Improving Informed Consent Improves Patient-Centered Care
Quality Feature — March 2016
Tex Med. 2016;112(3):41-45.
By Amy Lynn Sorrel
Informed consent is a hallmark of good old-fashioned patient care. But some Texas physicians and hospitals are finding ways to use the process as an opportunity to improve patient safety and patient-centered care.
Members of the Texas Medical Association Subcommittee on Transfusion and Transplantation noticed the state consent forms for blood transfusion were outdated, and the group's vigilance was instrumental in prompting changes that took effect in January. The Texas Medical Disclosure Panel (TMDP) — the state regulatory body overseeing informed consent for medical treatments — is taking additional steps to make state forms even more understandable for patients at a time when health literacy rates are low. And Parkland Health and Hospital System in Dallas recently took action to automate the informed consent process to free up physicians' time to focus on their patients.
The process, while routine, is about more than getting a signature on a piece of paper. It's a chance to get patients involved in their care, says Meredith A. Reyes, MD. The Houston pathologist is cochair of TMA's Subcommittee on Transfusion and Transplantation. "I talk to patients on a daily basis who don't feel like they know what's happening with their treatment. Whether it's transfusion or a procedure, they don't feel like doctors are talking to them in a way they can understand."
As evidenced by campaigns like Choosing Wisely, Dr. Reyes says physicians and patients face more pressure to make clinically and financially wise health care decisions. The informed consent process is yet another way to enhance those conversations, she says, but perhaps one that's overlooked.
"With the way health care is changing, we have to be more cognizant of the patient experience. If patients feel that they are fully informed and actively involved from the beginning and that they've made a choice with the physician, they tend to leave feeling more satisfied, no matter the outcome," Dr. Reyes said.
An important piece of that equation is making sure informed consent forms reflect the most current risks associated with a particular procedure or treatment regimen.
Having worked with transfusion teams at multiple hospitals, Dr. Reyes noticed a growing consensus that the forms drafted by the state largely addressed potential complications that were prevalent 20 years ago but not risks that are more common today. When it comes to blood transfusion, "the first things people think about are HIV and hepatitis. And now, those things are not zero risk, but they are no longer the highest risk."
Now, more common complications include bacterial infections, allergic reactions, and fluid overload. "Some of these are things we can't test for. The old transfusion forms reflected things that used to be of high risk, but we can test and screen heavily for HIV now, and it's not the No. 1 risk of transfusion," Dr. Reyes said.
In December 2013, the TMA subcommittee took the issue to TMDP. Under the auspices of the Texas Department of State Health Services, the panel of physicians and attorneys meets several times a year to review medical treatments and procedures and their associated risks on a rolling basis. (See "The Texas Medical Disclosure Panel [TMDP]).")
TMA proposed a list of additional hazards to include in the risks disclosures associated with the transfusion of blood and blood components, which TMDP reviewed and accepted, with some revisions.
Although the update process took roughly two years, "we feel it is a big improvement over the old form," which put both patients and physicians at risk of not having or providing the most up-to-date information on potentially adverse outcomes, Dr. Reyes said. She adds consent forms typically do not reflect alternatives to the treatments and procedures patients might undergo, which are just as important for physicians to discuss.
TMDP Chair Noah B. Appel, MD, says the panel relies on the expertise of its physician members, as well as input from professional medical societies and associations like TMA, in getting the latest information about medical treatments, surgical procedures, and the associated risks.
The more obvious purposes of informed consent, the Dallas interventional radiologist says, are protecting patients from making an uninformed decision when deciding whether to undergo a treatment or procedure, and protecting physicians from legal claims for failing to adequately disclose potential complications.
State law tasks TMDP with providing the framework for communicating those risks, "but the other very important piece is the conversation you have with the patient and establishing a rapport. A lot of people simply focus on having that form signed, but the form is really just to document that the conversation occurred," Dr. Appel said. "Especially for proceduralists like me, I often meet the patient shortly before the procedure, especially if it's an emergency. It's important to me for patients to feel comfortable, and I use that conversation to say, ‘Here's what we know; here are the risks; here are the potential benefits.’ And they can talk with me and ask me questions."
TMDP has collaborated with The University of Texas at Austin to address health literacy concerns over patients' ability to read and understand the state consent forms, which can be rather complex. The panel has help from UT's Department of Communication Studies to translate the forms to an average adult reading level.
But Dr. Appel emphasizes it's still the conversation that counts.
"The forms are there to document the fact that we talked about it. Physicians can have someone else [on the health care team] have the patient sign it. But you can't delegate the conversation to someone else," he said. "It's incumbent on physicians to break it down for someone who doesn't know medical terminology and who might be too sheepish to ask. But my generation of doctors and those subsequent are much different from the older way of practicing in that we should expect patients to ask questions and be part of the decisionmaking."
Documenting informed consent is nevertheless important to invoke state legal protections. Parkland found a way to meet those regulatory requirements and enhance physician-patient communication without complicating it. The Dallas hospital automated the entire informed consent process by fully integrating it into the electronic health record (EHR) system.
As with many hospitals, Parkland first used a hybrid system that required printing paper consent forms for signature, then scanning the documents back into the EHR.
The new tool launches within the EHR without a separate login or password so it's easier and faster for doctors to use. It automatically populates consent forms with patient and procedure information; stays current with TMDP updates; allows physicians to search easily for the proper form so they can have it ready before seeing the patient; and saves signed forms and digital images to the EHR as soon as they are complete. Patients sign easily using mobile tablets or workstations.
Parkland organized a team of experts from the hospital's medical, nursing, and legal staff and information technology, patient safety, and quality committees, among others, to map out the changes. While some physicians were reluctant at first to give up paper consent forms, Parkland reached a 72-percent utilization rate just one month after it went live.
"Without a doubt, the transition was bolstered by the early involvement of physicians and nurses, in addition to well-defined testing," Parkland staff wrote of the project in an article published in the October 2015 issue of Patient Safety & Quality Healthcare.
Parkland Chief of Infection Prevention Pranavi Sreeramoju, MD, says the initiative reinforces the hospital's quality improvement efforts by bolstering patient safety and patient-friendly care. The Dallas infectious disease specialist is a member of TMA's Council on Health Care Quality.
"Now we are in an age where physicians have to document almost everything. But when you have some documents on paper and some electronically, it's a challenge to make sure the paper record travels with the patient," she said. Automating the informed consent process ensures that every component of the patient's medical record is electronic and that all of those records are in one place so forms are not lost or misplaced.
Dr. Sreeramoju says digitizing informed consent may be difficult and expensive for small physician practices. But even in the hospital setting, "automation of the informed consent process means reduced waste and time, and it gives that time back to the doctors to spend with the patient. It's just good patient care, and it obviously required interdisciplinary teamwork to make this happen."
But Dr. Sreeramoju also views the informed consent process as an opportunity for improving care quality and patient satisfaction.
"The current regulatory and legal process for informed consent aims at communicating the so-called standard of care and community standard. The challenge and one of the downsides is, not everyone receives that information in the same way," she said. "Obviously, we need to follow the rules and requirements. But I would also encourage physicians to think more broadly about informed consent and use it as an opportunity to make sure the patient understands and is on board with his or her care."
Amy Lynn Sorrel can be reached by phone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by email.
The Texas Medical Disclosure Panel (TMDP)
- Who serves on the panel? Six physicians and three attorneys appointed by the Texas Department of State Health Services commissioner.
- What is its purpose? To determine which medical treatments and surgical procedures do and do not require specific risk disclosure to patients and to publish applicable disclosure and consent forms.
- How does the panel get information on treatments, procedures, and associated risks? From the expertise of the panel's physician members, as well as from professional medical societies and associations like TMA. Any proposed changes or updates to those lists are published in the Texas Register and open to public comment.
- Where can I find the latest consent forms and other TMDP information? Sign up for TMDP email updates, download consent forms, and find other information in the Frequently Asked Questions section. Please Note: Due to technical difficulties, these FAQs are not currently available on the Department of State Health Services website. TMA has posted the most recent FAQs, provided by DSHS, here.
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