PatientsChartingCourse

patients­ before, during, and at scheduled intervals after their surgeries­ for the lifetime of the patient and the orthopedic implant. This registry has allowed for comparison of surgical techniques, implant types, patient demographics,­ comorbid conditions, and long-term outcomes. It has allowed physicians to determine which surgical practices and implant models are most effective over time and has informed decision making on these issues. The registry has been a valuable clinical and research tool, allowing orthopedic surgeons, for example, to compare planned hip replacement surgery with 35,000 such operations performed since 1966. Work based on this registry has enabled continuous improvement in the processes of care, favorably influencing lengths of stay, resource use, and the results of care (i.e., delivery of high-value care). The registry has served as a data source for more than 800 academic publications. It has enabled CER and has led to improvements in information systems that facilitate and enhance the continuity of care delivery after surgery.

Mayo Clinic Warfarin Project

The Mayo Clinic Warfarin Project is a third example of conventional, focused clinical research designed to improve the quality of care. This intervention was launched with the goal of reducing warfarin-related over­ anticoagulation,­ which is acknowledged to be a leading iatrogenic illness. In 2005, 18,700 inpatients were treated with warfarin at Mayo Clinic. It was determined that 3.5 percent experienced iatrogenic overanticoagulation,­ with a score greater than 5.0 on the blood coagulation International ­Normalized Ratio (INR) laboratory test, resulting from in-hospital warfarin­ administration, and no definitive, published, evidence-based guidelines for administering warfarin in the hospital existed. We recognized that there was considerable variability in risk for iatrogenic overanticoagulation across the five states where Mayo Clinic practices. Therefore, a prospective study was designed to develop a standardized warfarin protocol that would improve outcomes. The goal was to reduce the number of inpatients who had a single recording of an unsafe inpatient INR (greater than 5.0) from 3.5 percent to less than 1.5 percent. This project involved standardized rulebased algorithms supported by the prescriber using computerized provider order entry, with the hospital pharmacist determining the final dose from these algorithms. This work takes advantage of the principle of reflexivity; the prescribing system algorithm was improved dozens of times through the “plan, do, study, act cycle” based on surveillance, performance data, and user feedback. Since implementation of the standardized, rule-based algorithms, consistently fewer than 1.5 percent of Mayo Clinic warfarin inpatients have had an INR above 5.0, and there has been no increase in the proportion of patients with an INR below 1.7 after the third dose. Thus not only was the risk of potential hemorrhage reduced, but also the risk

of clotting was not commensurately increased. This change in practice has significantly reduced the risk of inpatient warfarin-related adverse events.

Transformational Initiatives

The High Value Healthcare Initiative

A learning healthcare system has as its central focus improving the value of care. For many years, Mayo Clinic has maintained an institution­-wide emphasis­ on quality (best clinical outcomes, safety, and service), which has been applied both to the care of individual patients and through population­ -based strategies to manage chronic disease across communities of patients. Recently, Mayo Clinic has gone beyond its focus on the numerator­ (quality in terms of best outcomes, safety, and service) of the value equation (e.g., value = quality/cost) to address the denominator (i.e., the cost of care over time). Together with the Dartmouth Institute, Intermountain Healthcare, and the Geisinger Health System, Mayo is proposing a pilot project for the Innovation Center at Centers for Medicare & Medicaid Services (CMS) called the High Value Healthcare Project. This represents the first step in a broad-based initiative that will benchmark the costs of best practices over time, implement evidence-based best practice and patient shared decision-making models, and study new reimbursement models that better align payments with the outcomes of patient care. Together with similar initiatives under way around the country, the High Value Healthcare Initiative is motivating a fundamental transformation of health systems from their traditional focus on compliance with process to a more meaningful focus on results, outcomes, and value.

As famously reported by Balas and Boren (Balas and Boren, 2000), the lag time between the discovery of more efficacious forms of treatment and their incorporation into practice is unacceptably long—about 15–20 years. Moreover, a majority of patients at any given time receive care that is not supported by evidence-based research (Advisory Commission on Consumer Protection and Quality in the Health Care Industry, 1998). Stakeholders across the healthcare system—from patients to practitioners to payers—­ recognize the need for disruptive change to bring about fundamental improvements in health care. It is becoming increasingly apparent that such change requires new information systems to accelerate discovery, drive clinical research, identify best practices, and diffuse these practices rapidly across the profession.

BOX 2-2

Characteristics of the Knowledge-Driven

Healthcare Delivery System of the Future

•Patient-centered care—a focus on quality (best results) and coordination of care

•Real-time data and feedback for providers at the point of care (horizon scanning)

•A culture of collaboration, innovation, and translation of scientific knowledge into improved health for patients and communities

•Health information technology systems—integration, standardization, interoperability

•Delivery of high-value health care in an information-enabled single practice

health care. Although patient-centered care is often assumed, it is but by no means universally applied. Providers must design and implement systems to be focused on quality and team-based, integrated, coordinated care centered on the patient. To enable the evolution to a knowledge-driven, learning healthcare delivery system, future HIT systems must have the ­capability to provide real-time data and real-time feedback to providers at the point of care/point of need. This capability will require scanning disparate internal and external data resources to rapidly find answers to scientific, clinical, and operational questions. HIT systems must also be integrated, standardized, and highly interoperable. Finally, the delivery of high-value care in the information-enabled practice of medicine requires a culture of collaboration, innovation, and translation of scientific knowledge into improved health for patients and communities. Although perfect and complete actualization of the conceptual model for each of the above characteristics may be a long way off, an intense focus on the development of integrated, patient-centered, and knowledge-driven healthcare delivery systems will lead to better health care and better health.

ENHANCING THE CULTURE OF PATIENT

CONTRIBUTIONS TO LEARNING IN HEALTH CARE

Diane Simmons and Kenneth Getz, M.B.A.

Center for Information and Study on Clinical Research Participation

How can a durable relationship be built with the millions of past, present, and potential future clinical research study volunteers? A portfolio of strategic initiatives is needed to regain public trust in the clinical research enterprise and establish a culture that welcomes input from patients. Since its founding in 2004, the nonprofit Center for Information and Study on

Clinical Research Participation has developed an effective, multifaceted strategy of outreach and education to improve public understanding of the clinical research process and the important role of participation in advancing medical science. After a discussion of the current culture, this paper presents a number of examples of strategic initiatives for recruiting, retaining, and sustaining a community of study participants who will ultimately become the ambassadors for learning in health care.

Current Culture

During the past decade, public confidence and trust in the clinical research enterprise has eroded steadily (Center for Information and Study on Clinical Research Participation, 2006; HarrisInteractive, 2007; Kaiser Family Foundation, 2008). Distrust of clinical research professionals and of those organizations responsible for ensuring patient safety has increased dramatically. Public polls reveal startling statistics. For example, a 2007 poll among 1,726 U.S. adults found that 27 percent of respondents distrusted the Food and Drug Administration (FDA) “somewhat” or “very strongly.” That same poll found that only 31 percent of respondents believed that the FDA is effective at ensuring safety, down from 56 percent who held this belief in 2004 (HarrisInteractive,­ 2007). Equally alarming, nearly half (46 percent) of the 1,726 Americans polled said they distrusted Capitol Hill officials who govern regulatory oversight and drug development processes (HarrisInteractive,­ 2007).

Four of ten respondents (42 percent) distrusted pharmaceutical and biotechnology companies. The poll showed that a significantly higher percentage (39 percent) gave poor ratings to pharmaceutical and biotechnology companies for failing to serve consumers as compared with 1997, when 19 percent of Americans surveyed rated pharmaceutical and biotechnology companies on this item poorly (HarrisInteractive, 2007).

Nearly half (44 percent) of the 1,695 American adults polled in a January 2008 survey likewise reported having an unfavorable view of pharmaceutical and biotechnology companies. In that same survey, 27 percent of Americans said they did not trust these companies to offer reliable information about drug side effects and safety. And 45 percent said they did not trust research sponsors to inform the public quickly when safety concerns with a drug are uncovered (Kaiser Family Foundation, 2008).

The public displays similar levels of distrust in principal investigators and their study staff. A self-administered survey conducted among 717 U.S. adults in 2007 found high levels of public distrust in clinical research staff. This level of distrust was significantly higher among minority adults (HarrisInteractive, 2004). Nearly half (49 percent) of white respondents and 73 percent of minority respondents reported that it was “very likely”

or “somewhat likely” that they might be used as guinea pigs without their consent. One of four (25 percent) minority respondents and 22 percent of white respondents believed that their doctors would expose them to unnecessary risk in clinical trials (Braunstein et al., 2008).

The majority of respondents (72 percent) in a 2002 poll said they believed that physicians get involved in clinical research to help patients find new and better treatments (HarrisInteractive, 2002). Still, one of four said they believed that doctors and study staff are motivated to recruit volunteers primarily by money and selfish interests. In a 2005 survey, 25 percent of respondents said they believed physicians participate in clinical research to receive money from pharmaceutical and biotechnology companies, and another 20 percent said that physicians participate primarily for fame, glory, and publication rights (HarrisInteractive, 2005).

By extension, public distrust in clinical research professionals has tainted the public’s view of clinical research volunteers. In a 2002 poll, 8 of 10 Americans said they believed that study volunteers are taking a gamble­ with their health (HarrisInteractive, 2002). A 2006 survey conducted among 900 U.S. adults found that one of four believed people choose to participate in clinical research because they are “very sick without any other options” or they are “looking to make money.” A smaller percentage­—19 percent— believed that people choose to participate in clinical trials to benefit the public’s health. In that same survey, 34 percent of respondents said they “do not admire” people who volunteer for clinical trials (Center for Information and Study on Clinical Research Participation, 2006).

As public appreciation for study volunteers has waned, public willingness to participate in clinical trials has also dropped. Research!America, for example, reported that in 2004, 55 percent of those polled said they would be willing to participate in a clinical trial, down from 63 percent in 2001 (Woolley and Propst, 2005). A later public poll, conducted in 2007, found that only 41 percent of white adults and 28 percent of minority adults would be “very likely” or “likely” to participate in clinical trials (Braunstein et al., 2008).

Investigative sites report that growing levels of public distrust have contributed to delays in bringing new treatments to market and to increased drug development costs. Since 2000, spending on patient recruitment promotional programs by investigative sites and research sponsors has grown by 12 to 14 percent annually, reaching more than $500 million in 2003 (Korieth,­ 2004). Enrollment rates dropped from 75 percent in 2000 to 59 percent in 2006, and retention rates fell from 69 percent to 48 percent during that same period (Kaitin, 2008).

In an attempt to understand how to improve patient recruitment and retention rates, the Center for Information and Study on Clinical Research Participation conducted focus groups among study volunteers to probe for

factors that most inform and educate clinical research participants. This research was conducted in 2009 at Piedmont Medical Group in North Carolina. In these focus groups, participants emphasized the essential role of study staff and healthcare professionals in volunteer recruitment and retention. They consistently described relationships with study staff as tough but fair, disciplined but supportive. At a time when recruitment and retention strategies and tactics tend to marginalize the role of study staff and trusted healthcare professionals, the results of these focus groups strongly suggest the need to engage these professionals more effectively as real assets in the clinical trial process.

The focus group participants revealed core motivations of all study volunteers regardless of age and socioeconomic status. These motivations can serve as a blueprint for patient and public education and outreach. Study volunteers

•want to feel that they are taking control of their medical condition and well-being,

•want to develop personal relationships with study staff,

•want to be treated as human beings, and

•want to know that their participation will make a difference.

Participating in medical research as a way to steer personal and public health reinforces the drive toward patient-centered health care. Yet the ­focus groups clarified that “patient-centered” does not mean that they want medical autonomy. Despite common expressions such as “take control,” study participants from the focus groups explained that they do not seek total independence in their efforts to improve their well-being. The prospect of being accountable to the research coordinator spurred and sustained volunteers’ interest in trials. In fact, the volunteer–study staff relationship forms and solidifies at several critical junctures. When research sites reach out to potential volunteers with the right messages and modes of communication at decisive moments and invite them to begin conversations, the relationship grows into a lasting commitment to the center and its staff.

The focus group participants’ comments show that money-focused recruitment campaigns and comparisons of research volunteers to “guinea pigs” or “lab rats” depersonalize the trial experience and keep the volunteers from feeling as though they are truly part of an extended research team. Typical perceptions of clinical research participation must shift before people can take part proudly and comfortably in a research community. The emphasis on monetary compensation in media and recruitment rhetoric impedes public and participant recognition that volunteers are part of a vital exchange in which they are compensated for sacrificing their time, effort, and even physical welfare.

To be effective, the education provided before and after trials must reflect what volunteers expect, need, and want to know about clinical research. The public’s primary source for education about the clinical research enterprise is the media, which tend to focus on sensationalistic accounts of human error, concealment, fraud, and corruption. More than two-thirds (69 percent) of Americans are exposed to information on clinical research studies through television, radio, print media, and Internet advertising. Only one of seven adult Americans is exposed to information about clinical research studies from a primary or specialty care physician (HarrisInteractive,­ 2004). Although the public has the greatest trust in information from healthcare providers, the medical and health professional communities are largely absent from efforts to educate the public and prospective volunteer communities. In a recent survey conducted among board-certified physicians in active community practices throughout the United States, fewer than half reported referring their patients to clinical trials, with an average referral rate for each physician of less than one patient per year (Getz and Faden, 2008).

Without broad understanding and context, recruitment advertising and promotional messages are met with, at best, passing curiosity from the public and prospective volunteers. Only 20 percent of those diagnosed with severe and life-threatening illnesses report considering clinical trials as a healthcare option (HarrisInteractive, 2004). Despite a wealth of online information available, less than 5 percent of the general public knows where to find information about relevant clinical trials (Getz, 2004). And the public is largely unaware of where clinical research is taking place. A 2005 public poll found that 62 percent of respondents were unable to name a single institution, company, or organization where medical and health research is conducted (Woolley and Propst, 2005). Research sponsors rarely, if ever, respond to media coverage, as government and corporate employees are usually instructed not to interact with journalists for fear of bringing more attention to a story or of appearing defensive and self-serving. As a result, the public is receiving a largely one-sided education in the clinical trials industry from the media.

Outreach Initiatives and Their Impact

If the public is to be engaged, the stage must be set with a national public education media campaign. The Center for Information and Study on Clinical Research Participation developed a public service campaign, with pro bono support from the international advertising agency Ogilvy ­HealthWorld, to educate and win over the public regarding the importance of participation in clinical research. During the campaign’s yearlong development process and extensive focus group testing, strong support was expressed for the easy-to-remember messaging and acknowledgment of or-