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  • Shelly Davis, JD, BSN
  • Pat Folcarelli, RN, PhD
  • Larry Smith, JD


In the past, when a clinical case had an unexpected bad outcome, a traditional response from the institution and its malpractice insurance providers usually prevailed. And it was a hands-off, deny liability, and circle the wagons approach. During the past two decades of the patient safety movement, though, transparency and open communication following these events has been growing. An organized, full embrace of openness is taking hold with a growing number of medical malpractice insurance programs. The goal isn’t just transparency, but early and added involvement from the insurer and the health institution.

And it almost doesn’t matter if there was any negligence. It also doesn’t seem to lead to more lawsuits and higher costs.

Under various names and descriptions, such as “early resolution” or “CRP, Communication Resolution Program,” this concept is being championed by self-insured health systems, as well as commercial insurers from outside the hospital.

“For most cases, the communication is the resolution.”

Pat Folcarelli has been a pioneer in the early intervention space. She was Vice President for Health Care Quality at Beth Israel Deaconess Medical Center in Boston, and is now Vice President of Patient Safety at CRICO, the captive medmal insurer for the Harvard system. Folcarelli led the Massachusetts Alliance for Communication and Resolution Following Medical Injury and has published findings in BMJ Quality and Safety. Folcarelli says there is a reason the word communication comes first in the CRP acronym.

“Even in times where there has been a terrible outcome but the complication was not the result of negligence, so the care was within the standard of care but the patient or a family member had a negative outcome or an adverse experience, the communication itself is one of the things that I think is part of the resolution to the patient and family so that they have all the information that they need about what happened.”

Elements of early resolution programs, such as communication with patients and support for clinicians, can be a benefit for all cases with unexpected adverse outcomes. But a full early resolution program is designed for cases with significant harm to the patient and questions about whether the standard of care was met. CRP involves much more than communication about what happened clinically. It usually includes attention to emotional needs of providers, appropriate immediate financial support to patients, and an accelerated review of professional liability questions.

At BIDMC, Folcarelli’s patient safety and risk management departments instituted a CRP through the support of its captive insurance program, CRICO. Its success required buy-in from the hospital’s board as well. Folcarelli says you then need a six-to-nine-month lead-in to implementation, enough time for education of medical staff and training for front-line departments.

There is always a concern that all this activity and openness after an adverse event will lead to more lawsuits and costs.

“I try to think about this not so much in terms of cost but more as a patient safety initiative. But after about three years of doing this across hospitals, we did a study where we did, across four hospitals in Massachusetts, an analysis of before and after trends on case volume, cost, and time to resolution. And we actually compared that to the similar time period and trends in the non-implemented peer hospitals in Massachusetts. And what we found is that the CRP did not significantly alter the outcome. There was no worsening of liability trends after implementation. And this is very helpful to have this done as a peer reviewed researched process because it’s helpful then to lower the barriers for other people to move this forward by approaching it in a scientific way.”

At MedStar Health in the Baltimore/DC area, Larry Smith is VP of Risk Management, and president of its self-insurance program. Smith says MedStar’s Communication Resolution Program evolved over time.

“We had an approach that began years ago that led us in this direction, and that approach was part of our overall philosophy and culture within MedStar, which is one of full disclosure and openness and honesty, sounds pretty simple. As we were managing our claims, we realized that when we could identify when something we did or didn’t do had the impact on a patient of causing harm that it made no sense, inconsistent with our culture, to fight that issue in a medical liability malpractice claim. Better if we were to acknowledge that responsibility early on with the patient and begin the process of building a relationship where we can do the best we can to try to mitigate that harm, whatever that might mean. And so that’s really where it came from.”

Smith says that managing claims the old-fashioned way with defensiveness made legal sense on some level and was a little simpler to understand. In a way, “Don’t talk about it to anyone” was an easier legal approach.

“This process actually requires the organization in many instances to throw away its defense in connection with the claims that might come at them, because we’re going to give the information to the patient that could include the information regarding the harm and the cause of the harm which is our responsibility. So one of the things you have to be, I think, aware of if you go into this is that you do not have the ability later on to deny that this was our fault, acknowledged fault in the beginning. And that does put the organization at some legal jeopardy, and so the program needs to know how to deal with that issue. What I’ve said, however, to mitigate the concern is that truly if you’re organization that wants to do the right thing and truly if you identify that you’ve done something that’s caused harm, you certainly don’t want to be in a position of providing a defense against the plaintiff or the patient and the family in connection with that harm. You’re going to settle that claim anyway. This gives you an opportunity to establish a relationship with the family from the very beginning or the patient and allows that relationship of trust to potentially get to a better outcome for all parties.”

Physicians in particular are concerned about reporting requirements to the National Practitioner Data Bank, although there are some new allowances to reporting about early resolution cases as of 2020. Despite any trepidations, after implementation, both Folcarelli and Smith report near-universal appreciation from the clinicians involved in these cases.

“It’s a big lift for folks to begin to accept this new approach. But let me add parenthetically, not so parenthetically, let me add a very important statement that I’ve received from several of our physicians. One in particular stands out, horrible situation, a patient who was made a semi-quadriplegic as a result of a surgical error that occurred. And the surgeon who was involved in that, once everything was said and done, said that he really understood that one of these kinds of events can occur in anyone’s practice doing complicated spinal surgery, but he also said ‘thank God, I was some place where I was allowed to deal with that in an open and honest way with the patient and the family. I didn’t have to run and hide. I could be up front with them.’ That physician actually is a very good friend now of that family personally and was able to really have a relationship that allowed, even with that error, for him to do what he knew was the right thing to do.”

One sign of the potency of early intervention—aside from the topic’s increasing appearance on healthcare conference agendas across the country—is the fact that some commercial insurers are promoting it to their customer institutions. Shelly Davis is an attorney and the Director of Early Intervention at Constellation, a national medical professional liability insurer based in Minnesota. Constellation has its own initiative to promote early intervention programs at hospitals it insures.

“As a medical professional liability company, we are not on the front lines. It is our insureds, our health care team members, our physicians, our nurses, our physical therapists. They are on the front lines. And we started looking into what could we do as a medical professional liability company to better support our insureds with what they do? And we know any time a physician or any health care team member is involved in a near miss or a harm event, they lose sleep. They question whether or not they are good health care providers. They question their judgment. They don’t eat. And so we thought if we could help them as close to any harm event and help them get best prepared for harm events, that maybe that would be a better partnership than just being available as a medical professional liability company for payments or assessment and evaluation of claims and suits.”

Constellation’s HEAL program for harm events and near-misses has four core elements: early peer support to providers, fast outside review for standard of care questions, help with internal communication, and help with communicating with patients and families. In 2021, Davis’ company is extending the program to include customized assessments of early resolution programs at their client institutions. Whether it’s the AHRQ program or something else, Constellation helps its insured institutions make their early intervention programs the best they can be.

“A lot of our facilities think they are doing this already and they don’t need our help, but when you get into the weeds of what it is they are doing, they’re not doing the ideal job relative to support, expert reviews, communication support, and risk consultation. I had a situation where one of our insureds said ‘We’ve got this covered. We’re going to take care of the situation.” And this situation was a pathologist that diagnosed cancer that did not exist in a patient’s stomach and the stomach was removed only to find out that there was no cancer. And this facility said ‘we handle this all the time, we’ve been doing this for years and years.’ But the physician was told that he could not talk to the patient, and that’s all wrong. That’s all backwards.”

Institutions need to be careful not to take advantage of patients or families under duress or diminish any of their rights in the early intervention process. Pat Folcarelli:

“There are certainly cases where there’s a negative outcome where the standard of care was met and our final communication with the patient and family about what we found and our conclusion is not well received by the patient and family. And in those cases, patients and families can exercise their rights, and they do, to engage malpractice attorneys when they need to. But we know that we’ve done the best that we can to explain our summation or our understanding about what happened. So, I feel like the resolution, it may not be resolved for the patients and families, but we’ve done the best that we can to come to a resolution about what happened.”

More Early Resolution Resources

AHRQ has a web page dedicated to Communication and Resolution Programs, with its own process and toolkit for early intervention, called, CANDOR. There are also many resources available at the site for the Massachusetts Alliance for Communication and Resolution Following Medical Injury – also called MACRMI.

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