Collateral Damage: Take Two

“Doctors love to patronize and dominate. Their arrogance and indifference to the philosophy of informed consent is widely known. Surprisingly, most residents and doctors in teaching public hospitals tacitly endorse such reservations against information sharing. To most of them getting informed consent is a needless nuisance, to be delegated to a raw resident whose sole responsibility is to get the patient’s signature on the dotted line.”
Issues in Medical Ethics Volume 8, Number 4, October-December 2000…and Chapter One, Page 1 of Dan Walter’s book titled Collateral Damage

Walt Kelly, 1970

Walt Kelly, 1970

It has only been a few weeks since reading Dan’s book – yet I felt compelled to go back this weekend and read sections of it again. Since medical school, I rarely read something–even the Sunday paper–without a yellow highlighter in my hand, a side effect of the competitive paranoia instilled in me during medical school. I went back this weekend to the sections I had highlighted in Dan’s book, and found the quote above, right up front – Chapter One, Page One. I understand and appreciate why Dan purposely chose that quote to open his book.  I also knew why I had highlighted it a few weeks ago…long before I had finished reading Pam’s story and all the research Dan so eloquently presents  on the “cardiac ablation business”.

I had highlighted this section because that opening paragraph took me back to last summer, and our Telluride Patient Safety Roundtable and Resident Physician Summer Camp. Resident physician leaders from across the country spend one week immersed in patient safety with a major focus on open and honest communication. Over a three-week period during the summer, almost 100 residents and health science students join us in Telluride, CO to learn about important concepts related to patient safety and transparency. Here is a short video clip about the student summer camp, which has organically grown from a roundtable discussion of patient safety diehards and patient advocates over the last nine years into what is now an Educate the Young patient safety summer school. Patients help teach all sessions at the summer camp.

A three-hour session on informed consent/shared decision-making is part of the week-long curriculum in Telluride. At the end of this session last year, Paul Levy (@PaulFLevy, Not Running a Hospital) asked the residents how much informed consent training they had received during medical school and residency. With a show of hands, every resident acknowledged the three-hour session on informed consent/shared decision-making at the Telluride Summer Camp was more training than they received during their entire medical school and residency combined. We all agreed this was a sad commentary on the current state of medical education as it relates to patient centered care. One of our Telluride residents went even further when he posted this reflection on the day’s educational session:

I don’t think that I’ve ever thought so much about informed consent as I did today. A discussion about informed consent to the level of detail that we had today needs to be part of all residency training in the first days of orientation and as refresher training later on in training. All physicians can, and should, do much better in providing informed consent.

Over the years, I have come to know many patients and families who have been harmed from care. It seems almost every story that was shared had a serious breakdown in informed consent, or more appropriately, shared decision-making.  The families of Lewis Blackman and Michael Skolnik, and many others, might have chosen much different treatment courses if all the risks and procedural outcomes were shared with them.

We need to get this right. It is fundamental to ever achieving high quality, safe care.  If we don’t, we will continue to see unnecessary harm, more books like Collateral Damage and more films like The Faces of Medical Error…From Tears to Transparency. As Pogo says “We have met the Enemy…and he is us.”

Collateral Damage

I once heard Don Berwick say, shortly after taking over as Director for CMS, that he originally thought quality and safety where the biggest challenges facing healthcare today. But after spending time in the district, he quickly came to realize he was wrong. It was fraud that was the biggest challenge.

Collateral DamageHis message came to mind after recently reading a book given to me by Rosemary Gibson, entitled “Collateral Damage”, written by Dan Walter. I can honestly say that after reading the book, I felt embarrassed to be working in healthcare.

In the book, Mr. Walter shares the story of his wife, Pam, who underwent a cardiac catheter ablation procedure for an abnormal heart rhythm known as atrial fibrillation. He describes what went wrong during Pam’s procedure, and then details the pain, suffering, lack of transparency and denial of accountability that followed for both he and his wife. The procedure was performed at what is considered to be one of the best hospitals in the country, which makes the reader wonder what is going on at the “not so great” hospitals across the country, as well as who is defining what makes a hospital “great”. His aim in writing the book was to, “accurately portray what happened to my wife…without detracting from the skill, kindness and compassion of the majority of the people who work there…and to prove to Pam that she does matter, and to tell her that despite what the leadership of that hospital says, her life is important – and her story is important – and it deserves to be honestly told”.

The book is Mr. Walter’s account of the facts related to his wife’s care, so it is only his side of the story. However, it is remarkably well written, and gives a deeply researched account of the cardiac catheter ablation “business”. He includes information:

  • Taken from numerous publicly available FDA transcripts and testimonies on how unsafe these catheters were thought to be.
  • Promotional materials from companies making these catheters who were trying to get them through the FDA approval process hyping the wonderful results being seen in patients who were the first to be “experimented” on.
  • Transcripts from advisory panels and cardiology meetings where leading experts acknowledged the lack of evidence that these catheters even worked.
  • Conclusions from peer-reviewed journals showing complication rates much higher than what was being shared with patients.
  • Medical records highlighting a lack of real informed consent related to the risks and benefits of these procedures.

Mr. Walter also shares numerous other patient stories and holds nothing back. Not only does he name names, but he includes pictures of physicians and others who he and Pam encountered along their journey.

In one section of the book, the author shares thoughts on the difference between a “witness” and an “accomplice”, a witness being one who sees wrong and reports it.  He raises the question that if we as caregivers witness something wrong and don’t report it, aren’t we really accomplices to the wrong when we turn our back and walk away?  His statement caused me to reflect back on my career. As an anesthesiologist, I remember days when I was assigned to provide anesthesia for a catheter ablation case. Although I spoke with the patient about anesthesia related risks and benefits – I never thought of questioning the merits of the procedure I was to be a witness to. It was challenging enough keeping up with all the new findings in my specialty let alone comprehend everything being published in the numerous specialties anesthesiologists support. But after reading Pam’s story, I felt that I too may have been an “accomplice” to possible wrong doing.

I applaud Mr. Walter for sharing Pam’s story. I also struggle to understand why this book has not received similar attention, or the same hype experienced by authors of recent books published on medical error. Collateral Damage goes much deeper in highlighting problems facing healthcare today…a reason why I believe this book should be required reading for all resident physicians and health science students entering the field.

As quality and safety leaders and educators, our daily efforts are built around things like standard work processes, shared best practices, care bundles, checklists and universal protocols–“things” we do in the best interest of our patients. The bigger picture, as Don Berwick alluded to, requires that we overcome the personal, political, legal and financial agendas inherent within many high-level stakeholders. Otherwise, I sometimes feel we are just moving chairs around the deck of the Titanic.

For those interested, Dan’s book is available free on Amazon Kindle as of June 12th

John Wooden’s Spirit Alive and Well at MedStar Health

This week I again had the pleasure to hear Paul Levy (Not Running A Hospital) speak at a MedStar Health Quality & Safety retreat. Paul’s gentle reminder–that transparency in healthcare is something all of us have to own, not necessarily because someone is watching, but because we hold ourselves accountable to higher standards–was motivating. He quoted John Wooden–the great UCLA men’s basketball coach, reminding healthcare leaders in the room that, “If they haven’t learned it, you haven’t taught it.” As an athlete and coach myself, Coach Wooden has long been a virtual mentor for me. Wooden’s gentle giant approach and his unwillingness to settle for anything but the best effort everyday is an example of excellence in and of itself, but he was also a committed teacher and knew that if his students/players didn’t “get it”, his job was far from done.

Paul’s talk this week also reminded me that leading culture change in healthcare isn’t easy, and requires all of us to recommit to the principles we value–like transparency–even when it’s not necessarily the popular or easy choice. Wooden is a wonderfully invoked example of a leader whose commitment to his own foundational values of hard work, friendship, loyalty, cooperation and enthusiasm, led to unmatched success on the collegiate basketball hardwood.

What is our pyramid of success for healthcare, and can we stand firm–gently, calmly, confidently–because we know it’s the best way to achieve the safest, most cost-effective care for our patients?

And finally, here is a link to a previous Transparent Health blog invoking John Wooden’s spirit–this time around a Telluride Educational Roundtable discussion on the lack of training in informed consent and shared decision-making for resident physicians.

Transparency Begins With Informed Consent and Shared Decision-Making

In the trailer for The Story of Michael Skolnik, Rick Boothman, Chief Risk Officer for the University of Michigan Health System, introduces the film by saying:

I think it’s absolutely critical to understand that transparency begins with the informed consent concept…with a committment to reach a patient on every level and that disclosure…is simply nothing more than a committment to be honest with patients from the beginning and throughout that therapeutic relationship.

Harlan Krumholz, MD, Harold Hines Jr. Professor of Medicine (Cardiology) at Yale University continues the conversation in the trailer by sharing:

We have many patients who are having prescriptions or procedures or large surgeries that they would not necessarily choose if they understood all the facts. And that’s what we’ve got to fix in medicine. We’ve got to make sure that the choices that are being made are completely aligned with the patient’s needs, values, preferences and goals, and they are making the choice. So it’s not a matter of someone coming in and giving them a choice, which wouldn’t be what they would choose if they knew all the facts. We’ve got to give them the facts, and make sure we’re making the choices together that are right for them.

Both Rick and Harlan touch on two key components of Transparency, a foundational concept for high reliability organizations. Issues related to informed consent and shared decision-making are fundamental to any efforts focused on open and honest communication in healthcare. Is there any strength or quality to a therapeutic relationship if it lacks an informed consent process built upon transparency–one that reveals all risks, benefits and alternatives to the proposed procedure or treatment–or fails to have the patient share in the final decision?

True informed consent is a process that begins with a transparent sharing of information – an effective and honest communication between patient and caregiver. Patients should know how many similar procedures their surgeon or proceduralist has performed as well as information on outcomes like infection rates and other complications that have occurred. They should understand what risks are inherent to the procedure and are augmented or reduced by the patient’s current comorbidities and overall health. The provider should understand what risks the patient is willing to take versus attributing his or her own risk tolerance to the patient. But this does not occur as often as it should in the current healthcare system, and it would be interesting to prospectively evaluate how improving the informed consent process would affect outcomes. For example, in Harlan’s JAMA commentary from March 2010 on Informed Consent and Patient Centered Care, he suggests a new and improved informed consent which provides the patient with:

  1. An explanation of the procedure or test
  2. Potential Benefits
  3. Potential Risks
  4. Other Available Treatment
  5. Experience of Your Health Care Team
  6. Cost

What would you hypothesize the results of a prospective study to look like if greater care was taken upfront to ensure the patient understood all of the above, and shared in the decision-making? How would a stronger partnership between provider and patient affect outcomes? Patient satisfaction? Patient engagement? Readmissions?

The lack of training in informed consent and shared decision-making was made apparent during this year’s Telluride Patient Safety Student Summer Camps. Both skills need to be taught to medical students early on in their training and incorporated into the new culture of medicine. More on the state of medical education around this skill set later, but until then, a number of tools and resources are being made available to help patients and providers better understand how they can increase their knowledge in both areas. Dartmouth-Hitchcock is one such resource, and has a Center for Shared Decision-Making which provides information for providers and patients alike. Take a look, share additional resources–we’re in this together after all.

The Current State of Patient Safety Education for Future Caregivers…Who Do You Believe?

The Lucian Leape Institute (LLI), named after the physician many consider the “Father of Patient Safety” was formed in 2007. The Institute functions as a think tank and its mission is to provide thought leadership and a strategic vision for improving patient safety. The initial work of the LLI has focused on identifying and framing key transforming concepts that require system-level attention and action. The five transforming concepts identified are:

1) Medical education reform
2) Active consumer engagement in patient care
3) Provision of fully transparent care
4) Integration of care across health care organizations and delivery systems
5) Restoration of pride, meaning and joy in professional work.

The LLI believes success in each of these concepts is critical in moving the national patient safety agenda forward.

The first concept addressed by the LLI was medical education reform and I was delighted to be an invited member of the educational roundtable. We all believe substantial improvements in patient safety will be difficult to achieve without major medical education reform. Medical schools must not only assure that future physicians have the requisite knowledge, skills, behaviors, and attitudes to practice competently, but also are prepared to play active roles in identifying and resolving patient safety problems as well as leading quality improvement initiatives in the future.

The Roundtable published a white paper about two years ago titled, Unmet Needs: Teaching Physicians About Safe Patient Care. The white paper concluded that medical schools today are not doing an adequate job of laying the educational groundwork needed in knowledge and skill development required for the provision of safe, high quality patient care, to wit: systems thinking, problem analysis, human factors concepts, transparency, communication skills, patient-centered care, teaming concepts and skills, and dealing with feelings of doubt, fear, and uncertainty with respect to medical errors.

Conclusions by the Institute caused a lot of push back and rebuttal from many national and local medical education organizations, who believed medical education was doing fine when it came to patient safety and quality improvement curricula for students and residents—and this debate continues. While progress has been made in bringing patient safety into undergraduate and graduate medical education curricula over the past two years, we are still nowhere close to where patient safety education should be  in meeting the needs of the patient. This concern really hit home the past two weeks at our Telluride Patient Safety Summer Camp when resident physicians and medical students shared the following:

On the current state of patient safety education and training in medical school:
Almost all medicals students acknowledged that the four days they spent on patient safety education at the Telluride Summer Camp was more training than they get in their four years of medical school. While all schools have some training in patient safety, it is still infrequent and rarely longitudinal.

On Informed Consent/Shared Decision-making training:
After residents watched the award-winning film The Faces of Medical Error…From Tears to Transparency: The Story of Michael Skolnik and engaged in a two-hour discussion on important differences between informed consent and shared decision-making, Paul Levy asked the residents how much informed consent training they get during their medical school and residency. With a show of hands, every resident acknowledged the three-hour session on informed consent/shared decision making at the Telluride Summer Camp was more training than they received during medical school and residency put together. One resident commented:

I don’t think that I’ve ever thought so much about informed consent as I did today.  A discussion about informed consent to the level of detail that we had today needs to be part of all residency training in the first days of orientation and as refresher training later on in training.  All physicians can, and should, do much better in providing informed consent.

On understanding nursing, and the nurse’s role in team-based patient care:
On day two and three of the Student Summer Camp, Kathy Pischke-Winn, RN and Joe Halbach, MD shared educational strategies and tools for team-based care and effective communication between caregivers. The sessions were powerful – using case-based learning and role-plays, the students gained great insight into communication tools like SBAR (or ISBAR as the Australians attending the summer camp were quick to point out), write-down read-back, CUS and others. At the end of the two-day session, the students shared their complete lack of knowledge (and medical school training) prior to attending the summer camp regarding the important role of the nurse in patient care and other team-based care concepts.

One medical student commented:

Our discussion on the roles of nurses at different institutions was eye-opening in the sense that many of my peer medical students had very little knowledge about other allied health professionals.”

Another fourth-year medical student pointed out this lack of team-based patient care training cuts even deeper:

The discussion about nursing and doctoring reminded me of conversations I had with fellow classmates at school. We were studying for the NBME Behavioral Sciences exam and joking about the ethical dilemma practice questions we were working on. A common theme that we noticed is that any answer involving soliciting a nurse for help or consulting with a nurse would invariably be wrong. We agreed that answers involving nurses can be crossed off and it would be nice to get one on the test because we could narrow down the answers easier. Almost like how there used to rarely be positive depictions of minorities in the cinema, early medical education is nearly void of positive depictions of nurses.

I think we can all agree medical training and educating the young is not near where we need it to be especially in the areas of team-based, patient-centered care.

Shooting Free Throws and Mastering Patient Safety Skills

With the National Basketball Association playoffs having just ended, I couldn’t help but be reminded about the relationship between great coaches and great educators. The best coaches through the years have been some of the best teachers and provided examples of role models for leaders in many industries. Tracy Granzyk, MS, illustrates this relationship in an excellent post, John Wooden’s Spirit Alive and Well in Telluride, about the benefits of using leadership examples outside of healthcare, such as that of legendary UCLA basketball coach John Wooden, to improve communication during the patient-provider encounter. She writes:

“If they haven’t learned it, you haven’t taught it.” This was a Woodenism oft quoted at the Resident Patient Safety Summer Camp in Telluride by special guest faculty, Paul Levy. Wooden and Levy are both coaches and teachers in their respective fields–one hospital administration and the other NCAA Men’s Basketball. With that quote, they both take responsibility to the fullest extent for successfully transferring knowledge to those they themselves are charged with educating.

It became clear to all the resident physicians attending the Telluride Patient Safety Summer Camp that as caregivers, we do indeed assume the role of educator on a daily basis. How many ways, and how many times, do we need to say the same thing to our patients so that they truly understand issues such as risks, benefits, treatment alternatives and the possibility of doing nothing? As many ways, and as many times, as it takes. For as John Wooden says, “if they haven’t learned it, we have not taught it…” our patients in a way that conveys an understanding of their diagnosis or their upcoming procedure, and how both could affect the quality of their life. The role of educator is subtext to a medical education, and few graduate medical schools prepare future doctors to teach or coach patients.

As Granzyk points out, these two very important educational themes from Telluride – communication and education– highlight the need to improve on the transfer of knowledge to our patients and family members, and identifies where holes in medical education still exist. How much time is dedicated to development of these two skills that are cornerstones of patient-centered care throughout medical education? Not enough. Looking to leadership in industries outside healthcare to fill these gaps is one way to jumpstart the transfer of knowledge in a meaningful way.

Telluride has also proven to be a fertile educational environment where the need for skill development in these areas is a top level agenda item. One excellent communication technique between caregivers that was discussed at length with residents in Telluride this year, was the “write-down, read-back” method for handoff of a patient. This technique calls for the caregiver receiving the patient to listen to the caregiver handing off the patient relate details about that patient’s care, preferably in the SBAR format. As the handoff caregiver shares important issues related to the patient’s care, the receiving caregiver writes down the important notes, and then read the notes back to the caregiver handing off the patient. This technique is powerful because writing down notes leads to better recall of the case details, and it provides a form of traceable documentation.

A second excellent communication method also shared in Telluride last week, was the story of a physician asking his patient, “May I tape this conversation?” As the patient agreed, the entire meeting was then tape-recorded, with the patient thinking this to be a self-serving attempt at medical malpractice prevention. At the end of the encounter, the physician removed the tape from the recorder and handed it to the patient saying, “I know we discussed a lot of information today and you might not have completely taken it all in. Please take this tape home and listen to it. Have your family and friends listen to it too, and then let me know if you have any additional questions.” What a great example of patient-driven care—what a great example of teaching until the knowledge is imparted and can actually be used by the patient.

Can A Conversation Change An Outcome?

Keeping with our recent theme of story, narrative and film as powerful patient safety education tools, the second day at the Telluride Patient Safety Summer Camp finished with the residents viewing the award-winning film, The Faces of Medical Error…From Tears to Transparency: The Story of Michael Skolnik. The film addresses the important differences between informed consent and shared decision-making–important differences as they relate to open and honest communication in healthcare. The movie asks the question “Can a conversation change an outcome? Can a conversation save a life?” Through Michael’s clinical course and resulting outcome, viewers understand and appreciate that a shared decision-making conversation can change an outcome and save a life.

After watching the film, residents engaged in a two-hour conversation with faculty and safety leaders on issues related to informed consent and shared decision-making. The audience engagement in discussions and the consensus building that follows a film like The Story of Michael Skolnik are always lively and very educating. One of our residents, Todd Guth, posted a great reflection on the session at the Transparent Health blog. Here is an excerpt from that post:

Informed consent is a shared decision-making opportunity between patient and physician.  At its core, informed consent is a conversation with the goal of allowing the patient to ask questions and hopefully come away with a clear understanding of the procedure to be performed, as well and the risks and benefits of the procedure. Procedures, diagnostic tests, and medications can all be conversations that are pursued with patients under the vigilance of informed consent.

While the conversation is the essential element of informed consent, the informed consent paperwork can serve as both a checklist for the provider and a physical reminder to the patient that we are discussing potential harm and the physician will need the patient’s approval before pursuing any potentially risky treatment plans.

A discussion about informed consent to the level of detail that we had today needs to be part of all residency training in the first days of orientation and as refresher training later on in training.  All physicians can, and should, do much better in providing informed consent.

At the end of the session, Paul Levy asked the residents how much informed consent training they receive during medical school and residency. With a show of hands, every resident acknowledged the three-hour session on informed consent/shared decision-making at the Telluride Summer Camp was more training than they received during their entire medical school and residency combined. We all agreed this was a sad commentary on the current state of medical education in areas of patient centered care, and the data around informed consent taking place in hospitals is also discouraging. According to a March 2010 JAMA article written by Harlan Krumholz MD, Harold Hines Jr. Professor of Medicine (Cardiology) at Yale University, informed consent documents from 157 randomly selected US hospitals were shown to have limited educational value. Krumholz also shares results from two additional studies which found almost 70% of surgical patients studied did not read the informed consent form, and that many patients misunderstand the benefits and risks of their procedure altogether.

We cannot achieve a true partnership with our patients unless we have meaningful shared decision-making conversations that include a full understanding of a patient’s needs, preferences, values and goals. I echo Todd’s reflective assessment – All physicians can, and should, do much better in providing informed consent.