IHI Vice President and patient safety expert, Carol Haraden, PhD, comments on the power and popularity of “bundles” in improvement initiatives. While the allure of this tool is undeniable, says Haraden, quality teams should resist the impulse to label any list of good changes a bundle. She clarifies what a bundle is and is not, and suggests tips for using bundles most effectively to get results.
Q: What is a bundle?
A: IHI developed the concept of “bundles” to help health care providers more reliably deliver the best possible care for patients undergoing particular treatments with inherent risks. A bundle is a structured way of improving the processes of care and patient outcomes: a small, straightforward set of evidence-based practices — generally three to five — that, when performed collectively and reliably, have been proven to improve patient outcomes.
Q: What makes a bundle so special?
A: The power of a bundle comes from the body of science behind it and the method of execution: with complete consistency. It’s not that the changes in a bundle are new; they’re well established best practices, but they’re often not performed uniformly, making treatment unreliable, at times idiosyncratic. A bundle ties the changes together into a package of interventions that people know must be followed for every patient, every single time.
Q: So a bundle is a list of the right things to do for a given patient?
A: It resembles a list, but a bundle is more than that. A bundle has specific elements that make it unique.
The changes are all necessary and all sufficient, so if you’ve got four changes in the bundle and you remove any one of them, you wouldn’t get the same results — meaning: the patient won’t have as high a chance of getting better. It’s a cohesive unit of steps that must all be completed to succeed.
The changes are all based on randomized controlled trials, what we call Level 1 evidence. They’ve been proven in scientific tests and are accepted, well-established. There should be no controversy involved, no debate or discussion of bundle elements. A bundle focuses on how to deliver the best care — not what the care should be. We want providers to get right to work on the how: on completing steps x, y, and z for every patient.
The changes in a bundle are clear-cut and straightforward; they involve all-or-nothing measurement. Successfully completing each step is a simple and straightforward process. It’s a “yes” or “no” answer: “Yes, I did this step and that one; no, I did not yet do this last one.” Successfully implementing a bundle is clear-cut: “Yes, I completed the ENTIRE bundle, or no, I did not complete the ENTIRE bundle.” There is no in between; no partial “credit” for doing some of the steps some of the time.
Bundle changes also occur in the same time and space continuum: at a specific time and in a specific place, no matter what. This might be during morning rounds every day or every six hours at the patient’s bedside, for instance.
Q: Can you give an example?
A: The 5 Million Lives Campaign
has several bundles as “planks” or interventions. This initiative is likely a big factor in the popularity of the bundle — thousands of people in hospitals across the country have learned about bundles by applying them as part of their participation in the Campaign. There are two bundles in the Campaign that have been incredibly effective helping hospitals reduce to nearly zero the incidence of deadly infections that used to be so common they were accepted as unavoidable.
Central Line Bundle
: This is a set of five steps to help prevent “catheter-related blood stream infections,” deadly bacterial infections that can be introduced through an IV in a patient’s vein supplying food, medications, blood or fluid. The steps are simple, common sense tasks: using proper hygiene and sterile contact barriers; properly cleaning the patient’s skin; finding the best vein possible for the IV; checking every day for infection; and removing or changing the line only when needed.
: Ventilator-associated pneumonia (VAP) is a serious lung infection that can happen to patients on a ventilator. The Ventilator Bundle has four care steps: raising the head of the patient’s bed between 30 and 40 degrees; giving the patient medication to prevent stomach ulcers; preventing blood clots when patients are inactive; and seeing if patients can breathe on their own without a ventilator.
Q: What’s the problem with how people use bundles?
A: The concept of a bundle has such traction that people are trying to use them more often and in more ways than they really should. There’s a tendency to want to call everything a bundle, any checklist involving patient care procedures, for example. But a bundle isn’t a checklist, and just taking an ineffective checklist and calling it a bundle won’t make it any better. The goal is to make a process more reliable, and you do that by improving habits and processes. The magic of the bundle comes from the guidelines I’ve laid out here; the way the work is organized. People need to ask themselves: why will calling it a bundle make it better?
Q: What’s the difference between a bundle and a checklist?
A: A checklist can be very helpful and an important vehicle for ensuring safe and reliable care. The elements in a checklist are often a mixture of nice-to-do tasks or processes (useful and important but not evidence-based changes) and have-to-do processes (proven by randomized control trials). A checklist may also have many, many elements.
A bundle is a small but critical set of processes all determined by Level 1 evidence. And it needs to meet all the criteria I described previously. Because some elements of a checklist are nice to do but not required, when they are not completed, there may be no effect on the patient. When a bundle element is missed, the patient is at much greater risk for serious complications.
There’s also a level of accountability tied to a bundle that you don’t always have with a checklist. An identified person or team owns it. A checklist might be owned by everybody on a floor or on a team, but we know that, in reality, when it’s owned by everyone — nobody owns it! Things don’t always get done. So maybe the pharmacist does one thing in a checklist, a nurse another, the doctor something else, but really it’s no one person’s job at the end of the day. A bundle is a person or a team’s responsibility — period. And it’s their job at a certain point and time — during rounds every single day, possibly. So it isn’t the kind of thing where people say: “You check that, I’ll check this.” No. It’s very clear who has to do what and when, within a specific time frame. The accountability and focus give a bundle a lot of its power.
Q: Can you give an example?
A: Let’s take a discharge planning list. It’s a reminder list of things people on a team should be doing throughout the patient’s stay to help move the treatment process along toward discharge. People look at it often but no one typically “owns” it and there aren’t clearly delineated dates and times attached to each element. It’s so easy for incredibly busy nurses, aides, therapists, and doctors to assume that the next person will pick up where they left off.
Q: You’re not saying don’t bother with checklists, are you?
A: No, not at all. I don’t mean to diminish the importance of a checklist. They can be really helpful; sometimes essential. When you get on a plane, you should be grateful to know that the pilot won’t take off until going through every single task in the “pre-flight checklist.” It’s an incredibly important list; in fact, when you talk to a pilot, they don’t call it a “checklist,” they call it “pre-flight procedures.” It’s practically written in stone — revered and followed religiously with every flight. It’s more than a list: it’s a codified set of procedures.
Q: Is that the only problem with how bundles are used?
A: We’re also seeing a trend where people keep adding changes to an existing bundle, a valid bundle they’ve adopted. It gets bigger and bigger — ultimately to the point where it’s unworkable, impossible to follow and not effective anymore. If you do add changes to a bundle, the chance of success is much higher if you use the bundle criteria I’ve described here as a check for the appropriateness of inclusion.
Q: So, your final message about bundles is what?
A: A bundle is a specific tool with clear parameters. It has a small number of elements that are all scientifically robust, that when taken together create much improved outcomes. Don’t feel compelled to convert helpful checklists into overloaded bundles. If the concept of a bundle becomes so broad and loose in meaning, its power will start to diminish. We don’t want that to happen.