Assisting hospitals to do a better job in potential donor situations is a
major element in solving the organ donor shortage. This goes hand-in-hand
with catalyzing public commitment to organ and tissue donation, because
public education can only succeed if hospital practices improve. Again and
again, we find that barriers or breakdowns within the hospital setting are
major impediments for families facing donation. By improving the hospital
donation process, over 16,000 additional transplants per year could be
performed in the U.S. alone.
Over one-quarter of the time, families of patients eligible for donation
are not even asked to consider donation, according to our research findings
recently published in Critical Care Medicine and summarized here on page 2.
This problem can be fixed by focusing on hospital systems, using
successful strategies for institutionalizing "best practices."
Starting this summer, a group of leading hospitals--many of them transplant
centers--will be taking a more active role in improving organ donation
practices. In this issue of Progress Notes, we are proud to announce two
breakthrough collaborations to establish model donation practices in major
hospitals in North America. The first is a joint initiative with the
University HealthSystem Consortium (UHC), a group of leading U.S. academic
medical centers. UHC hospitals know the implications of the chronic
shortage of donor organs, since most are transplant centers. All are
dedicated to improving the quality of their services through well-designed,
performance improvement initiatives.
The second project is getting underway in Canada, starting in selected
hospitals in British Columbia and Alberta. While much of our past work has
focused on organ donation in the U.S., recent exchanges with organizations
in Canada and Europe confirm that we face common problems and that the
solution has common elements.
Our research and experience of the past several years have shown us the
elements of a better hospital system for organ donation. Hospitals need a
consistent, skillful response to potential donor situations built around a
standard protocol for donation. This must ensure identification of all
eligible donor cases; a well-orchestrated request to the family that
includes privacy, decoupling and participation by hospital staff and the
OPO coordinator; and seamlessly coordinated hospital and OPO efforts.
The "how" represents the next major challenge. While we are confident that
there is a core set of "best demonstrated practices" applicable to all
hospitals, each hospital must find the way to institutionalize these
practices to fit its own circumstances. Often when working in a new
hospital or region, we are warned, "You've never seen anything like our
situation." Each hospital and region truly has its own unique profile and
needs. However, we always observe common problems, whether in consistently
identifying potential donors or in organizing a sensitive and skillful
donation request.
Our work this year and next will be to figure out the most effective and
efficient ways to establish good donation practices in a range of
distinctly different hospitals. Ultimately we want the best practices in
organ donation to be universally understood and followed while responding
to local needs. Working with our partners at UHC and with hospitals in
Canada, we will soon learn the best ways to help hospitals and OPOs adopt
and maintain new practices successfully.
As we embark on new projects, we want to thank the UHC Executive Committee
and the leadership and staff of the organization for their encouragement
and expertise. Special thanks go to Raymond Schultze, M.D., a member of
our Board of Directors and active participant in UHC, and Ed Schwartz,
Director of the University of Nebraska Medical Center, for guiding the
development of the project with UHC. In Canada we have benefited greatly
from the support and participation of the British Columbia Transplant
Society in Vancouver and the HOPE program in Edmonton, Alberta.
Finally, we thank our major funders, Sandoz Pharmaceuticals Corporation and
Wyeth-Ayerst Laboratories in the U.S., and Sandoz Canada Inc., for
exemplifying the philosophy of "joining forces" and underwriting a major
portion of these exciting new ventures.
The following articles are contained in this issue of
Progress Notes:
The University HealthSystem Consortium (UHC) and The Partnership are embarking on a major initiative to improve organ donation practices in 24 leading hospitals nationwide. UHC, an alliance of 70 academic health centers, is a leader in developing new practices. UHC's mission is to pool resources, create economies of scale, improve clinical and operating efficiencies, and influence the direction and delivery of health care. Its member hospitals currently perform more than half of all solid organ transplants in the nation.
Building upon The Partnership's experience in helping hospitals improve organ donation, the project is designed to significantly increase organ donation in both transplant and non-transplant hospitals by implementing a standard donation protocol. Through pilot projects, The Partnership has confirmed that donation rates above 60 percent are realistically attainable, versus current average donation rates of approximately 33 percent.
"We could not begin to carry out a project of this scale without UHC and their expertise," says Michael J. Evanisko, Partnership President. "This will bring together a critical mass of hospitals and organ procurement organizations (OPOs) needed to improve and enhance the protocol so it can be adopted around the country. But most importantly, the project will be extremely valuable for the hospitals and OPOs that participate. Not only will they be able to examine and improve their own performance, but they will have the ability to compare their efforts and results with similar hospitals across the country."
The UHC Executive Committee enthusiastically endorsed the project in March. "This is just such a clear winner for everybody involved," says David Burnett, M.D., UHC Vice President and Director of UHC's Clinical Practice Advancement Center. "We're often approached with new technologies. In this case, it seemed like every party participating would clearly benefit from the activity."
The collaboration stems, in part, from the Joining Forces Conference hosted by The Partnership in June 1995, which concluded that transplant hospitals have a major stake in organ donation, but have rarely taken a proactive approach. The project will benchmark donation performance and establish reliable and useful measures of donation effectiveness in hospitals. Because there is currently no commonly accepted measure of donation performance, most hospitals do not have ready access to performance information that would help them improve their donation results.
Other project goals include: documenting improvements that occur when systematic donation practices are adopted; creating guidelines that other hospitals can utilize to improve donation; and providing a model for "joining forces" within the transplant field to attain a mutual goal and serve a pressing human need.
"Transplantation is an area of top strategic importance for our members, and there is a growing sense that the most important, and least pursued, avenue for success is to increase the level of organ donation in large hospitals," says Robert Baker, UHC President. "We are confident that the plan put forward by The Partnership can succeed, and have already started to explore opportunities to bring UHC capabilities, especially in collecting and reporting performance data, to bear on the project. We see important long-term implications for this work, and look forward to the day when hospitals around the country routinely follow 'best practices' in organ donation."
Recruitment for initial participants is underway. The ideal model will be to work in groups consisting of an OPO and two to three large hospitals in several geographic regions, with an equal mix of transplant and non-transplant hospital participants.
Non-member and non-transplant hospitals are encouraged to consider participating in this project as partners with UHC hospitals in their regions. "It makes sense for all major hospitals in a region to cooperate. It benefits everyone," says Carol Beasley, Partnership Managing Director.
Previous Partnership projects involving UHC member hospitals include: an intervention at the University of Kentucky Medical Center that more than tripled the number of donors; a pilot project at the University of Texas Medical Branch at Galveston that succeeded in increasing donation from 34 to 53 percent; and a similar project currently underway in Baltimore at the University of Maryland Medical System and Johns Hopkins Hospital that has the potential to increase donation to 60 percent or more.
"Transplant centers themselves must allocate time and resources to the task of acquiring organs," says Raymond Schultze, M.D., of UCLA Medical Center, former chair of the UHC board and current Partnership board member. "We know there is a need for a solution to this problem; we know there are opportunities; we have tools; we have potential partners. Through this breakthrough project, we can bring them together."
Project Overview
The collaborative intervention in the hospitals participating in the UHC/Partnership project will last six months, followed by a six-month monitoring period to ensure that long-term changes are successfully institutionalized. Implementation of a hospital-based donation system will include:
The ground-breaking project that will bring The Partnership's best-demonstrated practices for organ donation into hospitals nationwide is being made possible through the generous support of the pharmaceutical community. Sandoz Pharmaceuticals Corporation and Wyeth-Ayerst Laboratories, Inc., are providing an example of joining forces by funding the project in 20 and four hospitals, respectively.
"We, too, are very excited about the collaboration between the University HealthSystem Consortium and The Partnership for Organ Donation," says John J. Maddox, Senior Director, Sandoz Corporate Strategic Planning. "Sandoz was the first major corporation to see the potential in The Partnership's strategy for improving organ donation. With UHC involvement, we see an opportunity to transform organ donation practices in the U.S., starting with a group of institutions that have a history of leadership in the development and use of 'best practices.'"
All partners in the collaboration are united in their belief that the donor shortage is a solvable problem. "Through our clinical research experience, we are convinced that this endeavor has a high probability for success," states Nancy Durst Clementi, M.D., Vice President of New Products Marketing at Wyeth-Ayerst. "The Partnership is targeting the most critical point in the decision-making process, and it is everyone's hope that more lives can be saved through sensitive and consistent requests for organ donation."
Maddox agrees, "We have to pool resources for change. Fortunately, the pharmaceutical industry, UHC and The Partnership bring valuable expertise to such change efforts. Donation projects, similar to clinical testing for new pharmaceutical drugs, have to be of sufficient scale to achieve statistical significance, and must be tested across a range of institutions and practitioners. This large multi-site model has a great deal to offer in solving the organ donor shortage."
"We look forward to a fruitful collaboration that will be good for all participants, and especially the thousands of patients who are waiting for transplants," Maddox concludes.
A study by The Partnership and Harvard School of Public Health researchers estimates that 5,600 additional people each year could have transplants if hospitals improved their practices related to donation requests and prospective identification of suitable donors. The study was published in the March issue of Critical Care Medicine. (see related press release)
Based on examination of medical records in four geographic areas, the study estimates the total potential donor pool in the U.S. at 13,700, but also identifies barriers to achieving this number of donors. "Previous research has argued that families are the primary barrier to increasing the supply of critically needed organs, suggesting that any improvements will rely on changing broad public attitudes," says Steven Gortmaker, Ph.D., lead author on the study and Senior Lecturer at the Harvard School of Public Health. "We found that only one-third of potential donors became donors, but contrary to widely-held beliefs, only part of the gap could be explained by families deciding against donation. Based on our findings, we feel it is an error to 'blame' families, as the study shows that hospitals are falling far short."
Twenty-seven percent of potential donors were lost either because health professionals did not identify them as potential donors or did not ask the families about donation. The data showed that larger hospitals did no better in handling donation cases (i.e., achieving a high donation rate) than smaller hospitals. Similarly transplant centers were no more effective in organ donation than non-transplant centers.
The researchers argue that these patterns of non-donation can be modified. "First, we saw strong patterns of families not being asked. Nearly two-thirds of the cases where families were not asked to donate were patients older than 50 years. In addition, in 10 percent of cases, potential donors were simply not identified by the hospital. It may be that the poor performance of hospitals is a combination of lack of familiarity with the criteria for brain death and organ donation, as well as a reticence to ask families," says Carol L. Beasley, Partnership Managing Director.
The study also found a large number of potential donors lost--36 percent--due to families refusing consent. There were higher rates of non-consent among ethnic minorities, combined with much lower rates of identification and asking. In fact, family members of black patients were three times less likely to be asked to donate. The Partnership and the Harvard School of Public Health are completing analysis of the donation request process and will publish studies about opportunities to increase the rate of family consent.
This study was based on extensive medical review of thousands of cases in 125 hospitals in four regions of the U.S. The first segment of the study, initiated in 1990, included a non-random sample of 69 hospitals in regions encompassing Kentucky, northern California, Minnesota, North Dakota, South Dakota and the Washington, D.C., metropolitan area. In 1993, a random sample of hospitals in three of the four geographic areas was conducted. The findings in the second study corroborated the initial findings.
"The Critical Care Medicine article is first in a series of major research articles that together tell a powerful story of how the organ donor shortage can be solved," says Michael J. Evanisko, Partnership Founder and President. "This study exemplifies The Partnership's data-driven approach to solving the problem. The findings show immediate solutions--identifying all potential donors and making a sensitive donation request to their families--that will immediately increase donation rates and save the lives of more people awaiting transplants."
The Critical Care Medicine article has been reported by print and broadcast media nationwide, including Reuters News Service, American Medical News, Dialysis & Transplantation, Contemporary Dialysis & Nephrology, Transplant News, Transplant Chronicles, International Transplant Bulletin, Encore, and local television and radio stations. Following a request from Sen. Mike DeWine of Ohio, copies of the article were sent to the founding members of the Congressional Task Force on Organ and Tissue Donation and were distributed at a Senate Labor Committee hearing in April.
Action steps for hospitals
Hospital staff should notify their organ procurement organization (OPO) about any patient suspected to be at risk for brain death, regardless of age or prior medical history. OPOs have the most up-to-date criteria for donation and can advise on which patients are potentially suitable. Because they are highly trained and are experienced in offering donation in a culturally sensitive manner, OPO staff are an excellent source of assistance and advice in approaching families about donation.
Remember that the following are potential organ donors:
A group of hospitals, including three that perform almost one-fifth of all Canadian transplants, are the first participants in a new Partnership project to diagnose organ donor potential and implement effective donation practices in Canada. Ultimately, seven or more large Canadian hospitals will be involved, and results will be used to catalyze action planning at the local and national levels.
Little is known about the underlying potential for organ donation in Canada or how effectively the current system is realizing that potential. Canada's 15 donors-per-million-population is considerably lower than the U.S. rate of nearly 21 donors-per-million. More than 2,000 people are on transplant waiting lists in Canada.
The project's goals are to benchmark donation performance, establish reliable and useful measures of donation effectiveness, and significantly increase organ donation in a pilot group of Canadian hospitals. It will also raise awareness within the Canadian medical community about organ donation potential and performance, and the impact of using best-demonstrated practices.
"It appears that organ donation in Canada faces many of the same challenges we have been addressing in the U.S.," says Carol Beasley, Partnership Managing Director. "We see opportunities to improve performance through use of a protocol and hospital professionals trained specifically in managing the donor process."
The project will have three components: diagnosis, implementation and dissemination of project results. In all the participating hospitals, The Partnership will conduct standardized medical records review and hospital staff surveys. Each hospital will receive a detailed analysis of its findings.
Current participants in the diagnosis phase include Vancouver Hospital & Health Science Center and St. Paul's Hospital in Vancouver, British Columbia, and the University of Alberta Hospital and Royal Alexandra Hospital in Edmonton, Alberta.
"We are trying to maximize our organ donor pool and opportunities to benefit transplantation," says Bill Barrable, Director and Chief Executive Officer of the British Columbia Transplant Society. "The Partnership has had a very good track record in other hospitals, and they are experts in diagnosing opportunities to improve organ donation. Our goals are to gather better information and develop strategies to improve our performance that are based on the best information available, are relevant and will result in positive actions and results."
Prudence E. Taylor, Program Manager, Transplant Services, for the Hope Program at the University of Alberta Hospitals, says, "Not only do we need to identify our own areas for improving opportunities for donation, we alo need to compare individual programs' performances against other programs. The tools used by The Partnership will allow us to do this, both at the local level between hospitals and the national level, between provinces."
Additional hospitals are being sought to take part in the project. Typically, candidate hospitals will be trauma centers with at least 350 beds.
In a second phase of the project, two hospitals will be selected for full implementation of a systematic donation system. This will include a formalized donation protocol that incorporates best demonstrated practices; a designated team within the hospital with primary responsibility for carrying out the donation protocol; and a system for ongoing quality monitoring to ensure that the protocol is followed consistently over time.
The project will also provide an opportunity to pilot test a set of tools called Donor Action, developed through an international collaboration among The Partnership, Eurotransplant in The Netherlands and Organizacion Nacional de Trasplantes in Spain. The Donor Action tools are designed to help hospitals diagnose and improve their organ donation procedures.
The Partnership brings extensive experience in working successfully with hospitals in several regions of the U.S., and has worked on a limited basis with programs in Canada to share the Medical Record Review methodology and other information. "We anticipate making some adaptations for the Canadian healthcare system," says Beasley. "But the donor process has certain variables that are nearly universalÑpatient identification and an appropriate and sensitive request to the family."
The Partnership will share project findings and results at scheduled professional meetings. These presentations will provide the Canadian medical community with reliable baseline data on organ donation potential and performance, as well as two tangible examples of improved donation results.
The project is a collaborative funding model, with major funding provided by Sandoz Canada and a portion of costs contributed by participating sites.