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A rigorous clinical handoff protocol taught to medical residents for use at hospital shift changes led to a 23% decrease in medical errors and a 30% decrease in preventable adverse events, a study has concluded.

The handoff improvement plan involved a mnemonic to standardize oral and written handoffs, a faculty development program, training for the residents, and a sustainability campaign.

The study was conducted at nine pediatric residency training programs in the U.S. and Canada. The total study period was 18 months, consisting of 6 months each of pre-intervention outcomes assessment (to establish a baseline), implementing the intervention, and post-intervention data collection. The results covered 10,740 patient admissions.

The researchers "have done an amazing job of developing a very well designed study, with large sample size, with multiple centers, and geographically diverse," said , a medical educator at the , who was not involved in the program. Until now, studies of handoff improvements have been smaller in scale, usually at one institution, pertaining to a single discipline, she said -- nothing as large as this project.

Although the study was restricted to pediatric programs, Riesenberg said the results are probably applicable to other kinds of inpatient settings as well as a variety of care transitions.

The study was led by , a physician in medicine at Boston Children's Hospital, and had 36 co-authors from children's institutions in places like Honolulu, St. Louis, Salt Lake City, and Toronto. It appeared in .

"We know that handoffs are a leading source of miscommunication and medical errors, and a major cause of mortality in the U.S.," Starmer told MedPage Today. "There is certainly a heightened sense of awareness around this topic now."

highlighted the role of inadequate handoffs in medical errors in a 2001 report, has estimated that "80% of serious medical errors involve miscommunication between caregivers when patients are transferred or handed-off." The accrediting agency has included improved handoff techniques among its patient safety goals, and in 2009 it began working on a tool for better handoff communications.

Oddly, Starmer told MedPage Today, doctors in training have never received much specific instruction on how to pass along information to one another, especially at a change in shift. Nor has such training been mandated by agencies that regulate physician education. Typically, trainees have learned on the job by watching other people do it, but without any formal didactic instruction.

Over last 10 years, there has been increasing interest in understanding how fatigue affects medical decision-making. has limited the number of hours that medical residents may work. With shorter shifts, more handoffs occur.

Starmer's study group developed a mnemonic, or memory aid, to help doctors remember all the pieces of information they are expected to gather at the time of handoff. Their mnemonic is called I-PASS, and was 3 years ago. It stands for:

• I: Illness severity
• P: Patient summary
• A: Action list
• S: Situation awareness and contingency planning
• S: Synthesis by receiver

The I-PASS memory aid is modeled after (Situation, Background, Assessment, Recommendation) developed in the Kaiser Permanente system a few years ago to facilitate handoffs there.

Beyond instruction on the mnemonic device, included six more elements: a 2-hour workshop to teach teamwork and communication; a 1-hour role play and simulation exercise; a computer module for independent learning; a faculty development program; direct observation tools for faculty to give feedback to residents; and a process-change and culture-change campaign.

Errors were assessed by having a research nurse compile weekly lists of potential incidents from multiple sources, with two blinded physicians then reviewing the lists to determine whether incidents represented medical errors or preventable adverse events.

"A Skill"

"Handoffs are a skill. They are not something you can teach in a didactic lecture," Riesenberg said. You may be able to give the residents data on the importance of the handoff, she said, "but in order to do a really good handoff, you need practice, you need feedback, and they did that. They also provided a computer module, which was helpful. They provided faculty development. Then they also included a piece on culture change, which is hard to implement.

"They did some amazing things that all link together as a well-constructed bundle, that on the face of it make a lot of good sense." It's not really possible to say which element of the bundle made the difference, she noted. "Intuitively, I would say they are all important," Riesenberg said.

Medical residents are so busy during their shifts that they would be unlikely to adopt any transfer protocol that cost them extra time or mental energy. For that reason the study team paid close attention to how much time the handoffs actually took. They conducted time-motion observations at all the study sites by assigning research assistants to follow doctors around with a stopwatch for 8 to 12 hours, and then conducted an end-of-rotation survey to assess residents' perception of the handoff training. The investigators were particularly interested in how much time doctors spent on the computer or in the handoff, and whether they were diverted from direct patient care.

The handoff protocol did not increase the work load or take the doctor away from patient care, the group reported.

The text of the NEJM article notes that there is an association between implementation of the protocol and a 23% relative reduction in all medical errors and a 30% relative reduction in preventable adverse events, but it does not claim the intervention caused the changes.

"The only way we could definitely prove causality," Starmer said, "would be if we did a randomized, controlled trial, where a certain group of residents got the intervention and others didn't, like a new drug trial." It would not be practical or possible to blind doctors or patients to whether they were participating in the study, she added. "We tried to make the study design so that the association is quite strong."

The study is a "landmark," she said. "It is remarkable to have this robust educational intervention developed with such a multidisciplinary team and a rigorous curricular design. The scientific study where we assessed the impact of the intervention was equally rigorous and robust, with a direct patient outcome measure, a meaningful measure of reduction in errors. Those two things together are an exciting measure of the project for us."

Significantly, the quality metric is not a proxy measure or a process-of-care measure; it is a real patient outcome. The approach the study group took to measuring medical errors is considered to be "the gold standard methodology in the hospital setting," Starmer said. "We got a lot of things that go unreported by traditional hospital surveillance systems."

The study included three different types of data, Riesenberg said: self-report, process change, and patient outcomes. Other earlier studies never quite achieved all three: "What's been missing is good, strong evidence from a large geographically diverse sample that includes patient outcomes," she said.

The next step in the research on handoffs will be to determine whether these techniques can be adapted to other provider settings. is rolling out I-PASS for all providers, with a lot of success, Starmer said. "The concepts themselves are not that specific to pediatrics, which is one of the encouraging results here."

However, outcomes in the program were uneven across the study sites. Of the nine institutions participating, three did not achieve a reduction in preventable adverse events or medical errors.

"There is something unique about those three sites. One can only speculate what might have happened," Riesenberg said. Perhaps the protocol wasn't embraced as strongly at those sites as at the other six, she suggested.

"There is something called the hidden curriculum," she said. It's the difference between "what we teach the residents to do and what we actually do. If the physicians at those sites are doing handoffs a different way, or pooh-pooh the idea, then the hidden curriculum may over-ride these innovations." In that case, a human factors inquiry may be necessary to uncover why the curriculum didn't work at those sites.

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