colburn. The CPG expressively stayed away from trying to promote specific regimens of medications. For example, other guidelines promote starting with certain agents followed by a second-line agent by a third-line agents. The concern that we had about that approach is that the medication landscape is rapidly evolving. The options available to clinicians and patients are really diverse at this moment, and the data are not concrete regarding what works best for a single patient.

Rather than trying to go from one agent to the next, we thought it best to discuss with patients using the SHARE decision-making model, the adverse effects (AEs) and relative benefits that are involved with each medication class to determine what might be best for the person. We have many new agents with evidence for possible reductions in cardiovascular outcomes outside of their glycemic control properties. As those evidences promote a potentially better option for a patient, we wanted to allow the room in management tomake a decision together. I will say the CPG as well as all of the other applicable diabetes guidelines for T2DM promote metformin as the first therapy to consider for somebody with newly diagnosed T2DM because of safety and availability and the benefit that’s seen with that medication class. We ask clinicians to access the AHRQ website for updates as the medicines evolve.

In a rapidly changing landscape with new drugs coming into the market, each agency has on their individual website information about individual agents and their formulary status, criteria for use, and prior authorization requirements. We refer clinicians to the appropriate website for more information.

Dr. Conlin. There are a series of new medications that have recently come to market that seem to mitigate risk for hypoglycemia. Dr. Lugo, which treatment options carry greater risk? Which treatment options seem to have lesser risk for hypoglycemia?

Amy M. Lugo, PharmD. Insulin and the sulfonylureas have the highest risk of hypoglycemia. The sulfonylureas have fallen out of favor somewhat. One reason is that there are many newer agents that do not cause weight gain or increase the risk of hypoglycemia. Some of the newer insulins may have a lower risk of hypoglycemia and nocturnal hypoglycemia, in particular; however, it is difficult to conclude emphatically that one basal insulin analog is less likely to cause clinically relevant severe or nocturnal hypoglycemia events. This is due to the differences in the definitions of hypoglycemia used in the individual clinical trials, the open label study designs, and the different primary endpoints.

Dr. Conlin. How much affect on HbA_1c might I expect to see using SGLT2 inhibitors or GLP-1 agonists? What would be some of the potential AEs I have to be aware of and therefore could counsel patients about?

Dr. Lugo. Let’s start with SGLT2 inhibitors. It depends on whether they are used as monotherapy or in combination. We prefer that patients start on metformin unless they have a contraindication. When used as monotherapy, the SGLT2s may decrease HbA_1c from 0.4% to 1% from baseline. When combined with additional agents, they can have > 1% improvement in HbA_1c from baseline. There are no head-to-head trials between any of the SGLT2 inhibitors. We cannot say that one is more efficacious than another in lowering HbA_1c. The most common AEs include genital mycotic infections and urinary tract infections. The SGLT2 inhibitors also should be avoided in renal impairment. There was a recent FDA safety alert for the class for risk of ketoacidosis. Additionally, the FDA warned that patients
with a history of bladder cancer should avoid dapagliflozin, and canagliflozin has a warning for increased risk of bone fractures, amputation, and decreased bone density.

Other actions of the SGLT2 inhibitors include a reduction in triglycerides and a modest increase in both low-density lipoprotein cholesterol and highdensity lipoprotein cholesterol. The SGLT2 inhibitors also slightly decrease systolic blood pressure (by 4 mm Hg to 6 mm Hg) and body weight (reduction of 1.8 kg)

The GLP-1s are likely to be more efficacious in reducing HbA_1c. Typically we see 1% or greater lowering in HbA_1c from baseline. As a class, the GLP-1 agonists have a lower risk of hypoglycemia; however, the risk increases when combined with sulfonylureas or insulin. The dose of insulin or sulfonylurea will likely need to be decreased when used concomitantly.

Patients are likely to experience weight loss when on a GLP-1 agonist, which is a great benefit. Gastrointestinal AEs such as nausea are common. Adverse effects may differ somewhat between the agents.

Dr. Conlin. Patients’ experience of care is integral to their engagement with treatment as well as their adherence. Ms. Decesare, what are patients looking for from their health care team?

Elaine M. Decesare. Patients are looking for a knowledgeable and compassionate health care team that has a consistent approach and a consistent message and that the team is updated on the knowledge of appropriate treatments and appropriate lifestyle modifications and targets for the care of diabetes.

Also, I think that the team needs to have some empathy for the challenges of living with diabetes. It’s a 24-hour-a-day disorder, 7 days a week. They can’t take vacation from it. They just can’t take a pill and forget about it. It’s a fairly demanding disorder, and sometimes just acknowledging that with the patient can help you with the dialog.

The second thing I think patients want is an effective treatment plan that’s tailored to their needs and lifestyles. That goes in with the shared decision-making approach, but the plan itself really has to be likely to achieve the targets and the goals that you’ve set up. Sometimes I see patients who are doing all they can with their lifestyle changes, but they can’t get to goal, because there isn’t enough medication in the plan. The plan has to be adequate so that the patient can manage their diabetes. In the shared approach, the patient has to buy in to the plan. With the shared decision making they’re more likely to take the plan on as their plan.

Dr. Conlin. How do you respond to patients who feel treatment burnout from having a new dietary plan, an exercise program, regular monitoring of glucose through finger sticks, and in many cases multiple medications and or injections, while potentially not achieving the goals that you and the patient have arrived at?

Ms. Decesare. First, I want to assess their mood. Sometimes patients are depressed, and they actually need help with that. If they have trouble with just the management, we do have behavioral health psychologists on our team that work with patients to get through some of the barriers and discuss some of the feelings that they have about diabetes and diabetes management.

Sometimes we look at the plan again and see if there’s something we can do to make the plan easier. Occasionally, something has happened in their life. Maybe they’re taking care of an elderly parent or they’ve had other health problems that have come about that we need to reassess the plan and make sure that it’s actually doable for them at this point in time.

Certainly diabetes self-management education can be helpful. Some of those approaches can be helpful for finding something that’s going to work for patients in the long run, because it can be a very difficult disorder to manage as time goes on.

Dr. Colburn. Type 2 DM disproportionately affects individuals who are ≥ 65 years compared with younger individuals. Such older patients also are more likely to have cognitive impairment or visual issues. How do we best manage such patients?

Ms. Decesare. When I’m looking at the care plan, social support is very important. If someone has social support and they have a spouse or a son or daughter or someone else that can help them with their diabetes, we oftentimes will get them involved with the plan, as long as it’s fine with the patient, to offer some help, especially with the patients with cognitive problems, because sometimes the patients just cognitively cannot manage diabetes on their own. Prandial insulin could be a really dangerous product for someone who has cognitive disease.

I think you have to look at all the resources that are available. Sometimes you have to change your HbA_1c target range to something that’s going to be manageable for that patient at that time. It might not be perfect, but it would be better to have no hypoglycemia rather than a real aggressive HbA_1c target or a target range, if that’s what’s going to keep the patient safe.

Dr. Conlin. We thank our discussants for sharing very practical advice on how to implement the CPG. We hope this information supports clinicians as they develop treatment plans based on each patient's unique characteristics and goals of care.

Click here to read the digital edition.

Paul Conlin, MD. Thank you all for joining us to talk about the recently released VA/DoD Clinical Practice Guideline for the Management of Type 2 Diabetes Mellitus in Primary Care (CPG). We’ve gathered together a group of experts who were part of the CPG development committee. We’re going to talk about some topics that were highlighted in the CPG that might provide additional detail to those in primary-care practices and help them in their management of patients with diabetes.

A unique feature of the VA/DoD CPG is that it emphasizes shared decision making as an important tool that clinicians should employ in their patient encounters. Dr. Watts, health care providers may wonder how they can make time for an intervention involving shared decision making using the SHARE approach, (ie, seek, help, assess, reach, and evaluate). Can you give us some advice on this?

Sharon Watts, DNP. Shared decision making is really crucial to success in diabetes. It’s been around for a while. We are trying to make an emphasis on this. The SHARE approach is from the Agency for Healthcare Research and Quality (AHRQ). The AHRQ has a wealth of information on its website. What AHRQ emphasizes is making it brief but conversational when you’re using the SHARE approach with your patient. Most importantly, the patient needs to be in the center of this dialogue, expressing his or her values and preferences of what’s most important to the whole team. This is a team effort. It’s not just with a provider. That’s where providers get overwhelmed. You can ask your nurse to advise the patient to write down 1 or 2 questions that are really important about diabetes before they come to see you, before the encounter. We can refer patients to diabetes classes where a lot of this information is given. The patient can talk to the dietitian or the pharmacist. There’s a whole team out there that will help in SHARE decision making. It’s crucial in the end for the provider to help the patient reach the decision and determine how best to treat the diabetes with them.

Dr. Conlin. Can you give a brief description of the key components of the SHARE approach?

Dr. Watts. Breaking it down simply, providers can start off by asking permission to go over the condition or treatment options because this immediately sets the stage as a signal to the patient that they are important in controlling the dialogue. It’s not the provider giving a discourse. You’re asking for permission. The next step would be to explore the benefits and risks of any course taken. Use decision aids if you have them. Keep in mind your patient’s current health literacy, numeracy, and other limitations.

Next ask about values, preferences, or barriers to whatever treatment you’re talking about. For instance, will this work with your work schedule?

Then the last thing would be ask what the patient wants to do next. Reach a decision on treatment, whatever it is, and make sure that you revisit that decision. Follow up later to see if it’s really working.

Dr. Conlin. If I’m a busy clinician and I have a limited amount of time with a patient, when are the appropriate times to employ the SHARE approach? Can I break it into components, where I address some elements during one visit and other elements in another visit?

Dr. Watts. Absolutely. It can be spread out. Your team is probably already providing information that will help in the SHARE approach. Just chart that you’ve done it. We know the SHARE approach is important because people
tend to be adherent if they came up with part of the plan.

Dr. Conlin. Where does diabetes self-management education and diabetes self-management support fall into this framework?

Dr. Watts. Diabetes is a complex disease for providers and for the team and even more so for our patients. Invite them to diabetes classes. There’s so much to understand. The classes go over medications and blood sugar ranges, though you still may have to review it with the patient in your office. It saves the provider time if you have an informed and activated patient. It’s the same with sending a patient to a dietitian. I do all of the above.

Dr. Conlin. Many providers may not be familiar with this type of approach. How can I tell whether or not I’m doing it correctly?

Dr. Watts. The AHRQ website has conversation starters (www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/tools/index.html). Then make sure when you are with the patient to use Teach-Back. Have that conversation and say, “I want to make sure I understood correctly what we decided would work best for you.” Ask patients to say in their own words what they understand. Then I think you’re off to a great start.

Dr. Conlin. Many patients tend to be deferential to their health care providers. They were brought up in an era where they needed to listen to and respect clinicians rather than participate in discussions about their ongoing care. How do you engage with these patients?

Dr. Watts. That is a tough one. Before the patient leaves the office, I ask them: Are there any barriers? Does this work for your schedule? Is this a preference and value that you have? Is there anything that might get in the way of this working when you go home? I try to pull out a little bit more, making sure to give them some decision aids and revisit it at the next visit to make sure it’s working.

Dr. Conlin. We’ll now turn to a discussion of using hemoglobin A1c (HbA_1c) measurements in clinical practice. Dr. Aron, what factors can impact the relationship between HbA_1c and blood glucose? How should we use HbA_1c in the treatment of patients who come from varied ethnic and racial backgrounds, where the relationship to average blood glucose may be different?

David C. Aron, MD, MS. The identification of HbA_1c has been a tremendous advance in our ability to manage patients with diabetes. It represents an average blood glucose over the preceding 3 months but like everything in this world, it has issues. One is the fact that there is a certain degree of inaccuracy in measurement, and that’s true of any measurement that you make of anything. Just as you allow a little bit of wiggle room when you’re driving down the New Jersey Turnpike and watching your speedometer, which is not 100% accurate. It says you are going 65 but it could, for example be 68 or 62. You don’t want to go too fast or you’ll get a speeding ticket. You don’t want to go too slowly or the person behind you will start honking at you. You want to be at the speed limit plus or minus. The first thing to think about in using HbA_1c is the issue of accuracy. Rather than choose a specific target number, health care providers should choose a range between this and that. There’ll be more detail on that later.

The second thing is that part of the degree to which HbA_1c represents the average blood glucose depends on a lot of factors, and some of these factors are things that we can do absolutely nothing about because we are born with them. African Americans tend to have higher HbA_1c levels than do whites for the same glucose. That difference is as much as 0.4. An HbA^_1c of 6.2 in African Americans gets you a 5.8 in whites for the same average blood glucose. Similarly, Native Americans have somewhat higher HbA_1c, although not quite as high as African Americans. Hispanics and Asians do as well, so you have to take your patient’s ethnicity into account.

The second has to do with the way that HbA_1c is measured and the fact that there are many things that can affect the measurement. An HbA_1c is dependent upon the lifespan of the red blood cell, so if there are alterations in red cell lifespan or if someone has anemia, that can affect HbA_1c. Certain hemoglobin variants, for example, hemoglobin F, which is typically elevated in someone with thalassemia, migrates with some assays in the same place as thalassemia, so the assay can’t tell the difference between thalassemia and hemoglobin F. There are drugs and other conditions that can also affect HbA_1c. You should think about HbA_1c as a guide, but no number should be considered to be written in stone.

Dr. Conlin. I can imagine that this would be particularly important if you were using HbA_1c as a criterion for diagnosing diabetes.

Dr. Aron. Quite right. The effects of race and ethnicity on HbA_1c account for one of the differences between the VA/DoD guidelines and those of the American Diabetes Association (ADA).

Dr. Conlin. Isn’t < 8% HbA_1c a national performance measure that people are asked to adhere to?

Dr. Aron. Not in the VA. In fact, the only performance measure that the VA has with a target is percent of patients with HbA_1c > 9%, and we don’t want any of those or very few of them anyway. We have specifically avoided targets like < 8% HbA_1c or < 7% HbA_1c, which was prevalent some years ago, because the choice of HbA_1c is very dependent upon the needs and desires of the individual patient. The VA has had stratified targets based on life expectancy and complications going back more than 15 years.

Dr. Conlin. Another issue that can confuse clinicians is when the HbA_1c is in the target range but actually reflects an average of glucose levels that are at times very high and very low. How do we address this problem clinically?

Dr. Aron. In managing patients, you use whatever data you can get. The HbA_1c gives you a general indication of average blood glucose, but particularly for those patients who are on insulin, it’s not a complete substitute for measuring blood glucose at appropriate times and taking the degree of glucose variability into account. We don’t want patients getting hypoglycemic, and particularly if they’re elderly, falling, or getting into a car accident. Similarly, we don’t want people to have very high blood sugars, even for limited periods of time, because they can lead to dehydration and other symptoms as well. We use a combination of both HbA_1c and individual measures of blood glucose, like finger-stick blood sugar testing, typically.

Dr. Conlin. The VA/DoD CPG differs from other published guidelines in that we proposed patients are treated to HbA_1c target ranges, whereas most other guidelines propose upper limits or threshold values, such as the HbA_1c should be < 7% or < 8% but without lower bounds. Dr. Colburn, what are the target ranges that are recommended in the CPG? How were they determined?

Maj. Jeffrey A. Colburn, MD. It may be helpful to pull up the Determination of Average Target HbA_1c Level Over Time table (page S17), which lays out risk for patients of treatment as well as the benefits of treatment. We first look at the patient’s state of health and whether they have a major comorbidity, a physiologic age that could be high risk, or advanced physiologic age with a diminished life expectancy. In controlling the levels of glucose, we’re often trying to benefit the microvascular health of the patient, realizing also that eventually poor management over time will lead to macrovascular disease as well. The main things that we see in child data is that the benefits of tight glucose control for younger patients with shorter duration of type 2 diabetes mellitus (T2DM) is the prevention of retinopathy, nephropathy, and peripheral neuropathy. Those patients that already have advanced microvascular disease are less likely to benefit from tight control. Trying to push glucose very low can harm the patient. It’s a delicate balance between the possible benefit vs the real harm.

The major trials are the ADVANCE, ACCORD, and the VADT trial, which was done in a VA population. To generalize the results, you are looking at an intensive control, which was trying to keep the HbA_1c in general down below the 7% threshold. The patients enrolled in those trials all had microvascular and macrovascular disease and typically longer durations of diabetes at the time of the study. The studies revealed that we were not preventing macrovascular disease, heart attacks, strokes, the types of things that kill patients with diabetes. Individuals at higher HbA_1c levels that went down to better HbA_1c levels saw some improvement in the microvascular risk. Individuals already at the lower end didn’t see as much improvement. What we saw though that was surprising and concerning was that hypoglycemia, particularly severe hypoglycemia in the VADT trial was a lot more frequent when you try and target the HbA_1c on the lower end. Because of these findings, we proposed the table with a set of ranges. As Dr. Aron noted, HbA_1c is not a perfect test. It does have some variance in the number it presents. The CPG proposed to give individuals target ranges. They should be individualized based upon physiologic age, comorbidities, and life expectancy.

A criticism of the table that I commonly hear is what’s the magic crystal ball for determining somebody’s life expectancy? We don’t have one. This is a clinician’s judgment. The findings might actually change over time with the patient. A target HbA_1c range is something that should be adapted and evolve along with the clinician and patient experience of the diabetes.

There are other important studies. For example, the UKPDS trials that included patients with shorter durations of diabetes and lesser disease to try and get their HbA_1c levels on the lower end. We included that in the chart. Another concept we put forward is the idea of relative risk (RR) vs absolute risk. The RR reduction doesn’t speak to what the actual beginning risk is lowered to for a patient. The UKPDS is often cited for RR reduction of microvascular disease as 37% when an HbA_1c of 7.9% is targeted down to 7.0%. The absolute risk reduction is actually 5 with the number needed to treat to do so is 20 patients. When we present the data, we give it a fair shake. We want individuals to guide therapy that is going to be both beneficial to preventing outcomes but also not harmful to the patient. I would highly recommend clinicians and patients look at this table together when making their decisions.

Dr. Conlin. In the VA/DoD CPG, the HbA_1c target range for individuals with limited life expectancy extends to 9%. That may seem high for some, since most other guidelines propose lower HbA_1c levels. How strong are the data that a person with limited life expectancy, say with end-stage renal disease or advanced complications, could be treated to a range of 8% to 9%? Shouldn’t lower levels actually improve life expectancy in such people?

Dr. Colburn. There’s much less data to support this level, which is why it’s cited in CPG as having weaker evidence. The reason it’s proposed is the experience of the workgroup and the evidence that is available of a high risk for patients with low life expectancy when they reduce their HbA_1c greatly. One of the concerns about being at that level might be the real issue of renal glycosuria for individuals when their blood glucose is reaching above 180 mg/dL, which correlates to the 8% to 9% HbA_1c range. You may have renal loss and risk of dehydration. It is an area where the clinician should be cautious in monitoring a patient in the 8% to 9% HbA_1c range. With that being said, a patient who is having a lot of challenges in their health and extremely advanced conditions could be in that range. We would not expect a reversing of a micro- or macrovascular disease with glycemia control. We’re not going to go back from that level of disease they have. The idea about keeping them there is to prevent the risks of overtreatment and harm to the patient.

Dr. Conlin. Since patients with diabetes can progress over their lifetime from no complications to mild-to-moderate complications to advanced complications, how does the HbA_1c target range evolve as a patient’s condition changes?

Dr. Colburn. As we check for evidence of microvascular disease or neuropathy signs, that evidence often is good for discussion between the clinician and patient to advise them that better control early on may help stem off or reverse some of that change. As those changes solidify, the patient is challenged by microvascular conditions. I would entertain allowing more relaxed HbA_1c ranges to prevent harm to the patient given that we’re not going back. But you have to be careful. We have to consider benefits to the patient and the challenges for controlling glucose.

I hope that this table doesn’t make providers throw up their hands and give up. It’s meant to start a conversation on safety and benefits. With newer agents coming out that can help us control glucose quite well, without as much hypoglycemia risk, clinicians and patients potentially can try and get that HbA_1c into a well-managed range.

Dr. Conlin. The CPG discusses various treatment options that might be available for patients who require pharmacologic therapy. The number of agents available is growing quite markedly. Dr. Colburn, can you describe how the CPG put together the pharmacologic therapy preferences.

Dr. Colburn. The CPG expressively stayed away from trying to promote specific regimens of medications. For example, other guidelines promote starting with certain agents followed by a second-line agent by a third-line agents. The concern that we had about that approach is that the medication landscape is rapidly evolving. The options available to clinicians and patients are really diverse at this moment, and the data are not concrete regarding what works best for a single patient.

Rather than trying to go from one agent to the next, we thought it best to discuss with patients using the SHARE decision-making model, the adverse effects (AEs) and relative benefits that are involved with each medication class to determine what might be best for the person. We have many new agents with evidence for possible reductions in cardiovascular outcomes outside of their glycemic control properties. As those evidences promote a potentially better option for a patient, we wanted to allow the room in management tomake a decision together. I will say the CPG as well as all of the other applicable diabetes guidelines for T2DM promote metformin as the first therapy to consider for somebody with newly diagnosed T2DM because of safety and availability and the benefit that’s seen with that medication class. We ask clinicians to access the AHRQ website for updates as the medicines evolve.

In a rapidly changing landscape with new drugs coming into the market, each agency has on their individual website information about individual agents and their formulary status, criteria for use, and prior authorization requirements. We refer clinicians to the appropriate website for more information.

Dr. Conlin. There are a series of new medications that have recently come to market that seem to mitigate risk for hypoglycemia. Dr. Lugo, which treatment options carry greater risk? Which treatment options seem to have lesser risk for hypoglycemia?

Amy M. Lugo, PharmD. Insulin and the sulfonylureas have the highest risk of hypoglycemia. The sulfonylureas have fallen out of favor somewhat. One reason is that there are many newer agents that do not cause weight gain or increase the risk of hypoglycemia. Some of the newer insulins may have a lower risk of hypoglycemia and nocturnal hypoglycemia, in particular; however, it is difficult to conclude emphatically that one basal insulin analog is less likely to cause clinically relevant severe or nocturnal hypoglycemia events. This is due to the differences in the definitions of hypoglycemia used in the individual clinical trials, the open label study designs, and the different primary endpoints.

Dr. Conlin. How much affect on HbA_1c might I expect to see using SGLT2 inhibitors or GLP-1 agonists? What would be some of the potential AEs I have to be aware of and therefore could counsel patients about?

Dr. Lugo. Let’s start with SGLT2 inhibitors. It depends on whether they are used as monotherapy or in combination. We prefer that patients start on metformin unless they have a contraindication. When used as monotherapy, the SGLT2s may decrease HbA_1c from 0.4% to 1% from baseline. When combined with additional agents, they can have > 1% improvement in HbA_1c from baseline. There are no head-to-head trials between any of the SGLT2 inhibitors. We cannot say that one is more efficacious than another in lowering HbA_1c. The most common AEs include genital mycotic infections and urinary tract infections. The SGLT2 inhibitors also should be avoided in renal impairment. There was a recent FDA safety alert for the class for risk of ketoacidosis. Additionally, the FDA warned that patients
with a history of bladder cancer should avoid dapagliflozin, and canagliflozin has a warning for increased risk of bone fractures, amputation, and decreased bone density.

Other actions of the SGLT2 inhibitors include a reduction in triglycerides and a modest increase in both low-density lipoprotein cholesterol and highdensity lipoprotein cholesterol. The SGLT2 inhibitors also slightly decrease systolic blood pressure (by 4 mm Hg to 6 mm Hg) and body weight (reduction of 1.8 kg)

The GLP-1s are likely to be more efficacious in reducing HbA_1c. Typically we see 1% or greater lowering in HbA_1c from baseline. As a class, the GLP-1 agonists have a lower risk of hypoglycemia; however, the risk increases when combined with sulfonylureas or insulin. The dose of insulin or sulfonylurea will likely need to be decreased when used concomitantly.

Patients are likely to experience weight loss when on a GLP-1 agonist, which is a great benefit. Gastrointestinal AEs such as nausea are common. Adverse effects may differ somewhat between the agents.

Dr. Conlin. Patients’ experience of care is integral to their engagement with treatment as well as their adherence. Ms. Decesare, what are patients looking for from their health care team?

Elaine M. Decesare. Patients are looking for a knowledgeable and compassionate health care team that has a consistent approach and a consistent message and that the team is updated on the knowledge of appropriate treatments and appropriate lifestyle modifications and targets for the care of diabetes.

Also, I think that the team needs to have some empathy for the challenges of living with diabetes. It’s a 24-hour-a-day disorder, 7 days a week. They can’t take vacation from it. They just can’t take a pill and forget about it. It’s a fairly demanding disorder, and sometimes just acknowledging that with the patient can help you with the dialog.

The second thing I think patients want is an effective treatment plan that’s tailored to their needs and lifestyles. That goes in with the shared decision-making approach, but the plan itself really has to be likely to achieve the targets and the goals that you’ve set up. Sometimes I see patients who are doing all they can with their lifestyle changes, but they can’t get to goal, because there isn’t enough medication in the plan. The plan has to be adequate so that the patient can manage their diabetes. In the shared approach, the patient has to buy in to the plan. With the shared decision making they’re more likely to take the plan on as their plan.

Dr. Conlin. How do you respond to patients who feel treatment burnout from having a new dietary plan, an exercise program, regular monitoring of glucose through finger sticks, and in many cases multiple medications and or injections, while potentially not achieving the goals that you and the patient have arrived at?

Ms. Decesare. First, I want to assess their mood. Sometimes patients are depressed, and they actually need help with that. If they have trouble with just the management, we do have behavioral health psychologists on our team that work with patients to get through some of the barriers and discuss some of the feelings that they have about diabetes and diabetes management.

Sometimes we look at the plan again and see if there’s something we can do to make the plan easier. Occasionally, something has happened in their life. Maybe they’re taking care of an elderly parent or they’ve had other health problems that have come about that we need to reassess the plan and make sure that it’s actually doable for them at this point in time.

Certainly diabetes self-management education can be helpful. Some of those approaches can be helpful for finding something that’s going to work for patients in the long run, because it can be a very difficult disorder to manage as time goes on.

Dr. Colburn. Type 2 DM disproportionately affects individuals who are ≥ 65 years compared with younger individuals. Such older patients also are more likely to have cognitive impairment or visual issues. How do we best manage such patients?

Ms. Decesare. When I’m looking at the care plan, social support is very important. If someone has social support and they have a spouse or a son or daughter or someone else that can help them with their diabetes, we oftentimes will get them involved with the plan, as long as it’s fine with the patient, to offer some help, especially with the patients with cognitive problems, because sometimes the patients just cognitively cannot manage diabetes on their own. Prandial insulin could be a really dangerous product for someone who has cognitive disease.

I think you have to look at all the resources that are available. Sometimes you have to change your HbA_1c target range to something that’s going to be manageable for that patient at that time. It might not be perfect, but it would be better to have no hypoglycemia rather than a real aggressive HbA_1c target or a target range, if that’s what’s going to keep the patient safe.

Dr. Conlin. We thank our discussants for sharing very practical advice on how to implement the CPG. We hope this information supports clinicians as they develop treatment plans based on each patient's unique characteristics and goals of care.

Click here to read the digital edition.

Electronic consultations  (e-consults), also called e-referrals, are an alternative method of obtaining general patient information through the electronic health record (EHR) shared by primary care providers (PCPs) and specialists in the VHA. In the e-consult system, test results, medication lists, and other pertinent data are available.¹ Many PCPs are willing to use new technologies to maximize practice efficiency and patient convenience.² In the VHA’s hub-and-spoke model of care, e-consults have the potential to make delivery of specialty care more efficient by prearranging or completing necessary diagnostic testing and redirecting inappropriate referrals to the correct specialists.¹

Some early studies of e-consults report better communication, improved referral appropriateness, and greater access to specialty care as well as better continuity of care and information transfer between patients and PCPs.^3-5 Researchers at the VA Boston Healthcare System in Massachusetts found that 61% of specialists surveyed agreed that e-consults improve quality of care and found the approach beneficial to help initiate diagnostic testing prior to a face-to-face visit.⁶ However, researchers at the Michael E. DeBakey VAMC in Houston, Texas, found no improvement in care coordination.⁷ To date, there have been no large-scale evaluations of e-consult programs or assessments of implementation of e-consult programs.

Related: HHS Grants Fund Health IT in Communities

In early 2011, the VHA Office of Specialty Care Services (OSCS), Office of Specialty Care Transformation launched a national e-consult pilot as part of a broader effort to improve the delivery of patient-centered specialty care. This initiative was based on core concepts advanced by the American College of Physicians, which highlighted the importance of specialty care within a patient- centered medical home and provided a framework for collaboration.^8,9 The goals of the e-consult program were to improve access to specialty care for veterans and their PCPs, to enhance the collaborative relationship between PCPs and specialists, and to augment PCP education.

The OSCS created an Electronic Consultation Implementation Guide to help sites develop and implement each of their e-consult programs.¹⁰ The Implementation Guide established operating rules, strategies for engaging key stakeholders, and recommendations for provider education and training.

As with face-to-face referrals, e-consults are organized in a hub-and-spoke model, where community-based outpatient clinics (CBOCs) are linked to a central VAMC. An e-consult can be accessed by any CBOC, VAMC, medical center-based primary care clinic or specialist, and between medical centers that share the same EHR. There were 217,014 completed e-consults between May 2011 and December 2013 across VHA.¹¹

Some programs created an e-consult template to aid in the transition to electronic referrals (Figure). Although not mandatory, the template helped organize needed information to expedite the e-consult.

The objective of this evaluation is to describe the implementation of e-consults from the perspectives of PCPs, specialists, and other key staff involved in the pilot. Key findings were related to: (1) how the e-consult pilot was implemented; (2) how implementation of the e-consult pilot affected providers; and (3) to what extent the e-consult pilot achieved programmatic objectives from the provider’s perspective.

Methods

The authors conducted a key informant analysis with 2 waves of interviews at 8 e-consult pilot sites across the U.S., selected for variation on early progress in implementation. The sites cannot be identified based on an agreement with the VA Office of Labor-Management Relations.

Setting

The e-consult pilot involved 15 VAMCs in 2 cohorts: alpha sites, which began using e-consults in May 2011, and beta sites, which began using e-consults in July 2011. The alpha sites included 10 VAMCs in 12 medical specialties, with a total of 21 facility-specialty combinations. For the evaluation, sites were defined based on specialty, regardless of location within the same medical center (eg, cardiology and diabetes at the same VAMC would be 2 sites). Beta sites included 5 VAMCs with 6 medical specialties for a total of 6 sites. For 1 year, alpha sites received $175,000 and beta sites received $150,000 to support start-up activities.

Initial specialties included diabetes, hepatitis C, geriatrics, cardiology, liver transplant, dementia, gastrointestinal disease, pulmonary medicine, rheumatology, pain management, neurosurgery, infectious diseases, hematology/oncology, and vascular surgery. Facilities could add additional e-consult specialties but did not receive further funding.

Sample

Study participants were selected from 8 of the 15 pilot sites (geographic site/specialty combinations). Site selection was based on 2 measures of baseline e-consult implementation: (1) overall e-consult implementation rates, measured as the ratio of e-consults to all consults for the specialties of interest; and (2) CBOC participation, measured as the ratio of e-consults for patients from CBOCs vs e-consults for patients from primary care clinics located within the 152 VAMCs. Participation with CBOCs was important for ensuring that implementation factors that influenced uptake of e-consults within tertiary medical centers and between VAMCs and CBOCs could be identified. Two e-consult sites were randomly selected from each of the 4 resulting categories (VAMC high volume, VAMC low volume, CBOC high volume, and CBOC low volume). Volume data of e-consults were obtained from the VA Corporate Data Warehouse and assessed from the beginning of the pilot period to initial site selection, May 2011 to February 2012.

Respondents were identified using a modified snowball sampling process. Snowball sampling is a qualitative sampling technique that identifies study participants, who then identify other potential participants to participate in the study. The researchers started with the local e-consult initiative lead and then contacted the directors of primary care and specialty care services for help identifying PCPs, specialists, and support staff (nurse practitioners, pharmacists, program managers, informatics staff, and medical support personnel) engaged in the initiative. The goal for follow-up interviews was to interview at least 2 of the following respondents at each site: e-consult project manager, PCP, and/or specialist. Due to turnover and changes in clinic roles, some follow-up interviews were conducted with different individuals from the baseline interviews.

Data Collection

Interviews followed semistructured interview guidelines and included open-ended questions designed to elicit rich responses to a variety of aspects related to e-consult implementation, including patient needs, communication, leadership, resources, priorities, knowledge about the program, and unintended consequences. Follow-up interviews addressed how e-consults impacted the quality of specialty care; the impact of e-consults on Patient Aligned Care Teams (PACTs), the VHA patient-centered medical home initiative for primary care; and how e-consults have been used, eg, whether patients were involved in the decision to seek an e-consult.

Two interviewers who had participated in a 1-day, in-person training covering both data collection and analyzing key informant data conducted the 40 to 60 minute telephone interviews. One team member conducted the interview while the other took field notes. Interviews were also recorded. Follow-up probes were used to elicit specific examples and ensure sufficiently rich data. Following each interview, the notetaker reviewed the audio recording and filled in details in the field notes. The interview team debriefed and reviewed the augmented field notes and audio recordings, which became the primary data sources for the study.

Analysis

This was a qualitative descriptive analysis.¹² Interview data were analyzed using an iterative, inductive content analysis method using an open coding approach (ie, a priori codes were not defined for this portion of the analysis).¹³ Two members of the research team used audio recordings and summary transcripts simultaneously to code data. Summary transcripts were compared with the recorded interviews to assure fidelity.

The researchers used Atlas.ti (Berlin, Germany) qualitative data analysis software to organize the coding process. Emergent codes were iteratively added throughout the analysis to reflect quotations that did not adequately fit previously developed codes. Codes were combined weekly to biweekly. After the combinations were completed, the analytics team met to review meanings of codes to ensure consistency of coding and interpretations.

To create categories, broad themes were identified from interview responses and grouped under high- order headings that described distinct aspects of participant experience. The analysis was intentionally kept close to the original data to reflect and describe the participant’s experience as accurately as possible. In support of analytical rigor, members of the multidisciplinary research team, composed of clinicians, implementation scientists, and mixed methodologists, reviewed findings to assess their thoroughness, comprehensiveness, and representativeness across roles and participating sites.¹⁴

Results

The e-consult evaluation period was from November 1, 2011, to July 31, 2013. Key conclusions were drawn from both alpha and beta sites (Table). Baseline interviews were conducted with 37 participants at 8 sites from April 10, 2012, to August 6, 2012. Follow-up interviews were conducted with 21 of the 37 participants at the 8 sites. Follow-up interviews with either a PCP or specialist could not be scheduled at 1 site. Follow-up interviews were conducted from April 16, 2013, to June 18, 2013. Open coding continued until saturation (the point at which subsequent data failed to produce new findings).¹⁵ This occurred after analysis of 22 baseline interviews (12 PCPs, 6 specialists, 1 pharmacist, and 4 other staff members) and 17 follow-up interviews (10 PCPs, 4 specialists, 1 pharmacist, and 2 other staff members).

Implementation


The e-consults provided a programmatic structure to the more informal practice of obtaining diagnostic or therapeutic advice from a specialist. Several of the specialists interviewed described having previously used existing informal consult processes that were “like e-consult.” These specialists reported that their practice patterns did not change significantly since implementing e-consults, because they have been “using the Computerized Patient Record System (CPRS) in an e-consult way for many years.” In these cases, the primary change resulting from the initiative was that national VHA workload policy was revised so that e-consults were assigned a CPT (Current Procedural Terminology) code and specialists began receiving workload credit for completing e-consults.

At sites where an informal e-consult practice was already in place, the initiative was consistently described as flexible. Many specialists reported that this degree of flexibility allowed them to make a relatively easy transition to e-consults by adopting new mechanisms to support existing processes. The e-consult initiative also allowed specialists to formally document this work and to increase the efficiency of specialty care.

Specialists drove the implementation process across sites. The e-consults were envisioned as a collaborative process; however, during initial interviews, few specialists mentioned PCPs when describing the development and implementation of the e-consult program. Primary care providers also reported having little awareness of or input into how the initiative was implemented, although this had little consequence on the use of e-consults.

In a rare case, a PCP reported that poorly designed, lengthy e-consult templates were a major barrier to using e-consults for specific specialties. The PCP said, “E-consults have created an elaborate but extraordinarily cumbersome tool that is difficult for PCPs to actually accomplish, because you have a consult menu that requires a lot of data to be entered—a lot of history from the chart, a lot of exam findings, a lot of previous cognitive testing scores; neurologic findings—lab and imaging tests.”

Still, many other PCPs described receiving detailed information and guidance from e-consults. “E-consults help me to be more accurate. Many providers don’t have a comfort with pain management. To get guidance and education and to really hold our hand, this is how to do this…this has been a big change. If they give you a great response, then [for] the next patient [with that condition], you go back to that note and then follow what was said there,” said one PCP.

In follow-up interviews, providers and other key staff stated there were more data available on the patient as a result of the e-consult and, consequently, even when specialists determined that a patient needed an in-person visit, the data obtained in the e-consult improved the quality of the in-person consultation.

Enhanced Communication and Collaboration

Neither the PCPs nor the specialists were aware of the collaborative intent of the initiative. They focused, instead, on other key aims, such as increasing accessibility and minimizing unnecessary patient travel. Most participants were generally positive about e-consults during baseline interviews, and this perception increased over time.

Both the PCPs and the specialists reported improved communication following the launch of e-consults. In follow-up interviews, some PCPs reported that before e-consults, they had trouble getting timely responses from specialists unless they knew them personally. “You had to know the person in the old days,” one respondent said. “After e-consults, responses improved…e-consult is available to have the resources to tap that knowledge base, and the team is answering the question. I think it opens up access and information and knowledge to everybody.”

Many PCPs spoke positively about this new communication tool as an opportunity to learn from specialists and said they valued the input they received. They felt the increased interaction between the 2 groups positively benefited patient care. One example cited that collaborative communication improved care coordination for veterans: “We are able to step in with e-consults to coordinate services, and this has been huge in improving care.”

Furthermore, follow-up interviews found that all participating PCPs and specialists were communicating more frequently and effectively. “Services that have embraced e-consult give a lot of great information flowing back; it’s closer to a real-time conversation,” said one respondent. 


Related: Home-Based Video Telehealth for Veterans With Dementia

In baseline interviews, some specialists described how e-consults went against their belief that patient care is synonymous with face-to-face medical treatment and voiced dissatisfaction with e-consults as “sitting in front of a computer” rather than “seeing patients.” Others were concerned that medical center administration would not recognize the time it takes to conduct an e-consult and therefore not add necessary specialists staff. “E-consults take work and time, just like seeing a patient. I worry that won’t be seen,” one specialist said.

In order to successfully implement the e-consult initiative, providers and staff needed to incorporate new processes into their daily workflow.

Most sites did not develop a mechanism in which specialists received feedback regarding the outcome of their consultations. This lack of response created anxiety for some specialists in the absence of the face-to-face encounter, leaving some wondering whether they or the PCP had missed anything. According to one specialist, “That’s always in the back of your head: ‘Have I [the specialist] missed something?’”

In follow-up interviews, none of these concerns were raised. Primary care providers tended to speak of the care provided by specialists through e-consults in very positive terms, except in those instances where PCPs felt the e-consult template was difficult to use and required too much time to complete. “I was worried in the beginning about patients thinking less of me, but we ask for help all the time. We’re asking for help and not inconveniencing the patient; they seem to like it very much,” one PCP said.

The e-consults also complement PACTs. Initially, a few participants described soliciting patient input regarding the choice to have an e-consult or a face-to-face visit. During follow-up interviews, participants highlighted how well e-consults fit in to the PACT philosophy. One participant said, “The PACT team seeks to improve quality of care. E-consult fits very well with this, because answers to questions can come quickly, and the veteran may not need to come back to the clinic to be seen, even though things are still getting accomplished. E-consult works very well. E-consults were credited with improving access to specialty care as a tool for PACT.”

Achieving Program Objectives


Based on interviews, support for the e-consult program has increased over time as providers have gained experience with the program and have seen its benefits. Respondents at all sites consistently supported the concept of e-consults and expressed their belief in the importance and value of e-consults in improving patient-c entered care, primarily by reducing the need for patients to travel to see specialists, reducing the time to obtain feedback from specialists, and maintaining the provision of high quality care.

“Last year we only had 2 clinics categorized as e-consults. As of now we have 14 e-consults available for our providers. I think the numbers are growing. They are realizing the value of e-consults as far as the provider’s needs being met,” said one respondent.

The e-consults were credited with improving access to specialty care for veterans. Several participants stated that e-consults improved access to specialty care services and decreased travel for veterans. “It’s another way of getting care to the patient when the patient needs it without having to wait,” said one respondent.

Many PCPs described how difficult it was for patients to get to specialty appointments—particularly for their elderly, disabled, and rural patients—before the implementation of e-consults. “I like the fact that patients who live very far don’t have to come back. A lot of our patients are older…diabetic, see me Monday and back on Thursday. Now, they are able to stay home and follow the recommendations I write,” said one PCP.

Most providers were of the opinion that patients liked the program. “I think e-consults are helping patients...It’s been very successful regarding decreasing travel…Quicker response time for specialty care,” said a PCP. Several providers also stated in follow-up interviews that there was a greater degree of patient participation in the e-consult process and that “patients are definitely informed.”

Discussion

Most PCPs reported that the e-consults were an effective means of consultation and contained the information they needed to provide high-quality coordinated care. Most also found e-consult templates easy to complete. A majority of PCPs felt sufficient control over the choice of whether to use e-consults or an in-person visit, and a minority of patients were involved in the decision to receive an e-consult. Although the OSCS outlined guiding principles and operational rules in the Implementation Guide to help sites implement the e-consult program, its contribution was limited. Few examples were found that engaged PCPs in development of the e-consult program locally; involving patients in the decision to obtain a specialty consult electronically or in person; and PCPs feeding back results to specialists.

Implementing e-consults posed a number of challenges, including lack of resources to respond to referral requests, lack of referral policies and standardized procedures, and confusion related to roles and responsibilities. This is consistent with findings from another VHA research project of e-consults in 2 VHA health systems that was conducted prior to this national level e-consult pilot.⁷

Related: Using Facilitative Coaching to Support Patient Aligned Care Teams

Communication by OSCS of key aspects of the e-consult initiative will be critical as more sites implement e-consults. Since initiation of this pilot, workload specifications and credit have changed from 1 code to 3 codes, to more accurately reflect the amount of time a specialist consultant spends reviewing the EHR and responding to the consult. Without seeing the patient directly, specialists are more reliant on the PCP to describe the problem and provide adequate information in the e-consult request in order to provide recommendations back to the PCP.

Primary care physicians need to know that e-consults are available and determine when they are appropriate. A template or other guidance may be helpful to ensure adequate information is provided in the e-consult request; and the information provided by the specialist in response to the e-consult has to be sufficient for the PCP to provide care. VHA continues to expand the use of e-consults throughout the system, as this pilot found that the electronic option was often more timely than were face-to-face consultations. The result of this evaluation has informed national implementation of this effort.

Limitations

There are 3 main limitations to this study. First, because there was no practical way to preidentify participants who participated in implementing e-consults, a modified snowball sampling was used. However, this limited the degree to which the group was representative of the pilot participants. Second, the authors reported findings from a real-world initiative, not an experimental study. As such, not all participants in the first wave of key informant interviews were available for follow-up interview, which may have introduced bias. Third, the VHA is unlike most of the rest of the U.S. health care system in that it is a fully integrated system with salaried PCPs and specialists and an EHR.

Generalizability of the study may be limited, as a modified snowball sampling approach is not entirely random and has potential for community bias, because initial participants influence subsequent sampling. Additionally, though the sample size (n = 37) was sufficient for qualitative, in-depth analysis, it may be too small for confident generalization of findings. However, as health care moves toward an accountable care organization system, the authors’ analysis may provide insights.

Issues include revision of reimbursement policy for e-consults and developing or coordinating informational technology infrastructures to permit e-consults. It is also important to note that this evaluation reports solely on the extent of implementation of e-consults and the effects of e-consult implementation from the perspectives of staff, including specialists and PCPs.

Evaluating the effectiveness of the program in improving access, care coordination, and patient satisfaction was beyond the scope of the study. Further research is needed, because findings on those outcomes are critical for drawing inferences about this study’s implementation results.

Conclusion

The assessment of the e-consult system by providers and staff was based on a perception that e-consults are a valuable tool in providing greater access to quality care. Currently, e-consults have been expanded across VHA in medical and surgical specialties. VHA policymakers have drafted field guidance and a communication plan to support these efforts.

Acknowledgement
This material is based on work supported by the VA Office of Specialty Care Transformation, the office overseeing the e-consult initiative, and the Office of Research and Development Quality Enhancement Research Initiative.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Electronic consultations  (e-consults), also called e-referrals, are an alternative method of obtaining general patient information through the electronic health record (EHR) shared by primary care providers (PCPs) and specialists in the VHA. In the e-consult system, test results, medication lists, and other pertinent data are available.¹ Many PCPs are willing to use new technologies to maximize practice efficiency and patient convenience.² In the VHA’s hub-and-spoke model of care, e-consults have the potential to make delivery of specialty care more efficient by prearranging or completing necessary diagnostic testing and redirecting inappropriate referrals to the correct specialists.¹

Some early studies of e-consults report better communication, improved referral appropriateness, and greater access to specialty care as well as better continuity of care and information transfer between patients and PCPs.^3-5 Researchers at the VA Boston Healthcare System in Massachusetts found that 61% of specialists surveyed agreed that e-consults improve quality of care and found the approach beneficial to help initiate diagnostic testing prior to a face-to-face visit.⁶ However, researchers at the Michael E. DeBakey VAMC in Houston, Texas, found no improvement in care coordination.⁷ To date, there have been no large-scale evaluations of e-consult programs or assessments of implementation of e-consult programs.

Related: HHS Grants Fund Health IT in Communities

In early 2011, the VHA Office of Specialty Care Services (OSCS), Office of Specialty Care Transformation launched a national e-consult pilot as part of a broader effort to improve the delivery of patient-centered specialty care. This initiative was based on core concepts advanced by the American College of Physicians, which highlighted the importance of specialty care within a patient- centered medical home and provided a framework for collaboration.^8,9 The goals of the e-consult program were to improve access to specialty care for veterans and their PCPs, to enhance the collaborative relationship between PCPs and specialists, and to augment PCP education.

The OSCS created an Electronic Consultation Implementation Guide to help sites develop and implement each of their e-consult programs.¹⁰ The Implementation Guide established operating rules, strategies for engaging key stakeholders, and recommendations for provider education and training.

As with face-to-face referrals, e-consults are organized in a hub-and-spoke model, where community-based outpatient clinics (CBOCs) are linked to a central VAMC. An e-consult can be accessed by any CBOC, VAMC, medical center-based primary care clinic or specialist, and between medical centers that share the same EHR. There were 217,014 completed e-consults between May 2011 and December 2013 across VHA.¹¹

Some programs created an e-consult template to aid in the transition to electronic referrals (Figure). Although not mandatory, the template helped organize needed information to expedite the e-consult.

The objective of this evaluation is to describe the implementation of e-consults from the perspectives of PCPs, specialists, and other key staff involved in the pilot. Key findings were related to: (1) how the e-consult pilot was implemented; (2) how implementation of the e-consult pilot affected providers; and (3) to what extent the e-consult pilot achieved programmatic objectives from the provider’s perspective.

Methods

The authors conducted a key informant analysis with 2 waves of interviews at 8 e-consult pilot sites across the U.S., selected for variation on early progress in implementation. The sites cannot be identified based on an agreement with the VA Office of Labor-Management Relations.

Setting

The e-consult pilot involved 15 VAMCs in 2 cohorts: alpha sites, which began using e-consults in May 2011, and beta sites, which began using e-consults in July 2011. The alpha sites included 10 VAMCs in 12 medical specialties, with a total of 21 facility-specialty combinations. For the evaluation, sites were defined based on specialty, regardless of location within the same medical center (eg, cardiology and diabetes at the same VAMC would be 2 sites). Beta sites included 5 VAMCs with 6 medical specialties for a total of 6 sites. For 1 year, alpha sites received $175,000 and beta sites received $150,000 to support start-up activities.

Initial specialties included diabetes, hepatitis C, geriatrics, cardiology, liver transplant, dementia, gastrointestinal disease, pulmonary medicine, rheumatology, pain management, neurosurgery, infectious diseases, hematology/oncology, and vascular surgery. Facilities could add additional e-consult specialties but did not receive further funding.

Sample

Study participants were selected from 8 of the 15 pilot sites (geographic site/specialty combinations). Site selection was based on 2 measures of baseline e-consult implementation: (1) overall e-consult implementation rates, measured as the ratio of e-consults to all consults for the specialties of interest; and (2) CBOC participation, measured as the ratio of e-consults for patients from CBOCs vs e-consults for patients from primary care clinics located within the 152 VAMCs. Participation with CBOCs was important for ensuring that implementation factors that influenced uptake of e-consults within tertiary medical centers and between VAMCs and CBOCs could be identified. Two e-consult sites were randomly selected from each of the 4 resulting categories (VAMC high volume, VAMC low volume, CBOC high volume, and CBOC low volume). Volume data of e-consults were obtained from the VA Corporate Data Warehouse and assessed from the beginning of the pilot period to initial site selection, May 2011 to February 2012.

Respondents were identified using a modified snowball sampling process. Snowball sampling is a qualitative sampling technique that identifies study participants, who then identify other potential participants to participate in the study. The researchers started with the local e-consult initiative lead and then contacted the directors of primary care and specialty care services for help identifying PCPs, specialists, and support staff (nurse practitioners, pharmacists, program managers, informatics staff, and medical support personnel) engaged in the initiative. The goal for follow-up interviews was to interview at least 2 of the following respondents at each site: e-consult project manager, PCP, and/or specialist. Due to turnover and changes in clinic roles, some follow-up interviews were conducted with different individuals from the baseline interviews.

Data Collection

Interviews followed semistructured interview guidelines and included open-ended questions designed to elicit rich responses to a variety of aspects related to e-consult implementation, including patient needs, communication, leadership, resources, priorities, knowledge about the program, and unintended consequences. Follow-up interviews addressed how e-consults impacted the quality of specialty care; the impact of e-consults on Patient Aligned Care Teams (PACTs), the VHA patient-centered medical home initiative for primary care; and how e-consults have been used, eg, whether patients were involved in the decision to seek an e-consult.

Two interviewers who had participated in a 1-day, in-person training covering both data collection and analyzing key informant data conducted the 40 to 60 minute telephone interviews. One team member conducted the interview while the other took field notes. Interviews were also recorded. Follow-up probes were used to elicit specific examples and ensure sufficiently rich data. Following each interview, the notetaker reviewed the audio recording and filled in details in the field notes. The interview team debriefed and reviewed the augmented field notes and audio recordings, which became the primary data sources for the study.

Analysis

This was a qualitative descriptive analysis.¹² Interview data were analyzed using an iterative, inductive content analysis method using an open coding approach (ie, a priori codes were not defined for this portion of the analysis).¹³ Two members of the research team used audio recordings and summary transcripts simultaneously to code data. Summary transcripts were compared with the recorded interviews to assure fidelity.

The researchers used Atlas.ti (Berlin, Germany) qualitative data analysis software to organize the coding process. Emergent codes were iteratively added throughout the analysis to reflect quotations that did not adequately fit previously developed codes. Codes were combined weekly to biweekly. After the combinations were completed, the analytics team met to review meanings of codes to ensure consistency of coding and interpretations.

To create categories, broad themes were identified from interview responses and grouped under high- order headings that described distinct aspects of participant experience. The analysis was intentionally kept close to the original data to reflect and describe the participant’s experience as accurately as possible. In support of analytical rigor, members of the multidisciplinary research team, composed of clinicians, implementation scientists, and mixed methodologists, reviewed findings to assess their thoroughness, comprehensiveness, and representativeness across roles and participating sites.¹⁴

Results

The e-consult evaluation period was from November 1, 2011, to July 31, 2013. Key conclusions were drawn from both alpha and beta sites (Table). Baseline interviews were conducted with 37 participants at 8 sites from April 10, 2012, to August 6, 2012. Follow-up interviews were conducted with 21 of the 37 participants at the 8 sites. Follow-up interviews with either a PCP or specialist could not be scheduled at 1 site. Follow-up interviews were conducted from April 16, 2013, to June 18, 2013. Open coding continued until saturation (the point at which subsequent data failed to produce new findings).¹⁵ This occurred after analysis of 22 baseline interviews (12 PCPs, 6 specialists, 1 pharmacist, and 4 other staff members) and 17 follow-up interviews (10 PCPs, 4 specialists, 1 pharmacist, and 2 other staff members).

Implementation


The e-consults provided a programmatic structure to the more informal practice of obtaining diagnostic or therapeutic advice from a specialist. Several of the specialists interviewed described having previously used existing informal consult processes that were “like e-consult.” These specialists reported that their practice patterns did not change significantly since implementing e-consults, because they have been “using the Computerized Patient Record System (CPRS) in an e-consult way for many years.” In these cases, the primary change resulting from the initiative was that national VHA workload policy was revised so that e-consults were assigned a CPT (Current Procedural Terminology) code and specialists began receiving workload credit for completing e-consults.

At sites where an informal e-consult practice was already in place, the initiative was consistently described as flexible. Many specialists reported that this degree of flexibility allowed them to make a relatively easy transition to e-consults by adopting new mechanisms to support existing processes. The e-consult initiative also allowed specialists to formally document this work and to increase the efficiency of specialty care.

Specialists drove the implementation process across sites. The e-consults were envisioned as a collaborative process; however, during initial interviews, few specialists mentioned PCPs when describing the development and implementation of the e-consult program. Primary care providers also reported having little awareness of or input into how the initiative was implemented, although this had little consequence on the use of e-consults.

In a rare case, a PCP reported that poorly designed, lengthy e-consult templates were a major barrier to using e-consults for specific specialties. The PCP said, “E-consults have created an elaborate but extraordinarily cumbersome tool that is difficult for PCPs to actually accomplish, because you have a consult menu that requires a lot of data to be entered—a lot of history from the chart, a lot of exam findings, a lot of previous cognitive testing scores; neurologic findings—lab and imaging tests.”

Still, many other PCPs described receiving detailed information and guidance from e-consults. “E-consults help me to be more accurate. Many providers don’t have a comfort with pain management. To get guidance and education and to really hold our hand, this is how to do this…this has been a big change. If they give you a great response, then [for] the next patient [with that condition], you go back to that note and then follow what was said there,” said one PCP.

In follow-up interviews, providers and other key staff stated there were more data available on the patient as a result of the e-consult and, consequently, even when specialists determined that a patient needed an in-person visit, the data obtained in the e-consult improved the quality of the in-person consultation.

Enhanced Communication and Collaboration

Neither the PCPs nor the specialists were aware of the collaborative intent of the initiative. They focused, instead, on other key aims, such as increasing accessibility and minimizing unnecessary patient travel. Most participants were generally positive about e-consults during baseline interviews, and this perception increased over time.

Both the PCPs and the specialists reported improved communication following the launch of e-consults. In follow-up interviews, some PCPs reported that before e-consults, they had trouble getting timely responses from specialists unless they knew them personally. “You had to know the person in the old days,” one respondent said. “After e-consults, responses improved…e-consult is available to have the resources to tap that knowledge base, and the team is answering the question. I think it opens up access and information and knowledge to everybody.”

Many PCPs spoke positively about this new communication tool as an opportunity to learn from specialists and said they valued the input they received. They felt the increased interaction between the 2 groups positively benefited patient care. One example cited that collaborative communication improved care coordination for veterans: “We are able to step in with e-consults to coordinate services, and this has been huge in improving care.”

Furthermore, follow-up interviews found that all participating PCPs and specialists were communicating more frequently and effectively. “Services that have embraced e-consult give a lot of great information flowing back; it’s closer to a real-time conversation,” said one respondent. 


Related: Home-Based Video Telehealth for Veterans With Dementia

In baseline interviews, some specialists described how e-consults went against their belief that patient care is synonymous with face-to-face medical treatment and voiced dissatisfaction with e-consults as “sitting in front of a computer” rather than “seeing patients.” Others were concerned that medical center administration would not recognize the time it takes to conduct an e-consult and therefore not add necessary specialists staff. “E-consults take work and time, just like seeing a patient. I worry that won’t be seen,” one specialist said.

In order to successfully implement the e-consult initiative, providers and staff needed to incorporate new processes into their daily workflow.

Most sites did not develop a mechanism in which specialists received feedback regarding the outcome of their consultations. This lack of response created anxiety for some specialists in the absence of the face-to-face encounter, leaving some wondering whether they or the PCP had missed anything. According to one specialist, “That’s always in the back of your head: ‘Have I [the specialist] missed something?’”

In follow-up interviews, none of these concerns were raised. Primary care providers tended to speak of the care provided by specialists through e-consults in very positive terms, except in those instances where PCPs felt the e-consult template was difficult to use and required too much time to complete. “I was worried in the beginning about patients thinking less of me, but we ask for help all the time. We’re asking for help and not inconveniencing the patient; they seem to like it very much,” one PCP said.

The e-consults also complement PACTs. Initially, a few participants described soliciting patient input regarding the choice to have an e-consult or a face-to-face visit. During follow-up interviews, participants highlighted how well e-consults fit in to the PACT philosophy. One participant said, “The PACT team seeks to improve quality of care. E-consult fits very well with this, because answers to questions can come quickly, and the veteran may not need to come back to the clinic to be seen, even though things are still getting accomplished. E-consult works very well. E-consults were credited with improving access to specialty care as a tool for PACT.”

Achieving Program Objectives


Based on interviews, support for the e-consult program has increased over time as providers have gained experience with the program and have seen its benefits. Respondents at all sites consistently supported the concept of e-consults and expressed their belief in the importance and value of e-consults in improving patient-c entered care, primarily by reducing the need for patients to travel to see specialists, reducing the time to obtain feedback from specialists, and maintaining the provision of high quality care.

“Last year we only had 2 clinics categorized as e-consults. As of now we have 14 e-consults available for our providers. I think the numbers are growing. They are realizing the value of e-consults as far as the provider’s needs being met,” said one respondent.

The e-consults were credited with improving access to specialty care for veterans. Several participants stated that e-consults improved access to specialty care services and decreased travel for veterans. “It’s another way of getting care to the patient when the patient needs it without having to wait,” said one respondent.

Many PCPs described how difficult it was for patients to get to specialty appointments—particularly for their elderly, disabled, and rural patients—before the implementation of e-consults. “I like the fact that patients who live very far don’t have to come back. A lot of our patients are older…diabetic, see me Monday and back on Thursday. Now, they are able to stay home and follow the recommendations I write,” said one PCP.

Most providers were of the opinion that patients liked the program. “I think e-consults are helping patients...It’s been very successful regarding decreasing travel…Quicker response time for specialty care,” said a PCP. Several providers also stated in follow-up interviews that there was a greater degree of patient participation in the e-consult process and that “patients are definitely informed.”

Discussion

Most PCPs reported that the e-consults were an effective means of consultation and contained the information they needed to provide high-quality coordinated care. Most also found e-consult templates easy to complete. A majority of PCPs felt sufficient control over the choice of whether to use e-consults or an in-person visit, and a minority of patients were involved in the decision to receive an e-consult. Although the OSCS outlined guiding principles and operational rules in the Implementation Guide to help sites implement the e-consult program, its contribution was limited. Few examples were found that engaged PCPs in development of the e-consult program locally; involving patients in the decision to obtain a specialty consult electronically or in person; and PCPs feeding back results to specialists.

Implementing e-consults posed a number of challenges, including lack of resources to respond to referral requests, lack of referral policies and standardized procedures, and confusion related to roles and responsibilities. This is consistent with findings from another VHA research project of e-consults in 2 VHA health systems that was conducted prior to this national level e-consult pilot.⁷

Related: Using Facilitative Coaching to Support Patient Aligned Care Teams

Communication by OSCS of key aspects of the e-consult initiative will be critical as more sites implement e-consults. Since initiation of this pilot, workload specifications and credit have changed from 1 code to 3 codes, to more accurately reflect the amount of time a specialist consultant spends reviewing the EHR and responding to the consult. Without seeing the patient directly, specialists are more reliant on the PCP to describe the problem and provide adequate information in the e-consult request in order to provide recommendations back to the PCP.

Primary care physicians need to know that e-consults are available and determine when they are appropriate. A template or other guidance may be helpful to ensure adequate information is provided in the e-consult request; and the information provided by the specialist in response to the e-consult has to be sufficient for the PCP to provide care. VHA continues to expand the use of e-consults throughout the system, as this pilot found that the electronic option was often more timely than were face-to-face consultations. The result of this evaluation has informed national implementation of this effort.

Limitations

There are 3 main limitations to this study. First, because there was no practical way to preidentify participants who participated in implementing e-consults, a modified snowball sampling was used. However, this limited the degree to which the group was representative of the pilot participants. Second, the authors reported findings from a real-world initiative, not an experimental study. As such, not all participants in the first wave of key informant interviews were available for follow-up interview, which may have introduced bias. Third, the VHA is unlike most of the rest of the U.S. health care system in that it is a fully integrated system with salaried PCPs and specialists and an EHR.

Generalizability of the study may be limited, as a modified snowball sampling approach is not entirely random and has potential for community bias, because initial participants influence subsequent sampling. Additionally, though the sample size (n = 37) was sufficient for qualitative, in-depth analysis, it may be too small for confident generalization of findings. However, as health care moves toward an accountable care organization system, the authors’ analysis may provide insights.

Issues include revision of reimbursement policy for e-consults and developing or coordinating informational technology infrastructures to permit e-consults. It is also important to note that this evaluation reports solely on the extent of implementation of e-consults and the effects of e-consult implementation from the perspectives of staff, including specialists and PCPs.

Evaluating the effectiveness of the program in improving access, care coordination, and patient satisfaction was beyond the scope of the study. Further research is needed, because findings on those outcomes are critical for drawing inferences about this study’s implementation results.

Conclusion

The assessment of the e-consult system by providers and staff was based on a perception that e-consults are a valuable tool in providing greater access to quality care. Currently, e-consults have been expanded across VHA in medical and surgical specialties. VHA policymakers have drafted field guidance and a communication plan to support these efforts.

Acknowledgement
This material is based on work supported by the VA Office of Specialty Care Transformation, the office overseeing the e-consult initiative, and the Office of Research and Development Quality Enhancement Research Initiative.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Electronic consultations  (e-consults), also called e-referrals, are an alternative method of obtaining general patient information through the electronic health record (EHR) shared by primary care providers (PCPs) and specialists in the VHA. In the e-consult system, test results, medication lists, and other pertinent data are available.¹ Many PCPs are willing to use new technologies to maximize practice efficiency and patient convenience.² In the VHA’s hub-and-spoke model of care, e-consults have the potential to make delivery of specialty care more efficient by prearranging or completing necessary diagnostic testing and redirecting inappropriate referrals to the correct specialists.¹

Some early studies of e-consults report better communication, improved referral appropriateness, and greater access to specialty care as well as better continuity of care and information transfer between patients and PCPs.^3-5 Researchers at the VA Boston Healthcare System in Massachusetts found that 61% of specialists surveyed agreed that e-consults improve quality of care and found the approach beneficial to help initiate diagnostic testing prior to a face-to-face visit.⁶ However, researchers at the Michael E. DeBakey VAMC in Houston, Texas, found no improvement in care coordination.⁷ To date, there have been no large-scale evaluations of e-consult programs or assessments of implementation of e-consult programs.

Related: HHS Grants Fund Health IT in Communities

In early 2011, the VHA Office of Specialty Care Services (OSCS), Office of Specialty Care Transformation launched a national e-consult pilot as part of a broader effort to improve the delivery of patient-centered specialty care. This initiative was based on core concepts advanced by the American College of Physicians, which highlighted the importance of specialty care within a patient- centered medical home and provided a framework for collaboration.^8,9 The goals of the e-consult program were to improve access to specialty care for veterans and their PCPs, to enhance the collaborative relationship between PCPs and specialists, and to augment PCP education.

The OSCS created an Electronic Consultation Implementation Guide to help sites develop and implement each of their e-consult programs.¹⁰ The Implementation Guide established operating rules, strategies for engaging key stakeholders, and recommendations for provider education and training.

As with face-to-face referrals, e-consults are organized in a hub-and-spoke model, where community-based outpatient clinics (CBOCs) are linked to a central VAMC. An e-consult can be accessed by any CBOC, VAMC, medical center-based primary care clinic or specialist, and between medical centers that share the same EHR. There were 217,014 completed e-consults between May 2011 and December 2013 across VHA.¹¹

Some programs created an e-consult template to aid in the transition to electronic referrals (Figure). Although not mandatory, the template helped organize needed information to expedite the e-consult.

The objective of this evaluation is to describe the implementation of e-consults from the perspectives of PCPs, specialists, and other key staff involved in the pilot. Key findings were related to: (1) how the e-consult pilot was implemented; (2) how implementation of the e-consult pilot affected providers; and (3) to what extent the e-consult pilot achieved programmatic objectives from the provider’s perspective.

Methods

The authors conducted a key informant analysis with 2 waves of interviews at 8 e-consult pilot sites across the U.S., selected for variation on early progress in implementation. The sites cannot be identified based on an agreement with the VA Office of Labor-Management Relations.

Setting

The e-consult pilot involved 15 VAMCs in 2 cohorts: alpha sites, which began using e-consults in May 2011, and beta sites, which began using e-consults in July 2011. The alpha sites included 10 VAMCs in 12 medical specialties, with a total of 21 facility-specialty combinations. For the evaluation, sites were defined based on specialty, regardless of location within the same medical center (eg, cardiology and diabetes at the same VAMC would be 2 sites). Beta sites included 5 VAMCs with 6 medical specialties for a total of 6 sites. For 1 year, alpha sites received $175,000 and beta sites received $150,000 to support start-up activities.

Initial specialties included diabetes, hepatitis C, geriatrics, cardiology, liver transplant, dementia, gastrointestinal disease, pulmonary medicine, rheumatology, pain management, neurosurgery, infectious diseases, hematology/oncology, and vascular surgery. Facilities could add additional e-consult specialties but did not receive further funding.

Sample

Study participants were selected from 8 of the 15 pilot sites (geographic site/specialty combinations). Site selection was based on 2 measures of baseline e-consult implementation: (1) overall e-consult implementation rates, measured as the ratio of e-consults to all consults for the specialties of interest; and (2) CBOC participation, measured as the ratio of e-consults for patients from CBOCs vs e-consults for patients from primary care clinics located within the 152 VAMCs. Participation with CBOCs was important for ensuring that implementation factors that influenced uptake of e-consults within tertiary medical centers and between VAMCs and CBOCs could be identified. Two e-consult sites were randomly selected from each of the 4 resulting categories (VAMC high volume, VAMC low volume, CBOC high volume, and CBOC low volume). Volume data of e-consults were obtained from the VA Corporate Data Warehouse and assessed from the beginning of the pilot period to initial site selection, May 2011 to February 2012.

Respondents were identified using a modified snowball sampling process. Snowball sampling is a qualitative sampling technique that identifies study participants, who then identify other potential participants to participate in the study. The researchers started with the local e-consult initiative lead and then contacted the directors of primary care and specialty care services for help identifying PCPs, specialists, and support staff (nurse practitioners, pharmacists, program managers, informatics staff, and medical support personnel) engaged in the initiative. The goal for follow-up interviews was to interview at least 2 of the following respondents at each site: e-consult project manager, PCP, and/or specialist. Due to turnover and changes in clinic roles, some follow-up interviews were conducted with different individuals from the baseline interviews.

Data Collection

Interviews followed semistructured interview guidelines and included open-ended questions designed to elicit rich responses to a variety of aspects related to e-consult implementation, including patient needs, communication, leadership, resources, priorities, knowledge about the program, and unintended consequences. Follow-up interviews addressed how e-consults impacted the quality of specialty care; the impact of e-consults on Patient Aligned Care Teams (PACTs), the VHA patient-centered medical home initiative for primary care; and how e-consults have been used, eg, whether patients were involved in the decision to seek an e-consult.

Two interviewers who had participated in a 1-day, in-person training covering both data collection and analyzing key informant data conducted the 40 to 60 minute telephone interviews. One team member conducted the interview while the other took field notes. Interviews were also recorded. Follow-up probes were used to elicit specific examples and ensure sufficiently rich data. Following each interview, the notetaker reviewed the audio recording and filled in details in the field notes. The interview team debriefed and reviewed the augmented field notes and audio recordings, which became the primary data sources for the study.

Analysis

This was a qualitative descriptive analysis.¹² Interview data were analyzed using an iterative, inductive content analysis method using an open coding approach (ie, a priori codes were not defined for this portion of the analysis).¹³ Two members of the research team used audio recordings and summary transcripts simultaneously to code data. Summary transcripts were compared with the recorded interviews to assure fidelity.

The researchers used Atlas.ti (Berlin, Germany) qualitative data analysis software to organize the coding process. Emergent codes were iteratively added throughout the analysis to reflect quotations that did not adequately fit previously developed codes. Codes were combined weekly to biweekly. After the combinations were completed, the analytics team met to review meanings of codes to ensure consistency of coding and interpretations.

To create categories, broad themes were identified from interview responses and grouped under high- order headings that described distinct aspects of participant experience. The analysis was intentionally kept close to the original data to reflect and describe the participant’s experience as accurately as possible. In support of analytical rigor, members of the multidisciplinary research team, composed of clinicians, implementation scientists, and mixed methodologists, reviewed findings to assess their thoroughness, comprehensiveness, and representativeness across roles and participating sites.¹⁴

Results

The e-consult evaluation period was from November 1, 2011, to July 31, 2013. Key conclusions were drawn from both alpha and beta sites (Table). Baseline interviews were conducted with 37 participants at 8 sites from April 10, 2012, to August 6, 2012. Follow-up interviews were conducted with 21 of the 37 participants at the 8 sites. Follow-up interviews with either a PCP or specialist could not be scheduled at 1 site. Follow-up interviews were conducted from April 16, 2013, to June 18, 2013. Open coding continued until saturation (the point at which subsequent data failed to produce new findings).¹⁵ This occurred after analysis of 22 baseline interviews (12 PCPs, 6 specialists, 1 pharmacist, and 4 other staff members) and 17 follow-up interviews (10 PCPs, 4 specialists, 1 pharmacist, and 2 other staff members).

Implementation


The e-consults provided a programmatic structure to the more informal practice of obtaining diagnostic or therapeutic advice from a specialist. Several of the specialists interviewed described having previously used existing informal consult processes that were “like e-consult.” These specialists reported that their practice patterns did not change significantly since implementing e-consults, because they have been “using the Computerized Patient Record System (CPRS) in an e-consult way for many years.” In these cases, the primary change resulting from the initiative was that national VHA workload policy was revised so that e-consults were assigned a CPT (Current Procedural Terminology) code and specialists began receiving workload credit for completing e-consults.

At sites where an informal e-consult practice was already in place, the initiative was consistently described as flexible. Many specialists reported that this degree of flexibility allowed them to make a relatively easy transition to e-consults by adopting new mechanisms to support existing processes. The e-consult initiative also allowed specialists to formally document this work and to increase the efficiency of specialty care.

Specialists drove the implementation process across sites. The e-consults were envisioned as a collaborative process; however, during initial interviews, few specialists mentioned PCPs when describing the development and implementation of the e-consult program. Primary care providers also reported having little awareness of or input into how the initiative was implemented, although this had little consequence on the use of e-consults.

In a rare case, a PCP reported that poorly designed, lengthy e-consult templates were a major barrier to using e-consults for specific specialties. The PCP said, “E-consults have created an elaborate but extraordinarily cumbersome tool that is difficult for PCPs to actually accomplish, because you have a consult menu that requires a lot of data to be entered—a lot of history from the chart, a lot of exam findings, a lot of previous cognitive testing scores; neurologic findings—lab and imaging tests.”

Still, many other PCPs described receiving detailed information and guidance from e-consults. “E-consults help me to be more accurate. Many providers don’t have a comfort with pain management. To get guidance and education and to really hold our hand, this is how to do this…this has been a big change. If they give you a great response, then [for] the next patient [with that condition], you go back to that note and then follow what was said there,” said one PCP.

In follow-up interviews, providers and other key staff stated there were more data available on the patient as a result of the e-consult and, consequently, even when specialists determined that a patient needed an in-person visit, the data obtained in the e-consult improved the quality of the in-person consultation.

Enhanced Communication and Collaboration

Neither the PCPs nor the specialists were aware of the collaborative intent of the initiative. They focused, instead, on other key aims, such as increasing accessibility and minimizing unnecessary patient travel. Most participants were generally positive about e-consults during baseline interviews, and this perception increased over time.

Both the PCPs and the specialists reported improved communication following the launch of e-consults. In follow-up interviews, some PCPs reported that before e-consults, they had trouble getting timely responses from specialists unless they knew them personally. “You had to know the person in the old days,” one respondent said. “After e-consults, responses improved…e-consult is available to have the resources to tap that knowledge base, and the team is answering the question. I think it opens up access and information and knowledge to everybody.”

Many PCPs spoke positively about this new communication tool as an opportunity to learn from specialists and said they valued the input they received. They felt the increased interaction between the 2 groups positively benefited patient care. One example cited that collaborative communication improved care coordination for veterans: “We are able to step in with e-consults to coordinate services, and this has been huge in improving care.”

Furthermore, follow-up interviews found that all participating PCPs and specialists were communicating more frequently and effectively. “Services that have embraced e-consult give a lot of great information flowing back; it’s closer to a real-time conversation,” said one respondent. 


Related: Home-Based Video Telehealth for Veterans With Dementia

In baseline interviews, some specialists described how e-consults went against their belief that patient care is synonymous with face-to-face medical treatment and voiced dissatisfaction with e-consults as “sitting in front of a computer” rather than “seeing patients.” Others were concerned that medical center administration would not recognize the time it takes to conduct an e-consult and therefore not add necessary specialists staff. “E-consults take work and time, just like seeing a patient. I worry that won’t be seen,” one specialist said.

In order to successfully implement the e-consult initiative, providers and staff needed to incorporate new processes into their daily workflow.

Most sites did not develop a mechanism in which specialists received feedback regarding the outcome of their consultations. This lack of response created anxiety for some specialists in the absence of the face-to-face encounter, leaving some wondering whether they or the PCP had missed anything. According to one specialist, “That’s always in the back of your head: ‘Have I [the specialist] missed something?’”

In follow-up interviews, none of these concerns were raised. Primary care providers tended to speak of the care provided by specialists through e-consults in very positive terms, except in those instances where PCPs felt the e-consult template was difficult to use and required too much time to complete. “I was worried in the beginning about patients thinking less of me, but we ask for help all the time. We’re asking for help and not inconveniencing the patient; they seem to like it very much,” one PCP said.

The e-consults also complement PACTs. Initially, a few participants described soliciting patient input regarding the choice to have an e-consult or a face-to-face visit. During follow-up interviews, participants highlighted how well e-consults fit in to the PACT philosophy. One participant said, “The PACT team seeks to improve quality of care. E-consult fits very well with this, because answers to questions can come quickly, and the veteran may not need to come back to the clinic to be seen, even though things are still getting accomplished. E-consult works very well. E-consults were credited with improving access to specialty care as a tool for PACT.”

Achieving Program Objectives


Based on interviews, support for the e-consult program has increased over time as providers have gained experience with the program and have seen its benefits. Respondents at all sites consistently supported the concept of e-consults and expressed their belief in the importance and value of e-consults in improving patient-c entered care, primarily by reducing the need for patients to travel to see specialists, reducing the time to obtain feedback from specialists, and maintaining the provision of high quality care.

“Last year we only had 2 clinics categorized as e-consults. As of now we have 14 e-consults available for our providers. I think the numbers are growing. They are realizing the value of e-consults as far as the provider’s needs being met,” said one respondent.

The e-consults were credited with improving access to specialty care for veterans. Several participants stated that e-consults improved access to specialty care services and decreased travel for veterans. “It’s another way of getting care to the patient when the patient needs it without having to wait,” said one respondent.

Many PCPs described how difficult it was for patients to get to specialty appointments—particularly for their elderly, disabled, and rural patients—before the implementation of e-consults. “I like the fact that patients who live very far don’t have to come back. A lot of our patients are older…diabetic, see me Monday and back on Thursday. Now, they are able to stay home and follow the recommendations I write,” said one PCP.

Most providers were of the opinion that patients liked the program. “I think e-consults are helping patients...It’s been very successful regarding decreasing travel…Quicker response time for specialty care,” said a PCP. Several providers also stated in follow-up interviews that there was a greater degree of patient participation in the e-consult process and that “patients are definitely informed.”

Discussion

Most PCPs reported that the e-consults were an effective means of consultation and contained the information they needed to provide high-quality coordinated care. Most also found e-consult templates easy to complete. A majority of PCPs felt sufficient control over the choice of whether to use e-consults or an in-person visit, and a minority of patients were involved in the decision to receive an e-consult. Although the OSCS outlined guiding principles and operational rules in the Implementation Guide to help sites implement the e-consult program, its contribution was limited. Few examples were found that engaged PCPs in development of the e-consult program locally; involving patients in the decision to obtain a specialty consult electronically or in person; and PCPs feeding back results to specialists.

Implementing e-consults posed a number of challenges, including lack of resources to respond to referral requests, lack of referral policies and standardized procedures, and confusion related to roles and responsibilities. This is consistent with findings from another VHA research project of e-consults in 2 VHA health systems that was conducted prior to this national level e-consult pilot.⁷

Related: Using Facilitative Coaching to Support Patient Aligned Care Teams

Communication by OSCS of key aspects of the e-consult initiative will be critical as more sites implement e-consults. Since initiation of this pilot, workload specifications and credit have changed from 1 code to 3 codes, to more accurately reflect the amount of time a specialist consultant spends reviewing the EHR and responding to the consult. Without seeing the patient directly, specialists are more reliant on the PCP to describe the problem and provide adequate information in the e-consult request in order to provide recommendations back to the PCP.

Primary care physicians need to know that e-consults are available and determine when they are appropriate. A template or other guidance may be helpful to ensure adequate information is provided in the e-consult request; and the information provided by the specialist in response to the e-consult has to be sufficient for the PCP to provide care. VHA continues to expand the use of e-consults throughout the system, as this pilot found that the electronic option was often more timely than were face-to-face consultations. The result of this evaluation has informed national implementation of this effort.

Limitations

There are 3 main limitations to this study. First, because there was no practical way to preidentify participants who participated in implementing e-consults, a modified snowball sampling was used. However, this limited the degree to which the group was representative of the pilot participants. Second, the authors reported findings from a real-world initiative, not an experimental study. As such, not all participants in the first wave of key informant interviews were available for follow-up interview, which may have introduced bias. Third, the VHA is unlike most of the rest of the U.S. health care system in that it is a fully integrated system with salaried PCPs and specialists and an EHR.

Generalizability of the study may be limited, as a modified snowball sampling approach is not entirely random and has potential for community bias, because initial participants influence subsequent sampling. Additionally, though the sample size (n = 37) was sufficient for qualitative, in-depth analysis, it may be too small for confident generalization of findings. However, as health care moves toward an accountable care organization system, the authors’ analysis may provide insights.

Issues include revision of reimbursement policy for e-consults and developing or coordinating informational technology infrastructures to permit e-consults. It is also important to note that this evaluation reports solely on the extent of implementation of e-consults and the effects of e-consult implementation from the perspectives of staff, including specialists and PCPs.

Evaluating the effectiveness of the program in improving access, care coordination, and patient satisfaction was beyond the scope of the study. Further research is needed, because findings on those outcomes are critical for drawing inferences about this study’s implementation results.

Conclusion

The assessment of the e-consult system by providers and staff was based on a perception that e-consults are a valuable tool in providing greater access to quality care. Currently, e-consults have been expanded across VHA in medical and surgical specialties. VHA policymakers have drafted field guidance and a communication plan to support these efforts.

Acknowledgement
This material is based on work supported by the VA Office of Specialty Care Transformation, the office overseeing the e-consult initiative, and the Office of Research and Development Quality Enhancement Research Initiative.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Guidelines for treating diabetes mellitus are mostly based on clinical studies in middle-aged people, and recommendations tend to be the same for everyone, whether young and strong or elderly and frail. But diabetes management should be individualized, especially in the elderly, taking into account each patient’s medical history, functional ability, home care situation, and life expectancy. Aggressive glycemic control is less important than avoiding hypoglycemia and achieving a good quality of life.

This article reviews the general principles for recognizing and managing diabetes in elderly patients, focusing on the management of blood sugar per se. In a future issue of this journal, we will discuss some of the many complications of diabetes in the elderly.

DIABETES DIFFERS IN ELDERLY PATIENTS

“The elderly” is a heterogeneous group with widely varying physiologic profiles, functional capabilities, and life expectancy (on average, about 88 years for men and 90 years for women in the United States). Although the elderly are sometimes classified as “young-old” (age 65–80) and “old-old” (80+), this distinction is too simplistic for clinical decision-making.

Diabetes mellitus in the elderly also is heterogeneous. One distinction is the age at which the disease developed.

Aging is associated with declining beta-cell function and lower blood insulin levels independent of insulin resistance, and with insulin resistance itself. The risk of developing type 2 diabetes mellitus increases with obesity, lack of physical activity, and loss of muscle mass, all of which often develop with aging.¹

Middle-aged patients with diabetes have increased fasting hepatic glucose production, increased insulin resistance, and an abnormal insulin response to a glucose load. On the other hand, patients who develop diabetes at an older age tend to have normal hepatic glucose production. Older patients who are lean secrete markedly less insulin in response to a glucose load but have relatively less insulin resistance.² Patients who develop type 2 diabetes in old age are more likely to have near-normal fasting blood glucose levels but significant postprandial hyperglycemia.^3,4 Elderly patients who developed diabetes during middle age have metabolic abnormalities more typical of middle-aged patients with type 2 diabetes.

DIABETES IS COMMON, AND INCREASING IN PREVALENCE

By age 75, 40% of people in the United States have either glucose intolerance or diabetes mellitus.⁵ Metabolic syndrome, which is the constellation of insulin resistance (type 2 diabetes mellitus), hyperlipidemia, hypertension, and obesity, is more prevalent in people age 65 to 74 years than in younger and older people.³

The National Diabetes Surveillance System of the US Centers for Disease Control and Prevention estimated that the prevalence of diabetes mellitus in people 65 to 74 years old in 2005 was 18.5%, about 12 times the prevalence among those younger than 45years.⁶ The prevalence has been gradually increasing and has nearly doubled over the past 25 years, with certain groups—native Americans, Hispanics, and African-Americans—at particularly high risk of developing the disease.

Although the prevalence of diabetes in people older than 75 years is lower than among people in the 65-to-74-year range, the elderly segment of our population is increasing, and the impact of diabetes and its associated burden of death and disease from vascular complications is enormous.

SYMPTOMS ARE OFTEN NONSPECIFIC

Unfortunately, diabetes is underdiagnosed and frequently undertreated, resulting in even more disease and death.^7–9

Diabetes is often missed in the elderly because its presenting symptoms may be nonspecific, eg, failure to thrive, low energy, falls, dizziness, confusion, nocturia (with or without incontinence), and urinary tract infection.The classic symptoms of frequent urination (often leading to worsening incontinence), thirst, and increased hunger usually occur only when plasma glucose levels are above 200 mg/dL. Weight loss, blurred vision, and dehydration may also be present with high blood glucose levels. With lesser degrees of hyperglycemia, patients may have no symptoms or present with weight loss or signs and symptoms of chronic infection, especially of the genitourinary tract, skin, or mouth.

Hyperglycemia in elderly patients is also associated with reduced cognitive function (which may improve with blood glucose control).¹⁰

The American Diabetes Association recommends screening by measuring the fasting plasma glucose level every 3 years beginning at 45 years.¹¹ However, some experts believe that this method is inadequate for the elderly¹²; some suggest that screening should be done more often in those with risk factors for diabetes, including obesity, inactivity, hypertension, and dyslipidemia, all of which are common in the elderly. Targeted screening in patients with hypertension may be the most cost-effective strategy.¹³

Screening with hemoglobin A_1c levels is not recommended because of lack of standardization among laboratories.¹⁴

INDIVIDUALIZED MANAGEMENT IS BEST

Despite disease differences, the general goals for diabetes care are the same for all ages:

• To control hyperglycemia and its symptoms
• To prevent, evaluate, and treat macrovascular and microvascular complications
• To teach patients to manage themselves
• To maintain or improve the patient’s general health status.

Unfortunately, most specific recommendations are based on studies in younger people. Guidelines should ideally reflect the complexities of a particular clinical situation, but most recommendations are applied to the young and old alike, as well as to the relatively healthy and the frail and ill.^15–17 Consideration should be given to a patient’s health beliefs, severity of vascular complications and other medical problems, economic situation, life expectancy ,functional status, and availability of support services. In addition, some patients prefer aggressive treatment, while others would rather compromise some aspects of care in order to maintain a certain quality of life, to save money, or to avoid having caregivers provide treatment.

Age-related changes in pharmacokinetics as well as polypharmacy increase the risk of drug interactions and adverse effects, especially drug-induced hypoglycemia. In addition, age-associated changes in cognitive, visual, and physical function, dentition, and taste perception can reduce a patient’s ability to carry out treatment. Frequent hospitalizations also disrupt outpatient regimens.

Comorbidities make treatment more challenging, but some conditions—such as hypertension, renal insufficiency and eye disorders—make doctors more likely to control hyperglycemia more aggressively, fearing that the loss of a little more function in an impaired organ may lead to failure.

The benefits of tight glycemic control should be weighed against the risks and the realities of an individual situation. Priority should be given to achieving the best quality of life possible.¹⁷ Recent guidelines from the California Health Foundation and the American Geriatrics Association focused on the major health threats to older patients and prioritizing care for each person.¹⁵ The guidelines recommend screening for geriatric syndromes that are more prevalent inpatients with diabetes or are strongly affected by the disease or its treatment. Diabetes care should be examined in the setting of common geriatric problems: depression, polypharmacy, cognitive impairment, urinary incontinence, falls, and pain.

Heart risk trumps glycemic control

The expert panel¹⁵ concluded that rates of disease and death can be reduced more by targeting cardiovascular risk factors than by intensively managing hyperglycemia. One rationale is that it takes 8 years for aggressive glycemic control to reduce the risk of diabetic retinopathy or renal disease but only 2 years of treating hypertension and dyslipidemia to reduce the risk of cardiovascular disease.^15,17–21 A recent Japanese study found normal mortality rates in elderly patients under long-term, intensive multifactorial diabetes control.²² High-functioning, motivated patients could benefit from therapy aimed at achieving most or all of the recommended goals, but frail patients may suffer from applying all therapies and may benefit from only some of them.

If appropriate goals cannot be met, it may help to refer patients to a geriatric specialist to evaluate possible barriers to adherence such as depression or poor cognition, physical functioning, or support.

MANAGEMENT STRATEGIES

Weight loss and exercise help prevent diabetes

The Diabetes Prevention Program²³ randomized 3,234 people (mean age 51 years) with impaired glucose tolerance to receive either metformin (Fortamet, Glucophage) 850 mg twice daily or placebo or to undertake lifestyle modifications with goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. Compared with the placebo group, the lifestyle modification group had a 58% lower incidence of diabetes while those in the metformin group had only a 31% lower incidence. Among those older than 60 years, the advantage of lifestyle modification over metformin was even greater.

• Hemoglobin A_1c levels < 7.0%
• Preprandial blood glucose levels 90–130 mg/dL
• Bedtime blood glucose levels 110–150 mg/dL.

Guidelines from the Department of Veterans Affairs²⁴ and the American Geriatrics Society¹⁵ are slightly different, and are based on randomized trials in younger patients, primarily the Diabetes Control and Complications Trial (DCCT)²⁵ and the United Kingdom Prospective Diabetes Study(UKPDS).^21,26 A recent position statement from the American College of Physicians, based on a review of all the major guidelines, recommends the following: “Statement 1: To prevent microvascular complication of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A_1c level less than 7% based on individualized assessment is a reasonable goal for many but not all patients. Statement 2: The goal for hemoglobin A_1c should be based on individualized assessment of risk for complication from diabetes, comorbidity, life expectancy, and patient preferences.”²⁷

Although few data exist for elderly patients, these guidelines are the most current approach to treating diabetes in the elderly. Less stringent goals are appropriate for patients who have limited life expectancy, hypoglycemia unawareness (lack of autonomic warning symptoms of low blood sugar), seizures, dementia, psychiatric illness, or alcoholism. It is important to keep in mind the following as one strives for lower A_1c levels: Although the relative risk reduction accomplished by lowering hemoglobin A_1c is linear, the absolute risk reduction is log-linear—more benefit is gained by lowering hemoglobin A_1c from 9% to 8% than from 8% to 7%.²⁸

Hypoglycemia is a major limiting factor in glycemic control. Many risk factors for hypoglycemia are common in the elderly (Table 2). Hypoglycemia was a chief adverse event in both the DCCT and the UKPDS, with a twofold to threefold higher rate in patients who were intensively treated.²⁹ Even mild hypoglycemia in the elderly can result in an injurious fall, which can lead to long-term functional decline. The rate of severe or fatal hypoglycemia—the major risk of tight glycemic treatment—increases exponentially with age.^30–33

As people age, the mechanisms that regulate blood sugar are impaired: the glucagon response is diminished, which increases dependence on the epinephrine response to prevent hypoglycemia.³⁴ Medications such as beta-blockers, which can suppress the symptoms of hypoglycemia, may further impair the response. Consequently, older patients may be less aware of hypoglycemia, and the symptoms may be less intense. Renal insufficiency may also exacerbate the problem by reducing clearance of oral agents. In addition, confused patients may take extra doses of medications.

Patients with type 2 diabetes treated with insulin, sulfonylureas, or meglitinides should be evaluated for symptoms of hypoglycemia. Older patients may have more neuroglycopenic symptoms (eg, dizziness, weakness, confusion, nightmares, violent behavior) than adrenergic symptoms (eg, sweating, palpitations, tremors), although both types should be asked about during an evaluation.^2,32,33 Hypoglycemia may also present as transient hemiparesis, coma, or falls.³⁵

We carefully evaluate the glycemic regimen and care environment of any elderly patient who presents with a blood glucose level below 100 mg/dL. The regimen should be altered for less strict control if the patient is cognitively impaired, is at risk of falling, or has an unstable care situation (eg, has irregular meals or needs assistance with daily activities and does not have a regular caregiver). Patients at significant risk of hypoglycemia should be encouraged to check their blood glucose level with a fingerstick before driving.

Tight control in the hospital is controversial

Glycemic control in the hospital has traditionally been designed primarily to maintain “safe” blood glucose levels, ie, to prevent hyperglycemia-induced dehydration and catabolism while avoiding hypoglycemia. Recent studies have suggested that tighter glycemic control may reduce the rates of complications and death perioperatively and in patients with myocardial infarction or who are seriously ill in the intensive care unit, although the evidence is mixed.^36–38 Specific targets are controversial, and although studies have included some elderly patients, results cannot be generalized to this group.

DIABETES CARE TAKES A TEAM

Geriatric patients have complex problems. In the face of multiple comorbidities, difficult social situations, and polypharmacy, the physician can best address the drug therapy and lifestyle changes that diabetes management requires by working with a certified diabetes educator, dietitian, social worker, and pharmacist.

Nonpharmacologic therapy

The first step in therapy for glycemic control is diet and exercise, although such measures are often limited in the elderly.

Diet. Carbohydrate control can maintain euglycemia in some patients with type 2 diabetes. But for the elderly, especially those living in long-term health care facilities, malnutrition may be of more concern than obesity, making dietary restrictions harmful. Patients in danger of malnutrition should be given unrestricted menus with consistent amounts of carbohydrate at meals and snacks. Medications should be adjusted to control blood glucose levels if necessary.³⁹

For patients living in the community, dietary therapy should be individualized by a dietitian. Medicare covers up to 10 hours of diabetes education with a certified diabetes educator or registered dietitian within a 12-month period if at least one of the following criteria are met: the patient is newly diagnosed with diabetes, the hemoglobin A_1c level is higher than 8.5%, medication has been recently started, or the risk of complications is high.

Supplementation of vitamins and minerals is prudent. Supplemental magnesium, zinc, and vitamins C and E may improve glycemic control.^40–44

Exercise reduces insulin resistance, weight, and blood pressure; increases muscle mass; and improves lipid levels. Both aerobic and nonaerobic activity are beneficial.^45–47 The best time to exercise is 1 to 2 hours after a meal, when glucose levels tend to be highest. Either hypoglycemia or hyperglycemia may occur up to 24 hours following exercise, and medications may need to be adjusted.

Oral medications

Insulin

Insulin therapy is necessary if oral combination therapy proves insufficient. Insulin is generally required for patients with moderate or severe hyperglycemia, especially for those with renal or hepatic insufficiency.^52,53 Before prescribing insulin therapy to elderly patients, we need to consider their visual acuity, manual dexterity and sensation, cognitive function, family support, and financial situation.However, several studies showed that quality of life improves in the year after starting insulin for patients whose blood sugar was previously poorly controlled with oral agents.^54,55

An evening dose of neutral protamine Hagedorn (NPH) insulin is a good way to start. More complex regimens may be necessary, depending on glycemic goals.

A number of premixed preparations of various types of insulin with different durations of action are available. They may improve accuracy, acceptability, and ease of insulin administration, although glycemic control and the risk of hypoglycemia may not change or in fact may be worse.⁵⁶ Some patients may not achieve adequate glucose control with fixed-dose regimens.^57,58

Frequent, small, titrated doses of short-acting agents control hyperglycemia better, particularly postprandial hyperglycemia,resulting in less hypoglycemia. However, these regimens may be too complex for many elderly patients; a patient’s support system must be evaluated before recommending this type of therapy.

Most insulins are available in vials and in pens, the latter of which are quick and easy to use, provide precise doses, and can be managed by many elderly patients. Pens require the user to attach a needle, set the dose by a dial, and depress the plunger to inject the dose. Some are prefilled and disposable, others have refillable cartridges. Studies in patients older than 60 years have shown the pen systems to be more acceptable, safer, and more effective than conventional syringes.

If conventional syringes are used, low-dose syringes (30-unit or 50-unit), which have more visible unit markings, should be prescribed whenever possible rather than the 100-unit sizes. Magnifying devices that attach to a syringe are also available.

Studies have also shown that continuous subcutaneous insulin infusion is safe for selected elderly patients.

Incretin mimetics: Possibly well-suited

Incretins, such as glucagon-like peptide-1, are hormones released from the gastrointestinal tract in response to eating. They stimulate insulin secretion by non-glucose-related pathways.

Exenatide (Byetta), a 39-amino-acid peptide incretin mimetic, is a synthetic version of exendin-4, an incretin isolated from the saliva of the Gila monster. Recently approved for treating type 2 diabetes, it is given subcutaneously.^59,60 Oral dipeptidyl peptidase-4 inhibitors (sitagliptin and vildagliptin) decrease the degradation of endogenous incretin and thus prolong its action.⁶¹ Because a decline in glucose-mediated beta-cell insulin secretion is a major contributor to the development of diabetes in the elderly, the drug may be especially helpful for this population.However, further clinical research and experience is needed before specific recommendations for elderly patients can be made.

SELF-MANAGEMENT IS IMPORTANT

Patient education is critical

Patient education is a cornerstone of diabetes self-management,^62–66 and is especially important for patients who are cognitively impaired or who have limited language proficiency.Patient education is covered under Medicare Part B. Ample resources are available in print and electronic formats. Community resources can also be important.

Home glucose monitoring is simpler now

A patient’s insulin regimen should ideally be tailored according to home blood glucose level monitoring before and after meals and at bedtime. Medicare reimburses for once daily testing for patients who are not taking insulin and for three-times-daily testing for those taking insulin.

Elderly patients can be taught to reliably monitor their own blood glucose levels without diminishing their quality of life. Monitoring is now easier with new glucometers and test strips that use small amounts of blood. Testing can now also be performed on blood taken from the forearm, upper arm, thigh, or calf with the FreeStyle (TheraSense), One Touch Ultra (LifeScan) and Soft Tac (MediSense) meters. The Soft Tac meter lances skin and automatically transfers blood to the test strip, making use even easier. Talking glucometers are available for blind patients.

Coordination counts

A variety of models of chronic care delivery have been proposed. Regardless of which model is chosen, the complexities of management call for a multidisciplinary team approach, and coordination of care in order to ensure appropriate information flow becomes critical.

Editor’s note: In next month’s issue of this journal, Drs. Hornick and Aron will discuss the management of diabetic complications in the elderly, including coronary artery disease, neuropathy, and kidney disease.

Guidelines for treating diabetes mellitus are mostly based on clinical studies in middle-aged people, and recommendations tend to be the same for everyone, whether young and strong or elderly and frail. But diabetes management should be individualized, especially in the elderly, taking into account each patient’s medical history, functional ability, home care situation, and life expectancy. Aggressive glycemic control is less important than avoiding hypoglycemia and achieving a good quality of life.

This article reviews the general principles for recognizing and managing diabetes in elderly patients, focusing on the management of blood sugar per se. In a future issue of this journal, we will discuss some of the many complications of diabetes in the elderly.

DIABETES DIFFERS IN ELDERLY PATIENTS

“The elderly” is a heterogeneous group with widely varying physiologic profiles, functional capabilities, and life expectancy (on average, about 88 years for men and 90 years for women in the United States). Although the elderly are sometimes classified as “young-old” (age 65–80) and “old-old” (80+), this distinction is too simplistic for clinical decision-making.

Diabetes mellitus in the elderly also is heterogeneous. One distinction is the age at which the disease developed.

Aging is associated with declining beta-cell function and lower blood insulin levels independent of insulin resistance, and with insulin resistance itself. The risk of developing type 2 diabetes mellitus increases with obesity, lack of physical activity, and loss of muscle mass, all of which often develop with aging.¹

Middle-aged patients with diabetes have increased fasting hepatic glucose production, increased insulin resistance, and an abnormal insulin response to a glucose load. On the other hand, patients who develop diabetes at an older age tend to have normal hepatic glucose production. Older patients who are lean secrete markedly less insulin in response to a glucose load but have relatively less insulin resistance.² Patients who develop type 2 diabetes in old age are more likely to have near-normal fasting blood glucose levels but significant postprandial hyperglycemia.^3,4 Elderly patients who developed diabetes during middle age have metabolic abnormalities more typical of middle-aged patients with type 2 diabetes.

DIABETES IS COMMON, AND INCREASING IN PREVALENCE

By age 75, 40% of people in the United States have either glucose intolerance or diabetes mellitus.⁵ Metabolic syndrome, which is the constellation of insulin resistance (type 2 diabetes mellitus), hyperlipidemia, hypertension, and obesity, is more prevalent in people age 65 to 74 years than in younger and older people.³

The National Diabetes Surveillance System of the US Centers for Disease Control and Prevention estimated that the prevalence of diabetes mellitus in people 65 to 74 years old in 2005 was 18.5%, about 12 times the prevalence among those younger than 45years.⁶ The prevalence has been gradually increasing and has nearly doubled over the past 25 years, with certain groups—native Americans, Hispanics, and African-Americans—at particularly high risk of developing the disease.

Although the prevalence of diabetes in people older than 75 years is lower than among people in the 65-to-74-year range, the elderly segment of our population is increasing, and the impact of diabetes and its associated burden of death and disease from vascular complications is enormous.

SYMPTOMS ARE OFTEN NONSPECIFIC

Unfortunately, diabetes is underdiagnosed and frequently undertreated, resulting in even more disease and death.^7–9

Diabetes is often missed in the elderly because its presenting symptoms may be nonspecific, eg, failure to thrive, low energy, falls, dizziness, confusion, nocturia (with or without incontinence), and urinary tract infection.The classic symptoms of frequent urination (often leading to worsening incontinence), thirst, and increased hunger usually occur only when plasma glucose levels are above 200 mg/dL. Weight loss, blurred vision, and dehydration may also be present with high blood glucose levels. With lesser degrees of hyperglycemia, patients may have no symptoms or present with weight loss or signs and symptoms of chronic infection, especially of the genitourinary tract, skin, or mouth.

Hyperglycemia in elderly patients is also associated with reduced cognitive function (which may improve with blood glucose control).¹⁰

The American Diabetes Association recommends screening by measuring the fasting plasma glucose level every 3 years beginning at 45 years.¹¹ However, some experts believe that this method is inadequate for the elderly¹²; some suggest that screening should be done more often in those with risk factors for diabetes, including obesity, inactivity, hypertension, and dyslipidemia, all of which are common in the elderly. Targeted screening in patients with hypertension may be the most cost-effective strategy.¹³

Screening with hemoglobin A_1c levels is not recommended because of lack of standardization among laboratories.¹⁴

INDIVIDUALIZED MANAGEMENT IS BEST

Despite disease differences, the general goals for diabetes care are the same for all ages:

• To control hyperglycemia and its symptoms
• To prevent, evaluate, and treat macrovascular and microvascular complications
• To teach patients to manage themselves
• To maintain or improve the patient’s general health status.

Unfortunately, most specific recommendations are based on studies in younger people. Guidelines should ideally reflect the complexities of a particular clinical situation, but most recommendations are applied to the young and old alike, as well as to the relatively healthy and the frail and ill.^15–17 Consideration should be given to a patient’s health beliefs, severity of vascular complications and other medical problems, economic situation, life expectancy ,functional status, and availability of support services. In addition, some patients prefer aggressive treatment, while others would rather compromise some aspects of care in order to maintain a certain quality of life, to save money, or to avoid having caregivers provide treatment.

Age-related changes in pharmacokinetics as well as polypharmacy increase the risk of drug interactions and adverse effects, especially drug-induced hypoglycemia. In addition, age-associated changes in cognitive, visual, and physical function, dentition, and taste perception can reduce a patient’s ability to carry out treatment. Frequent hospitalizations also disrupt outpatient regimens.

Comorbidities make treatment more challenging, but some conditions—such as hypertension, renal insufficiency and eye disorders—make doctors more likely to control hyperglycemia more aggressively, fearing that the loss of a little more function in an impaired organ may lead to failure.

The benefits of tight glycemic control should be weighed against the risks and the realities of an individual situation. Priority should be given to achieving the best quality of life possible.¹⁷ Recent guidelines from the California Health Foundation and the American Geriatrics Association focused on the major health threats to older patients and prioritizing care for each person.¹⁵ The guidelines recommend screening for geriatric syndromes that are more prevalent inpatients with diabetes or are strongly affected by the disease or its treatment. Diabetes care should be examined in the setting of common geriatric problems: depression, polypharmacy, cognitive impairment, urinary incontinence, falls, and pain.

Heart risk trumps glycemic control

The expert panel¹⁵ concluded that rates of disease and death can be reduced more by targeting cardiovascular risk factors than by intensively managing hyperglycemia. One rationale is that it takes 8 years for aggressive glycemic control to reduce the risk of diabetic retinopathy or renal disease but only 2 years of treating hypertension and dyslipidemia to reduce the risk of cardiovascular disease.^15,17–21 A recent Japanese study found normal mortality rates in elderly patients under long-term, intensive multifactorial diabetes control.²² High-functioning, motivated patients could benefit from therapy aimed at achieving most or all of the recommended goals, but frail patients may suffer from applying all therapies and may benefit from only some of them.

If appropriate goals cannot be met, it may help to refer patients to a geriatric specialist to evaluate possible barriers to adherence such as depression or poor cognition, physical functioning, or support.

MANAGEMENT STRATEGIES

Weight loss and exercise help prevent diabetes

The Diabetes Prevention Program²³ randomized 3,234 people (mean age 51 years) with impaired glucose tolerance to receive either metformin (Fortamet, Glucophage) 850 mg twice daily or placebo or to undertake lifestyle modifications with goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. Compared with the placebo group, the lifestyle modification group had a 58% lower incidence of diabetes while those in the metformin group had only a 31% lower incidence. Among those older than 60 years, the advantage of lifestyle modification over metformin was even greater.

• Hemoglobin A_1c levels < 7.0%
• Preprandial blood glucose levels 90–130 mg/dL
• Bedtime blood glucose levels 110–150 mg/dL.

Guidelines from the Department of Veterans Affairs²⁴ and the American Geriatrics Society¹⁵ are slightly different, and are based on randomized trials in younger patients, primarily the Diabetes Control and Complications Trial (DCCT)²⁵ and the United Kingdom Prospective Diabetes Study(UKPDS).^21,26 A recent position statement from the American College of Physicians, based on a review of all the major guidelines, recommends the following: “Statement 1: To prevent microvascular complication of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A_1c level less than 7% based on individualized assessment is a reasonable goal for many but not all patients. Statement 2: The goal for hemoglobin A_1c should be based on individualized assessment of risk for complication from diabetes, comorbidity, life expectancy, and patient preferences.”²⁷

Although few data exist for elderly patients, these guidelines are the most current approach to treating diabetes in the elderly. Less stringent goals are appropriate for patients who have limited life expectancy, hypoglycemia unawareness (lack of autonomic warning symptoms of low blood sugar), seizures, dementia, psychiatric illness, or alcoholism. It is important to keep in mind the following as one strives for lower A_1c levels: Although the relative risk reduction accomplished by lowering hemoglobin A_1c is linear, the absolute risk reduction is log-linear—more benefit is gained by lowering hemoglobin A_1c from 9% to 8% than from 8% to 7%.²⁸

Hypoglycemia is a major limiting factor in glycemic control. Many risk factors for hypoglycemia are common in the elderly (Table 2). Hypoglycemia was a chief adverse event in both the DCCT and the UKPDS, with a twofold to threefold higher rate in patients who were intensively treated.²⁹ Even mild hypoglycemia in the elderly can result in an injurious fall, which can lead to long-term functional decline. The rate of severe or fatal hypoglycemia—the major risk of tight glycemic treatment—increases exponentially with age.^30–33

As people age, the mechanisms that regulate blood sugar are impaired: the glucagon response is diminished, which increases dependence on the epinephrine response to prevent hypoglycemia.³⁴ Medications such as beta-blockers, which can suppress the symptoms of hypoglycemia, may further impair the response. Consequently, older patients may be less aware of hypoglycemia, and the symptoms may be less intense. Renal insufficiency may also exacerbate the problem by reducing clearance of oral agents. In addition, confused patients may take extra doses of medications.

Patients with type 2 diabetes treated with insulin, sulfonylureas, or meglitinides should be evaluated for symptoms of hypoglycemia. Older patients may have more neuroglycopenic symptoms (eg, dizziness, weakness, confusion, nightmares, violent behavior) than adrenergic symptoms (eg, sweating, palpitations, tremors), although both types should be asked about during an evaluation.^2,32,33 Hypoglycemia may also present as transient hemiparesis, coma, or falls.³⁵

We carefully evaluate the glycemic regimen and care environment of any elderly patient who presents with a blood glucose level below 100 mg/dL. The regimen should be altered for less strict control if the patient is cognitively impaired, is at risk of falling, or has an unstable care situation (eg, has irregular meals or needs assistance with daily activities and does not have a regular caregiver). Patients at significant risk of hypoglycemia should be encouraged to check their blood glucose level with a fingerstick before driving.

Tight control in the hospital is controversial

Glycemic control in the hospital has traditionally been designed primarily to maintain “safe” blood glucose levels, ie, to prevent hyperglycemia-induced dehydration and catabolism while avoiding hypoglycemia. Recent studies have suggested that tighter glycemic control may reduce the rates of complications and death perioperatively and in patients with myocardial infarction or who are seriously ill in the intensive care unit, although the evidence is mixed.^36–38 Specific targets are controversial, and although studies have included some elderly patients, results cannot be generalized to this group.

DIABETES CARE TAKES A TEAM

Geriatric patients have complex problems. In the face of multiple comorbidities, difficult social situations, and polypharmacy, the physician can best address the drug therapy and lifestyle changes that diabetes management requires by working with a certified diabetes educator, dietitian, social worker, and pharmacist.

Nonpharmacologic therapy

The first step in therapy for glycemic control is diet and exercise, although such measures are often limited in the elderly.

Diet. Carbohydrate control can maintain euglycemia in some patients with type 2 diabetes. But for the elderly, especially those living in long-term health care facilities, malnutrition may be of more concern than obesity, making dietary restrictions harmful. Patients in danger of malnutrition should be given unrestricted menus with consistent amounts of carbohydrate at meals and snacks. Medications should be adjusted to control blood glucose levels if necessary.³⁹

For patients living in the community, dietary therapy should be individualized by a dietitian. Medicare covers up to 10 hours of diabetes education with a certified diabetes educator or registered dietitian within a 12-month period if at least one of the following criteria are met: the patient is newly diagnosed with diabetes, the hemoglobin A_1c level is higher than 8.5%, medication has been recently started, or the risk of complications is high.

Supplementation of vitamins and minerals is prudent. Supplemental magnesium, zinc, and vitamins C and E may improve glycemic control.^40–44

Exercise reduces insulin resistance, weight, and blood pressure; increases muscle mass; and improves lipid levels. Both aerobic and nonaerobic activity are beneficial.^45–47 The best time to exercise is 1 to 2 hours after a meal, when glucose levels tend to be highest. Either hypoglycemia or hyperglycemia may occur up to 24 hours following exercise, and medications may need to be adjusted.

Oral medications

Insulin

Insulin therapy is necessary if oral combination therapy proves insufficient. Insulin is generally required for patients with moderate or severe hyperglycemia, especially for those with renal or hepatic insufficiency.^52,53 Before prescribing insulin therapy to elderly patients, we need to consider their visual acuity, manual dexterity and sensation, cognitive function, family support, and financial situation.However, several studies showed that quality of life improves in the year after starting insulin for patients whose blood sugar was previously poorly controlled with oral agents.^54,55

An evening dose of neutral protamine Hagedorn (NPH) insulin is a good way to start. More complex regimens may be necessary, depending on glycemic goals.

A number of premixed preparations of various types of insulin with different durations of action are available. They may improve accuracy, acceptability, and ease of insulin administration, although glycemic control and the risk of hypoglycemia may not change or in fact may be worse.⁵⁶ Some patients may not achieve adequate glucose control with fixed-dose regimens.^57,58

Frequent, small, titrated doses of short-acting agents control hyperglycemia better, particularly postprandial hyperglycemia,resulting in less hypoglycemia. However, these regimens may be too complex for many elderly patients; a patient’s support system must be evaluated before recommending this type of therapy.

Most insulins are available in vials and in pens, the latter of which are quick and easy to use, provide precise doses, and can be managed by many elderly patients. Pens require the user to attach a needle, set the dose by a dial, and depress the plunger to inject the dose. Some are prefilled and disposable, others have refillable cartridges. Studies in patients older than 60 years have shown the pen systems to be more acceptable, safer, and more effective than conventional syringes.

If conventional syringes are used, low-dose syringes (30-unit or 50-unit), which have more visible unit markings, should be prescribed whenever possible rather than the 100-unit sizes. Magnifying devices that attach to a syringe are also available.

Studies have also shown that continuous subcutaneous insulin infusion is safe for selected elderly patients.

Incretin mimetics: Possibly well-suited

Incretins, such as glucagon-like peptide-1, are hormones released from the gastrointestinal tract in response to eating. They stimulate insulin secretion by non-glucose-related pathways.

Exenatide (Byetta), a 39-amino-acid peptide incretin mimetic, is a synthetic version of exendin-4, an incretin isolated from the saliva of the Gila monster. Recently approved for treating type 2 diabetes, it is given subcutaneously.^59,60 Oral dipeptidyl peptidase-4 inhibitors (sitagliptin and vildagliptin) decrease the degradation of endogenous incretin and thus prolong its action.⁶¹ Because a decline in glucose-mediated beta-cell insulin secretion is a major contributor to the development of diabetes in the elderly, the drug may be especially helpful for this population.However, further clinical research and experience is needed before specific recommendations for elderly patients can be made.

SELF-MANAGEMENT IS IMPORTANT

Patient education is critical

Patient education is a cornerstone of diabetes self-management,^62–66 and is especially important for patients who are cognitively impaired or who have limited language proficiency.Patient education is covered under Medicare Part B. Ample resources are available in print and electronic formats. Community resources can also be important.

Home glucose monitoring is simpler now

A patient’s insulin regimen should ideally be tailored according to home blood glucose level monitoring before and after meals and at bedtime. Medicare reimburses for once daily testing for patients who are not taking insulin and for three-times-daily testing for those taking insulin.

Elderly patients can be taught to reliably monitor their own blood glucose levels without diminishing their quality of life. Monitoring is now easier with new glucometers and test strips that use small amounts of blood. Testing can now also be performed on blood taken from the forearm, upper arm, thigh, or calf with the FreeStyle (TheraSense), One Touch Ultra (LifeScan) and Soft Tac (MediSense) meters. The Soft Tac meter lances skin and automatically transfers blood to the test strip, making use even easier. Talking glucometers are available for blind patients.

Coordination counts

A variety of models of chronic care delivery have been proposed. Regardless of which model is chosen, the complexities of management call for a multidisciplinary team approach, and coordination of care in order to ensure appropriate information flow becomes critical.

Editor’s note: In next month’s issue of this journal, Drs. Hornick and Aron will discuss the management of diabetic complications in the elderly, including coronary artery disease, neuropathy, and kidney disease.

Guidelines for treating diabetes mellitus are mostly based on clinical studies in middle-aged people, and recommendations tend to be the same for everyone, whether young and strong or elderly and frail. But diabetes management should be individualized, especially in the elderly, taking into account each patient’s medical history, functional ability, home care situation, and life expectancy. Aggressive glycemic control is less important than avoiding hypoglycemia and achieving a good quality of life.

This article reviews the general principles for recognizing and managing diabetes in elderly patients, focusing on the management of blood sugar per se. In a future issue of this journal, we will discuss some of the many complications of diabetes in the elderly.

DIABETES DIFFERS IN ELDERLY PATIENTS

“The elderly” is a heterogeneous group with widely varying physiologic profiles, functional capabilities, and life expectancy (on average, about 88 years for men and 90 years for women in the United States). Although the elderly are sometimes classified as “young-old” (age 65–80) and “old-old” (80+), this distinction is too simplistic for clinical decision-making.

Diabetes mellitus in the elderly also is heterogeneous. One distinction is the age at which the disease developed.

Aging is associated with declining beta-cell function and lower blood insulin levels independent of insulin resistance, and with insulin resistance itself. The risk of developing type 2 diabetes mellitus increases with obesity, lack of physical activity, and loss of muscle mass, all of which often develop with aging.¹

Middle-aged patients with diabetes have increased fasting hepatic glucose production, increased insulin resistance, and an abnormal insulin response to a glucose load. On the other hand, patients who develop diabetes at an older age tend to have normal hepatic glucose production. Older patients who are lean secrete markedly less insulin in response to a glucose load but have relatively less insulin resistance.² Patients who develop type 2 diabetes in old age are more likely to have near-normal fasting blood glucose levels but significant postprandial hyperglycemia.^3,4 Elderly patients who developed diabetes during middle age have metabolic abnormalities more typical of middle-aged patients with type 2 diabetes.

DIABETES IS COMMON, AND INCREASING IN PREVALENCE

By age 75, 40% of people in the United States have either glucose intolerance or diabetes mellitus.⁵ Metabolic syndrome, which is the constellation of insulin resistance (type 2 diabetes mellitus), hyperlipidemia, hypertension, and obesity, is more prevalent in people age 65 to 74 years than in younger and older people.³

The National Diabetes Surveillance System of the US Centers for Disease Control and Prevention estimated that the prevalence of diabetes mellitus in people 65 to 74 years old in 2005 was 18.5%, about 12 times the prevalence among those younger than 45years.⁶ The prevalence has been gradually increasing and has nearly doubled over the past 25 years, with certain groups—native Americans, Hispanics, and African-Americans—at particularly high risk of developing the disease.

Although the prevalence of diabetes in people older than 75 years is lower than among people in the 65-to-74-year range, the elderly segment of our population is increasing, and the impact of diabetes and its associated burden of death and disease from vascular complications is enormous.

SYMPTOMS ARE OFTEN NONSPECIFIC

Unfortunately, diabetes is underdiagnosed and frequently undertreated, resulting in even more disease and death.^7–9

Diabetes is often missed in the elderly because its presenting symptoms may be nonspecific, eg, failure to thrive, low energy, falls, dizziness, confusion, nocturia (with or without incontinence), and urinary tract infection.The classic symptoms of frequent urination (often leading to worsening incontinence), thirst, and increased hunger usually occur only when plasma glucose levels are above 200 mg/dL. Weight loss, blurred vision, and dehydration may also be present with high blood glucose levels. With lesser degrees of hyperglycemia, patients may have no symptoms or present with weight loss or signs and symptoms of chronic infection, especially of the genitourinary tract, skin, or mouth.

Hyperglycemia in elderly patients is also associated with reduced cognitive function (which may improve with blood glucose control).¹⁰

The American Diabetes Association recommends screening by measuring the fasting plasma glucose level every 3 years beginning at 45 years.¹¹ However, some experts believe that this method is inadequate for the elderly¹²; some suggest that screening should be done more often in those with risk factors for diabetes, including obesity, inactivity, hypertension, and dyslipidemia, all of which are common in the elderly. Targeted screening in patients with hypertension may be the most cost-effective strategy.¹³

Screening with hemoglobin A_1c levels is not recommended because of lack of standardization among laboratories.¹⁴

INDIVIDUALIZED MANAGEMENT IS BEST

Despite disease differences, the general goals for diabetes care are the same for all ages:

• To control hyperglycemia and its symptoms
• To prevent, evaluate, and treat macrovascular and microvascular complications
• To teach patients to manage themselves
• To maintain or improve the patient’s general health status.

Unfortunately, most specific recommendations are based on studies in younger people. Guidelines should ideally reflect the complexities of a particular clinical situation, but most recommendations are applied to the young and old alike, as well as to the relatively healthy and the frail and ill.^15–17 Consideration should be given to a patient’s health beliefs, severity of vascular complications and other medical problems, economic situation, life expectancy ,functional status, and availability of support services. In addition, some patients prefer aggressive treatment, while others would rather compromise some aspects of care in order to maintain a certain quality of life, to save money, or to avoid having caregivers provide treatment.

Age-related changes in pharmacokinetics as well as polypharmacy increase the risk of drug interactions and adverse effects, especially drug-induced hypoglycemia. In addition, age-associated changes in cognitive, visual, and physical function, dentition, and taste perception can reduce a patient’s ability to carry out treatment. Frequent hospitalizations also disrupt outpatient regimens.

Comorbidities make treatment more challenging, but some conditions—such as hypertension, renal insufficiency and eye disorders—make doctors more likely to control hyperglycemia more aggressively, fearing that the loss of a little more function in an impaired organ may lead to failure.

The benefits of tight glycemic control should be weighed against the risks and the realities of an individual situation. Priority should be given to achieving the best quality of life possible.¹⁷ Recent guidelines from the California Health Foundation and the American Geriatrics Association focused on the major health threats to older patients and prioritizing care for each person.¹⁵ The guidelines recommend screening for geriatric syndromes that are more prevalent inpatients with diabetes or are strongly affected by the disease or its treatment. Diabetes care should be examined in the setting of common geriatric problems: depression, polypharmacy, cognitive impairment, urinary incontinence, falls, and pain.

Heart risk trumps glycemic control

The expert panel¹⁵ concluded that rates of disease and death can be reduced more by targeting cardiovascular risk factors than by intensively managing hyperglycemia. One rationale is that it takes 8 years for aggressive glycemic control to reduce the risk of diabetic retinopathy or renal disease but only 2 years of treating hypertension and dyslipidemia to reduce the risk of cardiovascular disease.^15,17–21 A recent Japanese study found normal mortality rates in elderly patients under long-term, intensive multifactorial diabetes control.²² High-functioning, motivated patients could benefit from therapy aimed at achieving most or all of the recommended goals, but frail patients may suffer from applying all therapies and may benefit from only some of them.

If appropriate goals cannot be met, it may help to refer patients to a geriatric specialist to evaluate possible barriers to adherence such as depression or poor cognition, physical functioning, or support.

MANAGEMENT STRATEGIES

Weight loss and exercise help prevent diabetes

The Diabetes Prevention Program²³ randomized 3,234 people (mean age 51 years) with impaired glucose tolerance to receive either metformin (Fortamet, Glucophage) 850 mg twice daily or placebo or to undertake lifestyle modifications with goals of at least a 7% weight loss and at least 150 minutes of physical activity per week. Compared with the placebo group, the lifestyle modification group had a 58% lower incidence of diabetes while those in the metformin group had only a 31% lower incidence. Among those older than 60 years, the advantage of lifestyle modification over metformin was even greater.

• Hemoglobin A_1c levels < 7.0%
• Preprandial blood glucose levels 90–130 mg/dL
• Bedtime blood glucose levels 110–150 mg/dL.

Guidelines from the Department of Veterans Affairs²⁴ and the American Geriatrics Society¹⁵ are slightly different, and are based on randomized trials in younger patients, primarily the Diabetes Control and Complications Trial (DCCT)²⁵ and the United Kingdom Prospective Diabetes Study(UKPDS).^21,26 A recent position statement from the American College of Physicians, based on a review of all the major guidelines, recommends the following: “Statement 1: To prevent microvascular complication of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A_1c level less than 7% based on individualized assessment is a reasonable goal for many but not all patients. Statement 2: The goal for hemoglobin A_1c should be based on individualized assessment of risk for complication from diabetes, comorbidity, life expectancy, and patient preferences.”²⁷

Although few data exist for elderly patients, these guidelines are the most current approach to treating diabetes in the elderly. Less stringent goals are appropriate for patients who have limited life expectancy, hypoglycemia unawareness (lack of autonomic warning symptoms of low blood sugar), seizures, dementia, psychiatric illness, or alcoholism. It is important to keep in mind the following as one strives for lower A_1c levels: Although the relative risk reduction accomplished by lowering hemoglobin A_1c is linear, the absolute risk reduction is log-linear—more benefit is gained by lowering hemoglobin A_1c from 9% to 8% than from 8% to 7%.²⁸

Hypoglycemia is a major limiting factor in glycemic control. Many risk factors for hypoglycemia are common in the elderly (Table 2). Hypoglycemia was a chief adverse event in both the DCCT and the UKPDS, with a twofold to threefold higher rate in patients who were intensively treated.²⁹ Even mild hypoglycemia in the elderly can result in an injurious fall, which can lead to long-term functional decline. The rate of severe or fatal hypoglycemia—the major risk of tight glycemic treatment—increases exponentially with age.^30–33

As people age, the mechanisms that regulate blood sugar are impaired: the glucagon response is diminished, which increases dependence on the epinephrine response to prevent hypoglycemia.³⁴ Medications such as beta-blockers, which can suppress the symptoms of hypoglycemia, may further impair the response. Consequently, older patients may be less aware of hypoglycemia, and the symptoms may be less intense. Renal insufficiency may also exacerbate the problem by reducing clearance of oral agents. In addition, confused patients may take extra doses of medications.

Patients with type 2 diabetes treated with insulin, sulfonylureas, or meglitinides should be evaluated for symptoms of hypoglycemia. Older patients may have more neuroglycopenic symptoms (eg, dizziness, weakness, confusion, nightmares, violent behavior) than adrenergic symptoms (eg, sweating, palpitations, tremors), although both types should be asked about during an evaluation.^2,32,33 Hypoglycemia may also present as transient hemiparesis, coma, or falls.³⁵

We carefully evaluate the glycemic regimen and care environment of any elderly patient who presents with a blood glucose level below 100 mg/dL. The regimen should be altered for less strict control if the patient is cognitively impaired, is at risk of falling, or has an unstable care situation (eg, has irregular meals or needs assistance with daily activities and does not have a regular caregiver). Patients at significant risk of hypoglycemia should be encouraged to check their blood glucose level with a fingerstick before driving.

Tight control in the hospital is controversial

Glycemic control in the hospital has traditionally been designed primarily to maintain “safe” blood glucose levels, ie, to prevent hyperglycemia-induced dehydration and catabolism while avoiding hypoglycemia. Recent studies have suggested that tighter glycemic control may reduce the rates of complications and death perioperatively and in patients with myocardial infarction or who are seriously ill in the intensive care unit, although the evidence is mixed.^36–38 Specific targets are controversial, and although studies have included some elderly patients, results cannot be generalized to this group.

DIABETES CARE TAKES A TEAM

Geriatric patients have complex problems. In the face of multiple comorbidities, difficult social situations, and polypharmacy, the physician can best address the drug therapy and lifestyle changes that diabetes management requires by working with a certified diabetes educator, dietitian, social worker, and pharmacist.

Nonpharmacologic therapy

The first step in therapy for glycemic control is diet and exercise, although such measures are often limited in the elderly.

Diet. Carbohydrate control can maintain euglycemia in some patients with type 2 diabetes. But for the elderly, especially those living in long-term health care facilities, malnutrition may be of more concern than obesity, making dietary restrictions harmful. Patients in danger of malnutrition should be given unrestricted menus with consistent amounts of carbohydrate at meals and snacks. Medications should be adjusted to control blood glucose levels if necessary.³⁹

For patients living in the community, dietary therapy should be individualized by a dietitian. Medicare covers up to 10 hours of diabetes education with a certified diabetes educator or registered dietitian within a 12-month period if at least one of the following criteria are met: the patient is newly diagnosed with diabetes, the hemoglobin A_1c level is higher than 8.5%, medication has been recently started, or the risk of complications is high.

Supplementation of vitamins and minerals is prudent. Supplemental magnesium, zinc, and vitamins C and E may improve glycemic control.^40–44

Exercise reduces insulin resistance, weight, and blood pressure; increases muscle mass; and improves lipid levels. Both aerobic and nonaerobic activity are beneficial.^45–47 The best time to exercise is 1 to 2 hours after a meal, when glucose levels tend to be highest. Either hypoglycemia or hyperglycemia may occur up to 24 hours following exercise, and medications may need to be adjusted.

Oral medications

Insulin

Insulin therapy is necessary if oral combination therapy proves insufficient. Insulin is generally required for patients with moderate or severe hyperglycemia, especially for those with renal or hepatic insufficiency.^52,53 Before prescribing insulin therapy to elderly patients, we need to consider their visual acuity, manual dexterity and sensation, cognitive function, family support, and financial situation.However, several studies showed that quality of life improves in the year after starting insulin for patients whose blood sugar was previously poorly controlled with oral agents.^54,55

An evening dose of neutral protamine Hagedorn (NPH) insulin is a good way to start. More complex regimens may be necessary, depending on glycemic goals.

A number of premixed preparations of various types of insulin with different durations of action are available. They may improve accuracy, acceptability, and ease of insulin administration, although glycemic control and the risk of hypoglycemia may not change or in fact may be worse.⁵⁶ Some patients may not achieve adequate glucose control with fixed-dose regimens.^57,58

Frequent, small, titrated doses of short-acting agents control hyperglycemia better, particularly postprandial hyperglycemia,resulting in less hypoglycemia. However, these regimens may be too complex for many elderly patients; a patient’s support system must be evaluated before recommending this type of therapy.

Most insulins are available in vials and in pens, the latter of which are quick and easy to use, provide precise doses, and can be managed by many elderly patients. Pens require the user to attach a needle, set the dose by a dial, and depress the plunger to inject the dose. Some are prefilled and disposable, others have refillable cartridges. Studies in patients older than 60 years have shown the pen systems to be more acceptable, safer, and more effective than conventional syringes.

If conventional syringes are used, low-dose syringes (30-unit or 50-unit), which have more visible unit markings, should be prescribed whenever possible rather than the 100-unit sizes. Magnifying devices that attach to a syringe are also available.

Studies have also shown that continuous subcutaneous insulin infusion is safe for selected elderly patients.

Incretin mimetics: Possibly well-suited

Incretins, such as glucagon-like peptide-1, are hormones released from the gastrointestinal tract in response to eating. They stimulate insulin secretion by non-glucose-related pathways.

Exenatide (Byetta), a 39-amino-acid peptide incretin mimetic, is a synthetic version of exendin-4, an incretin isolated from the saliva of the Gila monster. Recently approved for treating type 2 diabetes, it is given subcutaneously.^59,60 Oral dipeptidyl peptidase-4 inhibitors (sitagliptin and vildagliptin) decrease the degradation of endogenous incretin and thus prolong its action.⁶¹ Because a decline in glucose-mediated beta-cell insulin secretion is a major contributor to the development of diabetes in the elderly, the drug may be especially helpful for this population.However, further clinical research and experience is needed before specific recommendations for elderly patients can be made.

SELF-MANAGEMENT IS IMPORTANT

Patient education is critical

Patient education is a cornerstone of diabetes self-management,^62–66 and is especially important for patients who are cognitively impaired or who have limited language proficiency.Patient education is covered under Medicare Part B. Ample resources are available in print and electronic formats. Community resources can also be important.

Home glucose monitoring is simpler now

A patient’s insulin regimen should ideally be tailored according to home blood glucose level monitoring before and after meals and at bedtime. Medicare reimburses for once daily testing for patients who are not taking insulin and for three-times-daily testing for those taking insulin.

Elderly patients can be taught to reliably monitor their own blood glucose levels without diminishing their quality of life. Monitoring is now easier with new glucometers and test strips that use small amounts of blood. Testing can now also be performed on blood taken from the forearm, upper arm, thigh, or calf with the FreeStyle (TheraSense), One Touch Ultra (LifeScan) and Soft Tac (MediSense) meters. The Soft Tac meter lances skin and automatically transfers blood to the test strip, making use even easier. Talking glucometers are available for blind patients.

Coordination counts

A variety of models of chronic care delivery have been proposed. Regardless of which model is chosen, the complexities of management call for a multidisciplinary team approach, and coordination of care in order to ensure appropriate information flow becomes critical.

Editor’s note: In next month’s issue of this journal, Drs. Hornick and Aron will discuss the management of diabetic complications in the elderly, including coronary artery disease, neuropathy, and kidney disease.