Why was the Patient Centered Primary Care Medical Home unsuccessful? It was not really implemented!

 

In a recent post on the blog of the Medical Care section of the American Public Health Association (APHA), Dr. Gregory Stevens wrote Is something going wrong with the Patient-Centered Medical Home? His concern was engendered by the results of a study in the journal Medical Care (also published by the Medical Care section) by Colasurdo, Pizzimenti, et al., “The Transforming Outcomes for Patients Through Medical Home Evaluation and reDesign (TOPMED) Cluster Randomized Controlled Trial: Cost and Utilization Results”. This study examined a sample of practices implementing the PCMH model and showed varied results. The trends were toward more emergency visits, fewer hospitalizations, and unchanged costs. This was not supposed to be the result, and was a disappointment to Dr. Stevens, especially given that he was mentored by Dr. Barbara Starfield, whose research documented the beneficial impact of Primary Care on quality of care, cost, and population health.

First, some effort to clarify the terms; PCMH stands for both Primary Care Medical Home (as it generally does in the settings studied by Colasurdo, et al.), as well as Patient-Centered Medical Home, which is the term Dr. Stevens uses (actually, Colasurdo. uses both. The fact that both Primary Care and Patient Centered have the same initials is kind of cool, but it can be confusing, Indeed, in 2006 an organization called the Patient-Centered Primary Care Collaborative (PCPCC) was created. The impetus came from Dr. Paul Grundy, a physician and former VP of IBM who had recognized that the medical care costs paid by IBM in countries with a strong primary care base were much lower, even when controlling for the fact that many of those countries had national health insurance (because, in either case, IBM was paying the costs). This group, now renamed the Primary Care Collaborative, counts as members providers (both physicians and health systems), insurers, employers, pharmaceutical companies, patient-advocacy groups, and others. At the time of its creation, it was considered potentially revolutionary; with all of these major groups ostensibly buying into the benefits of primary care, the primary care specialties (family medicine, general internal medicine, general pediatrics) thought that there might finally be adequate recognition of their work. So, while of course being “Patient-Centered” is very important, it is the “Primary Care” that characterized these practice changes.

They were optimistic, but, unsurprisingly, overly optimistic. While having all those players in the PCPCC seemed like a good idea, but their agendas are not necessarily aligned with those of primary care; they can be summarized as “make money”. So they loved the “at lower cost” piece, and kind of liked the idea that maybe there was something magic in primary care that could lead to higher quality and greater patient satisfaction while spending less. Of course, it is not magic, but requires a coherent strategy to implement a structure in which the strengths of primary care were realized.

Dr. Starfield identified these strengths as the “4 Cs” of primary care:

• first-Contact care

• longitudinal Continuity over time

• Comprehensiveness, with capacity to manage majority of health

problems, and

• Coordination of care with other parts of the health care system

Starfield states ‘A primary care physician practices first-contact, comprehensive and coordinated care within the context of long-term person-focused relationships.’ (Starfield B, Oliver T. Primary care in the United States and its precarious future. Health & social care in the community. 1999;7(5):315-323). These characteristics allow the identification of which specialties are actually primary care (family medicine, general internal medicine, general pediatrics, geriatrics) and which are not. For example, it does not include either emergency medicine (yes for first-contact, no for continuity) or obstetrics-gynecology (many women’s primary physician, but scarcely comprehensive, dealing only with the reproductive tract).

The term PCMH (whichever “PC” you choose, or both) has not much been used lately. The more recent formulation has been the “Triple Aim” of higher quality, greater patient satisfaction, and lower cost, even more recently expanded to include physician (or clinician) satisfaction and lower rates of burnout to make it the “Quadruple Aim”. But, according to the study by Colarsudo and summarized by Stevens, it hasn’t worked. Why?

There were two major flaws in the implementation of the PCMH (or, if you like, PCPCMH). The first is a national issue which needs to be addressed as a baseline, something which is necessary if not sufficient to ensure quality, is that the US does not have a universal health insurance system. (And, of course, everyone is not covered by IBM.) That means that whatever the benefits of primary care are (and I believe they are enormous), they will not be realized by the entire population, The fact that so many people have no insurance or have inadequate insurance makes the whole enterprise of trying to reform the American health system in any significant way impossible. When so many people haven’t got the money to access medical care (and in this regard, having poor quality insurance, with high copays and deductibles, is often worse than no insurance, despite what advocates for ACA / Obamacare claimed), they delay care. They not only end up in the emergency room rather than a primary care office, they end up there when they are much sicker, more likely to require hospitalization, and more difficult to treat and cure. Until this is addressed, any attempt to make any kind of major reform that is intended to improve the health of the overall population is doomed.

 

The other major flaw in implementing the PCMH was that the power players in US healthcare, the health systems and insurance companies, decided to try to realize the lower cost on the front end. They did not make the investments needed to ensure that primary care could function effectively to achieve what should be considered the two truly important aims, higher quality and greater patient satisfaction. As in every endeavor that seeks to make – or save – money, course upfront investment was necessary, but shockingly little was invested. For starters, there was a need for a lot more primary care clinicians than we currently have in the US to be able to ensure that people can have access, and that doctors have enough time with their patients and are not being asked to churn so many patients through. Without this you won’t be able to realize the long-term benefits of primary care identified by Dr. Starfield and others. You won’t get quality or patient satisfaction if people are being rushed through like cattle.

For there to be enough primary care physicians and other clinicians you have to start with paying them more without concomitantly asking them to “produce” more. Too few medical students are entering primary care, seeing both the heavy workload and relatively lower pay (also a marker of lower status). Concomitantly, to the degree that achieving these goals can be facilitated by other staff doing much of the work to maintain registries, remind patients of preventive care, etc., those staff have to be hired and trained. The wrong way to do it is how it has been done: requiring the clinician, rather than other staff, to enter all this data into the Electronic Health Record, using the most expensive and highly-trained members of the team to spend their time doing secretarial work instead of seeing patients. Indeed, primary care clinicians are now finding that they often spend more time charting than interacting with patients; this is a recipe for them to burn out and leave, not to increase either their satisfaction or that of their patients.

The solutions are clear – take care of the problems. More students need to choose to enter primary care, and this means that primary care clinicians have to be paid as much as other specialists (whether by paying PC more or paying the others less) and have workloads that encourage them to spend as much time as necessary with each patient listen to them, address their problems, and communicate effectively; that is, to provide them with quality care, to be able to deliver on the potential benefits of primary care. The cost savings come at the back end, from fewer unnecessary referrals to other specialists, from fewer emergency visits, and fewer hospitalizations. But they come after the necessary investments have been made and the systems have time to adjust. As in any other industry you cannot take your profit before you have produced your product.

And, of course, we need to ensure that everyone is insured, and well-insured. The best way to do this is to have everyone in the same insurance program, with the same benefits. Medicare for All. Everybody in, nobody out.

Medical interventions we shouldn't be getting: issues of cost, health, and equity

Many of us are concerned about the cost of medical care, particularly in the US. We are also concerned about the care that we, ourselves or our families and friends receive. We want the diagnostic tests and treatments we get to be likely to benefit us and to not cause us harm. Or, if there is chance that we may be harmed, that the probability and degree of benefit exceeds the probability and degree of harm. Sometimes there can be a tension here: we want to spend less on health care globally (and certainly less on the portion that just goes into the pockets of big corporations, like pharmaceutical companies and device manufacturer, insurers and huge health provider networks), but don’t want to scrimp on things that may benefit us. Especially when we are well-insured and not paying for it directly out of our pocket.

Fortunately, there are many times when these two different interests come together, when tests or treatments that are costly are also of no benefit to us, and may cause us harm. The problem is that sometimes our doctors recommend them to us anyway, or, frankly, we ask for them (because we’ve read about it on the Internet or seen an ad on TV or because a doctor recommended it for our Cousin Shirley who had the same thing, or at least something that sounded a little the same). How can we, as patients, know when our doctors are recommending a test or treatment that is not indicated for us, will not benefit us, may even cause us harm? How do we know when we are appropriately advocating for ourselves as opposed to asking for something inappropriate? It is not easy, but we can try.

One answer is NOT to reject all medical recommendations for diagnosis or treatment, to assume that something “natural” is always right. Medicine can do a lot; it can treat a lot of illnesses that can cause you to suffer or die prematurely. There are many tests that are proven useful or valuable for making diagnoses. Another is to not reject things simply because they cost money (difficult when you don’t have much and they cost a lot), but also not to ask to have them because you have money (or insurance). To a great extent it is asking your doctor questions, asking about the degree of benefit, hoping that they are up to date, trying to question what the likely benefit is from another test or treatment, especially if costly. It also, sadly, means understanding if the doctor themselves, or a company they work for, stands to make profit on the test or treatment, since this creates a conflict of interest (but certainly does not mean that it always or usually isn’t appropriate).

There is an entire medical literature on medical overuse, and your doctor should be familiar with it, or at least the most egregious overuses that are in her/his field. A recent article in JAMA Internal Medicine , “Update on Medical Practices That Should Be Questioned in 2015”, by Morgan et al., reviews some of these.[1] The authors reviewed the literature on articles published in 2014, and came up with 104 that at least one of the 3 thought was very important, and 33 that all agreed were very important. The article reports on the “Top 10”, because this is a nice, round number and because it seems to be a manageable number of things for doctors to remember. Just these 10 represent a lot of excess tests and excess expense.

I will summarize some of these 10 (the ones I feel are most relevant; you can find them all in the article), both to remind doctors and other health care providers who might not have seen it, and because other readers may have had these tests recommended. Before doing so, it is important to review the difference between a screening test, done on the general population (or a subset of it) who don’t have any symptoms, and a diagnostic test, which may be the same test done on someone with symptoms related to what that test tests for. Frequently a test is useful for diagnosis for someone with symptoms but in someone without may not only be of little use, but find “false positives” that end up leading to more testing with more cost and greater risk.

• There Is No Benefit to Screening for Asymptomatic Carotid Stenosis.  None, for screening. Ultrasound or other tests may be of value for people with TIAs or other symptoms.
• Screening Pelvic Examinations Are Inaccurate in Asymptomatic Women and Are Associated With Harms That Exceed Clinical Benefits. Again, none, for screening. You can’t screen for ovarian cancer. I have been trying to convince my residents of this for years, despite their being often taught otherwise by OB-Gyns. This is the part where the provider puts his/her hands inside. It is NOT the same as a Pap smear, which is recommended for screening.
• Head Computed Tomography Is Often Ordered but Is Rarely Helpful. Often finds clinically insignificant abnormalities. Also, often repeated with no added benefit. (“A retrospective cohort analysis reviewed 130 patients admitted for any cause at least 7 times during a 1-year period to a tertiary care center. Patients received a mean of almost 7 CT scans, including 3 head CT scans. More than one-third (36%) of head CT scans were ordered to evaluate for altered mental status. Only 4% (7/127) of head CTs had clinically significant findings that resulted in a change in management.”)
• Thyroid Cancer Is Massively Overdiagnosed, Leading to Concrete Harms.  Study is from S. Korea, where they screen for it.
• There Is No Benefit to Paracetamol (Acetaminophen) for Acute Low Back Pain. “The median times to recovery were 17 days in both of the paracetamol groups and 16 days in the placebo group.” This does not mean we should be using opioids, though. In fact, when we give opioids for good reasons, like postoperative pain…
• Postoperative Opioid Use Continues Past the Postoperative Period.

Some overuse comes because practices once felt to be appropriate, but now shown not to be, are being taught to trainees, who either don’t know or are loathe to disagree with their instructors. Some comes, consciously or not, from the potential for providers to make money. Another recent JAMA Internal Medicine[2] study looked at family medicine and internal medicine residents who saw “secret shoppers”, standardized patients who were requesting inappropriate imaging. About 25% of the time the tests were ordered, which could be seen as either bad or good (75% of the time they weren’t). The study also showed no difference between those residents who got significant feedback and those who didn’t, and similar (and generally good) techniques of communicating to the patients why these were not indicated. An interesting wrinkle is that some of the tests chosen (MRI or CT for new-onset uncomplicated low back pain) were imaging studies not recommended by the American Academy of Family Physicians and American College of Physicians (Internal Medicine) as part of the “Choosing Wisely” campaign, but are not recommended against by the  American Academy of Orthopaedic Surgeons in their “Choosing Wisely recommendations. Of course, orthopedists stand to benefit from doing surgery on these patients. (By the way, among the recommendations of the AAFP is not doing screening pelvic examinations!)

What is the social justice issue here? After all, tests and treatments that are not indicated should not be done on anyone, regardless of financial or insurance status, racial or ethnic characteristics. Indeed, one could argue that those with more money or better insurance would be the most likely recipients of extra tests. But poorer, or less well-insured, people often don’t get the tests and treatments that they actually need (which has often been discussed in this blog; see for example Dead Man Walking: People still die from lack of health insurance, November 17, 2013), while tests and treatments are overused for others. This creates the (accurate) perception of a two-class health care system, and the (sometimes, perhaps, less accurate) perception that the disadvantaged are, in addition to not getting care they need, are not getting discretionary care that benefits the wealthy. Also, the more money spent globally on unnecessary medical care, the less available for necessary non-medical initiatives (housing, food, education) that would actually create better health.

A single payer system would not in itself achieve this goal, but it would create far more equity in the allocation of healthcare dollars, and at least eliminate the profit motive that might impact the recommendations of some providers and healthcare institutions.

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[1] Morgan DJ, Dhruva SS, Wright SM, Korenstein D, Update on Medical Practices That Should Be Questioned in 2015, JAMA Intern Med. 2015 Dec 1;175(12):1960-4. doi: 10.1001/jamainternmed.2015.5614.

[2] Fenton JJ, Kravitz RL, Jerant A, et al., Promoting Patient-Centered Counseling to Reduce Use of Low-Value Diagnostic Tests: A Randomized Clinical Trial, JAMA Intern Med. Published online December 07, 2015. doi:10.1001/jamainternmed.2015.6840

Patient-centered research: answering the questions that matter to people

“Large investments are too often made in studies that provide poor-quality evidence,^1​ are overtly biased,² are not applicable to most patients,^3​ or yield results that do not address the real concerns of individuals facing clinical decisions.^4,5”  [1] (Patient Centered Outcomes Research Center, JAMA, April 18, 2012)

Indeed. This is not only “too often”, it is in fact characteristic of most research, whether sponsored by the National Institutes of Health (NIH), foundations, or private companies. The reasons for this are that it is easier to do and it relatively well funded (thus the “large investments”).

Many years ago, researchers, particularly those providing primary care, distinguished between “disease-oriented evidence” (DOEs) and “patient-oriented evidence” (POEs, or later, adding “that matters”, POEMs). The first is about showing that a treatment improves a disease. The second is looking at what treatments improve the life of a person. There is a big difference. A simple example might be in looking a regimen for diabetes that minimizes the complications from high blood sugar by keeping the average blood sugar much lower than had previously been the goal (called “tight control”). Disease-oriented evidence might show that using frequent insulin injections to keep the blood sugar in the low-normal range reduces the long-term negative effects of diabetes. A patient-oriented approach, however, looks at the overall impact on the person, not just the disease. Does the patient find it difficult to administer more frequent injections of insulin and check their blood sugar? Do they spend a significant amount of time with blood sugar that is in fact too low (after all, reducing the average increases the probability that sometimes it will be too low), and feel fuzzy-headed and unable to live the lives they wish to? Or feel dizzy? Or that a certain percent actually pass out from low blood sugar? Maybe break their hips and end up in the hospital or even dying from its complications? Even though their diabetes is in “good” control? “The disease was controlled but the patient died from a complication of treatment” is not a desirable patient-oriented outcome!

The motivation for private companies, most often pharmaceutical companies, to fund disease-oriented research is fairly obvious. Their sole agenda is to make profit, so they are interested in supporting research that shows that their drugs are effective for treating certain conditions. They have a number of advantages in this arena:

·         Showing “effectiveness” requires, by FDA criteria, only to show that a new drug or other treatment is more effective than placebo, not than the currently available treatments;

·         Since they are paying for it, they can suppress the publication of results that do not show their drugs in a good light;

·         They have to show only that it modifies the disease, not that it is the best choice for any individual patient (thus it is Disease-oriented, rather than Patient-oriented);

·         In lieu of patient-centered research, they have huge marketing budgets (far in excess of their research budgets) to advertise their products to both providers and directly to patients once they have been approved by the FDA.

Why NIH would mostly fund this sort of research is more complicated. Part of it is that an entire industry has been built around doing disease-oriented research, largely in biological science laboratories, but also in doing clinical trials in people. Thousands of academics and the institutions at which they work are dependent upon such funding to maintain and advance their careers and institutions. The review committees that make recommendations to approve or disapprove funding are “peer” committees, made up of people who do, largely, the same kind of work. This is good because they can understand and evaluate the science involved (a really bad thing would be for a group of politically-appointed ideologues to make the decisions, and this sometimes has occurred), but they are limited by their understanding of how research is done and what its goals should be. This relates to a second challenge – patient-oriented research is more complicated, more difficult to do, and leads to less “clear” outcomes. Of course, it is more relevant to patients and their providers making decisions about their care, but it is harder to fit into a rigid research model in which all but one variable is tightly controlled. This can lead to research that is done because it is possible to do it, rather than because it answers the questions that we have (see “Defining Streetlight Research”, February 26, 2009). Most traditional NIH researchers have no objection to patient-oriented research, but in an era of limited funding availability might be quite concerned if funding it decreased the amount available for the kind of work that they do.

Trying to address this, the Affordable Care Act of 2010 established the Patient-Centered Outcomes Research Institute (PCORI) to apply the rigorous standards of Clinical Effectiveness Research (CER) to treatment of patients, not diseases. One clear need here is that people, particularly older people, often have more than one disease. The “right” treatment for a patient’s cancer needs to take into account its effect on his/her diabetes – or heart disease, hypertension, arthritis, depression, alcoholism, glaucoma, poverty, and yes, maybe, another cancer – in any or all combination. Because we care for the person, who may have any or all of these conditions, primary care doctors are likely to be more sensitive to these interactions than are physicians caring for only one of them. It is for this reason that we have advocated for a National Center for Primary Care to look at the comprehensive care of patients differently than the existing disease-oriented Centers (e.g, the National Cancer Institute, the National Center for Heart, Lung and Blood Disorders, the National Institute of Mental Health) have.

The article in the April 18, 2012 issue of JAMA from which the opening quotation is drawn, “Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research”, includes the following case as an example:

“A 78-Year-Old Man with Heart Failure, Diabetes, and Renal Failure. Mr B was admitted to his local hospital for the fourth time this year. Mr B experienced symptoms of shortness of breath and weight gain that led him to contact his physician, who recommended another hospitalization. He lives with his wife in a 2-story house located 30 miles from the hospital. He has recently been unable to climb the stairs to his bedroom. Mr B requires outpatient hemodialysis 3 times per week, but missed his last dialysis treatment because he felt too tired to go. This is his second hospital admission after missing a dialysis appointment. After each admission, Mr B received standard discharge instructions on how to care for himself at home. Mr B's highest priority is his independence, including the ability to drive and to remain in his own home.”

To make appropriate decisions about Mr B’s care requires not only considering the interplay of his several chronic diseases, but the circumstance of, and his own preferences and goals for his life. This cannot be done by employing solely the findings of disease-oriented research.

PCORI is not a National Institute for Primary Care, but it may help to achieve some of the same goals. In the same issue of JAMA, Joe Selby (the director of PCORI) and colleagues list the both the statutory criteria for PCOR-funded research:[2]

1. Effect on the health of individuals and populations
2. Probability of improvability through research
3. Inclusiveness of different populations
4. Current gaps in knowledge/variation in care
5. Effect on health care system performance
6. Potential to influence decision making
7. Patient-centeredness
8. Rigorous research methods
9. Efficient use of research resources

and their proposed priorities for national research:

1. Assessment of options for prevention, diagnosis, and treatment
2. Improving health care systems
3. Dissemination and communications research
4. Addressing disparities
5. Accelerating patient-centered outcomes research and methodology

None of these are disease specific, although unquestionably much of the research that is funded by PCORI will look at people with specific diseases. These criteria, however, recognize the need for treatment plans to take into account all aspects of a person, and by extension the family and community of which they are a part. This includes addressing the disparities that exist between groups, especially poor and minority groups; that is to say, addressing issues of social determinants of health and social injustice.

Maybe we will finally get funding for studies that provide us will more useful information for caring for actual people.

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[1] Methodology Committee of the Patient Center Outcomes Research Institute, “MethodologicalStandards and Patient-Centeredness in Comparative Effectiveness Research”, JAMA, 2012;307(15):1636-1640. doi: 10.1001/jama.2012.466.

[2] Selby JV, Beal AC, Frank L, “The Patient-Centered Outcomes Research Institute (PCORI) National Priorities for Research and Initial Research Agenda”, JAMA 2012;307(15):2583-4. Doi: 10.1001/jama.2012.500