Informed consent is not just a piece of paper. Informed consent is a process—discussion, questions and answers, followed by understanding, comprehension, decision and, ultimately, consent.
Healthcare providers must ensure the patient gives knowledgeable consent. This means the provider has explained all the pertinent information regarding the proposed treatment/procedure; has provided the patient the opportunity to ask questions and has answered those questions to the patient's satisfaction; has documented the informed consent process in the medical records; and has secured the patient's signature on a thorough informed consent document signifying knowledgeable consent.
Where and how you obtain informed consent matter as well. A study published in the Journal of Bone and Joint Surgery in 2005 found that an orthopedic surgeon's risk of incurring a medical malpractice claim increased when informed consent was obtained on the hospital ward or in a pre-operative area. The risk was lower when informed consent was obtained in an office setting by the attending surgeon (and the discussion was documented in the surgeon's office notes).
And in medical malpractice suits that proceed to trial under a theory of lack of informed consent, when a thorough, executed informed consent document exists, the provider successfully defends the lawsuit 74% of the time.
Real world case study
A patient presented to the ER complaining of fever and intense lower abdominal pain, which the ER physicians determined was caused by acute diverticulitis. Subsequent to an informed consent discussion with the attending surgeon, the patient consented to emergency laparoscopic surgery by first signing the hospital's informed consent document and then signing another informed consent document required by the attending surgeon (not a hospital employee).
The laparoscopic procedure was successful, but during the operation the attending surgeon and two surgical residents encountered improper anatomy placement and inadvertently severed the patient's vas deferens. The severing resulted in a testicular infection and the patient's subsequent sterility.
The patient sued both the hospital—legally responsible for the actions of the two surgical residents—and the attending surgeon, alleging medical negligence and lack of informed consent. At trial, the plaintiff's lawyer argued that not only was it negligence to sever the vas deferens, but the hospital's informed consent document did not reflect any mention of risk to the urinary tract or reproductive capability.
However, the second informed consent document—which was more thorough and contained the handwritten notation, "risks include . . . urinary function . . . sterility . . . impotence"—showed that the attending surgeon had discussed tertiary risk to the urinary tract and reproductive capability.
The jury returned a verdict of no liability against the attending surgeon yet found the hospital liable for the negligence of the residents, premised on the hospital's informed consent document not delineating the potential risk of damage to the urinary tract or reproductive anatomy.
Practice tips
Explain things simply and plainly; you greatly decrease the chances of future problems if the patient knows exactly what is going to happen and what to expect post-procedure. (Malpractice claims oftentimes originate from a "surprise" negative outcome; a patient who understands the result as "the risk the doctor warned me about" is less likely to file a claim.)
Discuss expectations, perhaps even questioning what the patient expects as a result. Patients often have unrealistic expectations for the outcome of a procedure.
Never guarantee success; document in the informed consent that the patient understands and acknowledges there is no guarantee of success.
Provide the patient any educational materials you have regarding the disease, condition, treatment, etc., and note such in the chart; consider highlighting phrases in the materials you believe particularly relevant.
The greater a procedure's risk, the more carefully and thoroughly you should explain things to the patient.
Include whatever risks and potential complications are specific to the procedure, instead of merely relying on the language included on a pre-printed form.
If the patient has an increased risk of complication, discuss such thoroughly with the patient and note those increased risks/complications on the informed consent document and in your office notes/chart.
If possible, conduct the informed consent discussion in an office setting prior to the scheduled date of the procedure; document the discussion and patient's consent in your office notes/chart.
Alan G. Williams, JD, is the author of Physician, Protect Thyself: 7 Simple Ways NOT to Get Sued for Medical Malpractice and an attorney with Physicians MedicaLegal Prevention in Orange Park, FL. This article originally ran in the September issue of Private Practice Success, a HealthLeader's Media publication.
When you're in charge of a hospital that is working to improve its quality and patient safety, you need to be focused. At all times, quality care must be an integral part of what's happening at your hospital, and it must be woven into your organization's mission, vision, and values, says Les Donahue, CEO of Saint Thomas Hospital in Nashville. And he ought to know.
Five years ago, Saint Thomas was struggling. Its mortality rates were higher than they should have been. It was treading water financially, and when compared to its peers, it had a higher than expected rate of adverse events. But today, the organization is thriving, and its accomplishments were recently validated by Thomson Reuters, who named Saint Thomas to the 100 Top Hospitals Performance Improvement Leaders list.
Donahue says the award is certainly an honor, but it wasn't a surprise to hospital executives, who have made quality and patient safety a central focus of the organization. I recently talked with him about the award, the turnaround, and maintaining the organization's focus. Here are some highlights from my recent e-mail conversation with him:
ML: In 2002, when this study began, your organization had higher mortality rates and experienced more adverse events than its peer hospitals, but today, that's all changed. Mortality rates are down, the number of adverse events is now lower than expected, and your hospital is financially healthy. What's changed?
LD: Our focus has been, and remains on, the mission, quality, safety, and service. We are not satisfied until we excel in all of these elements. This helps us provide superior care to our patients. In addition, we have an intense focus on priorities for action that have led to improvements across all Ascension hospitals, particularly quality improvement initiatives. We have committed considerable resources to develop a culture of safety, based on the latest techniques for reducing errors, including new behavior based expectations for physicians, and staff that reduces adverse events.
ML: How important is a CEO's involvement in this kind of change? Why must change come from the top?
LD: The hospital's senior leadership team, as well as the medical staff leadership, is passionate about quality, safety, and service. Our culture is committed to performance improvement.
ML: We hear a lot about how patients are coming to the hospital sicker and experiencing more comorbidities than in the past. Still, your hospital was able to reduce the average length of stay by nearly a day. How did you accomplish this?
LD: We believe patient outcomes improve as our efficiency improves. We have instituted "lean methodologies" that assist us in removing waste, which reduces the length of stay, and allows us to provide more focus on patient throughput.
ML: Making any kind of quality improvements takes the involvement of everyone who provides patient care at the hospital, yet sometimes hospital leaders and physicians don't see eye-to-eye when it comes to performance improvement efforts. What was the secret to keeping all of Saint Thomas's physicians—both employed and affiliated physicians—aligned with these efforts?
LD: Saint Thomas is blessed to have physician leaders who are highly engaged and aligned with our mission and organization goals. Our medical staff, as well as staff leaders, shares the same passion for quality, safety, and service, and we work actively to avoid the "we" or "them" mindsets.
ML: Thomson Reuters says many hospitals have been "treading water" over the past five years—meaning that they've been struggling to remain financially healthy and to turn a profit while improving patient outcomes. What has been Saint Thomas' secret?
LD: Our intense focus on the mission, quality, safety, and service has resulted in volume growth. So it's a simple formula, take care of the most important things first, and the financial strength will follow.
ML: Looking back on the last five years at Saint Thomas, what advice would you give to fellow hospital CEOs about their role in improving quality at their hospital?
LD: Their highest priority needs to focus on creating a culture of quality. It starts at the top.
ML: Finally, are the changes at Saint Thomas possible at any hospital?
LD: Yes, all of the ingredients are the same and simple. Have a great staff, focus on quality and follow your mission, vision, and values. The key is the environment. Your associate and physician leaders must be liberated, creative, seek their own answers, the result is excellent care.
Editor's note: Learn more about the leader's role in inspiring quality performance during HealthLeaders Media's annual Top Leadership Teams in Healthcare conference, October 16 and 17, 2008 at the Drake Hotel in Chicago. A panel of representatives from Alegent Health, Christus, and Northwest Community Hospital of Arlington Heights, IL, will be on hand to discuss how their organizations are successfully using transparency to improve the quality of care offered at their facilities. For more information, visit the TLT Web site: www.topleadershipteams.net.
Maureen Larkin is quality editor with HealthLeaders magazine. She can be reached at mlarkin@healthleadersmedia.com.
Note: You can sign up to receive HealthLeaders Media QualityLeaders, a free weekly e-newsletter that reports on the top quality issues facing healthcare leaders.
The face of healthcare is changing, with the growth of online medical information and other similar technologies. Recent data suggests that the number of patients utilizing e-resources to find such information is growing as well. A report by the Center for Studying Health System Change has found that the number of American adults going online to find medical information has doubled from 2001 to 2007.
The federal Health and Human Services agency has named an additional 11 communities to the 14 already designated as Chartered Value Exchanges. Heathcare collaborations that are focused on making quality and pricing information publicly available, the designation is being hailed by some as a "growing national movement."
Ten groups participating in the Physician Group Practice Demonstration project hit performance targets on 25 out of 27 quality measures, although only four groups qualified for performance bonuses. This has prompted some doubt, amid rising hopes, about the future feasibility of the project. This is the second in a four-year Medicare pay-for-performance project.
Some veteran doctors take offense at the high value younger physicians place on work-life balance, flexibility, and limited leadership commitment, saying it's disloyal and signifies a poor work ethic.
However, there are younger physicians who say they've developed some of these views after witnessing older doctors' struggles in the field, and they don't want to go down the same road.
To maintain a solid partnership in a practice with the potential for a generational divide, develop a structure in which everyone is on the same team, whether that is welcoming the new physician or communicating a conflict, says Marcus F. Keep, MD, FACF, FRCSC, a medical director and practicing neurosurgeon at Swedish Neurosurgical Associates in Englewood, CO.
"We have a large cluster [of physicians] in the 50- to 60-year-old age group, which will pose a challenge as they edge closer to retirement. We understand that the physicians who have trained recently are part of a generation that has very different expectations than those that came before," says Louis S. Snitkoff, MD, FACP, medical director at CapitalCare Medical Group in Albany, NY, a 75-physician primary care group with 22 facilities in four New York counties.
Some physicians at CapitalCare work less than full-time, but most of the group's sites accommodate their compensation formulas and make adjustments to components of their overhead expense, Snitkoff says. Some physicians also choose to work through their lunch break, and others have defined sessions in the morning, afternoon, and/or evening with breaks scheduled in between.
"We have attempted to create an environment where the physician's medical knowledge, clinical skills, and personal attributes are valued more than whether he or she is willing to work 60–80 hours per week," Snitkoff says. "We have been able to respect the needs of our physicians while meeting the needs of our patients and the organization as a whole."
This article as adapted from one that originally ran in the September issue ofThe Doctor's Office, a HealthLeaders Media publication.
The healthcare industry started with a theory: If payments to providers are tied to performance, overall quality of care will improve.
It has been a while since my last science class, but from what I remember about the scientific method, the next steps after you've developed a hypothesis are roughly: 1) conduct experiments, and 2) measure the results against your original prediction.
From Medicare's Physician Quality Reporting Initiative and Physician Group Practice Demonstration to a variety of private-payer P4P plans, the idea has been tested plenty of times at this point. So how does it hold up against the initial goals?
Well, that depends on who you ask. There certainly is evidence that physicians and hospitals will change behavior when working under a performance-based system, although some attribute that in part to an "observer effect" (i.e., physicians tend to change behavior when they know they're being measured, regardless of the financial consequences).
But many physicians remain skeptical. There seem to be three major problems with P4P in its current form:
1. Insufficient incentives. CMS boasted last month that 10 groups earned $16.7 million in incentive payments under its P4P demonstration program. However, some have raised concerns that that's not enough to really offset the costs of participating. Even in private-payer P4P programs, incentives rarely exceed 2-3% of a doctor's overall compensation. To really have an impact, that percentage will have to increase.
2. Administrative burdens. Even a small bonus might be considered worthwhile if the P4P programs weren't such an administrative headache. Doctors are frustrated. In an MGMA survey released this week, 63% of PQRI participants reported difficulty capturing and submitting data, and a whopping 93% had difficulty accessing their reports. The entire premise of P4P hinges on data collection and feedback. If that isn't happening efficiently, the program won't work.
Some of these problems are just initial bugs that can be fixed. The American College of Physicians offers an example of a doctor participating in PQRI who was forced to submit a one-cent charge per code so that Medicare's carrier would register the submission, and he then had to go back and manually write off the charges afterward. These administrative hassles—as well as actual costs associated with collecting data—can effectively cancel out bonus payments if they aren't large enough.
3. Unintended consequences. Writing in the New York Times this week, Sandeep Jauhar, MD, argues that "whenever you try to legislate professional behavior, there are bound to be unintended consequences." If you define performance based on whether antibiotics are administered to a pneumonia patient within six hours, will doctors rush their diagnoses or begin overprescribing antibiotics? If physicians are rewarded based on outcomes, will they be tempted to cherry pick patients who can comply with the measures? These are legitimate questions that will only become more important to answer as the size of incentive payments grows.
Most of the criticisms have to do with the execution of the programs rather than their broader goals. There still isn't enough evidence to rule out the original hypothesis—that tying payment to performance can improve quality. So despite all of the flaws, we shouldn't necessarily scrap the entire concept.
But this also isn't the time to roll P4P out to the entire industry. Many believe the PQRI and other demonstration programs are trial balloons for a mandatory federal pay-for-performance system in the near future. Momentum is taking us in that direction, but CMS and other P4P architects should slow down and pay attention to the feedback offered by physicians and address the serious concerns that have been raised.
We need more experiments before jumping to any serious conclusions.
Elyas Bakhtiari is a managing editor with HealthLeaders Media. He can be reached at ebakhtiari@healthleadersmedia.com.
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The American Medical Association is now looking for feedback on the 2007 Physician Quality Reporting Initiative developed by the Centers for Medicare & Medicaid Services. Results of the confidential survey will help the AMA and other agencies to advocate for any future changes to the PQRI.
Experts agree that improving the quality of healthcare can be as simple as paying financial incentives for more quality work as well as setting minimum quality standards for workers. However, William Roper, chairman of the board of directors of the National Quality Forum, told the Senate Finance Committee this week that changing the healthcare industry's views about quality initiatives won't happen overnight.
As the insurer campaigns to convert into a for-profit company, Horizon Blue Cross Blue Shield of New Jersey is threatening to cut two Pennsylvania hospitals out of its treatment networks. Horizon has notified subscribers that it is terminating contracts with Children's Hospital of Philadelphia and the University of Pennsylvania Health System when they expire later this year. Roughly 28,000 subscribers use those facilities.
