In September 2007, Kathryn Sabadosa, 41, wife, mother of two, avid hiker, and quality improvement manager for the Cystic Fibrosis Foundation via the Dartmouth Institute for Health Policy and Clinical Practice (TDI), was diagnosed with ductal carcinoma in situ, or DCIS, the most common kind of non-invasive breast cancer. The following month, after a mastectomy, the pathology formally diagnosed Sabadosa with stage IIA breast cancer.
At first, Sabadosa was left to conduct her own research on breast cancer care by scouring Web sites and endlessly poring over articles and blogs on the subject. "I didn't have a real sense of how this would impact me personally," she tells Managed Healthcare Executive.
For Sabadosa, there was no clear "best" treatment option. "I wasn't able to determine what options had value for me—a lumpectomy or mastectomy," she explains.
Enter the Center for Shared Decision Making at the Dartmouth-Hitchcock Medical Center, in Lebanon, N.H. There, a counselor helped Sabadosa direct her personal searching, understand the pathology and screening reports, and find women who recently had faced the same decisions she was facing. Sabadosa and her husband also reviewed a video on early-stage breast cancer treatment, a breast cancer treatment handbook, and several brochures about breast cancer. She also was given a post-video questionnaire that asked her what she understood; which features of each option matter most; what treatment decision she was leaning toward; and what role she wanted to play in her decision.
This decision aid (DA) and handbook proved to be invaluable in having a much more productive conversation with her surgeon, according to Sabadosa. "This process helped in the decision making with the surgeons and oncologists," she says.
After the surgeon received the report that summarized Sadbadosa's health history, personal needs and decision-making needs, she walked Sabadosa through the findings and asked if she was feeling strongly about a surgery choice.
"For me, this was a critical turning point in my decision to have a mastectomy without reconstruction," Sabadosa says. "For very personal reasons . . . I was very clear on the path of treatment that I felt was right for me. Also, after reviewing the surgery options and complications, it became very important to me to avoid lymphedema, which could develop after a lymph node dissection. It was more important to me than losing a breast. My surgeon was very respectful of my choices and I had trust that she was going to do everything possible for a good outcome. It gave me a sense of being in control of my choices and it brought my values to the surface for the providers and me. I also avoided more appointments with plastic surgeons, having clearly identified that I did not wish to have reconstructive surgery.
"I think the biggest benefit was identifying what was an important outcome for me," she adds. "When I was finished with the process, I was clear on what I wanted for results and so was my surgeon."
This practice of shared decision making (SDM)—the collaboration between patients and caregivers to arrive at an informed, value-based healthcare decision when treatment options have features that patients value differently—is gaining recognition among health plans as a key function of a patient-centric model of care. SDM has been shown to improve patient engagement and compliance with care, promote better decision quality and reduce the total cost of care, according to experts.
"A patient armed with the information and empowered to make decisions in partnership with their clinician has the potential to have a major impact on cost, quality and outcomes," says Floyd J. Fowler Jr., PhD, president of the Foundation for Informed Medical Decision Making (FIMDM), a non-profit organization in Boston. "SDM consistently improves the quality and value of the medical encounter by allowing the doctor to focus on the issues that matter most to the patient."
When patients are better informed about treatment options, they may make decisions that are more aligned with their personal values, rather than opting for a more invasive or expensive procedure, says Brian P. Wicks, MD, president of the Washington State Medical Assn. Washington became the first state to endorse SDM in May 2007.
"The main priority of the WSMA is to make Washington a better place to practice medicine and to receive care," Dr. Wicks says. "Shared decision making is one step toward accomplishing that goal by building upon the valued physician/patient relationship."
Dr. Fowler points to recent research from John E. Wennberg, of the Dartmouth Institute for Health Policy and Clinical Practice, who has urged the Centers for Medicare and Medicaid Services to lead in establishing informed patient choice as the standard for determining medical necessity for discretionary surgery. In a November/December 2007 Health Affairs article, Wennberg and other Dartmouth researchers said that they believed SDM helps patients become fully informed about their illness, understand the likely outcomes of various options and participate in decisions about medical care.
"We know from [Wennberg's] decades of research into medical practice variation that care is delivered in a manner that has more to do with supply and other factors than it has to do with patient-driven choice," Dr. Fowler says.
As in Sabadosa's case, video DAs are used to complement shared decision making. DAs are produced in several formats: video, audio, paper and Web-based tools are currently available. There are DAs for specific decisions, as well as the generic Ottawa Personal Decision Guide for decisions for which there is no DA, or when a patient needs a structured process to follow to make a decision. Regardless, a high-quality DA delivers evidence-based, balanced and unbiased information that empowers the patient to collaborate with their clinician in a decision process.
"One way to engage patients more actively and proactively in self-management of chronic illness is to use decision aids as part of the outreach, coupled with call centers with nurse health coaches available by phone," says Kate Clay, MA, BSN, RN, program director at the DHMC's Center for Shared Decision Making.
More than 50 randomized clinical trials involving the use of DAs have clearly demonstrated that patients are more conservative in their choices of tests and interventions when they are fully informed of the risk and benefits, according to Dr. Fowler. "Those results lead one to think that particularly for treatments that are overused and/or in areas that are delivering high rates of services, overall costs would likely go down," he says. "However, we do not have good long-term studies to enable us to know exactly what the net economic impact of informing patients would be."
Dr. Fowler adds that it seems almost certain that informed patients will not choose more care, and that "it is easy to argue that the value received will be much higher if we ensure that those who get back surgery, knee replacements or bypass surgery are the right patients, the ones who understood their choices and concluded these are the best treatments for them," he says.
There is now strong evidence from numerous clinical trials that patient DAs not only improve decision quality, as Dr. Fowler points out, but also reduce unwarranted variations in the use of healthcare options that informed patients do not value, according to David Arterburn, MD, MPH, assistant investigator, Group Health Center for Health Studies.
Group Health is currently working on a system-wide strategy to provide DAs to its member patients through an Internet-based portal and personal medical record called MyGroupHealth, which was originally implemented in 2000.
"One byproduct of this reduction in variation can be reduction in healthcare use, and similarly, reduction in health costs," Dr. Arterburn says. "This may be true for regions that have relatively high rates of delivering certain types of care. However, the converse may also be true—there may be certain regions that have relatively low rates of delivery of particular services—their rates may increase after implementing DAs. Thus, the goal of SDM is to match healthcare delivery with the demand for that care among informed patients—it is not a cost-control measure per se. In some cases, DAs may save money. In others, they may increase costs."
MHE Advisor Al Lewis, president of the Disease Management Purchasing Consortium International Inc. (DMPC), Wellesley, Mass., believes that it is difficult to determine if SDM saves money.
"This is among the harder because it's so tough to establish a baseline," Lewis says. "What is being substituted for what else— DMPC uses some specific measures which no one can argue with, such as hospice referrals and length of stay. On a macro-measurement basis, we look at surgery rates, too, for many types of surgeries. But we also look at therapies which one would expect to see increasing, if surgeries are being avoided. If, for example, back surgeries go down, but physical therapy increases, that suggests surgery avoidance with conservative therapy. If they both went down, that suggests fortunate random variation or maybe a local back surgeon retired."
The use of DAs and decision support is an important step in achieving what Wennberg calls the 'right' rate of surgeries, tests, etc., according to Clay. "The rate at which well-informed patients choose one option or the other is the 'right' rate. The rate is driven by informed patient preference, based on patients' values and social circumstances, rather than on physician recommendation. Sometimes this drives a rate up, and this may be good, if effective care is underutilized. Sometimes this drives the rate down, also good, as this will save money. But in the end, the rate for preference-sensitive healthcare options should be the rate at which those undergoing the care prefer one choice over another."
So called preference-sensitive decisions, which involve patients making valued-based judgments about the benefits and harms of their treatment options, are most amenable to the SDM process, according to experts.
"All elective surgeries are preference-sensitive," Clay explains. "Screening decisions are preference-sensitive. Any decision with multiple treatment options and good evidence that all options have similar outcomes are good ones [i.e., breast cancer surgery choices], as well as decisions for which the evidence about which option is best is lacking [i.e., prostate cancer treatment]."
Other common examples of preference-sensitive decisions include options for treating low back pain, osteoarthritis of the hip and knee, benign prostatic enlargement, as well as many cancer screening decisions.
"There can be wide regional practice variations in the use of preference-sensitive healthcare," Group Health's Dr. Arterburn says. "For example, in Washington state, the likelihood of having a prostatectomy or low back surgery varies three- to five-fold from one region to another. These variations may be 'unwarranted' when they are not consistent with the distributions of informed patients' preferences."
Treatments for which there is good evidence that one option is the best one [e.g., antibiotics for pneumonia] are not preference-sensitive, but recommended care that sometimes is associated with treatment guidelines, Clay explains. "There are some decisions, such as whether to have medical management vs. stenting vs. by-pass surgery for artery disease, that should be preference-sensitive but because the decision often comes in the emergency department, it is not amenable to careful deliberation and therefore more difficult to use the SDM and DA approach," she says.
PLANS AND SDM
Back in 2005, HealthPartners began to provide SDM within existing patient support programs. "The need for decision support is identified and then initiated concurrently as other services are delivered by nurse navigators, case and disease managers and health coaches," says Karen Kraemer, RN, CMC, HealthPartners senior director of case management. "These case managers provide the largest volume of SDM support.
HealthPartners is measuring outcomes of decision support, including SDM, in its quality metrics. "Decision support improves patient engagement and involvement with care and results in better decision quality," Kraemer says. "We have early indications that patients and members who receive decision support services tend to choose more conservative treatment. The assumption is that there will be a reduction in the total cost of care."
Aetna views SDM as a way to bring patients and doctors together to make healthcare decisions based on the best available evidence about treatment, weighing potential benefits and harms and considering patient preferences, according to Patricia Mueller, MD, Aetna's head of medical operations.
The health plan offers a variety of tools and information to help members make better-informed decisions about their healthcare. One tool that relies heavily on the idea of SDM is Informed Care Decisions.
Available through Simple Steps to a Healthier Life, Aetna's personalized online health and wellness program, Informed Care Decisions is an information therapy tool that provides members with confidential, personalized treatment information for more than 40 diseases and conditions.
"The information within the tool is developed and regularly reviewed by pharmacists and medical specialists in each of the condition areas," Dr. Mueller explains. "The tool presents information using simple language so consumers can easily understand their options for treatment. Aetna medical directors also review the information to ensure consistency with Aetna standards."
Another way Aetna helps members make more informed decisions about their healthcare is through MedQuery and the MedQuery Member Messaging programs. MedQuery identifies opportunities for improved care and delivers patient-specific, evidence-based treatment guidelines to physicians. MedQuery with Member Messaging enhances MedQuery by sending Care Considerations directly to members two weeks after the Care Consideration has been sent to their physician.
BARRIERS TO WIDESPREAD DA ADOPTION
There are a number of barriers to the widespread use of DAs, according to Dr. Arterburn. They include:
- Lack of a clear plan for ensuring good standards for DAs;
- Lack of access to DAs;
- A need for training of practitioners to use DAs and engage patients in DAs;
- A need for working practice models that incorporate SDM and DAs.
"Good DAs are expensive to produce because they must be regularly updated when the evidence-based changes," Dr. Arterburn says.
The International Patient Decision Aid Standards (IPDAS) Collaboration, a group of researchers, practitioners, consumers and policy makers from around the world have reached consensus on the essential content, development process and evaluation. Decision aids are now catalogued and rated for their quality using these standards at www.decisionair.ohri.ca/AZinvent.php
Knowledge about and comfort with using SDM and decision aids is very limited among physicians nationwide, according to Clay. In fact, she says that not even all Dartmouth physicians are routine users, even though the opportunity and infrastructure exist. At Dartmouth's Spine Center, several physicians require patients who are making a decision about back surgery to view a SDM video prior to signing the surgery consent form. "They believe that if they document that this has been 'prescribed' for the patient and that the patient watched the video, that the decision is well informed and that there is evidence of exactly what information has been given to the patient. If there is ever any question, the video is good evidence," Clay says. "And even more of a motivation for the physicians is that they want to be sure that patients receive high-quality, unbiased evidence-based information, know all their options and choose based on their values."
Dr. Wicks agrees. "If a competent patient signs am acknowledgement of SDM, it constitutes evidence that the patient has given his or her informed consent, that can only be rebutted by 'clear and convincing evidence.' This is a higher standard of defense for a physician than the 'preponderance of evidence' standard that currently exists for doctors who used informed consent forms."