The AJT Report
News and issues that affect organ and tissue transplantation
The Breakthrough Collaborative's guidelines and training for hospitals and OPOs have increased U.S. donation rates
When LifeSource, the Upper Midwest Organ Procurement Organization (OPO) in Minneapolis, decided to join the Organ Donation & Transplantation Breakthrough Collaborative, they rubbed out a traditional line in the sand that put hospital treatment on one side and organ procurement on the other. “Historically, the hospital cared for the patient until the end,” says LifeSource CEO Susan Gunderson. “Then there was a hand-off to the OPO. It was a clear divide.”
Following best-practice guidelines and training provided by the Breakthrough Collaborative, LifeSource formed a partnership with donor hospitals, from the hospital's CEO to the physicians, nurses, and social workers. Or, as Gunderson puts it, “we're talking with each other, rather than at each other.” As a result, the regional OPO experienced earlier hospital referrals, improvements in approaching donor families, and a partnership with ER and ICU staff in managing donors—all leading to an increase in donation rates from 65% in 2004 to 79% in 2007.
LifeSource is just one of the nation's 58 OPOs participating in the Breakthrough Collaborative since its formation in 2003. Over the past four years, the number of donor hospitals that have achieved or surpassed the Collaborative's goal of a 75% donation rate has increased more than sevenfold, from 55 in 2003 to 392 in 2007, based on a pool of 716 hospitals that met eligibility criteria.
The Collaborative's History
Under the direction of the Health Resources & Services Administration (HRSA), the Organ Donation & Transplantation Breakthrough Collaborative was launched in September 2003 using a model developed by the Institute for Healthcare Improvement, which conducted site visits, interviews, and a review of six high-performing OPOs and 16 outstanding OPO-affiliated hospitals. At that time, the national conversion rate average was 48%. The Collaborative set a goal of 75%.
Collaborative participants attended centralized training sessions and then returned home to test new approaches while staying in touch with Collaborative staff via e-mails, conference calls, and written reports. Organ donation increased by 10.8% during the first year.
“The purpose of the Breakthrough Collaborative is not to dictate medical practice,” says Virginia McBride, director of the HRSA Division of Transplantation's Breakthrough Collaborative Initiative. “What works in one hospital doesn't work in another. What we're doing is using all our collective knowledge to provide best-practice guidelines that hospitals and OPOs can adapt to meet their specific needs.”
The Collaborative was launched with a goal of 3.7 organs recovered and transplanted per donor. While national numbers have remained unchanged, McBride says that certain individual donation service areas have demonstrated higher rates using the donor management goals suggested by the Collaborative.
The newest effort, called the Transplant Center Growth and Management Collaborative, was formed in 2007 to help high-performing transplant centers increase the number of transplants performed and handle the increased volume efficiently. Two training sessions have been held, with another scheduled for October in Nashville.
“I was very skeptical when this was first rolled out,” says Goran Klintmalm, MD, Baylor University transplant surgeon and current president of the American Society of Transplant Surgeons. “It sounded like a pie-in-the-sky plan, maybe even like a tent revival with emphasis on hope and testimony. But there's no question that the increase in organ donation we've seen in the last three to four years is related to the Collaborative effort.”
When asked if she met with resistance in the beginning, McBride says that “some hospitals have been more motivated than others. But once participants experienced success, other organizations wanted to join.”
What Works for LifeSource
“Our success is based on deepening relationships with donor hospitals, physicians, nurses and the administration,” Gunderson says. For example, to improve the approach to families, LifeSource conducts what they call a “huddle” with the donor's nurse, physician, social worker, and others, as needed. Together, the group decides the best way to approach the family.
When the LifeSource team noticed that their lung donation rates were low compared with those of other OPOs, they formed a “lung summit” team with representatives from their two local lung transplant centers, the University of Minnesota Medical Center Fairview and the Mayo Clinic. “One of the barriers we identified was an inability to get timely bronchoscopies on donors because we couldn't find staff in the donor hospital to do this,” says Gunderson. “Pulmonologists at the University and Mayo helped us by training a few of our staff members to do bronchoscopies. We improved both efficiency and quality of lungs donated.”
But What About …
While the success of the Collaborative is impressive, some members of the transplant community wonder if there isn't implied pressure to accept increasing numbers of substandard expanded criteria donor organs. “If somebody thinks an organ isn't appropriate for their patient, they shouldn't use it,” says Timothy Pruett, MD, president of the Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS). “The appropriateness of a specific organ or a specific patient is an allocation-related issue, not a Collaborative issue.”
The appropriateness of a specific organ or a specific patient is an allocation-related issue, not a Collaborative issue.
—Timothy Pruett, MD, OPTN/UNOS president.
“The Collaboratives are not regulatory in any way, and organ acceptance is not obligatory,” stresses McBride. “CMS [Centers for Medicare and Medicaid Services] certainly has performance standards for OPOs and transplant programs, but the role of HRSA is to help OPOs and transplant programs succeed.”
Eventually, it comes down to donation rates. As noted by Gabriel M. Danovitch, MD, a transplant physician with the University of California, Los Angeles, “In transplantation, we need to understand the biology of rejection. We need to develop new drugs and understand how they work. But organ donation is the key. We need to regard organ donation as a science in itself.”
News Media Hype and Immunosuppressant Therapy
You're not alone if your patients have recently asked to be taken off immunosuppressant drugs after they read news reports of studies that appeared in the January issue of the New England Journal of Medicine.
Earlier this year the news media went wild, touting studies out of Harvard, Stanford and Westmead Children's Hospital in Sydney, Australia, that could “free many patients from having to take anti-rejection drugs for the rest of their lives,” as stated in an Associated Press article. The Los Angeles Times said “Massachusetts researchers have been able to wean four of five kidney transplant patients off antirejection drugs.” The Reuters wire service article led by saying that “injecting blood or bone marrow cells into people who have just received a donated kidney can reduce the need for drugs that suppress the immune system.”
So it's not surprising that patients believed they could toss out their medications. Several patients contacted Flavio Vincenti, MD, professor with the division of nephrology at the University of California, San Francisco, asking for a bone marrow transplant so they could stop their drugs. He cautioned that the studies were preliminary, the procedures were complicated and rejection might still occur.
If medical professionals were the only ones reading the scientific articles, it might not be such a problem. John Curtis, MD, from the medical center of the University of Alabama at Birmingham, says, “Most studies need to be confirmed. The news media should carry this warning.”
Interesting, but Not Practical
A supporter of and participant in tolerance research, Dr. Vincenti congratulates the Harvard, Stanford and Australian investigators for their efforts. “The studies are important mechanistically because they show one path to achieve tolerance. However, it is unlikely that these strategies can have wide applications,” he says. “Less risky and invasive approaches need to be investigated if we are to achieve tolerance in a significant number of transplant patients.”
Apparently the concept isn't all that new. The University of Virginia's Thomas Pruett, MD, notes, “It's been around for a while, with mixed results. You have to put it in context as to what's really different from what's been done before.”
Emory University's Allan Kirk, MD, sums it up nicely: “In general, this is an important step, but [it] remains applicable only in selected patients under very closely monitored, clinical trial situations. It remains to be seen if it represents a better way to go, but it is definitely work that should be pursued.”