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© 2007 American Public Health Association
DOI: 10.2105/AJPH.2005.077701
HEALTH POLICY AND ETHICS |
Howard K. Koh, Christine M. Judge, and Hillel R. Alpert are with the Division of Public Health Practice, Harvard School of Public Health, Boston, Mass. At the time of the study, Marsha D. Jacobson and Anne Marie Lyddy were with the New England Organ Bank, Newton, Mass. Kevin J. O’Connor, Sean M. Fitzpatrick, and Richard S. Luskin are with the New England Organ Bank, Newton. At the time of the study, Milly Krakow was an independent consultant for the Massachusetts Department of Public Health, Boston.
Correspondence: Requests for reprints should be sent to Howard K. Koh, MD, MPH, Division of Public Health Practice, Harvard School of Public Health, 677 Huntington Ave, Landmark Center, 3rd Fl East, Boston, MA 02115 (e-mail: hkoh{at}hsph.harvard.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONTHE MASSACHUSETTS ORGAN DONATION...DISCUSSIONReferences |
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Despite the growing disparity between organ supply and demand in the United States, few initiatives have attempted to close the gap through systematic population-based public health endeavors.
We examined the evolution, implementation, and outcomes of the Massachusetts Organ Donation Initiative, a statewide effort that included a unique partnership among organ procurement organizations, major teaching hospitals, and the state’s department of public health. Lessons from this initiative have contributed to growing national efforts for increasing organ supply and have provided insights for addressing this continuing public health challenge.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONTHE MASSACHUSETTS ORGAN DONATION...DISCUSSIONReferences |
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THE GROWING DISPARITY between organ supply and demand is a major public health crisis. In the United States, more than 90 000 patients await organ transplants, but only about 27 000 transplants are performed annually.1 The supply of available organs from deceased donors fails to meet the demand.2 Specifically, although national organ donation has increased by more than 60% from 1994 to 2003, the increase in the number of individuals who need transplants has risen twice as fast. As a result, in 2003 more than 7000 individuals died while on waiting lists,1 a tragic example of the "donation gap."3
The 1984 National Organ Transplant Act addressed the need for equitable and efficient organ procurement and distribution and led to the formation of the Organ Procurement and Transplantation Network. Hospitals in this network collaborate with 58 organ-procurement organizations (OPOs) nationwide to coordinate the recovery of organs for transplantation. Since 1986, administration of the Organ Procurement and Transplantation Network has been contracted to the United Network for Organ Sharing. As part of this structure, the OPOs educate the public about donation, engage potential donor families to gain informed consent, manage the clinical care of consented donors, and coordinate the surgical recovery of organs. Furthermore, OPOs ensure that donated organs are allocated in accordance with policies and regulations set forth by the United Network for Organ Sharing/Organ Procurement Transplantation Network. Each OPO is a nonprofit agency assigned to a geographic region by the Centers for Medicare and Medicaid Services.
Improving donation rates from eligible donors could potentially narrow the donation gap. Two 2003 publications placed the average nationwide conversion rate (percentage of potential donors that became organ donors) at only 35% and 43%, respectively.4,5 Few states, however, have made the challenge of systematically maximizing organ supply a public health priority.
We examined the evolution, implementation, and lessons learned from the Massachusetts Organ Donation Initiative—a statewide effort that included a unique partnership among OPOs, major teaching hospitals, and the state’s public health department. We also examined the qualitative and quantitative outcomes of this initiative.
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THE MASSACHUSETTS ORGAN DONATION INITIATIVE |
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Formulating the Initiative
In May 1999, the Massachusetts Department of Public Health (MDPH) convened a statewide task force to generate strategies for increasing organ donation. The group consisted of MDPH officials, major teaching hospital chief executive officers, OPO officials, advocates, health insurers, legislators, and other interested parties. The OPO that represents most of Massachusetts—the New England Organ Bank—worked closely with the MDPH to launch the task force. A second OPO, LifeChoice Donor Services (which serves a portion of western Massachusetts), also participated.
The task force first weighed considerations for an intensive statewide public education campaign but moved to other options, because broad public support for organ donation was already known to be high.6 Previous studies have shown that the major limiting factors in organ donation are lack of referral to the OPO and failure of families to consent7 (attributed to the sensitivities of suggesting organ donation to those struggling to comprehend the brain death of a loved one). To meet these challenges, researchers summarized consensus recommendations for improving consent rates, including systematic identification of donors by hospitals, decoupling the donation request from the explanation of brain death, and early involvement of trained OPO staff as central figures in making donation requests.8–10 Although some comprehensive hospital-focused interventions had previously addressed systems issues by orchestrating the series of critical steps involved,8 few population-based efforts existed.
Ultimately, the task force settled on a relatively inexpensive statewide hospital-based intervention that focused on reaching families during a time of critical decisionmaking. Of the more than 70 Massachusetts acute care hospitals, 9 transplant centers—with a combined patient population that represented about two thirds of the state’s potential eligible organ donors—were the target for an intervention (Table 1
).
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The initiative focused on a number of key principles. First, the goal was not only to improve the interaction between OPOs and the 9 hospitals during critical windows of opportunity but also to capitalize on the convening and oversight power of the MDPH. Second, the initiative uniquely relied on the leadership of the 3 partner organizations—the chief executive officers of the 9 hospitals, the chief executive officer and senior leaders of the New England Organ Bank (the major OPO), and the commissioner and senior officials of MDPH—while minimizing the burden on any single party. Third, the initiative required virtually no additional funds. Fourth, the initiative was data-driven, with outcomes measured continuously in accordance with quality improvement techniques. Fifth, the initiative underscored the strategy of system change for medical centers with competing priorities.
Enlisting Support From Hospital Chief Executive Officers
During a period of time that extended from late 1999 to the summer of 2000, the MDPH commissioner and a senior OPO official visited each of the 9 chief executive officers to request a personal commitment to the initiative. Specifically, each chief executive officer was asked to (1) appoint a senior-level liaison (e.g., chief medical officer) to work externally with MDPH and OPO staff while directing practice changes internally at all levels of the hospital’s organization, (2) personally review semiannual data on the hospital’s organ donation progress and publicly share these outcomes with hospital leaders during staff meetings, and (3) personally attend semiannual project meetings at the MDPH.
Applying the Tenets of Quality Improvement to Organ Donation
Quality improvement is a systematic approach to tracking and modifying processes and outcomes for achieving the highest level of impact12 in complex settings. Quality improvement has special relevance to organ donation, because donation occurs in busy hospital settings, it involves many people acting individually and in collaboration, and it requires the successful occurrence of a series of events. Tenets of quality improvement relevant to the initiative were (1) a fact-based analytic approach that involved continuous collection and analysis of data, (2) a determination of the root cause of each problem to be solved, (3) the development of a specific action plan that addressed each root cause, and (4) ongoing measurement and analysis to verify the validity of apparent solutions.
Focusing on Data
As part of the quality improvement strategy, collection and analysis of data helped define each step in the course of action. For example, a newly created New England Organ Bank Referral/ Family Discussion Survey facilitated collection of detailed information on every potential donor (regardless of whether donation occurred). This new instrument gathered greater detail than previously was available on issues such as timing of the referral and the process of gaining access to the patient or family by OPO staff. Dates, times, hospital units, and names of all personnel involved in the consent process were recorded, analyzed, and summarized for the liaisons in a joint data collection effort by the hospitals and OPOs. Higher-level summaries went to the MDPH and hospital chief executive officers.
The OPOs collected, analyzed, and distributed the aggregate data and tracked outcomes such as numbers of potential donors (determined by death record review), referral rates (percentage of potential donors that were referred by hospital staff to the OPO), consent rates (the percentage of families approached that consented to donate), and conversion rates (the percentage of potential donors that became organ donors; Table 2). The liaisons focused on issues specific to their hospitals and provided attention not only to the systemic implementation of procedural changes in their hospitals but also to personal assessment of individual cases in which the donation process met obstacles. For example, all liaisons agreed to be paged day or night to provide real-time intervention for active cases (which proved necessary only once or twice a year).
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There was increasing project sophistication as the initiative evolved. For example, initial standardized monthly hospital progress reports provided by OPOs to all liaisons evolved into data reports provided weekly or even in real time. Additionally, standardized reports were distributed and discussed during the MDPH semiannual meetings, where data were presented that showed both aggregate and individual results from the 9 hospitals (individual hospital data were de-identified to maintain confidentiality; chief executive officers and liaisons knew their own hospital codes, but others did not).
Identifying and Targeting Root Causes
During the MDPH semiannual meetings, hospital chief executive officers and liaisons, OPO staff, and MDPH staff jointly reviewed statewide data and discussed strategies for addressing problems that were raised. Consistent with the literature, the initial MDPH meeting during the fall of 1999 confirmed that 2 prevalent conditions accounted for most of the lost donation opportunities: lack of timely referral of potential donation cases to the OPO, and exclusion (or inadequate inclusion) of OPO staff during the consent process.
Under the 1998 Health Care Financing Administration (now Centers for Medicare and Medic-aid Services) Medicare Conditions of Participation,13 all hospitals are obligated to notify OPOs of impending deaths in a timely manner. OPO staff then can be available to the family at the bedside if an organ donation is possible. An unreferred case, which by definition cannot progress to donation, is a lost opportunity. During the initial MDPH meeting, all liaisons assumed their hospitals were complying with the Medicare Conditions of Participation, but the data showed referral rates were averaging only 83%, with some hospitals as low as 43%. The liaisons implemented changes designed to improve referral rates on the basis of increasingly detailed and specific OPO data. For example, identifying specific units or even individual provider teams that were not referring patients enabled the liaisons to make focused interventions.
Improving OPO participation during the consent process was more complex.9 Medical staff often approached families because they felt it was part of their role as health professionals. However, the 1998 Medicare Conditions of Participation stressed that only OPO staff or specially trained designated requestors should approach families to broach the topic and to explore the delicate issues involved. Studies have shown that donation rates rise substantially when trained OPO staff (rather than busy untrained hospital clinicians, especially inexperienced house staff in teaching hospitals) make the request.14
Because few hospital chief executive officers and liaisons initially felt comfortable turning over the consent process, a modest first step was initially approved—OPOs supplied liaisons with small pocket cards that guided doctors and nurses in practical ways of introducing OPO staff to bereaved families. Liaisons then distributed these pocket cards to intensive care unit and emergency department medical staff.
During the course of the intervention, liaisons initiated additional hospital procedures for increasing the role of OPO staff in consent discussions. More detailed analyses by OPO staff could pinpoint windows of opportunity (e.g., times, shifts, and even teams of medical personnel) where a focused intervention could potentially improve referral, consent, and conversion rates. For example, 1 liaison pointed to the successful recruiting of heads of all intensive care units (e.g., medical, surgical) as vital to the project. Another instituted standardized training for house staff starting intensive care unit rotations. Ultimately, all 9 hospitals adopted practices that mandated OPO staff to conduct, or be meaningfully involved in, all consent discussions.
Building Relationships Among the 3 Major Partners
Well before the advent of the initiative, OPO staff had maintained a high level of visibility in the 9 hospitals and, in some cases, had even established offices there. The added support of the chief executive officers and the liaisons during the initiative improved OPO relationships with numerous hospital staff in varied roles and ranks. Over time, OPO leaders and hospital chief executive officers publicly recognized those who had contributed meaningfully to important breakthroughs in donation, which further generated motivation and pride in the endeavor.
The MDPH high-level semiannual meetings underscored the department’s continued commitment, kept the chief executive officers informed and committed, and provided an important platform for hospital-to-hospital collaboration. Some amount of peer pressure undoubtedly motivated the chief executive officers to maintain attendance. Incremental improvements were celebrated and provided the basis for the next round of data-based actions. For example, as trust increased among the chief executive officers, 1 chief executive officer disclosed that his was the hospital with the least improvement and asked the others for help.
Improving Outcomes and Sustaining the Initiative
Among the 9 participating hospitals, donations increased to 103 donors in 2001 (from 73 in 1999 and 68 in 2000; Table 2
). The increased donor number reflected improvements in rates of referral, consent, and conversion. By 2001, the overall referral rate for the 9 hospitals approached 94%, with 3 achieving a 100% referral rate. The aggregate consent rate rose to 67%, and among individual hospital consent rates, the minimum rate increased from 29% to 52%, and the maximum rate increased from 75% to 100% (achieved in 2 hospitals). The conversion rate rose from about 44% (1999 and 2000) to nearly 60% (2001). Two hospitals showed exceptional success qualitatively associated with a shift in hospital culture. As 1 hospital liaison summarized, "We doctors used to be uncomfortable when [New England Organ Bank] staff were on the floor. Now we are uncomfortable when they are not present" ( John Chessare, MD, MPH, personal communication, August 2003). Momentum, however, stalled.
The last MDPH semiannual meeting occurred in mid-2002, before a change in the initiative’s leadership. Outcomes subsequently declined. Although the referral rate decreased slightly from its high of 93.6% (2001) to 90.4% (2003), the consent rate and conversion rate experienced greater declines (66.9% to 45.6% and 59.5% to 37.8%, respectively). We performed grouped logistic regression testing (which assumed that the initiative occurred in 2000 and 2001 but not in 1999, 2002, or 2003) with control for secular trend, and found that the initiative was associated with a higher referral rate (odds ratio [OR]=1.75; 95% confidence interval [CI]=1.07, 2.87; P=.025), a higher consent rate (OR=1.40; 95% CI=1.03, 1.90; P=.030), and a higher conversion rate (OR=1.49; 95% CI=1.12, 1.98; P=.006).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONTHE MASSACHUSETTS ORGAN DONATION...DISCUSSIONReferences |
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To our knowledge, the Massachusetts Organ Donation Initiative is the first statewide effort to increase organ supply through a unique partnership of OPOs, major teaching hospitals, and the state’s public health department. The initiative, which required a minimum of additional work and virtually no additional financial resources, focused on a common goal, enabled each party to make unique contributions, and responded to data with concrete actions and follow-up. The 3 partners committed to the following responsibilities:
- The MDPH convened 2 high-level meetings a year to review the overall status of the initiative, share the aggregate and individual hospital data on donation rates from the 9 hospitals, and collaborate with the New England Organ Bank.
- Hospital chief executive officers elevated organ donation to a major priority, publicized the issue within their hospitals, and raised expectations that donation should be routine rather than unusual. Moreover, they assigned a senior-level liaison to redesign hospital systems to maximize donation, track and review donation outcomes as a quality measure during hospital staff meetings, and attend 2 statewide meetings per year with the MDPH, OPO leaders, and other participating chief executive officers.
- OPOs reemphasized their primary role as the interface with the potential donor family during the consent process, maximized the coordination of donation teams within each hospital, and collected and distributed comprehensive data. They also provided timely data analyses that prompted next steps for incremental gain.
By 2001, the aggregate conversion rate and consent rate for the 9 Massachusetts transplant centers rose to nearly 60% and 67%, respectively. These were the highest statewide levels in the approximately 10 years of tracking such data. The aggregate referral rate increased from 83% to nearly 94%; several individual hospitals showed even more dramatic improvements. The number of organ donors rose to 103 in 2001 (from 73 in 1999 and 68 in 2000), with statistically significant increases in the referral rate, consent rate, and conversion rate.
Although the initiative was not designed as a controlled scientific intervention study with a formal comparison group, we attribute improved outcomes to a number of factors. First, a statewide partnership that included the commitment and a closely integrated working relationship among the 3 major partners promoted unprecedented coordination without placing an undue burden on any individual party. Second, combining quality improvement principles12 with resources from both hospitals and OPOs provided real-time, immediate feedback that was used to target action. In this case, the data supported actualizing best practices previously described in the medical literature; specifically, that hospitals refer all imminent deaths to the OPO so that their trained staff could handle sensitive consent discussions.9,15 A recent study has shown the value of a related approach that uses in-house coordinators in level 1 trauma centers to build early and close relationships with the family and thus increase organ recovery.7
Third, implementing a fact-driven standard that was supported by comprehensive and frequent data collection and analysis provided the feedback loop for improving donation outcomes. Each hospital liaison was a designated high-level donation champion who was appointed by and represented the chief executive officer and who was willing to work flexibly within the culture and the structure of the hospital. Fourth, the 9 hospital chief executive officers (and liaisons) were both collaborators and friendly competitors and did not want to be viewed as underperformers compared with their peers. Fifth, the initiative was designed as a win-win for everyone involved; the MDPH, OPOs, and each hospital could justifiably point to their specific and collective contributions. Sixth, other factors may have contributed to the peak performance, such as possible increasing compliance with the 1998 Medicare Conditions of Participation and the slight increase in the number of potential donors in 2001.
We offer these thoughts within the broader context of scholarly qualitative research, where investigators apply an iterative process to identify patterns in collected data and experiences, organize them into an appropriate typology or conceptual framework, and then collect more information to challenge the framework. Although we have emphasized the value of quality improvement tenets that guided process tracking for the initiative, additional analyses of theoretical frameworks, typologies, and other qualitative methods derived from health policy research would strengthen future research in this field.16–20
The initiative contributed to growing national efforts. Notably, after interviewing key OPO and hospital officials nationwide, the US Department of Health and Human Services released a 2003 report that delineated 7 principles and 15 best practices.4 The report explicitly cited the principles and themes of the systems approach employed in Massachusetts,4 with New England Organ Bank OPO staff representing about a quarter of those interviewed. Lessons from the initiative also reaffirmed the conclusions of a national study, which recommended that efficient coordination of organ donation efforts should focus on larger hospitals with high concentrations of potential and actual donors.21
Also, the initiative was a forerunner to renewed efforts by the Health Resources Service Administration Organ Donor Breakthrough Collaborative22 for implementing the Institute for Healthcare Improvement’s Rapid Replication project in several hundred medical centers across the country. Three of the 10 national faculty members who took initial leadership roles in the collaborative also were champions of the Massachusetts initiative; in fact, 1 initiative leader served as the national collaborative co-chair.
Sustainability
Unfortunately, sustaining the initiative was a major challenge. After an initial marked improvement that peaked in 2001, the consent and conversion percentages subsequently dropped. Many factors may have contributed. The dramatic aftermath of September 11, 2001, which included anthrax and precipitous budget crises, engulfed the MDPH (and indeed all state health departments nationwide), diverted much attention away from organ donation, and disrupted momentum during a vulnerable time for program implementation. Turnover among the hospital chief executive officers and at the MDPH and the New England Organ Bank compounded the negative impact, because the departure of some of the initiative’s champions represented a substantial loss of bully pulpit exposure within each of the 3 partner organizations. Moreover, turnover of nursing and house staff in the teaching hospitals remains a constant educational challenge. Because organ donation represents a small-numbers event in the United States (currently about 7000 deceased donors annually,1 or 24 per 1 million population), even a slight slippage can affect outcomes.
Pluye et al. noted that sustainability of public health programs is driven by the critical processes of routinization and standardization.23 In particular, improving sustainability may require stabilization of organizational resources, attention to incentives, and standardization of policies at the national level. With respect to the last point, the Joint Commission on Accreditation of Healthcare Organizations implemented a new donation quality standard regarding OPO–hospital interactions in 2005, and it has begun to monitor conversion rates as a means of evaluating hospital performance.24 Also, if adopted, a proposed set of lengthier donation-related leadership standards from the Joint Commission on Accreditation of Healthcare Organizations could be in effect by 2007.25 Preliminary results from the Organ Donation Breakthrough Collaborative, whose principles stress the routinization and standardization of systems changes (through redesign, implementation, tracking, and refinement), offer the promise of moving "from best practice to common practice."22,26
Future Considerations
Closing the donation gap in the future will involve not only learning from the experience detailed here but also resolving many other issues with respect to living donors, donors after cardiac death,27 ethical incentives,28 legislative options, donor registries, mandated choice, aggressive donor management,29 and first-person consent statutes.2 The Massachusetts Organ Donation Initiative shows the potential of a unique partnership among OPOs, major teaching hospitals, and the state public health department in increasing statewide organ donation rates. Further research30 is needed to ensure sustainability and to translate lessons learned that will save lives.
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Acknowledgments |
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We are grateful to Pam Albert, Kathy Atkinson, David Barrett, Donald Berwick, John Chessare, Francis Delmonico, Paul Dreyer, Karen DiSanto, Michael Epstein, Rick Fowler, Joan Gorga, Gary Gottlieb, Sanford Kurtz, Paul Levy, James Mandell, James Mongan, John O’Brien, Thomas O’Donnell, Jeffrey Otten, Anne Prestipino, Deborah Savaria, Peter Slavin, Kirkpatrick Tans, Mark Tolosky, Elaine Ullian, David Weiner, and Anthony Whittemore for their commitment and support.
Human Participant Protection
No protocol approval was needed for this study.
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Footnotes |
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Peer Reviewed
Contributors
H. K. Koh, M. D. Jacobson, and R. S. Luskin originated the project, supervised all aspects of its implementation, and interpreted findings. A. M. Lyddy, K. J. O’Connor, and S. M. Fitzpatrick assisted with project implementation and data collection. M. Krakow and C. M. Judge synthesized analyses and assisted with writing and reviewing drafts of the manuscript. C. M. Judge also assisted with data interpretation. H. R. Alpert assisted with data analysis and conducted regression analyses.
Accepted for publication February 4, 2006.
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References |
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13. US Dept of Health and Human Services, Office of Inspector General. Medicare Conditions of Participation for Organ Donation: An Early Assessment of the New Donation Rule. Washington, DC: US Dept of Health and Human Services; 2000. DHHS Report No. OEI-01–99-00020.
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