The Role of Health Literacy in Improving Health ......Feb 14, 2020  · The Role of Health Literacy in Improving Health Communication and Informed Consent . Terry Davis, PhD. Professor

The Role of Health Literacy in Improving Health Communication and Informed Consent

Terry Davis, PhDProfessor of Medicine & Pediatrics

Connie Arnold, PhDProfessor of Medicine

February 14, 2020Ochsner IRB

What do IRBs need to know about Health Literacy?

• Health literacy is the ability to obtain, understand and use health information and services, to make appropriate health decisions.

• HL is affected by an individual’s capacities, AND by researchers’, providers’ and health systems’ ability to provide clear, understandable, and useful information and services.

• Nearly 9 of 10 adults have difficulty using health information that is routinely available in healthcare facilities and the media.

• IRBs often approve documents that do not conform to their own readability guidelines.

• We must not blame individuals for not understanding information that has not been made clear to them.

• Everyone, no matter how educated, is at risk for misunderstanding health information if the issue is emotionally charged or complex.

http://www.nih.gov/clearcommunication/healthliteracy.htm

The single biggest problem within communication is the illusion that it has taken place. George Bernard Shaw, Playwright

Communication does not take place because we tell somebody something.

Communication takes place when we observe patients closely and get signals that we are on the right track; that we have started at a place they are familiar with and track their ability to follow us.

We forget what it’s like not to know something.

Alan Alda, Actor. Center for Communicating Science, Stony Brook University

3

Communication is key to Informed Consent Insight for Health Professionals

Health Literacy Challenges • The DHHS’s National Health Literacy Action plan calls for health

information to accurate, accessible, understandable and actionable.

• Health professionals often fail to grasp the wide chasm between what they want to communicate and what patients understand.

• With consent for procedures and tests clinicians often fail to adequately describe risks or present alternatives.

• Health literacy Universal Precautions means assuming all patients are at risk of not understanding health information needed to make informed decisions. We need to speak in plain language and encourage questions.

• Patient portals and health websites deliver and store a vast array of health info but are typically overly complex, technical and difficult to use and understand.

United Health Foundation, Department of Education

U.S. Health Leaders Highlight Importance of Health Literacy in Research and Clinical practice

• Health research must provide information that is clear and evidence based so people can make sound and safe decisions.

• Health literacy is fundamental to helping people make informed health care decisions.

• All health sectors need to commit to meeting people where they are with health information that is easy to understand.

• Health literacy and plain language are vital in FDAs messages.

Francis Collin, NIH Director

Amy Abernethy, FDA

Tom Corry, CMS Director

Brett Giroir, Asst. Secretary DHHS

National Assessment of Health LiteracyAssessed clinical, preventive, & navigational tasks

Below Basic

14%Proficient

12%

Intermediate

53%Basic

22%

N = 19,000 adults, 152 tasks (28 health-related)

Calculate share of health insurance based on table

Determine when okay to drink before medical test based on short instructions

Circle date on doctor’s appointment slip

Determine time to take medicine based on label

61% Adults > 65 are Basic or Below Basic

Literacy Rates by Parish

% Adults with lowest Literacy Skills

National Institute for Literacy 1998

LA ranks 49th in literacy, 50th in overall health. 1 in 3 LA Adults have very low literacy. Rates double for low-income , elderly and minorities- our most vulnerable pts.

>30%

20%-30%

15% to 20%

< 15%

Health Literacy Linked to Poor Health Outcomes

People with limited health literacy are less likely to: • understand consent for procedures & trials• accurately understand and manage chronic disease• adhere to treatment plans, interpret labels, take meds appropriately • ask questions• use preventive services• understand discharge instructions • use patient portals and apps to track health behavior

They are more likely to have: • poorer physical and mental health • delayed diagnoses• increased ER use, avoidable hospitalizations, and readmission

AHRQ 2004. Literacy and health outcomes. Evidence Report ; Davis T, Annals Intern Med, 2006; Sanders L, Arch Pediatr Adoles Med, 2009; Dewalt 2004, 2010 Evidence Based Review; DeWalt DA, J Gen Intern Med. 2004. Chew LD, Am J Surg, 2004; Muslow, Am J Surg. 2012.Koh , H Health Affairs 2012

Red Flags For Limited Literacy“You Can’t Tell By Looking”

• May say “I forgot my glasses.”

• Incomplete intake forms

• Frequently missed appointments

• Unable to give coherent, sequential history

• Not taking medications correctly

• Asks fewer questions

• Lack of follow-through with referrals

* Health Literacy and Patient Safety: Help Patients Understand – A Manual for Clinicians. 2nd edition. Chicago: AMA Foundation and AMA, 2007. www.ama-assn.org/ama1/pub/upload/mm/367/healthclinicians.pdf

Video

It’s Hard to Be a Patient

We Need to Do a Better Job of Patient Communication and Support

• Less than 1 in 5 patients recall what doctors tell them

• It is common for patients to say they understand yet be poorly informed about their diagnoses, prognoses and care plan.

• 20% -30% do not fill initial prescriptions.

• 50% do not take meds as prescribed. Almost 50% with chronic diseases stop taking meds in the 1st year.

• Clinic visit times and hospitalizations are shorter.

• Patients often need help and support in remembering to take meds, improve health behavior, and sustain improvement.

Why Are Patients Non-Adherent with Meds?

• Not clear how to take the medicine

• Forget to take med or get Rx refilled

• Too complex

• Side effects

• Not seeing benefit

• Believe meds aren’t necessary

• Cost / insurance

• Relationship with provider J Oncol Prac 2015, JAMA 2002

VideoIt’s Easy to Make a Mistake

Hidden problem: Health Numeracy Understanding numbers used in health care

You drink this whole bottle of soda. How many grams of total carbohydrates does it contain?

• 67.5 grams

• 32% answered correctly

• 200 primary care patients

• 73% private insurance

• 67% at least some college

• 78% read > 9th grade

• 37% math > 9th grade

Rothman R, Am J Prev Med, 2006

Health Numeracy Linked to Poor Diabetes Knowledge and Control

• 90% of patients struggled to understand food labels • 67% patients had poor estimation of portion sizes • 25% could not interpret glucose meter• 40% could not calculate carbohydrate intake • 30% could not dose insulin correctly

• Diabetes numeracy skills associated with self-management, self-efficacy, and A1C

Huizinga et al, BMC Health Services Res, 2008, Cavanaugh et al, Annals of Internal Medicine, 2008Rothman et al, AM J Prev Med, 2006; Huizinga et al, Am J of Prev Med, 2009

Percentages & probability are challenging for many

Approximately half of U.S. adults are unable to calculate a tip.

* Kirsch IS, et al., Adult Literacy in America, 1993; Lipkus IM, et al., Med Decis Making, 2001

1 in 5 college-educated adults don’t know:• what is a higher risk – 1%, 5%, or 10%• Or understood .01 is the same as 1 in

100.

Only 1 in 21 OBs accurately estimated the probability that a child has Downs after a positive test. Actual restaurant receipt

Assessing Literacy

• Years of schooling is NOT a good measure of literacy level (reading comprehension often 2-5 grade levels < education level).

• Formal assessments provide a proxy measure of health literacy and can be used to compare results in the literature.

• Patient’s score on literacy test is an indication they may struggle to understand and act on oral or written health information.

• All existing tests measure literacy in health context (i.e. not health literacy).

Davis TC. Am J Health Behavior. 2013.

Literacy Tests Used in Healthcare Research

• The most commonly used• REALM (Rapid Estimate of

Literacy Medicine)• TOFHLA (Test of Functional

Health Literacy)• NVS (Newest Vital Sign)

• These are often referred to as tests of health literacy

Qualitative:How confident are you filling out medical forms by yourself?Extremely – Quite A Bit – Somewhat – A Little Bit – Not At All( 0 ) ( 1 ) ( 2 ) ( 3 ) ( 4 )

Tests and ordering instructions are in resources at the end of the presentation.

• For clinical use –test clinics /systems in the aggregate.

• Testing individual patients will NOT confirm their ability to understand and act on health information.

• No evidence that individual literacy testing improves health care or outcomes when testing is done strictly for clinical use.

• To get the most accurate measure of patient’s specific health literacy clinically use “teach back.”

• “Universal precautions” (plain language) are recommended to make materials user-friendly.

Cautions about Assessing Health Literacy Clinically

What about Research MaterialMany Validated Instruments Fail to Consider Literacy

• Patients may struggle to independently read and answer validated commonly used surveys.

• May have trouble navigating questionnaires.

• Patients may not understand the stems & just check off answers.

• Likert scales are often challenging for those with low literacy especially if Qs vary in intensity or frequency.

• Too many Likert options are overwhelming ( limit to 5) .

• Avoid yes/no unless followed by a question that validates answer:

• Do you know what a mammogram is?

• If yes, can you tell me in your own words what it is.

Disparities in Clinical Trials

• Disparities exist in understanding and access to clinical trials and biorepositories among adults with:

• low socioeconomic status• racial and ethnic minority groups • who live in rural areas

• Less than 5% of cancer patients are enrolled in a clinical trial - less than 10% of these are minorities.

• Less than 3% of NCI cancer control studies focus on rural areas/

• Effective strategies are needed to provide culturally appropriate, understandable information and easier access to clinical trials.

Caplan. A PLOS Biol, 2017 biomedical Odyssey.blog Hopkins Medicine 2017 ,Collins , NEJ 2016

Lack of Diversity in Personalized Medicine

• NIH reports “the data we have is too white.”

• World wide over 50 genomic studies with 100,000 participants - 87%, European descent, 3%, African descent, 0.5% Hispanic.

• Diverse participation is necessary to identify how specific drugs and treatments are most useful for different groups.

• Privacy, trust, transparency, data quality, integrity and responsible return of genomic data to participants is being discussed.

Communicating Genomic Research and Biobanking Information is Challenging

• Precision medicine and genomic testing are creating a widening gap in knowledge of researchers and community providers, patients and the public.

• Researchers often assume patients and providers know more than they do about clinical trials and understand the jargon.

• Plain language, culturally appropriate, accessible information is lacking.

• Data validity of patient self-report surveys?

• Responsible return of genomic data to participants.

Findings from focus groups with underrepresented populations

72%, African America ,11% Hispanic , 22% rural

• Almost all interested in research but not aware of studies or how to find out about them or enroll. Most are willing to participate but are never asked.

• Participants most interested in studies on disease they or their family had.

• People are increasingly aware of personalized medicine due to TV ads on genomic treatments and 23 & Me.

• Most said they would enroll in genomic studies – even if no benefit to them.

• Some concerned with who will see information and if it would be a barrier to jobs, insurance, immigration, etc.

• Few had looked for clinical trials on internet or social media.

Participant Suggestions for Clear, Acceptable Communication

Clinical trial - study (People understood the term study)

Biobanking - your blood or tissue will be stored in a bank

Genomics - sounds intimidating, alarming; did not mean anything to most participants

Minorities are needed in clinical trials - most treatments based on studies with majority of white participants. ALL people are needed for studies to improve treatments and find cures.

Targeting minority recruitment appears suspicious - Tuskegee.

Hispanic patients wanted information in Spanish.

Most participants wanted to know: • What are you going to do with my blood sample? • How much information about ‘me’ are you going to keep? • What is it going to be used for?

Consideration for Enrolling Hispanic Patients • Need written materials in Spanish & language-concordant

provider, CRA.

• Hispanic patients did not like to use family member as translator.

• Hispanic patients are more likely to want to include family in decision.

• All had signed consent for treatment - all consents were in English.

• Get most health information from their provider/clinic - in Spanish.

• Church and family also trusted sources for health information.

• One man with heart disease had a Spanish language App on his cell phone.

Tips for health providers to improve health communication

1. Slow down – focus on patient’s “need to know and DO ”

2. Avoid medical jargon, use plain language3. Use pictures, teaching tools (pamphlets, brown bag meds)

4. Limit advice (1-3 concepts)

Engage patient - elicit buy in Write brief take - home information

5. Attend to patient’s culture and goals6. ‘Teach back’ / ’show back’ to confirm understanding

7. Be positive and motivating-follow up with ‘touch points’

Strategy for Limiting InformationLessons learned from patients

Tell me 3 • What’s wrong? (briefly) (Diagnosis)

• What do I need to do? (Treatment)

• Why is it important that I do this? (Benefit/Context)

If meds – “break it down” for me• What’s it for? (indication)• When to take? How many pills at a time, how long? (duration)• Why? (benefit)• What to expect? (side effects)• How much does it cost? Will insurance cover it? What are other options?

Pictures Can be Good Teaching ToolsPatients may not understand or use measurements

Healthy Carbs

Fruits and VeggiesProteins

Current materials available at: http://www.nchealthliteracy.org/hfselfmanage.html

• Specific and to the point

• Pictures and colors convey message

• Action oriented

User-Friendly Does Not Mean “Dumbed Down”

Adults with high education till prefer simpler health material

UNC Heart Failure study

Guides focused on:• Patient not disease• ‘Need to know and do’

Help patients change health behavior:• Increase knowledge and confidence managing disease• Help patients solve self-care problems• 5 million distributed nationally

American College of Physician’s Patient Self-Management Guides:

A good model to engage people in their health

7 Top Communication Takeaways

1. Sit down, focus on your patient, engage them, listen to their concerns. Be emotionally present, authentic.

2. Include family when appropriate. 3. “Meet” patients where they are and focus on what they need to

know and do, make it patient-centered.4. Concise, plain language information is easier to understand and

use. 5. Think about what you are asking patients to do - be concrete,

specific, 6. Make is interactive 7. Use teach back to confirm understanding.

Research Landscape is ChangingClear oral and written communication is essential

Cohn E, J of Nursing Scholarship, 2007

• Clinical research is growing - 2.3 million patients a year sign consent forms

• Consenting patients takes an increasing amount of time, preparation, and training

• Today’s studies more likely to include multiple sites, large number of participants, data sharing and biospecimens confidentiality concerns

• There is growing regulatory scrutiny

• Funding agencies concerned that patient comprehension is poor

Consent ChecklistTo help ensure patients can read & understand form

Is it written in plain language?

Are consistent terms throughout the form

Is it written in active (not passive) voice

- “your signature” vs “signature of patient”

Is it formatted for reading ease?

Is it too long, is information manageable or overwhelming?

What is plan for discussing information with patients?

Does form and consent discussion help patients make a decision about participation in the study?

Simplify & Shorten Complex Language

Unnecessary and complicated language, long sentence:

You have been selected as a possible participant in this study because you have a moderate to very-high risk pulmonary embolism, and it is not known if retrievable vena cava filters reduce mortality or reduce recurrence of nonfatal pulmonary embolism or if complications of vena cava filters outweigh the benefits in such patients.

Shorter, easier-to-read sentence:You are being asked to be in the study because you have had a pulmonary embolism (clot that goes from your legs to your lungs).

Make This More “To-the-Point”

The goal of the tissue bank or repository is to support theLSUHSC-S Dept. of Surgery research in order to improveour understanding of those molecular factors thatcontribute to cancer and that may lead to prevention,early detection, and cure.

For example:The goal of this research is to learn what makes cellsturn into cancer.

Writing Tips to Improve Reading Ease• Use active (not passive) voice

• Break text into manageable chunks (“lump & clump”)

• One idea per short paragraph

• Limit paragraph to 3-4 lines

• Aim for ≤ 8th grade

• Average education level of US adults ≥ 12th grade yet average reading level is ~ 8th grade

Clump Information in Manageable Chunks

• This is a research study. You are being asked to take part because you have COPD (chronic obstructive pulmonary disease).

• There are not many ways to treat COPD. New medicines are needed to improve patients’ ability to breathe better especially during exercise.

• This study will test a new medicine (inhaled iloprost) to help you breathe easier. It is a mist which you breathe in (inhale) using an inhaler (nebulizer).

• The FDA has said it is ok (approved) to use with patients with high blood pressure in the lungs. The FDA has not said it is ok (approved) for COPD.

• It is being tested because it may help you breathe easier.

6th grade level

Shorten Paragraphs –One Idea Per Paragraph

Too much (9 lines):You are being asked to take part in this study because you have prostate cancer that is only partially responding to hormone therapy. Abiraterone acetate is a hormonal tablet that has been approved by the Food and Drug Administration (FDA) for more advanced prostate cancer patients who have received chemotherapy. It is considered investigational for your type of prostate cancer. We will be looking to see if abiraterone acetate improved the effectiveness of standard hormonal shots or injections. (The prostate specific antigen (PSA) is a blood test used in prostate cancer screening and also to follow prostate cancer. In this study, we will follow your PSA level to help determine if abiraterone acetate is beneficial. The main goal of this study is to see if abiraterone acetate with prednisone reduces PSA.

4-line paragraph:You are being asked to take part in this study because you have prostate cancer. Researchers at X hope to learn if a hormonal tablet (abiraterone acetate) is helpful with prostate cancer. The effect of the prostate cancer will be measured by a blood test (prostatic specific antigen or PSA).

Use Bullets, Lists, and Less Text

Clean Layout Improves Reading Ease

• White space

• Bullets, lists

• Bolding

• Simple headers

• Short Sentences• Break text into manageable

chunks (“lump & clump”)

• One idea per short paragraph

• Limit paragraph to 3-4 lines

Develop Content from Patient’s Perspective

• Use conversational tone

• Get to the point

• Make key messages easy to pick up

• Focus on need to know and do vs. nice

to know

• Use pictures to help convey message

• Get patient and provider input

Improve Risk CommunicationProvide both positive and negative frames.

• “6 in 10 men who have surgery to treat prostate cancer will be impotent. This means 4 in 10 will not.”

Give absolute estimates - not relative.• Drug X could reduce your risk of breast cancer by 50% (relative)• Drug X could reduce your 5-year risk from 4% to 2% (absolute)

Sheridan (2003 J Gen Intern Med) found: • When benefit expressed in relative terms - 57% of patients chose to take

drug.• When benefit expressed in absolute terms - 15% chose the drug • 16% were indifferent

Controversy about Absolute vs. Relative Risk

• Changes in risk appear larger when presented using relative vs absolute.*

• Relative risk can inappropriately lead patients to believe treatment is more effective than it is.*

• Physicians are more likely to recommend treatment if information was presented using relative risk.**

*Forrow L, et al., Am J Med, 1992; Barron J, J Risk Uncertain, 1997; Akl E, et al., Cochrane Database Syst Rev, 2011; **Chao C, et al., J Clin Oncol, 2003; Bobbio M, et al., Lancet, 2007;

Remember Tables require math skills

Reading a table requires:• Understanding rows and

column headings

• Selecting the right row + column of interest

• Locating the cell at that intersection

• Scanning up and down and back and forth repeatedly

Study Week Screen Screen 1 1 1 2 2 3

Study Day

Assessment

Aa Bb 1c 3±2

℗

7±3 10±2

℗

14±3 21±2

℗

Informed consent X

Inclusion/exclusion X X

Demographic Questions X

Medical history X

Prior & current medications X X X X X X X X

XXX medications X X X X X X X X

Vital signs X X X X X

Physical exam X X X XWeight in clinic X X X X

Weight at home X

X X X X X

Receive weight diary X X X

Review/ return diary X X X X X

RecommendationsMake no assumptions about understanding.

Make the implicit explicit

Ask open-ended questions to assess for understanding

Tailor information for the patient. What is their understanding of the risks of their disease, treatment, etc.

Reinforce important messages.

Confirm comprehension

Simplify numerical concepts

Teach Back is Effective Tell me in your own words:

• Goal of the Research and Protocol• “Why are we doing this research?” “What is the study

about?”• “What will you be doing if you agree to be in this

study?”

• Benefits and Compensation • “Will being in this study help you in any way?”

• Risks• “Is there anyway being in this study will be bad for you

or hurt you?”

• Voluntariness• “Can you decide you do not want to be in the study?”• “Will that change your healthcare?”

AHRQ, 2008

• All patient materials need to be written in plain language and formatted for reading ease.

• Our health information and websites need to be understandable, actionable and developed with input from patients.

• Pictures can help convey key messages.

• Message needs to focus on the patient and their need to know and do and the benefit as opposed to focus on the disease or the study.

• On going support “touch points” are needed to help patients improve health behavior and outcomes.

• Confirm understanding using ‘teach back’.

• Consent is always an ongoing process. The consent form is just one piece of the pie.

Health Literacy Recommendations