JMC: The primary aim of the campaign was to avoid 100,000 unnecessary deaths over an 18-month period in participating hospitals. We estimated that over 122,000 lives were saved. That comes as a result, we believe, of work on a variety of improvement initiatives that hospitals are making, in addition to their work on the interventions that were at the heart of the 100,000 Lives Campaign. That estimate was generated by collecting mortality data from a baseline year – 2004 – and comparing that to performance in the campaign period, which ran from December 2004 through June 2006. After adjusting for patient volume and patient acuity, we were able to estimate the change in mortality that had been observed in that period. People will focus on the lives saved results, but there are some other interesting results. I think the campaign really raised awareness nationally about the problem of variability in the quality of American health care, and the proactive response of so many hospitals around the country. In addition, we built what we refer to as a reusable national infrastructure for driving change and for supporting hospitals in making these improvements. That consists of about 150 mentor hospitals nationwide, chosen based on their willingness to act as coaches to peer facilities on specific interventions. The campaign also includes what we call "nodes" – state-level campaign offices that support implementation of the interventions, host meetings, raise awareness and help drive enrollment. They are typically a consortium of state hospital associations, quality improvement organizations, nurses associations and state medical societies. So, in addition to raising the question, "What should we do to transform American health care?" we’re also asking, "What’s the infrastructure that we can create to actually support that change in happening?"

JMC: It should be possible to isolate the effects of the campaign, and we’re awaiting some data – particularly some patient acuity information – to be able to make a stronger estimate. It’s important to note that the primary aim of the campaign was not to prove that the campaign itself was effective. It was to mobilize hospitals around the country in improving the quality of their care – through this initiative and through any other complimentary initiatives. That’s why we undertook this initiative with crucial partners like the Joint Commission on Accreditation of Health Care Organizations, the American Nurses Association, the American Medical Association, the CMS and the CDC. Over 3,100 hospitals participated in the 100,000 Lives Campaign, representing about 75 percent of all hospital beds in the country, given the average size of the hospital enrolling in the campaign – which is on the larger side.

JMC: Hospitals are directly reporting to us which intervention they’re committed to introducing at some point, and indicating to us when they’re actually beginning to introduce those interventions. Participation didn’t require implementing all six interventions of the campaign, but we strongly encourage hospitals to make plans to introduce all six as quickly as they possibly could. The number of hospitals committed to working on all six of the campaign interventions was about 45 percent. In terms of individual interventions, about 60 percent of hospitals adopted the rapid response team intervention to help patients at early signs of deterioration. About 77 percent of facilities adopted the intervention to deliver evidence-based care for acute myocardial infarction. Each of the campaign’s other four interventions were adopted by 60 to 75 percent of hospitals. The other four interventions were: avoiding medication errors through medication reconciliation – making sure that patients have the right medications at every transition point in their care process; and then we had three infection-related interventions looking at reducing surgical site infections, reducing ventilator-associated pneumonia, and reducing central venous line infections. Our big push over the summer months, after the formal 18-month milestone of the campaign, was to encourage hospitals to get to all six – to achieve saturation, as we call it.

JMC: IHI tries to design efficient and effective models of care, identify effective interventions and spread them as broadly as possible. Our study of how change gets spread tells us that, if you reach a critical mass of organizations that are introducing any intervention, in time others will follow. We felt that, with each intervention being implemented at over 60 percent of hospitals, we had significant traction and hospitals would continue to move forward, provided that we continue to offer support. In the meantime, the amount of harm that exists in American hospitals is still tremendously high and our work isn’t done. We trust that continued work on the existing interventions will yield good results, but we also need to push the pace and find ways to drive things forward.

JMC: In the spirit of not completely overwhelming participating facilities, we wanted to say, "If you’ve made a good start and built a good foundation with the first six interventions, these interventions are actually going to follow naturally." Where we looked at reducing adverse drug events through medication reconciliation in the 100,000 Lives Campaign, now we’re focusing on preventing errors associated with high alert medications – anti-coagulants, sedatives, narcotics and insulin. Where we looked at central line infections and ventilator-associated pneumonia, now we’re expanding our focus to look at Methicillin-Resistant Staph infection (MRSA). Where we looked at surgical site infections in the 100,000 Lives Campaign, now we’re looking at a whole host of changes around surgery that are pushed by the Surgical Care Improvement Project – which IHI is a part of with JCAHO, CMS, CDC, the American College of Surgeons, the American Hospital Association and many others. Where we were looking at providing more reliable care around heart attacks in the first phase, now we’re looking at providing reliable evidence-based care for congestive heart failure. In addition, we’re introducing an intervention to prevent pressure ulcers – which are a major source of harm and a cause of suffering that we could significantly reduce. We’re also introducing a new intervention focusing on something that is non-clinical, what we call "getting boards on board" – leveraging hospital boards of directors as major drivers of change. If they can train their attention on improvement in quality, study quality results at their meetings and in their organizational scorecards, they’re really going to help drive change and help transform hospitals.

JMC: It’s been quite positive and I think that stems in part from the fact that these do grow very naturally out of the first set of interventions, so people don’t feel like it’s irrational or overwhelming. I think also, participating hospitals know that these are major sources of harm: infection, medication error, surgical complication, are right up there at the top of the list. So, we’re covering a lot of the areas of concern of these facilities. In particular, I would say that MRSA is something many hospitals are very eager to move forward on, and the governance intervention – getting boards on board – seems to have resonated strongly, as well. I think organizations know that, if they get their boards engaged, that’s going to be a major driver of change. We’ll know better in late January and February about whether there has been a change in the enrollment rate. At this stage we’re categorizing it as "opt-out enrollment." When they submit their data to us in this current data submission period, hospitals will let us know if they’re not going to be with us for the 5 Million Lives Campaign. We are seeing a number of new enrollments from large systems and individual facilities. I strongly believe that we won’t see much disenrollment, and we have observed new hospitals and systems enrolling – over 50 new facilities in the last week alone.

JMC: They don’t. We’re asking them to adopt as many interventions as they possibly can, as rapidly as they possibly can. Some organizations are declaring that they’re going to introduce all 12; others are saying they’ll continue to work on the first six interventions and add one or two more. Again, our principle here is that by having graduated involvement, by allowing people to enter at their own speed, we allow more people to be involved and we increase the learning network. But at the same time, we’re constantly trying to incent people and drive them to do more, faster.

JMC: Our goal is to move from having enrolled 3,000 hospitals to enroll over 4,000 hospitals, so it’s an ambitious goal. The way we’re going to go about that is to connect with a few large systems that weren’t a part of the prior initiative, and also to see if there are ways that we can connect with smaller facilities. The average participating facility in the 100,000 Lives Campaign was on the larger side, but that means that rural facilities and critical access facilities may not have been as engaged, so that’s where we really need to focus our recruitment efforts. Working with rural facilities is a major area of focus for us.

JMC: It’s a concern, but based on the energy and commitment we witnessed in the 100,000 Lives Campaign, we are confident that hospitals will continue to be devoted to this work. They know change is necessary, and the fact that they can become involved on a graduated basis – that they aren’t required to do everything all at once – should make this more palatable. I’d add too that we’ve gone to great lengths to make sure that these initiatives are well-aligned with other national initiatives. If hospitals are pursuing other national improvement projects from our partner organizations – like JACHO, CMS, Leapfrog, National Quality Foundation, National Safety Foundation, American Heart Association – they will be tracking information that’s the same and they’ll be working on initiatives that are aligned. We’re really making a strong effort here to simplify the process.

JMC: I think that in most instances these interventions represent changes in systems or changes in process. What’s necessary is a study of existing processes and an introduction of these best practices in a way that guarantees that they’ll be introduced reliably. That requires testing them in different environments, foolproofing them, making sure people can’t do the wrong things by putting necessary supplies and equipment all in the same place, or creating checklists so that people are forced to think about these things every time they insert a central line, or every time they administer a high alert medication. The key is creating systems and processes that essentially force the correct behaviors. So, this is not an effort to say to physicians, nurses and other clinicians that they’re not working hard enough or doing as well as they can. In fact, we know that they’re doing tremendous work and that the devotion they’re giving to their patients is enormous. It’s just to say that we need to create processes and systems that will avoid as many errors as possible. A major criterion for us is that we identify interventions that can be introduced through a change in process, and not through an infusion of additional resources. In many cases these are things that hospitals are already doing. They’re already trying to prevent MRSA and reduce harm from high alert medications. The question is how can we introduce a process in the current work that just makes it more safe and more reliable.

JMC: The chief aim of this campaign is to avoid five million instances of harm over a two-year period. We estimate that there are about 15 million instances of harm in hospitals per year. The way we’re going to measure our progress against that goal is by retrospective chart review of a representative sample of American hospitals to look at their performance in our baseline year, which will be 2006, and compare that to the campaign period – 2007 to 2008. Our goal is that reviews be done by an independent group trained by us, or actual IHI employees, who would be able to make sure that the consistency with which the data is collected is there and that it’s independent and robust. The exact tool that we’ll be asking people to use is called the Global Trigger Tool. When hospitals are doing retrospective chart review to study the amount of harm in their facility, the tool gives them triggers or clues to where the harm is actually occurring. Many hospitals are saying to us, whether or not they’re selected to be a part of this representative sample, that they fully intend to track harm across their facility using this tool. Tens, probably hundreds of hospitals already do. We’re also going to continue to collect mortality information from hospitals because that is, of course, the most acute form of harm.

JMC: Our definition of medical harm is unintended physical injury resulting from, or contributed to, by medical care – including the absence of indicated medical treatment – that requires additional monitoring, treatment or hospitalization, or that results in death. It’s a pretty broad definition. Some studies of harm will only look at instances that require additional hospitalization or result in death. We’re broadening that, and even something that requires just additional monitoring or treatment is in our definition. In addition to harm that’s caused by medical care, it includes the absence of indicated medical treatment, so errors of omission would be included in there as well.