Tuesday, February 24, 2009

Quality and Chronic Disease Management

JAMA (Feb 18, 2009) has an interesting commentary by Patrick Conway and Carolyn Clancy of the Agency for Healthcare Research and Policy (AHRQ) on “Transformation of Health Care at the Front Line”,[1] which tries to address issues of quality assessment and cost, and emphasizes the need for studies to be done at the “front line” of medical care – actual community-based practices, rather than only at academic health centers. AHRQ has funded much of this research, including funding of projects carried out by “practice based research networks”, networks of community based practitioners, usually coordinated at an AHC (frequently in departments of Family Medicine or Preventive / Community Medicine). They note the existence of a “multitude of quality organizations” that have developed standards and measures, but call on them to focus on “high priority measures such as those that influence outcomes on high-prevalence diseases, demonstrate baseline performance variability, and have potential mechanisms to improve results…measures should increasingly focus on patient-centered outcomes.” They also note that current measures, which focus on individual clinician-patient interactions, undervalue the importance of teams in care.

Conway and Clancy also address Health Information Technology, Comparative Effectiveness, Quality Collaboratives and Learning Networks, and very importantly, Clinician Training. This last includes what seems to be slightly odd: “This focus on quality improvement, coordination of care, and measuring results is especially critical for training future generalist physicians.” I am certain that this means to address the fact that generalist physicians will be critical in coordinating patient care, not to exempt subspecialists from quality improvement; after all, the effectiveness of standards implemented by and measured in the practices of generalist physicians will be completely negated if subspecialists are not subject to the same standards; if they are allowed to continue, as is very often the case currently, to provide procedures because they are available, may be effective, are profitable but not necessarily cost-effective, and done in isolation from an approach to the overall care of the patient.

One very large effort to address quality were the 15 randomized trials of care coordination for chronic disease in Medicare patients known as the Medicare Coordinated Care Demonstration, supported by the Centers for Medicare and Medicaid Services (CMS), and reported on by the independent evaluator, Mathematica Policy Research, Inc., in the Feb 11, 09 issue of JAMA.[2] Each of these trials was conducted by an institution (community hospital [3], academic medical center [3], integrated delivery system –i.e, hospital and associated practices [1], private for profit care-coordination agency [5], long-term care facility [1], retirement community [1]hospice [1]) and involved 15 states + DC (Iowa and Maryland were in two each, and one hospital covered patients in 4 states). The main effort was to use care coordination to try to decrease hospitalizations, and thus costs (as hospitalization is the main driver of cost) in various chronic disease populations. Most of these programs used nurses (usually RNs, though in one case LPNs, to call – with greatly varied frequency, or visit in only a few of the cases) patients with chronic diseases. The bottom line is that they didn’t work to reduce costs through reduced hospitalizations, although they do not really report on benefit to patient outcomes (as previously addressed in this blog, improved outcomes may not cost less). Two of the programs did have fewer hospitalizations, and two had significant increases in cost (one program was in both groups). Two (including the other program with fewer hospitalizations) had non-statistically-significant trends toward lower cost.

A very important factor is that the participants in these studies were different from the mean for all Medicare beneficiaries. They were had higher educational levels, and were less likely to be Hispanic, younger than 65 (since people who are on Medicare < 65 must be disabled, this would potentially select for healthier people, or at least exclude a large number of sick ones), or on Medicaid (a proxy for poverty). They also had nearly three times higher costs/beneficiary in the year prior to entry into the study ($1555 vs $552). An even more important issue is that the programs were allowed to set their own criteria for entry into – and exclusion from – their study populations:

“Four programs explicitly excluded beneficiaries younger than 65 years [who, as noted above, would be particularly sick] and 13 programs excluded those patients with end-stage renal disease or receiving dialysis. Fourteen programs excluded beneficiaries with certain other conditions, including terminal illness, conditions that affected their ability to learn self-management (e.g., serious mental illness or dementia), or conditions that were complex to manage but unrelated to target diagnoses (e.g., human immunodeficiency virus/AIDS)…”

Such exclusions make the studies easier to conduct, and would tend to make the outcomes look better (although they still didn’t) but make them less useful to apply to the real world, where people do have mental illness, HIV/AIDS, end-stage renal disease, and even more, have multiple chronic diseases, not just one or two. Many of them are also poor, on Medicaid, disabled, and Hispanic. Thus, while these studies, in multiple settings, seem to fit the criterion of “front line” that Conway and Clancy describe, the exclusions and the differences in the study populations from all Medicare beneficiaries would limit their applicability even if they were effective; they are still “effectiveness” than “efficacy” studies.

In this regard, this study is another illustration of the problems of most research studies, whether laboratory, clinical, or even (as this one) community based. They are “streetlight” studies that set out to answer questions that are possible, or easy, to answer, rather than the actual questions that we need answers to. By excluding participants, paying them, providing free benefits (all of which may be components of ethical research, ironically), by setting conditions not replicable in the entire community, their usefulness can be very limited. The Medicare studies, based in the community and involving sick people are, even with their limitations, more useful than most. Unfortunately, they did not demonstrate savings, but savings alone cannot be the only criterion (we have addressed cost-effectiveness, Feb. 13). Conway and Clancy speak of “patient-centered outcomes”, but we really need more – patient-important outcomes, by which really we mean mortality and quality of life.

Finally, as I have to note so often, studies of quality, and of cost, and even of cost-effectiveness, are taking place in the context of our current non-system of health care, with ridiculous financial motivators for practice and no coordinated national approach to health or health policy, and are therefore extraordinarily limited. A national health financing system, single payer or otherwise, will not guarantee quality or cost control, but its absence will virtually guarantee failure when pilot programs, even “successful” ones, are moved into the general population.

[1] Conway PH, Clancy C, “Transformation of health care at the front line”, JAMA 18Feb09;301(7):763-5
[2] Peikes D, Chen A, Schore J, Brown R, “Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials”, JAMA 11Feb09;301(6):603-18.

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