It’s no secret the Institute for Healthcare Improvement (IHI) was on to something big when it launched its 100,000 Lives Campaign. Since its inception, countless interventions have been implemented in health systems across the country, and countless lives have been affected positively from these initiatives.
One concept spawned from this epic campaign was that of the “bundle.” A bundle is a group of best practices that, when implemented together, show proven success in improving patient outcomes. It is a collection of processes needed to effectively care for patients undergoing particular treatments with inherent risks.
The idea, according to IHI experts, is to bundle together several scientifically-grounded elements that are essential to the improvement of clinical outcomes. It is interesting to note that at least two of the six interventions at the heart of the 100,000 Lives Campaign, depend on implementing bundles, according to the IHI Web site.
Bonnie L. Zell, MD, MS, an IHI fellow, says the concept of bundles was developed to help healthcare providers more reliably provide the best care. “It is a structured way to improve the processes of care and patient outcome,” she shares.
A bundle should be relatively small and straightforward. Bundles generally consist of three to five interventions, according to Zell, and “when performed collectively, they have reliably been proven to improve patient outcomes.
“These components have been proven effective by a body of science behind it,” Zell points out. “And a method of execution with complete consistency is key.”
Zell says that the IHI looks at bundles differently than being “just a group of interventions.” She says the key is where they see the evidence that doing them all is “critically important.”
“For instance, in our MRSA initiative, those five interventions that we have are not bundled; it is not a bundle of interventions,” she compares. “We recommend things such as active surveillance cultures to be considered, but we are not saying that you have to do that in order to have success. However, with the catheter-related blood stream infection (BSI) and the ventilator-associated pneumonia, these are bundles. The ventilator bundle, the central line bundle and the severe sepsis bundle ... they are based upon whether you need to do all things to get the results that you are looking for.”
What’s the Difference?
Zell points out that there has been confusion between a bundle and a list. “The problem with how people use bundles is that everybody kind of wants to take every list that they see and say this is a bundle, but it isn’t. Because a bundle is not, ‘Here’s five or six interventions to choose from,’ it is (more than that).”
She offers the example of suggested step within the MRSA initiative. Not all of the recommendations listed must be adhered to for successful outcomes. “For example, everyone needs to be doing the hand hygiene, but not everybody needs to do the active surveillance cultures. Everybody needs contact precautions, but the point is that this is just a list of interventions to choose from. It is not a ‘bundle’,” she reiterates.
A bundle is more than a list, she says. “They are changes that are all necessary and all sufficient,” she shares. “It’s not that the changes in the bundles are new — they are well-established best practices — but they are not usually performed reliably together or necessarily in the right order. They are all based on randomized controlled trials. They are all things that are well established. There is no controversy.
There is no debate about them. What the bundle does is links all of these together and says you need to do them all and you need to do it every time. A bundle ties these changes together into a package of interventions that must be followed for every patient, every time.”
The Bundled Approach
The most important aspect to the success of bundles is that with a bundle, you have to do it all. “You have to do it all or you do not get credit for anything,” Zell asserts. “If you have four changes in a bundle and you do not do any one of them, you are not going to succeed. You have to do them all. That is the concept of the bundle. It’s an all or nothing approach.
“Understand that you are measuring everything at a certain percentage. In other words, let’s say there are four things in a bundle. If you do one of those things 70 percent of the time, and you do the other thing 80 percent of the time and another thing 50 percent of the time, and the last thing 20 percent of the time; the chances of you doing everything right is really low. So, your score may be 10 percent. Although you may be doing something at 80 percent, it doesn’t count. You have to do it all reliably, every time. Your goal is to do all four of those things at the 95-percent level. That’s when you are really giving good, reliable care.”
She continues, “You need to be checking and monitoring each one of those interventions to make sure it’s at a high reliability level. The goal is to do it every single time. You do not give yourself credit for partial adherence to the bundle — you only give yourself credit when you are doing them all. Ask yourself, ‘How often are you doing every single one of them?’ That’s where you get your points.”
The “points” that Zell is referencing is that of IHI’s new scoring system for clinicians that “up the stakes on reliability,” according to IHI’s president and CEO, Donald Berwick, in his plenary speech in December 2004 to launch the IHI 100,000 Lives Campaign.
As the Web site notes, “Rather than scoring ourselves, he said, for successfully completing individual steps in a list of proven interventions for a group of patients, what if we rate ourselves ‘on a pass-fail basis for the whole bundle of things? A patient gets a yes if we actually did everything we planned to do, and a no if anything, even one thing, was left out. This bundled scoring system pushes us to raise the bar on health care performance.’”
Implementing bundles of interventions can be challenging, to say the least. Making one change system-wide is enough to control, but several? All at once?
“You roll them out as ‘this is what you need to do,’” Zell suggests. “You roll them out in unity. If that’s too much to take on all at once, then you might roll one out at a time. Start with “X” and quickly move to the others, but you can’t really start feeling like you are making progress until you are doing it all.
“Understand you are not going to see great results until you are doing everything reliably.”
She says that IHI offers a plethora of tools to aid in implementation and ongoing management of these and other initiatives. “They offer how-to guides, specific checklists, specific strategies for implementation, who needs to be involved, how to change the culture ... it’s all very detailed,” she notes. “It’s spectacular the amount of information there is on the IHI Web site. What IHI also does is serve as a resource and kind of a convener by having all kinds of conference calls where all the different groups get on calls. There are sometimes hundreds and even thousands on these calls. They talk about their successes and how they’ve done it and they share best practices.”
She says contact information for the mentor hospitals also is available, “so you can contact them for tips, etc.,” she shares.
A Breakdown of the Bundles
The Ventilator Bundle is a series of interventions related to ventilator care that, when implemented together, will achieve significantly better outcomes than when implemented individually. The key components of the Ventilator Bundle are:
- Elevation of the head of the bed
- Daily “Sedation Vacations” and assessment of readiness to extubate
- Peptic ulcer disease prophylaxis
- Deep venous thrombosis (DVT) prophylaxis
The Central Line Bundle is a group of evidence-based interventions for patients with intravascular central catheters that, when implemented together, result in better outcomes than when implemented individually. The key components of the Central Line Bundle are:
- Hand hygiene
- Maximal barrier precautions upon insertion
- Chlorhexidine skin antisepsis
- Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters
- Daily review of line necessity with prompt removal of unnecessary lines
The Severe Sepsis Bundles are a distillation of the evidence-based recommendations found in the 2004 practice guidelines recommended by the Surviving Sepsis Campaign. IHI recommends hospitals implement two different severe sepsis bundles. Each bundle articulates objectives to be accomplished within specific timeframes.
The Severe Sepsis Resuscitation Bundle describes seven tasks that should begin immediately, but must be accomplished within the first six hours of presentation for patients with severe sepsis or septic shock. Some items may not be completed if the clinical conditions described in the bundle do not prevail in a particular case, but clinicians must assess for them. The goal is to perform all indicated tasks 100 percent of the time within the first six hours of identification of severe sepsis. Sepsis Resuscitation Bundle:
- Serum lactate measured
- Blood cultures obtained prior to antibiotic administration
From the time of presentation, broad-spectrum antibiotics administered within three hours for emergency department (ED) admissions and one hour for non-ED intensive care unit (ICU) admissions. In the event of hypotension and/or lactate > 4 mmol/L (36 mg/dl):
- Deliver an initial minimum of 20 ml/kg of crystalloid (or colloid equivalent)
- Apply vasopressors for hypotension not responding to initial fluid resuscitation to maintain mean arterial pressure (MAP) > 65 mm Hg
- In the event of persistent hypotension despite fluid resuscitation (septic shock) and/or lactate > 4 mmol/L (36 mg/dl):
- Achieve central venous pressure (CVP) of > 8 mm Hg
- Achieve central venous oxygen saturation (ScvO2) of > 70 percent
The Sepsis Management Bundle lists four management goals. Efforts to accomplish these tasks should also begin immediately, but these items may be completed within 24 hours of presentation for patients with severe sepsis or septic shock. Sepsis Management Bundle:
- Low-dose steroids administered for septic shock in accordance with a standardized ICU policy
- Drotrecogin alfa (activated) administered in accordance with a standardized ICU policy
- Glucose control maintained greater than lower limit of normal, but lower than 150 mg/dl (8.3 mmol/L)
- Inspiratory plateau pressures maintained < 30 cm H2O for mechanically ventilated patients
IHI teams are currently testing the implementation of two new bundles: the Elective Induction Bundle and the Augmentation Bundle. Components of the Elective Induction Bundle include:
1. Gestational Age 39 Weeks or Greater This element refers specifically to the documentation of gestational age in the current chart prior to the initiation of the induction. The “who” and “how” and “what” to use for the gestational age can be left up to the individual sites, although American College of Obstetricians and Gynecologists (ACOG) guidelines exist.
2. Reassuring Fetal Status This element refers to the documentation of fetal well being prior to beginning the induction, which has specific definitions. It is recommended that National Institute of Child Health and Human Development (NICHD) criteria be used.
3. Pelvic Examination This element includes documentation of a complete pelvic assessment with cervical examination (dilation, effacement, station of the presenting part, cervical position and consistency; Bishop’s Score), clinical pelvimetry and an assessment of the fetal presentation.
4. Absence of Hyperstimulation This element refers to the documentation of the absence of hyperstimulation during the induction process. Components of the Augmentation Bundle include:
1. Estimated Fetal Weight This element refers specifically to the documentation prior to the start of augmentation.
2. Reassuring Fetal Status
3. Pelvic Examination
4. Absence of Hyperstimulation
Source: Institute For Healthcare Improvement: www.ihi.org/NR/rdonlyres/6DD8269F-DF88-4268-A2B0-5A7D4585C3D2/2508/PerinatalCareBundlesrevNov06.pdf
For more information on the above listed bundles, or to read the posted improvement reports on each of these bundles, visit the IHI Web site at www.ihi.org.