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Clinical Crossroads | Clinician's Corner

A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans

Thomas Bodenheimer, MD, Discussant
JAMA. 2007;298(17):2048-2055. doi:10.1001/jama.298.16.jrr70000.
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Mr P has long-standing hypertension, obesity, and diabetes mellitus and has experienced life-threatening cardiovascular events. Mr P is receiving evidence-based clinical care but has adhered to his medical regimen poorly and remains at considerable risk of future catastrophic cardiovascular events. Practicing evidence-based medicine should be a 5-step process: research uncovers the evidence, clinicians learn the evidence, clinicians use the evidence at every visit for every patient, clinicians make sure patients understand the evidence, and clinicians help patients incorporate the evidence into their lives. Research demonstrates, however, that clinicians do not use the evidence at every visit, patients may misunderstand what took place in the visit, and clinicians are not always effective in helping patients incorporate the evidence into their lives. These failures reflect the difficulty faced by clinicians attempting to address multiple issues while providing sufficient information and engaging in collaborative decision making during a brief clinical visit.

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Reader's Response to A 63-Year-Old Man with Multiple Cardiovascular Risk Factors and Poor Adherence
Posted on October 26, 2007
American University of the Caribbean
Conflict of Interest: None Declared
Mr. P has hypertension, type 2 diabetes, widespread atherosclerosis, the metabolic syndrome, and obesity. Presumably he has a history of hyperuricemia and acute gout as he has been on allopurinol. Apparently he also has osteoarthritis of the hip. Because of his history of pulmonary embolism and the risks of surgery for him, I would refer him to a neurologist to exclude the possibility that his back and hip pain have a neurological rather than an orthopedic cause. In view of his history of diabetes and his erectile dysfunction, I would also ask that neuropathy or autonomic dysfunction be excluded. Because of his difficulty in discussing things, I would also check that he does not have any urinary or prostate symptoms, get a PSA measurement, and check his triglyceride and HDL-cholesterol levels. His drug treatment has been in keeping with the principles of evidence-based medicine. I would only question the use of allopurinol and amlodopine because I don't have enough details to know why and when these were prescribed. Because he has stage B cardiac failure as defined by the ACC/AHA(1) it is very appropriate for him to be on lisinopril and atenolol. Lisinopril is also very appropriate as he is a diabetic with microalbuminuria.(2) In view of poor compliance, I would consider using an ARB rather than lisinopril to avoid his developing a cough. His hypertension needs to be better controlled as it should be 130/80 mmHg or less.(2) To achieve this carvedilol might be a better choice than atenolol as it has additional antihypertensive properties. If his BP is still not sufficiently controlled then furosemide would also take care of his pitting edema. I would continue treating him with atorvastatin, aiming to keep his LDL-cholesterol <60-70 mg/dL and his HDL-cholesterol >40 mg/dL.(3) I would continue the use of metformin as it does not cause weight gain or hypoglycemia, but would also consider the addition of a DPP-4 inhibitor (sitaglipitin) as this assists in a more physiological response to increases in blood glucose.
Compliance with chronic treatment is often a problem.(4) As his wife needs to be increasingly involved in his medical care, it is important that this is discussed thoroughly with and agreed to by both Mr. P and his wife. But Mr. P's compliance will only be improved if there is better communication established in his therapeutic encounters.(5) Mr. P’s experience of having to wait for his office appointments is a common problem and must be dealt with. Not to do so is ignoring his right to having his time constraints also regarded as important.
Unfortunately, there are obviously no simple answers to improving patient compliance.(4-6) In addition, there is not much evidence-based data to use either.(6) Patients require time and a willingness to really listen to them if they are to be able to truly communicate. As his physician has difficulty communicating with Mr. P then use of a nurse (practitioner) with more time might be a valuable move. Brokensha(7) has provided a number of very sensible suggestions for improving communication with patients as part of assisting with their compliance.
Mr. P and his wife will possibly be more willing to take suggested treatment more seriously if they understand the treatment suggested to them. This could be facilitated by making reliable explanatory leaflets available as can be found on the American College of Physicians’ online site (PIER Patient Information).(8)
Dr David M Paton American University of the Caribbean 1 University Drive, Cupecoy St Maarten Netherlands Antilles
No relevant financial interests.
1. Hunt SA, Abraham WT, Chin MH et al: ACC/AHA 2005 Guidelines update for the diagnosis and management of chronic heart failure in the adult – summary article. J. Am. Coll. Cardiol. 2006; 46: 1116-1143.
2. American Diabetes Association: Standards of Medical Care in Diabetes – 2007. Diabetes Care 2007; 30: S4-S41.
3. Smith SC, Allen J, Blair, SN et al: AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update. Circulation 2006; 113: 2362-2372.
4. Krousel-Wood M, Hyre A, Muntner P et al: Methods to improve medication adherence in patients with hypertension: current status and future directions. Curr. Opin. Cardiol. 2005; 20: 296-300.
5. Krueger KP, Berger BA, Felkey B: Medication adherence and persistence: a comprehensive review. Adv. Ther. 2005; 22: 313-356.
6. McDonald HP, Garg AX, Haynes RB: Evidence on the effectiveness of interventions to assist patients’ adherence to prescribed medications is limited. JAMA 2002; 288: 2868-2879.
7. Brokensha G: Strategies to assist patient compliance with lifestyle changes. Aust. Prescr. (1998) 21:92-94. Accessed on October 24, 2007 at http://www.australianprescriber.com/magazine/21/4/92/4/
8. American College of Physicians: PIER patient information. Accessed on October 24, 2007 at http://www.acponline.org/fcgi/pierpi.pl
The "polypill" for "polyproblems"!
Posted on October 22, 2007
Elsayed Z. Soliman, MD, MS
Wake Forest University School of Medicine
Conflict of Interest: None Declared
Mr P's care is a clear example of the gap between what we "should" do as physicians and what we "can" do. Unfortunately, current evidence-based medicine mainly addresses the interventions in ideal situations with highly adherent people, not in real life situations where people are much less compliant. In other words, the current research is concerned with "efficacy," not "effectiveness." Hence, I do not think that there is anyone to blame in Mr P's care, considering current practice and knowledge. In Mr P's case, the physicians are trying to implement what they have been told is good for patients and Mr P is behaving the same way as many patients. The science on the efficacy of life-saving interventions, either behavioral and/or pharmacological, is strong, but the challenge is to increase its application by enhancing effectiveness, availability, affordability, adherence, and sustainability.
Many high risk patients such as Mr P would benefit from treatment with several drugs proven to reduce cardiovascular disease. Therefore, a combination pill using fixed-dose formulations of effective drugs would have the potential to overcome 2 problems: adherence to multiple pills and inadequate dosages often prescribed in routine clinical practice(1) - the same as Mr P's case. The combination pill referred as the "polypill" gained widespread attention with Wald and Law's 2003 paper describing a fixed dose "polypill" comprising a statin, 3 antihypertensive agents at half doses (a Ã-blocker, a diuretic, and an angiotensin-converting enzyme inhibitor), aspirin (75 mg), and folic acid (0.8 mg)).(2) The claimed benefit of the "polypill" would achieve a more than 80% reduction in cardiovascular events if applied to everyone older than 55 years.(2) According to Wald and Law, any reduction in cardiovascular risk factors regardless of the baseline values would lead to reduction in cardiovascular risk. Therefore, screening for risk factors would not have much importance if the "polypill" were to be prescribed. This could be important if it would permit reducing the number of visits to doctors, the thing that Mr P and many other patients hate to do.
The idea of using multiple ingredients in the same pill is not very new. A pill combining amlodipine and atorvastatin (in dose combinations 5mg/10mg, 5mg/20mg, 5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg, 10mg/40mg, and 10mg/80mg) has been licensed by the FDA in USA and marketed at slightly less than the cost of the two drugs separately since 2003. Until the "polypill" becomes commercially available, Mr P could benefit from such available combinations. There is no doubt that the ingredients of the proposed polypill should be revised to match the current evidence-based medicine in different patient groups.
Finally, I believe that retired people like Mr P would really benefit from "group" activities such as the gym community. I hope his knees get better with the surgery and he will be in a better position to go back to the gym.
Disclosure: The author is an investigator in a polypill feasability study to be conducted in Sri Lanka.
1. WHO. Secondary prevention of noncommunicable diseases in low and middle income countries through community based and health service interventions. WHO-Wellcome Trust meeting report, August 2001.
2. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003;326:1419.
Helping Mr. P
Posted on October 17, 2007
Michael Pignone, MD, MPH
UNC Department of Medicine
Conflict of Interest: None Declared
In terms of his cardiovascular risk, Mr. P has excellent glycemic control and lipid levels, two key markers of cardiovascular risk, and has been prescribed key therapies for reducing such risk: aspirin, statin, and ACE inhibitor. (1) Currently, his most important clinical issues appear to be his hip pain and hypertension. The hip pain has reduced his current quality of life and has limited his ability to exercise, which was an effective strategy for other problems. Lack of exercise and use of NSAIDs may have exacerbated his hypertension. Before he has hip surgery, he would benefit from better hypertension control. As such, we would recommend discontinuing the NSAIDs and would use opiates for pain relief in the meantime. We would then focus on improving his blood pressure control. Diagnostically, depression and obstructive sleep apnea should be considered, as they could affect his quality of life, adherence, and blood pressure control.
The key issue for Mr.P, however, is not in the selection of diagnostic tests or evidence-based treatments, but in the fundamental roles that he, his wife, and his health care providers play in his care and adherence. Currently, Mr. P is not optimally engaged in his care. The relationship between Mr. P and his physician Dr. Z is not optimal, and may be characterized by incomplete trust and communication.
As noted by Dr. Z, the visit structure has been a barrier. Mr. P, like most patients, does not like to be kept waiting; he values timeliness and the opportunity to interact with his doctor. Dr. Z would likely benefit from evaluating and systematically adjusting his office workflow and/or better utilizing team care to reduce idle waiting time. (2) Until such changes, Dr. Z's practice could simply schedule Mr. P for the first visit of the day.
In terms of his self-care, Mr. P and his provider both recognize that his current situation is not optimal. However, Mr. P has many strengths: 1)he has insurance and a regular care provider; 2) he has a relatively high socioeconomic status; 3) he is presumably well-educated and literate; and 4) he has successfully accomplished major behavior change in the past: stopping smoking and increasing his exercise.
The main characteristics that make his care difficult include: 1) he finds it difficult to express his discontent; 2) he has an external locus of control, particularly with respect to his medications; 3) he has some resistance to taking medication, perhaps because it signifies that he is "ill."
We would recommend that Mr. P and his providers begin with a re- assessment of the therapeutic relationship. Dr. Z and his staff should give Mr. P significant praise about successful behavior changes in order to build his confidence and self-efficacy. They should also perform focused education around the benefits of hypertension control as a means of reducing cardiovascular risk and explore potential means for increasing medication adherence, such as the use of pill boxes. We would also suggest linking better hypertension control with his desire for successful, uncomplicated hip replacement surgery.
Mr. P's case also presents at least two dilemmas that have not been well studied to date: 1) the extent to which Mr. P and his care team should rely on his wife to ensure his adherence. For patients with cognitive impairment, this strategy is likely to be quite effective; however, assuming he has no cognitive impairment, relying on Mrs. P may exacerbate the problems with disengagement and external locus of control. 2) Whether his care can be substantially improved using a physician care- dominated model, or whether systems change is required for improvement. A recent systematic review found the use of multi-disciplinary teams with enhanced responsibility for non-physician providers to be one a key factor in improving glycemic control. (3)
In our multi-disciplinary team-based environment, we would support the physician-patient relationship through the help of mid-level providers and trained care assistants, using a registry and evidence-based algorithms to better deliver care. Such an approach is effective in improving glycemic control, reducing blood pressure, and improving patient and provider stisfaction. (4,5)
Michael Pignone, MD, MPH; Robb Malone, Pharm D; Carolyn Menzie Darren DeWalt, MD, MPH
University of North Carolina Division of General Internal Medicine UNC Center for Excellence in Chronic Illness Care
1. Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F, Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J, Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007; 115(1):114-26.
2. Potisek NM, Malone RM, Shilliday BB, Ives TJ, Chelminski PR, DeWalt DA, Pignone MP. Use of patient flow analysis to improve patient visit efficiency by decreasing wait time in a primary care-based disease management programs for anticoagulation and chronic pain: a quality improvement study. BMC Health Serv Res. 2007 Jan 15;7:8. PMID: 17224069
3. Shojania KG, Ranji SR, McDonald KM, Grimshaw JM, Sundaram V, Rushakoff RJ, Owens DK. Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis. JAMA. 2006 Jul 26;296(4):427-40. PMID: 16868301
4. Rothman RL, Malone R, Bryant B, Shintani AK, Crigler B, Dewalt DA, Dittus RS, Weinberger M, Pignone MP. A randomized trial of a primary care- based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. Am J Med. 2005 Mar;118(3):276-84. PMID: 15745726
5. Malone R, Bryant Shilliday B, Ives TJ, Pignone M. Development and Evolution of a Primary Care-Based Diabetes Disease Management Program. Clin. Diabetes 2007; 25: 31-35.
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