|US Organ Donation Breakthrough Collaborative Increases Organ Donation
|Teresa J. Shafer MSN, RN, CPTC
Dennis Wagner MPA
John Chessare MD, MPH
Marie W. Schall MA
Virginia McBride MPH, RN, CPTC
Francis A. Zampiello MD
Jade Perdue MPA
Kevin O'Connor PA
Monica J.-Y. Lin PhD
James Burdick MD
|Critical Care Nursing Quarterly
Volume 31 Number 3
Pages 190 - 210
More than 92000 Americans are on waiting lists for organ transplants, and an average of 17 of them die each day while waiting. The US Organ Donation Breakthrough Collaborative (ODBC), which began in 2003 at the request of the Secretary of the US Department of Health and Human Services, was a formal, concerted effort of the donation and transplantation community to bring about a major change to improve the organ donation system. The nationwide Collaborative was housed within a Health and Human Services agency, the Health Resources and Services Administration (HRSA) Division of Transplantation, and included participation of the organ procurement organizations (OPOs) throughout the United States and the American hospitals with the largest organ-donor potential. HRSA leaders used the Breakthrough Series Collaborative method, originally developed by the Institute for Healthcare Improvement, as the model for the intervention. Expert practitioners drawn from hospitals and OPOs that had already demonstrated their ability to achieve and sustain high organ donation rates were chosen as faculty for the collaborative and best practices were gleaned from their institutions. The number of organ donors in Collaborative hospitals increased 14.1% in the first year, a 70% greater increase than the 8.3% increase experienced by non-Collaborative hospitals. Moreover, the increased organ recovery continued into the post-Collaborative periods. Between October 2003 and September 2006, the number of total US organ donors increased 22.5%, an increase 4-fold greater than the 5.5% increase measured over the same number of years in the immediate pre-Collaborative period. The study did not involve a randomized design, but time-series analysis using statistical process control charts shows a highly significant discontinuity in the rate of increase in participating hospitals concurrent with the Collaborative program, and strongly suggests that the activities of the Collaborative were a major contributor to this increase. Given the stable nature of the historical increases over many years, the HRSA estimates that more than 4000 annual additional transplants have occurred in association and apparently as a result of these increases in organ donation.
DESPITE remarkable improvements in basic and clinical science in the field of transplantation, treatment of patients awaiting transplantation continues to be hampered by an inadequate supply of organs for those who could benefit from this life-sustaining therapy. During the decade of the 1990s, the rate of organ donation increased only 29.2% (from 4507 organ donors in 1990 to 5824 in 1999), whereas the national waiting list grew 228% (from 20 481 persons in 1990 to 67 224 in 1999) (Table 1).1 With more than 92 000 Americans on the waiting list for organ transplants as of 2005, and with an average of 17 of them dying each day while waiting, the historical, low rate of increase in organs available for transplantation cannot close the gap between demand and supply.
||Table 1. Organ donors, waiting list, and deceased organ transplants
Numerous programs in both public and private sectors have tried in the past 2 decades to increase organ donation. Private sector efforts have focused both on broader public education and on enlisting hospitals. Traditional governmental efforts have included the federal tools of legislation, regulation, agency reorganization, and multimillion dollar investments in grants designed to increase organ donation. However, despite this activity, the calendar years 1999 through 2003 witnessed annual growth in the number of deceased organ donors of only 2.4% per year (Tables 1 and 3).
||Table 2. Concentration of the US organ-donor potential
In 2003, the US Department of Health and Human Services, through its Health Resources and Services Administration (HRSA), conceived and embarked upon a program to transform the national organ donation and transplantation system. The government collaborated with the donation and transplantation community in an attempt to effect major system change. In this article, we describe the process used in the program and the changes in organ donation rates that accompanied these efforts.
In an effort to rapidly increase organ donation, former Health and Human Services Secretary Tommy Thompson and HRSA staff within the Division of Transplantation worked with the Institute for Healthcare Improvement (IHI) to develop a strategy to engage 800 hospitals with the largest organ-donor potential from among the nearly 6000 acute care hospitals in the country. The goal was to increase the rate of organ donation (known as "conversion rate") from the initial level of 52% to 75% by the end of the initiative. This goal was reflected in the aim statement of the Organ Donation Breakthrough Collaborative (ODBC) that was assembled for this purpose: "Committed to saving or enhancing thousands of lives a year by spreading known best practices to the nation's largest hospitals, to achieve organ donation rates of 75% or higher in these hospitals."1
The US organ-donor potential is primarily concentrated in only 15% of the acute care hospitals in the United States (Table 2). The initial organ donation rate of 52.7% in the top 800 hospitals with the greatest donation potential in 2003 (73% of US eligible organ donors) translated into 4419 individual organ donors. An increase in these hospitals to 75% would add 1867 organ donors among these hospitals, and, assuming an average of 3.1 organs recovered per donor, an additional 5601 organs per year. If all hospitals reached the goal of 75%, the US donation system had the potential to increase the number of organ donors nationally by 2855 (6457-9312) and, with this same assumption, an additional 8850 (20 370-29 220) organs available for transplantation.
In June 2003, the HRSA invited each of the nation's 58 organ procurement organizations (OPOs) to submit applications to participate in the Collaborative. OPOs are regional, nonprofit organizations responsible for coordinating organ and tissue donations at hospitals throughout the United States and are designated by the federal government to serve specific regions. Each interested OPO was asked to form an improvement team and work with 1 or more affiliated hospitals that had been identified by the Organ Procurement and Transplantation Network (OPTN) as being among the top 300 hospitals in the United States, with the highest number of eligible organ donors on the basis of the number of death notifications of eligible organ donors made by hospitals to OPOs between August 2002 and January 2003. (Because OPOs are required to report the number of hospital death notifications and the number of eligible organ donors to the OPTN on a monthly basis, the data were readily available to identify the hospitals with the greatest organ-donor potential.)
Hospitals self-selected whether to volunteer to participate in the Collaborative. The OPOs bore primary responsibility for funding Collaborative team expenses, and therefore each OPO chose the number of hospitals to participate in the team. The HRSA encouraged OPOs to select hospitals with a strong interest in participation. Teams comprised 3 to 5 persons from among both OPO staff and hospital staff and included primarily organ procurement coordinators, critical care nurses, physician intensivists, trauma surgeons, transplant surgeons, neuroscientists, and OPO and hospital leadership. In accord with recommendations of the IHI Breakthrough Series Collaborative methodology, a system-level leader and a day-to-day leader from each participating OPO and hospital were identified on each team.
The voluntary application process for phase I garnered participating teams from 44 OPOs and 95 of the nation's largest organ-donor potential hospitals. In addition, a team from Quebec, Canada, participated. The Collaborative was conducted in 2 phases or "waves." In phase I, each of the 95 hospitals chose to participate either in the learning sessions in person or in a remote fashion through collaboration with the OPO. No matter how they participated, all hospitals in phase I tested changes in their organ donation systems and provided monthly data. Phase II followed in September 2004, with a second Collaborative that incorporated teams from 50 of the 58 OPOs in the United States and a total of 131 large organ-donor potential hospitals.
Phase I ran for 12 months, beginning in October 2003, and phase II ran for 8 months, beginning in October 2004. Each phase consisted of a cycle of learning sessions and action periods, as displayed in Figure 1. For each phase, the HRSA team collaborated with a selected faculty of 21 expert practitioners drawn from 6 of the nation's OPOs and 18 of the largest organ-donor potential hospitals that had achieved and sustained high organ donation rates.
||Figure 1. Collaborative engine.
The project employed the so-called "Breakthrough Series Collaborative" methodology for its core design, originally developed by the IHI, a nonprofit education and research organization, in the early 1990s.2-4 The IHI's collaborative model was originally grounded in social theory and technical approaches to improvement in large systems, and it has been refined continually since by the IHI and others.5 Collaboratives employ a combination of in-person meetings ("learning sessions"), with regular conference calls, online resources, and monthly reporting to support participants to effect and learn from change, rapidly adapting to their local settings practices that have been proven to work elsewhere or in scientific studies.
Participating teams met in October 2003, for learning session 1, at which they were introduced to the Collaborative aim (a 75% conversion rate at each participating hospital), change package strategies (specifying best practice ideas initially assembled by the Collaborative's faculty group),6 measurement and data submission requirements, and the Model for Improvement (MFI).7 The MFI served as the means by which teams would identify and test promising changes contained within the change package in their local organ donation systems.
For the ODBC, the faculty group identified best practices by intensive review both of existing literature and of procedures in OPOs and organ donor hospitals with high conversion rates, and then organized explanations of these practices into what the IHI terms a "change package." The initial ODC change package identified 4 overarching strategies comprising 26 key "change concepts" and 57 "action items" (Appendices A and B). Overarching strategies are broad plans for achieving systemwide improvement. A change concept within a strategy is an approach or a heuristic that has been found to be useful in pursuing that strategic element. The 4 overarching strategies for systemwide improvement were (a) unrelenting focus on change, improvement, and results; (b) rapid early referral and linkage; (c) integrated donation process management; and (d) aggressive pursuit of every donation. Action items represent specific ideas for implementing changes. Results garnered from testing action items within these 4 strategies dominated the hundreds of presentations given by teams both at the learning sessions and at "home" in their organ donor service area (DSA).
At the conclusion of the first learning session, teams returned home for a 3-month action period to test changes using the Plan, Do, Study, Act (PDSA) cycles that lie at the core of the MFI. The learning sessions were held every 3 to 4 months. Between learning sessions, teams shared the results of their system changes and lessons learned with each other through monthly conference calls and ongoing dialogue on an active Internet listserve. Teams used the listserve to share resources, request assistance from one another and from faculty, brainstorm solutions to problems, and identify successes (Fig 1). In phase II, improvement leaders in each OPO reached out to several hundred additional hospitals not directly involved in the Collaborative through regional meetings, satellite links to national organ transplantation meetings, regional and national conference calls, and online resources.
To assist the Collaborative, the HRSA convened approximately quarterly meetings of a leadership coordinating council (LCC), a group of senior executives and elected leaders of 16 major national associations and organizations with a stake in organ donation.
Participating teams set straightforward "stretch" goals (Table 3), the most important of which was to achieve a 75% conversion rate of potential organ donors to actual organ donors and were introduced to improvement methods to test and adapt proven practices rapidly to their own settings.6
||Table 3. Goals and measurements
For the duration of both project phases, hospitals and OPOs submitted raw data for the calculations to track the process and outcome measures through an Internet-based Access database. Data collected included the following: organ referrals, eligible organ donors, organ donors, no-consents, no next-of-kin/other, medical examiner denials, the number of times the organ referral was made in a timely manner, and the number of times the family request for donation was made by a designated requestor. Hospital-specific and collaborative-wide rates for each of the tracked measures were reported on a monthly basis by the participating teams on run charts. Control limits were calculated for the collaborative-wide conversion rate run chart for both phase I and phase II (Fig 2).
||Figure 2. Phases 1 and 2 conversion rates.
In addition to monthly process and outcomes data, teams were also asked to report in a narrative form the changes being tested, lessons learned from PDSA cycles, and challenges to improvement. On the basis of the combined monthly narrative and data reports, teams exhibiting improved outcomes and progress toward the 75% conversion rate goal were selected to be profiled. Collaborative faculty interviewed these high-performing teams and analyzed their testing and results. The profiled teams then presented their specific donation system changes at subsequent learning sessions both in person and in video format.
Analyses were performed on the Collaborative hospitals (n = 131) against historical performance and against non-Collaborative hospitals. In addition, an analysis of the total US organ donor population from both Collaborative and non-Collaborative hospitals was performed. Because 86% of the nation's OPOs participated in collaborative (50/58), their DSA size representing 83% of the US population, and because 44% of the nation's top 300 hospitals with the greatest amount of organ-donor potential (131/300) participated in the collaborative (Table 2), the changes made in these OPOs and hospitals resulted in national increases in the number of organ donors. The total number of US organ donors defined by pre- and post-Collaborative 12-month periods are included along with the calendar year US organ donor data in Table 1.
Before the Collaborative, conversion rates in the participating hospitals averaged 51.5% and ranged from 21% to 88%, with 46.5% of participating hospitals falling below 50% conversion. The conversion rate increased steadily over the course of the 2 collaborative phases, from 51.5% in 2003 to 65% in 2005 for the Collaborative hospitals (Fig 2). Using calendar year 2002 and 2005 data from the Scientific Registry of Transplant Recipients, 42 of 95 hospitals participating in phase 1 and 41 of the 131 hospitals participating in phase 2 reached the 75% conversion rate goal, compared with only 19 of the 95 hospitals and 23 of the 131 hospitals achieving that same benchmark in the calendar year before their entry into the collaborative. These achievements represent respectively a 121% and a 78% increase in participating hospitals achieving that same benchmark.
Figure 3 shows the cumulative percentage increase or decrease in the number of organ donors from month to month for Collaborative participant hospitals compared with nonparticipating hospitals for the initial Collaborative period from October 2003 through September 2004, compared with an analogous time period in the previous year. The number of organ donors in Collaborative hospitals increased 14.1% in the first year, a 70% greater increase than the 8.4% increase experienced by non-Collaborative hospitals.8
||Figure 3. Cumulative percent increase of deseased donors for Collaborative versus non-Collaborative hospitals (October 1, 2003, to September 30, 2004-First full year of Collaborative).
The 8.4% post-Collaborative difference in donation outpaced the established yearly trend of 2.4%. Table 4 shows the results of 8 separate Poisson regression models (2 for each organ type) modeling the number of organ donors per hospital by year and month. Models identified as "underlying yearly change" were adjusted for preversus post-time period and being a collaborative participant separately. Models identified as "post-Collaborative difference" were further adjusted for an interaction of pre-versus post-Collaborative participant. All models were adjusted for month, total bed size, level 1 or 2 trauma center, and ratio of intensive care unit beds to total beds. There were statistically significant increases in total donors, standard criteria donors (SCDs), and donation after cardiac death donors (DCDs) after the Collaborative began, above the baseline trend and near significant increases in expanded criteria donors (ECDs) over the baseline trend.
||Table 4. Increase in organ donation during Collaborative outpaces established yearly trend
In addition to analysis of collaborative hospital data, total US organ donor increases were examined. Data on all US organ donors were obtained from the OPTN and represent a complete census of all organ donors and eligible organ donors. As of September 2006, the number of organ donors in the United States increased 22.5% for the combined collaborative and post-Collaborative periods from October 2003 through September 2006, compared with a 5.5% increase for the same period of time immediately preceding the start of the Collaborative (October 1999-September 2003). Monthly records were broken during 33 of 36 months following the start of the Collaborative (Fig 4).1
||Figure 4. Monthly US organ donors (8015 donors in 2006).
A 10-year control chart shows the magnitude and continued increases in the number of organ donors per month through May 2006 (Fig 5). Control limits were exceeded twice during the collaborative periods, requiring that new control limits be set for the subsequent periods. The May 2006 data point in the "new system" indicates a point beyond 3 SDs from the performance expected from the stable, history-beyond a "3-sigma" control limit. According to statistical process control theory, this change strongly suggests that a special cause of changing performance is occurring exactly concurrent with the Collaborative program. The process control chart indicates that the current donation process is operating at an average rate of approximately 678 organ donors per month, compared with 514 before the Collaborative period.
||Figure 5. US monthly organ donors (SPC chart).
The annual increase in recovery of SCDs of 4.4% per year following the start of the Collaborative represents a 1528% increase over the 0.3% annual increase during the same length of time in the pre-Collaborative period. Increases in the Collaborative compared with pre-Collaborative years were found in both the ECD and the DCD categories (Table 4).
Over the course of the first Collaborative, teams determined which practices from the initial change package produced sustained high organ donation rates. The most effective changes were ultimately condensed into First Things First and High Leverage Changes. These overlapping best practices are summarized in Appendices A and B. First things first are the basic building blocks that must be present to achieve a successful program of organ donor identification, consent, management, and recovery. High leverage changes refer to action items in the 4 strategies in the change package that proved to have a powerful effect on change concepts across strategies and a direct relationship to outcomes and results. As an example, the action item, "master effective requesting," directly addressed increasing consent rates, the number 1 system action found to convert a potential organ donor into an actual donor. Many elements must be addressed to master this high leverage change effectively: (a) timely, early referral of the potential organ donor to the OPO (identification); (b) identification of the most effective requestor, who must then be dispatched to the hospital; (c) coordination of a "team huddle" by the requestor, involving the attendant healthcare professionals in a coordinated consent process; and (d) debriefing of the team after the event. Such carefully coordinated action not only improves interaction with families, yielding high rates of organ recovery, but also sets the stage for future learning.
For the first time in more than a decade, concurrent with this program, the rate of rise of organ donations has increased beyond the single-digit annual percentage figures. The number of organ donors per month in the United States has grown at an unprecedented rate since the start of the Collaborative in October 2003. The increases in conversion rates associated with improved referral processes and consent rates yielded a 3-fold increase in the annual percentage growth in organ donors for the 3-year period following the start of the Collaborative compared with the 3-year period before the Collaborative (Table 5). The increase in US organ donors in the 12-month period following the start of the Collaborative translated into an additional 607 organ donors over the previous 12-month period from 6981 organ donors to 7537 (Table 1). This 9.5% increase in total US organ donors in the first year was followed by an 8.0% increase in the following 12-month period, October 2004 through September 2005, and an additional 5.0% increase the following 12-month period, October 2005 through September 2006, for a total increase of 22.5% over the 36-month period of the Collaborative (Table 1). Only 2 years in the previous 16 years had seen any type of increase approaching those seen with the Collaborative. In 1998, a 5.8% increase followed the introduction of the Centers for Medicare & Medicaid Services Hospital Conditions of Participation, which required hospitals to refer, in a timely manner, all deaths to OPOs. In 1990, the 12.2% increase may have resulted from strengthened OPO practices following various legislative efforts to increase organ donor identification. Others have noted the increase in US organ donors following the Collaborative compared with historical trends.9
||Table 5. Increase in organ donation pre-and post-Collaborative
A descriptive analysis of the national donation trend indicates an average 7.5% annual growth rate post-Collaborative in comparison with a 1.8% average growth rate pre-Collaborative (Table 5). Because approximately 90% of the nation's potential organ donors are found in only 15% of its hospitals, it is critical that the performance of these hospitals improve to make a meaningful change in the number of organ donors. The national initiative to engage the nation's hospitals with the largest organ-donor potential with the nation's OPOs in a collaborative effort to increase the number of organ donors strongly suggests that national improvement is possible using a collaborative methodology.
Several factors appear to have played important roles in this national initiative. First, the rapid testing, adaptation, and replication of successful practices are at the core of increased organ donation performance in hospitals and OPOs with high organ donation rates. Nurses, physicians, OPO staff, and other healthcare professionals worked together on teams to examine best practices, apply them in their own institutions, and share their success with others. An early example of this was the application of implementation of clinical "triggers" for referral of potential organ donors. OPOs had long known that an early, timely notification before brain death was associated with higher rates of donation. Physicians and nurses would often resist or fail to see the importance of the timing of referrals. Learning from other teams the clinical status of the patient that was used to prompt or "trigger" a referral led to early collaboration between OPO staff and hospital staff in any number of process measures measured in donation.10,11
Second, the LCC played a key role in providing leadership support for the Collaborative aim, and, in the process, it became a new and powerful force in the work to generate national increases in donation. The national organizations in the LCC endorsed the goals of the collaborative and participated in pushing these goals out to their members and stakeholders. For example, the Joint Commission (JCAHO) significantly ramped up its support and involvement on organ donation in several ways. For example, the JCAHO adopted the Collaborative's 75% donation rate goal as the standard of evaluation when JCAHO surveyors visit hospitals in their accreditation reviews, collaborated with the faculty and Collaborative co-chair to produce a training video on donation best practices for JCAHO surveyors, and issued letters of invitation from the JCAHO President Dennis O'Leary requesting that hospital CEOs participate in Collaborative Learning Sessions. JCAHO surveyors were trained on organ donation outcome and process goals to assess during hospital surveys. In sum, the JCAHO sent a powerful and immediate message to the nation's hospitals that donation outcomes were measurable and that substandard performance would be noticed. The leadership of the JCAHO in the Collaborative induced other national organizations to commit to the project as well.
Third, the discipline of rigorous data reporting and measurement of the process and outcomes standards forced participants to focus on results. Steady focus on the 75% conversion rate goal appeared to reinforce enthusiasm and dedication among the healthcare professionals involved in the collaborative.
That the annual percentage increase following the start of the Collaborative was largest for SCDs is noteworthy because, in the past, the greatest gain in US organ donors has been achieved through large increases in the recovery of ECDs-older donors.12 In fact, transplant surgeons, who have generally claimed that the only accessible increases in organ donors in the United States were due to the relaxation of organ donor criteria standards and the use of ECD organs, soon discovered otherwise in this Collaborative program. The substantial increase in SCDs reflects a fundamental change in the core donation system, indicating that the gains in organ donors were not made simply by working harder at doing the same thing. The increase in SCDs could be made only by improving the consent rates on these cases. These cases, for example, young trauma victims, comprise a distinct portion of the organ donor pool, a portion that cannot be increased by "loosening" criteria. Because the pool of such organ donors had already been identified and could not be enlarged, the system of obtaining consent, which is affected by all of the change strategies, had to change to convert more of these potential SCDs.
The success of the organ donation Collaborative in the United States has been recognized and is now being replicated internationally. Key national organ donation and transplantation leaders from both Canada and Australia have participated in US learning sessions, met extensively with the Collaborative faculty, and subsequently have secured funding and support to launch their own organ donation collaborative. Australia held its first learning session in June 2006. An October 12, 2006, press release by Australians Donate reports that a 40% increase in organ donor rates has been achieved by hospitals participating in the first 3 months of the Australians Donate National Organ Donation Collaborative. The Canadian Council on Donation and Transplantation launched the first learning session of its collaborative in November 2006.13 Resources needed for a Collaborative to be coordinated in the way in which the ODBC was conducted would require not only the modest governmental expenditure referred to earlier but also some effort by the participating hospitals in allowing their staff to attend 3 to 4 learning sessions per year, of 2 days each in duration. OPO resource investment was of the type that would be expended by an OPO in the normal course of business, only in this instance, such work and resource investment would be focused on best practices-What Works.
In its design and evaluation, the Collaborative project has several limitations. First, the sheer size of this national collaborative, with its hundreds of hospitals, transplant centers, and OPO participants, informational outreach programs to others, and the numerous leadership organizations involved, makes it impossible to determine the percentage of donation increases owing to the activity of the Collaborative teams themselves. This was not a randomized controlled trial, and some proportion of the improvement might be appropriately attributed to interventions occurring independent of the Collaborative processes and the PDSA testing by teams. The sudden change in the rate of increase in donations shown on control charts, at the 3-sigma level of significance, to be exactly coincident with the Collaborative processes, combined with the detailed narrative information collected from the participants, strongly suggests that the Collaborative process was at least, in part, a cause of the major increases in organ supply, at least until a strong, competing, external force can be identified as an alternative cause.
Second, because hospitals volunteered for the Collaborative, rather than being randomly assigned, the predicted effects of the Collaborative process cannot be generalized with confidence to the entire population of US hospitals. In this case, because participating hospitals have such high organ-donor potential, the Collaborative process can be judged important and successful (within the limits of inference from the control chart analysis) in itself. It remains to be determined whether similar increases in donations could be accomplished through Collaborative participation on a nonvoluntary basis and whether other methods of spread of successful changes can accomplish the same end.
Third, because of the complex, interactive, and potentially synergistic nature of the "first things first" and "high leverage changes" action items in the change package, it was not possible to determine precisely the relative or absolute weight of the action items in producing changes. One cannot determine, for example, how much of a 50% increase in consent rate can be attributed to early notification of the potential organ donor versus the involved healthcare professionals "huddle" before the consent request.
The apparent success of this voluntary federal initiative, implemented in collaboration with thousands of front-line caregivers from hospitals, OPOs, and transplant programs across the nation, suggests that rapid, systematic, cost-effective, and successful national healthcare transformations are possible, at least among volunteering organizations, with a modest federal investment of only $2 million to $4.5 million annually. The HRSA conservatively estimates that more than 4000 additional transplants have occurred as a result of the increases that have already occurred. The 75% conversion rate that seemed at first an extremely ambitious goal soon became a reality for many hospitals and OPOs across the nation.
The change process that began with the initial 2 ODBCs is continuing. Work to spread the practices stemming from the Collaborative is increasing as more of the nation's largest hospitals enroll in this effort. A separate collaborative, the Organ Transplantation Breakthrough Collaborative, was launched in October 2005, with the goal of increasing the number of organs transplanted from each organ donor from the then-current national average of 3.06 to 3.75. Additional collaborative development activities are currently under way to expand rapidly the capacity to handle the increased volume of organs for transplantation.
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