Low literate patients are a high-risk group - not just because they have a higher chance of suffering a poor outcome, but also because the hospital is at higher risk for being sued for malpractice. Doctors and hospitals can be held liable for adverse outcomes if the information provided to patients was incomprehensible to the patient. Communication failures can lead to adverse events in the courtroom.
This chapter discusses some of the most important issues that concern us today, both as healthcare providers and consumers:
1. Informed Consent and Low Literacy The principle of informed consent-that patients have the right to participate in decisions about their own health care-is a widely accepted tenet of medical ethics and law. The reason implementing informed consent is so challenging may be embedded in the term itself: one of its components-information-comes from the doctor, and the other-consent-comes from the patient. Typically, informed consent has two parts: a process in which the doctor explains the procedure and its risks and its benefits to the patient. Then, the patient signs a legal document called an informed consent form, which becomes a part of his medical record and serves to document that he has given the doctor permission to do the procedure after understanding what it entails. The problem is that consent forms are often long and detailed, and this glut of complicated information rarely facilitates comprehension or informed decision-making. Instead of enhancing understanding, informed consent forms often end up overwhelming, confusing, or intimidating patients.
It appears that consent forms are deliberately badly-designed. They seem to serve the purpose of protecting the doctor, rather than educating the patient because they are written by lawyers for lawyers. Hospital informed consent forms have virtually no bearing on the patient being truly informed or being aware of what is going to take place. Patients are typically asked to sign informed consent forms minutes before the procedure is to begin, often in a state of stress and fear (on top of being ill). Taking their signature seems to have become a formality, and they are expected to sign the document quickly so that the doctors schedule is not affected. Often these forms provide blanket authorisation for doing anything, which protects the hospital, but actually removes informed consent, because it means the surgeon can do anything he sees fit.
With regards to informed consent, low literate patients are a high-risk group - not just because they have a higher chance of suffering a poor outcome, but also because the hospital is at higher risk for being sued for malpractice. Doctors and hospitals can be held liable for adverse outcomes if the information provided to patients was incomprehensible to the patient. Communication failures can lead to adverse events in the courtroom.
Courts have held that the patients inability to read a consent form invalidates signed consent, and have shifted the burden to the physician to prove that informed consent was provided in some other way. Judges have made clear that when a physician is aware of an impediment to patient understanding, such as poor literacy or a communication barrier, the physician has a legal duty to address the impediment in order to obtain informed consent. This is why hospitals are investing in health literacy and patient education systems, thus creating smarter, more engaged patients, who can take better care of themselves. Health literate patients are less likely to have negative outcomes, thus reducing the risk of malpractice suits. The law can serve as a carrot as well as a stick. If the fact that the doctor used health literacy tools when obtaining informed consent can be used as a defence against the claim that the patient was not educated about possible risks and complications, this would help encourage doctors to use these routinely. Some courts have considered the use of patient-friendly informational materials as proof that the patient provided informed consent.
In order to fix a broken process, progressive companies are now using technology to enable patients to provide online digital consent. The web-based iMedConsent solution (@http://www.dialogmedical.com/) prepares procedure-specific consent forms, covering more than 2,200 treatments and procedures. The clinical content library includes anatomical images and videos to enhance patient understanding. These resources can be personalised by the doctor, and the patient can review them from the comfort of home, thus saving the doctors time as well. The signed documents can be automatically stored, ensuring that critical documents are never lost or misplaced. This is smart use of technology to enhance patient safety and it also reduces the risk of the doctor being sued for malpractice, since it standardises and automates the informed consent processes.
2. Health insurance
Patients buy health insurance because they understand that costs of health care are rising and they need to protect themselves if they fall ill. Most assume that if they have medical insurance they are going to be able to afford medical care if they need it. Sadly, this is not always true. When you buy a health insurance policy, the friendly company agent is very happy to come to your house, take your signature on the health insurance form, and collect your premium. The company will also faithfully send you annual reminders for your premium payments. However, when its time to submit your claim for reimbursement of medical expenses, things can get quite hairy. The processes at health insurance companies seem to be designed to reject as many claims as possible, no matter how legitimate they maybe. This is hardly surprising, because health insurance companies are profit-making, and the longer they can hold on to your premiums (their "float"), the more money they stand to make.
It is only when your claim gets rejected that you start to carefully study the health insurance form you signed many moons ago. You find it is full of baffling terms, including "exclusions", "co-payments", "deductibles ", "pre-existing conditions", and "usual, customary, and reasonable charges" - terms that sounds like Greek and Latin and which your agent never bothered to explain when collecting the premium. Insurers seem to be deliberately keeping their customers in the dark by burying all the exclusion clauses in masses of fine print. The reason they do this is simple - its all about money. The forms are designed to purposely obfuscate: to make the claim process so difficult that people give up on pursuing their claims, even if they valid, because they cannot cope with the hurdles the insurance company places in their path. This is hardly surprising, since the forms are designed by health insurance company lawyers, to protect the interests of the health insurance company.
Make sure you disclose everything that is required in the form - please do not sign a blank form and leave it to the agent to fill the form later. If you do not disclose a preexisting disease then you run the risk of your policy being cancelled or a renewal being denied if this fact is discovered later. Keep a copy of all documents submitted to the insurance company for your future reference and remember that any promise made by the agent or even an official of the insurance company has no value unless it is in writing.
The US government has now taken concrete steps to ensure that patients can make sense of what their policy covers and what it does not. The Affordable Care Act - the new health reform law - requires health insurers to provide concise and comprehensible information about health plan benefits and coverage. In India, patients are much more vulnerable and the Consumer Dispute Redressal Forums are log-jammed with unhappy and angry patients who feel cheated because their insurance company has refused to pay claims on all kinds of flimsy pretexts.
3. Laboratory tests
You are accustomed to having blood tests done when you go to your doctor because they provide important diagnostic clues about disease. Lab tests offer the doctor a window into your body and when the pathology laboratory translates your blood into a stream of numbers, units and acronyms, your doctor can analyse this data to make the right diagnosis. However, most lab reports dont seem designed to provide you with any intelligible information whatsoever. The typical blood test report is an exercise in obfuscation, a document that needs to be interpreted by a physician. However, lab reports dont have to be unintelligible. With some thought, the results can be displayed so that they are as informative to patients as they are to physicians. Patients need to be able to understand their blood test "numbers", so they can translate this knowledge into action, and become participants in their own health.
Lets look at blood sugar levels for example. Diabetics need to monitor blood sugar levels continuously, and every diabetic knows that better control means better health and lower medication costs. The blood sugar report should help the patient and his doctor manage the disease. However, rather than just providing a single blood sugar level number, it would be much more helpful to the patient if serial values were provided in the form of a graph, so the patient could clearly see how well he was controlling his sugar levels. The good news is that even though labs still dont do this, clever websites such as SugarStats (@http://www.sugarstats.com)enables patients to track their blood sugar levels free of cost. This is a valuable online diabetes management tool - and similar sites need to be developed to manage other chronic diseases as well.
4. Personal Health Records (PHRs)
Ideally, the results of blood tests, X-rays, diagnostic scans and other information needs to be provided to patients in the right context, so they can track it and make sense of it. The best way to do this would be upload it to the patients EHR (electronic health record). A PHR is an online tool (@http://www.myphr.com) which can help to increase health literacy and transform patients into better-educated consumers of healthcare. The PHR enables us to put the I in HealthIT! The information in PHRs is portable, protected and private, and its ownership lies solely with the patient. The key to success is to ensure that the information is displayed in a format that is easily understandable for the patient. Further research is needed to develop a usercentred interface design for EHRs, which provides them with a dashboard that displays basic information, and enables them to "drill down" for the relevant details they want to explore. While its easier to teach educated patients how to utilise this information to make decisions, patients without an adequate understanding of their own healthcare may be overwhelmed and discouraged when presented with a PHR.
However, this is actually a great opportunity to improve their health literacy because a major advantage of the PHR is the ability it affords the patient to be an active member of the medical team and not just a passive consumer of healthcare services. An active team member will seek to understand the content of his own PHR. This desire can serve as a powerful motivating force in improving their personal health literacy, especially when the doctor prescribes customised information directly to the PHR, to help patients make sense of their reports. Not only do PHRs provide patients with health information at their fingertips, they make it easier for patients to connect online with their doctors through patient portals. By encouraging patients to ask questions and find out more, their health literacy improves, and health outcomes are better.
While it is true that patients with low health literacy will require extra help to learn to use their PHR, it is a worthwhile investment in their lifelong health. The PHR can actually increase social capital in the form of better doctor-patient relationships and improved health literacy. Patients are the largest untapped healthcare resource and PHRs can help them to manage their own health. The PHR that Kaiser Permanente offers it members, My Health Manager, is one of the biggest success stories in healthcare. It has reached four million users, and over the past year, users have accessed the portal more than 100 million times. The Blue Button initiative, rolled out recently by the US government, which enables users to download their personal health data at the click of a button holds great promise, because it encourages transparency and empowers patient with information.
5. Pharmaceutical companies and medications
A major problem for patients with low literacy is managing their medications. Many people, especially the elderly, take multiple medications, in varying doses, and at different times during the day. These medicines often have side effects, and some can cause complications by interacting with each other. Pharmaceutical companies are required by law to provide patients with medication nformation in the package. These leaflets are supposed to help patients take their medications properly. However, most leaflets come with the following problems:
- Small text, crammed together
- Poorly printed, small, hard-to-decipher warning labels symbols
- Unclear, non-standardised instructions
- Complex language that can be hard to understand
I wonder how many patients even bother to read these leaflets, leave alone understanding what they convey.
The information doesnt seem to be designed with the patient in mind at all. It appears that pharmaceutical companies print leaflets just to comply with the law and to protect themselves from lawsuits should the patient suffer from a complication as a result of the drug. Not only does this represent a missed opportunity to teach patients; unintelligible leaflets are actually a potentially grave risk to the health of patients, who are often clueless about the side effects and complications of the medicines they are taking because the leaflets are unreadable.
There are some great examples of well-designed patient information leaflets @ http://www.choiceandmedication.org/cnwl/. These serve as a very good model for how pharmaceutical companies can teach patients with poor literacy the information they need to know about their medicines. The pharmaceutical industry needs to adopt the motto: "Educate before you medicate!"
Fortunately, things are changing for the better. European law now states:
"The package leaflet must be written and designed to be clear and understandable, enabling users to act appropriately, when necessary with the help of health professionals." (Title V of Council Directive 2001/83/EC (as amended) Article 63(2).)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also issued guidelines to help improve these package inserts:
- Use plain language, simple punctuation, short paragraphs, and bullet points
- Use an easy-to-read font
- Use headings and colour to help patients navigate the text
- Consider the use of simple, easy to understand symbols and pictographs
The full guidelines can be accessed @http://www.mhra.gov.uk/home/groups/pla/documents/websiteresources/con049314.pdf.
6. Tackling public health problems by improving health literacy
Poor health literacy makes the work of public health officials much more difficult. Even though we have very effective anti TB drugs to treat tuberculosis (TB), this preventable infectious disease remains prevalent in India today. This is usually presented as a public health problem, but the burden of individual TB patients is not just medical. They suffer from social stigma as well - both internal, because they are ashamed of their disease and external, because community members ostracise them. Another major problem is incomplete adherence to treatment because the duration of treatment is long (usually six months or longer), combination therapy is required, and side effects may be unpleasant.
When doctors prescribe antiTB medicines to their patients, they expect them to take these as advised. However, many low-literacy patients stop taking the medicines after a few weeks, when they start feeling better, because they conclude that the medicines have worked successfully and that the TB is cured. After all, if they are feeling fine, why should they take any more drugs? Doctors call these patients noncompliant nd think of them as being difficult patients, who do have enough sense to follow their doctors orders! However, its not that these patients are stupid or obstinate - its just that the doctor has not done a good job in explaining to them why they need to continue taking their medicines for so long.
As you can imagine, its not easy explaining the concept of microscopic bacilli to uneducated patients! The formation of TB clubs, where patients with TB form groups to support each other, has helped to reduce the stigmatisation of TB; and to improve patient compliance as well. TB clubs are formed by groups of TB patients who met while attending outpatient appointments. Each club elects a leader who ensures that all members attend the TB clinic and arranges weekly club meetings, where members can support each other and share problems. The TB clubs have also identified people in the community with suspected TB, encouraged them to seek diagnosis and treatment. @http://www.who.int/tb/people_and_communities/comm care/background/en/index7.html
The concept of TB clubs has been expanded to include the creation of school TB clubs. The "Little doctors club / Schools TB Clubs Program", teaches school children to become ambassadors of TB, in spreading awareness about the disease among their class mates, school, home and the community as a whole. The awareness thus created aims to enhance the case detection & treatment success rates in the targeted communities.(@http://www.schooltbclubs.com/projdes.html)