Challenging Pharma towards Patient Centered Studies

Pharma effectively trains a "Challenger" Salesforce, as described in Harvard Business Review. We recently met with Dr. Molony to discuss the development of a short lunch lecture series at UT-Houston which would better prepare medical students to deal with this type of salesforce. In the long run, pharma will deliver only the evidence that doctors demand. As we begin to demand patient centered studies, leading Pharmas will react by funding more appropriate studies. Then, patient centered evidence becomes a competitive advantage.

Collaborative :: Silos

Recently, our leadership team has been developing a plan to study and improve the ability of our teaching hospital to comply with best practices in the blood pressure management of acute stroke patients. Coincidentally, we will be working with the hospital to implement findings from studies our neurologists acted as reviewers, contributors, or even lead authors.

UT Houston and Memorial Hermann have recognized that it’s not enough to be a thought leader; ideas must be transformed into clinical practice. This goal isn’t accomplished by establishing a separate “Translational” organization, furthered by flashy rhetoric, or supported by a partnership with a neighboring business school. Rather than discuss the need for “bench to bedside” initiatives, quality transformation has been fully integrated into the culture of UT Houston medical school and its main teaching hospitals. The initiative has been championed by our dean, and its vision accomplished through the leadership of our faculty mentor, Dr. Eric Thomas. Today, Quality Improvement physicians are in place as distinct leaders in most clinical departments. In this way, Patient Safety benefits from direct accountability of named individuals and by delegation through well structured responsibilities.

We engaged the QI leader of the neurology department to help us refine our project proposal. He identified several flaws. Additionally, in his role, he had the credibility to request that our proposal be reviewed by the Chief of Neurology and several Stroke Neurologists. Our collaborative effort was further strengthened by his engagement of nursing staff who noted our project required an understanding of admission criteria. We were promptly supplied with that documentation and the nursing Stroke Coordinator was available for follow-up questions. Within a few days we had received constructive comments from several organizational facets. Many we immediately integrated into our proposal; others we sidelined to discuss with our mentors how additional study metrics may overextend our scope.

What’s unique in these efforts is not that medical students are engaged in clinical research. That’s common in any medical school. Fortunately, we attend the rare medical school in which a group of students is able to organize and be counseled by these experts. It is a unique structure that wholeheartedly supports quality improvement. A culture sufficiently pervasive that even its student’s perspective of clinical problems may initiate change.

QI Revolutions Lower Barriers to Improvement

Over the past year, 2directions has met with leading physicians to learn from their successful QI projects. We were most impressed by projects which achieved demonstrable benefits to their patients and to their medical care organization. One such project was Dr. Bela Patel’s success at Memorial Hermann Hospital, in which she essentially eliminated ventilator associated pneumonias (VAP) from her ICU for five years and counting. Review of her achievements highlights patients who experience fewer adverse outcomes and arrive home sooner.

To accountants, those patient-centered results equate to cost savings and increased turnover. Previously, 2directions presented an analysis of how bed turnover is one of the primary drivers of hospital efficiency. Better turnover increases capacity and widens bottlenecks that otherwise limit patient flow. It’s much easier to justify those benefits through a low cost, low risk quality improvement project, than through heavy capital expenditure and disruptive construction of new beds. We estimate her work releases $1.7 million from the annual operating budget and avoids $3 million of capital expenditures.

Her work provides meaningful patient stories and a compelling business case. But even as Bela Patel’s Medical Intensive Care Unit has gone without a VAP for five years, in most hospitals, VAPs remain a monthly occurrence. This observation led 2directions to ask what barriers prevent rapid adoption of such tremendous accomplishment to other healthcare institutions.

Several of us at 2directions have experience outside healthcare. Software, industrial manufacturing, and retail provide reference of successful scale: the explosive growth of social networks, the economics of precision in mass production, and fashion trends. The answer to why scale is not possible in quality improvement is the same reason my former employer, IBM Consulting, has been tremendously successful, even in economic downturn -- QI is a highly customized service. Solutions aren’t simply adopted, they must be adapted. Even if the solution has proven successful elsewhere, adaptation is required, and it is an expensive process that calls upon local heroes to successfully shift the organization to the new clinical approach.

It became our conviction that QI scale is hindered by two cultures. The clinical culture is hesitant to change processes. Physicians are apt to believe in a system in which hard work, by competent people, delivers the best patient outcomes. We need a change agent that will risk reputation and expend great efforts to demonstrate that even better patient outcomes are possible through QI. The financial culture of the hospital is hesitant to invest in projects which disrupt the current model. Reluctance can be overcome by a salesperson who understands the hospital’s financial drivers, and uses those drivers to connect their offering to better business outcomes. We need a similarly equipped salesperson for QI.

Understanding these barriers to scale, and the capabilities needed to surmount them, we considered the equipment which would enable physicians to overcome them. We aim to refine our blueprint and begin to fabricate these tools over the next 8 months. However, ours is not a “if we build it, they will come” type solution. Only participation by QI Physician Leaders will substantiate our vision. Therefore our first step was to garner support for our concept from the American Medical Association. We drafted a resolution which describes the problem we identified and our approach to a solution, and presented it to the AMA medical student section (MSS) to ask for promotional support. The MSS formally adopted our resolution at their national meeting in New Orleans one week ago. It’s a milestone we are excited to share. The next step will be for physicians to debate this resolution on the floor of the House of Delegates, at the AMA meeting in Chicago this summer. Passage would be a strong catalyst to improve collaboration between QI leaders.

Social Coordination of Healthcare

The whole costs less than the sum of the parts.

According to data collected till 2009 for the 100,000 Homes Campaign, about half of our nation's hundreds of thousands of homeless people have either a medical, mental, or substance abuse problem, and one quarter have all three. Unfortunately, their healthcare provider of choice--emergency departments--is the most expensive one.

Providing regular housing to homeless people on its own decreases their per-capita health care cost from $28,436 to $6,056, according to Boston's Health Care for the Homeless program. However, just as five percent of our country's population uses fifty percent of our healthcare resources, there is a similar stratification of need among the homeless. Patients with a cluster of chronic needs, or a debilitating condition that can be improved with a few weeks or months of treatment can be channeled away from acute care, if given assistance in navigating the healthcare system. Coordination of care by nurses and social workers connects them with primary care and this team combats the mental health, substance abuse, and social issues. Developing a first-name relationship and giving tailored, ongoing support, makes the difference in these successful programs.

Communities from Portland to Philadelphia are identifying and partnering with these homeless patients. In one success story, Portland's Recuperative Care Program has been taking high-need patients from the ER into a 30-day medical home and assigning them care coordinators, and has reported rates of 74% medical recovery and 61% discharge to stable housing. Oregon Health and Science University hospital leaders report that since 2005, they paid $500,000 to the program and thereby saved $3.5 million in costs, by reduced retreatment visits in the ER. At the heart of these results are care coordinators who know the patients personally, and help them execute primary-care centered, long-term plans.

System-level healthcare integration is not only important for the homeless. Disjointed, high-cost, acute care for the homeless is reminiscent of our broader system. Truthfully, few of us find a medical home. Perhaps these programs are the first stones to be thrown in a Copernican Revolution which recasts the patient at the center of our medical system. Patient health at the bottom line is the organizing principle, and primary care is the organizer. Without them, specialty interventions become so many soldiers without a general or a plan.

Craig C, Eby D, Whittington J. Care Coordination Model: Better Care at Lower Cost for People with Multiple Health and Social Needs. Institute for Healthcare Improvement white paper.

Electronic Access vs. Safety

I was listening to public radio cruising north on 59 toward LBJ when I heard Dean Sittig discussing a new study on privacy in electronic health data. A study by PriceWaterhouse Coopers suggests that privacy standards are not keeping pace with access to health care information. Health care workers are gaining increased access to protected health information (PHI) on mobile devices at the risk of these devices not having sufficient privacy standards to prevent security breaches.

This was fascinating to me because Memorial Hermann just released Care4 access to iphone and ipad users. Is this access necessary and reasonable to allow doctors to treat their patients appropriately and effectively? To be sure, handheld electronic devices are commonplace among physicians, residents, and students alike. I have been using my ipod touch (because I refuse to pay the outrageous data fee for any smartphone) consistently to look up dosages on epocrates. Similarly, one of my residents rarely uses paper for rounds, but rather his ipad for access to Epic. Would it be more convenient for me to look up a patient’s recent BMP while walking without having to sit down and log into a computer? Probably, but I’m unsure whether the benefits outweigh the risks.

The trouble with the study is that it doesn’t seem to offer any answers, similar to much of the research done so far in electronic health records. I’m left with an uncanny feeling of uncertainty about current policy regarding handheld devices and access to PHI.

You can listen to Dean Sittig’s 1 minute NPR clip right here.
http://app1.kuhf.org/articles/1316724294-Study-Suggests-Healthcare-Industry-Falling-Short-In-Protecting-Digital-Records.html

Rural Research

A recent article in the British Medical Journal, by Perry, et al., presented evidence that a CT scan within 6 hours of symptom onset yields 100% sensitivity in the diagnosis of subarachnoid hemorrhage (SAH), when read by a trained radiologist. The results suggest that in this setting the need for lumbar puncture (LP) is greatly diminished. If this data is trusted, and physicians use the CT scan as the Gold Standard, then an invasive procedure may be avoided. Currently, when a CT scan doesn’t highlight any blood, physicians are likely to order an LP to be certain that SAH is safe to rule out.
Citation: BMJ 2011; 343:d4277

However, this study is concerned with the utility of CT, not making LP obsolete. In 2008 I detoured from a cross country move, to drive through a small Kentucky town, after a sign for a hospital drew me off the road. Banners hung across the hospital’s entrance to celebrate its recent implementation of a smoke-free campus. I wonder whether the benefits of CT or smoking cessation was the first to affect the practice of those physicians.

Even without the evidence demonstrated in the Perry study, hospitals in the Texas Medical Center have long been using CT to aid the diagnosis of SAH. This study justifies ordering a CT scan to identify subarachnoid bleed when there is a suspicion of SAH. While its data is not game changing along Fannin Street, it does reinforce CT scans’ legitimacy as a covered diagnostic test, even by the stingiest of health insurer.

As the indicated uses for CT broaden, perhaps rural hospitals are more likely to purchase the advanced equipment. However, in the near term, it’s critical that research begin to focus on the way medicine is practiced in these rural areas. To do so requires dedicated NIH grants stipulating funds be spent in a rural setting.
Conducting research in this manner would inform us of the methods rural physicians use to make a diagnosis when using a less technologically advanced toolbox. Likely, we’d learn something from their practice, or maybe we’d remember things our profession has largely forgotten. But more importantly, we’d face a reality that medicine must be practiced differently by people living in rural areas.

Today’s rhetoric favors preventative medicine and seems to delight in our failure to prevent disease. Politicians introduce the topic as if they originated the idea of prevention, and admonish physicians for not participating in their unnamed solution. The natural reaction is to parry, "Society as a whole fails to take the responsibilities necessary to prevent disease; this is not the fault of physicians." Rather than join in meaningless debate, the physician profession must lead improvement. One action is the research of Primary Care methods, with aims to determine how to better prevent disease.

Today, it’s not uncommon that complicated patients in rural, East Texas be transported to Houston for higher level care. A tenet of Quality Improvement is that transportation is waste. While the patient is moved, the standard of care is temporarily lowered. Currently, the vast majority of research is conducted at tertiary care referral centers. Broadening our focus of research to include rural areas, in addition to tertiary care centers, would bolster the quality of care provided in the rural setting. Where academic researchers travel, medical residents and fellows follow, in search of training. As the government begins taxing Graduate Medical Education programs, the already meager resident salaries will thin further. A number of medical school graduates are likely to appreciate the opportunity to train in a location where their salary offers a higher standard of living.

Several factors may converge to favor the development of rural medical care. By studying the patient populations in the primary setting we’d learn more about prevention.

Heads Down, Thumbs Up

Acute ischemic stroke patients may benefit by simply lowering the head of their bed. An inverse relationship was demonstrated between bed angle and residual blood flow to ischemic brain tissue. Similarly, Jugular Venous Distension becomes clearer when a patient is reclined. Therefore, this finding is not totally surprising. What is compelling is that the improvement is distinct and occurs even across small gradients: 15 degrees is preferred to 30 degrees even if not as ideal as a patient laying flat.

Clinically implementing the finding still requires a bit of common sense judgement. Patients with dysphagia are at an increased risk of choking which is greater when they lay flat. Because the same patient who has suffered a midbrain stroke is often dysarthric, they are at risk to silently aspirate. A real risk of choking must be weighed against the perfusion benefit described in the study. Occupational therapy can help in the management of these stroke patients.

While the hospital bed controls which set head angle are simple, keeping a patient's head down can be more complex. Patient compliance is required. Those short of breath when laying down (orthopnea from Congestive Heart Failure), and those prone to choking (dysphagic after a midbrain stroke) desire to sit up. Many stroke patients spend the first hours after the diagnosis of stroke in the ER. Therefore, the ER staff must also understand the importance of heads down just as well as the specialized staff of a dedicated stroke team. Even once admitted to a stroke unit, visitors may raise a patient's head earlier than is desired. Technicians who perform cardiac echos may raise the bed or ask the patient to prop themselves up, into positions which obtain a better ultrasound image. A well-meaning family member will often raise the head of a patient's bed, allowing the patient to more easily see and interact with family, at the expense of critical perfusion.

The heads down study has encouraged neurologists to emphasize a seemingly small detail to physicians and practitioners outside their specialty. It can be found by referencing: Neurology. 2005 Apr 26;64(8):1354-7.Heads down: flat positioning improves blood flow velocity in acute ischemic stroke. Wojner-Alexander AW, Garami Z, Chernyshev OY, Alexandrov AV.

"Ischemic stroke is a potentially reversible process that is dependent on restoration of arterial blood flow within a window of cellular viability that varies according to the severity and duration of the flow deficit. Measures that promote blood flow during the acute phase of ischemic stroke may directly impact the subsequent development of brain infarction and associated clinical deficit. One such measure may be flat head-of-the-bed (HOB) positioning to promote a gravity-induced increase in arterial flow to ischemic brain tissue; however, patients with stroke and other neurologic diagnoses are routinely positioned using 30° HOB elevation by paramedics and emergency room personnel."

Source: Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX 77030, USA

Photo by Flickr user: chimothy27