strengthening provider patient communication skills in clinical trials

STRENGTHENING PROVIDER PATIENT COMMUNICATION SKILLS IN CLINICAL TRIALS

About ENACCT

A non-profit organization founded in 2004

Our Mission: To improve access to cancer clinical trials through education and collaboration with communities, health care providers, and researchers

We seek to increase cancer clinical trial participation and access to quality care for all cancer patients—especially from underserved communities

Agenda

Accrual: Our perspective Consent- we know about that… Consent-A greater focus on comprehension

Literacy and Language Cultural Competency: Creating a Patient Centered

Consent Process

Trying on some new ways to explain old concepts

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ENACCTs Perspective on the “accrual problem”4

What Will it Take to Accrual?

While numerous challenges face clinical research, often overlooked are challenges related to ineffective and/or inefficient operational procedures community relationships Physician/research staff communication

with patients

National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. 2010. Institute of Medicine of the National Academies; Ford, J.G., et al. (2005). Evidence Report: Technology Assessment (Summary), (122) 1-11; Wendler D., PLoS Med, Feb;3(2):e19. Epub 2005; Ulrich CM, James JL, et al Contemp Clin Trials. 2010 May;31(3):221-8; Comis RL, et al. J Oncol Pract. 2009;5(2):50-6

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© 2013 ENACCT Inc. All Rights Reserved

Increasing Accrual is Based on a Conversation Between Providers & Patients, But…

1. How can we get more of these conversations to take place?

2. How can we ensure quality patient-provider communication around

consent, especially for ethnic and racial minority groups?

1 eligible and interested patient

Pt 3

Pt 1Pt 2

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Addressing Quality of Care

“Therapies offered through CCTs should ideally be considered the preferred treatment choice for physicians and patients, if they are available” NCCN, 2008

Physicians should “strive to make participation in clinical trials a key component of clinical practice and to achieve…high accrual rates of 10% or more. (Institute of Medicine, 2010)

COC 2015 Accreditation Guidelines

Participation in Cancer Research as Quality Care

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3% vs. 20%: What’s Going On?

Low rates of participation 3% of all adults when approximately 20% are eligibleEven fewer minority, elderly and rural

populations CCTs are quality cancer care but often considered

apart from standard treatment

So how many patients are we missing?

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Christian, M. C., & Trimble, E. L. (2003).. Cancer EpidemW iology Biomarkers & Prevention. 12: 277s-283s. Cancer clinical trials: A resource guide for outreach, education, and advocacy. (2006). Retrieved from the NCI web site ; Digest Page: Boosting Cancer Trial Participation. (2008). Retrieved from the NCI web site ; Brawley, O. (2004). Journal of Clinical Oncology. 22(11): 2039-2040. Murthy, V,H. et al (2004). JAMA. 291(22):2720-6.; Stewart et al. (2007). Annals of Surgical Oncology. 14(12):3328–3334; Dilts, D. (2008). Personal correspondence; February 2, 2008.

Addressing Disparities

IOM: increasing clinical trial participation among minorities can impact health disparities

Addressing issues of diversity and representation

affects study results NIH, FDA mandates

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Participation in Cancer Research: A Call to Action

1. Total census of patients of patients treated is closely matched to the demographics of the clinic’s catchment area

2. CCTs selected for local implementation will more appropriately meet the needs of local patients

3. 100% of patients starting treatment will be effectively screened for CCT eligibility

4. 100% of eligible patients will be offered CCT participation

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Quality Improvement Goals toIncrease Cancer Trials Accrual


Quality Improvement Goals toIncrease Cancer Trials Accrual5. Normalization of CCTs through effective internal,

external communication6. All patients interested in participation will have

their information, knowledge and behavior needs met through the consent process

7. All enrolled patients will receive adequate support to ensure their compliance and retention throughout the CCT

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Consent Process: What we “know”12

Informed Consent Process

The purpose of the trial What will happen during

the trial The risks and potential benefits Their individual rights

Must Explain to Participants…

Components Affecting Consent

Optimal Consent Process

Limited English

Values

Ethnicity

Desire for info

Physical Stress

Culture

Emotional Stress

Comprehension

Learning Style

Health Literacy/Literacy

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Why it Matters

Overreliance on the consent form rather than the process Exclusive use of “Take it home” procedure to assess

understanding

Inadequate assessment of comprehension Difficulty addressing multitude of patient needs in

context of clinical trials

Most people who participate in research do not understand common medical and research terms

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Key Factors Around Optimal Consent Process Written and verbal communication using plain

wording, and delivered in the language of the patient

Clinical encounters that are patient-centered and meeting literacy, language and cultural needs of the patient

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Health Literacy and Limited English Proficiency: Their Impact on Cancer Clinical Trials

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Definition of Health Literacy

“The degree to which individuals have the capacity to obtain, communicate, process, and understand basic health information and services needed to make appropriate health decisions.”

- Affordable Care Act

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What is Health Literacy?

Skills in: Reading Writing Basic Math Speech Comprehension

Capacity to: Obtain Process and Understand Basic

Health Information

Relies on cultural/conceptual knowledge

Literacy Health Literacy

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Percentage of US Adults in Each Health Literacy Category

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Percentage of adults in each health literacy level, by race/ethnicity, 2003

14 9 2441

13 259

22 19

3425

1823

28

53 58

41 31

5245 59

12 14 2 4 18 7 3

0%

20%

40%

60%

80%

100%

TotalWhiteBlack

Hispanic APIAI/A

NMultir

acial

ProficientIntermediateBasicBelow Basic

Prevalence & Disparities

Source: NAAL

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DVD: Health Literacy

AMA Health Literacy Kitwww.ama-assn.org

Weiss B et al. American Medical Association (March 2003)


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Health Literacy Equation: Consider Impact with Clinical Trials

Skills/Abilities x Difficulty/Complexity = Health Literacy

X =

Potential “Red Flags” for LowHealth Literacy Doesn’t ask questions Says he/she forgot glasses Incomplete forms Missed appointments

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Weiss 2003, Katz et al 2007


The Form Itself

Large fonts, short lines, lots of white space, bulleted lists, and chunked text with headings make documents easier to read

New NCI Template

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Resource: The PRISM Readability Toolkit

An 81‐page handbook for researchers illustrating how to use plain language in consent forms and other study materials.

Background information on health literacy & readability, template language for consent forms, an extensive alternative word list, several before‐and‐after examples, and more!

Download a free PDF at www.tinyurl.com/prismtoolkit

PRISM Online Training: http://prism.grouphealthresearch.org

Who are Patients with Limited English Proficiency? Individuals who do not speak English as their

primary language and who have a limited ability to read, speak, write, or understand English

Over 8% of U.S. residents - 21 million people - do not speak English well

In 4.4 million households – 11.9 million people – no one speaks English very well

US Census

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Patients with LEP and Trials

Many are overlooked May have harder time reading and understanding

health-related information, even in own language IRBs provide little guidance regarding inclusion of

LEP patients in research Anticipate and prepare language access needs for LEP

patients BEFORE they walk through the door Appropriate translation of written materials AND use

of interpreter services are both KEY

OHRP approved “short form”

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Patients with LEP and Trials

HHS Guidance: OBTAINING AND DOCUMENTING INFORMED CONSENT OF SUBJECTS WHO DO NOT SPEAK ENGLISH

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Maintain focus on the patient and watch for cues of understanding/confusion

Must comply with confidentiality guidelines Family members should not serve as interpreter Even trained interpreters may not understand

nuances around trials NOTE: Research staff is still in charge of consenting

process; interpreter is merely the means of communicating with the patient

Patients with LEP and Trials-Working With Interpreters

Adapted from A Physician’s Practical Guide to Culturally Competent Care, available at https://www.thinkculturalhealth.hhs.gov/


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Use plain language Encourage interpreters and patients to interrupt

when they do not understand and make every possible attempt to simplify and clarify

Respect professional boundaries and abide by the code of ethics of interpreters

Recognize that sight translation requires a different order of skills

Working With Interpreters: Things to Remember


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Working With Interpreters: Things to Remember

Do a pre-session with the interpreter, directing them to interpret in the first person

Interpreter should be seated or standing next to the patient.

The provider should face the patient so that they have direct eye contact with each other

Ira SenGupta, CCHCP


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Ensuring Understanding During Consent (for everyone)

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Worst Question to Ask to Check Understanding

Do You Understand?

Adapted from Health Literacy Introductory Kit (AMA, 2003)

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Tips to Enhance Understanding During the Consent Process Improve verbal communication

• Speak slowly and use clear, simple language• Use the “teach back” technique • Use the “chunks and checks” technique• Discuss specific behaviors (what the patient will do)

Complement and modify written language• Consider using pictures, flow charts, models, or other

graphics to supplement the spoken word • Use translated forms

Adapted from Health Literacy Introductory Kit (AMA, 2003)

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Tips to Enhance Understanding During the Consent Process (cont’d) Create a shame-free environment

• Look for clues of low literacy and react non-judgmentally

• Offer help with paperwork• Read materials aloud • Give permission to ask questions

Use available resources• Offer the opportunity for family and friends to be

with patients during discussions• Language line, interpreters

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Sample Scripts to Assess Comprehension I want to make sure I explained everything clearly. If

you were trying to explain what you’re doing in this study to a family member, what would you say?

Let’s review the main side effects...what are the two things I asked you to watch out for?

What questions do you have?

S. Titus et al., "Do you understand? An ethical assessment of researchers' description of the consenting process," J Clin Ethics 7 (1996): 60-8

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Sample Scripts to Assess Comprehension Tell me in your own words what this study is all about. Tell me what you think will happen to you in this study. What do you expect to gain by taking part in this

research? What risks might you experience by participating in

the research? What are your alternatives (other choices or options

to participating in this research)?S. Titus et al., "Do you understand? An ethical assessment of researchers' description of the consenting

process," J Clin Ethics 7 (1996): 60-8

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Patient-centered consent process39

What Is Patient-Centered Care?

“Providing care that is respectful of and responsive to individual patient preferences, needs, and value, ensuring that patient values guide all clinical decisions.” (Institute of Medicine. Crossing the Quality Chasm, 2001)

“Quality healthcare achieved through a partnership between informed and respected patients and their families and a coordinated healthcare team.” (National Health Council. http://www.nationalcouncil.org/initiatives/putting_patients.htm)

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Patient-Centered Factors Affecting Optimal Decision Making Emotional, Physical, Cognitive Overload +

decisional conflict

Ineffective Patient- Provider Communication Different cultures and values Different learning styles Low Health Literacy Limited English Proficiency


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What About Culture?

Culture is the customs, beliefs, values, knowledge, and skills that guide a people’s behavior along shared pathsLinton, R. The Study of Man. New York, NY: Appleton Press, 1947.

Not restricted to race or ethnicity!!

Linton R. The Study of Man (1947)

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What We See and What We Don’t 43


We Are All Complex Cultural Beings!

Complex Cultural Being

Language Color

Values

Ethnicity

Race

Sexual Orientation

Class

Ability/disability

Age

Health

Education

Economic Realities

Profession/work

Spiritual Beliefs

Health Literacy

Ira SenGupta, CCHCP 2006

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Learning Styles and the Consent Process

Visual Learner

Auditory Learner

Sensory Learner

Kinesthetic Learner

Adapted from: Teachers Make The Difference by Susan Kovalik

We learn best when there is a match between our preferred learning style and how new information is presented


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Patient Centered Communication Around Tx Decision-Making Assess patients needs and preferences Acknowledge emotions involved in decision-making Speak in simple language

Need to know vs nice to know at this time

Use graphic illustrations to help communicate risk (for ex. 100-person diagram)

Use of decision aids (booklet, facts sheets, websites, etc.) to help patient consider care options

Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. 2001; Charles C Gafni A, Whelan T.. Soc Sci Med.. 1999; 49: 651-661.;Charles C Whelan T Gafni BMJ 1999; 319: 780-782; Fagerlin A wang C Ubel PA. Med Descis Making. 2005; 25: 398-405; Timmermans D, Molewijk B, Stiggelbout A, Kievit J. Patient Edu Couns. 2004; 54: 255-263; Fuller R, Dudley N, Blacktop J. Postgrad Med 2002; 78: 543-544;Fuller R , Dudley N, Blacktop J.. 2001; 30: 473-476.

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Fostering a Partnership

Core communication skills and strategies for shared decision-making: Declare the agenda Endorse question asking Explore patient’s values and lifestyle through open

ended questions, clarification and validation Present a clear statement and summary Close the consultation

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Fostering a Partnership

o Partners in a joint venueo Shared enterpriseo Invitation to participate (participant vs. subject)o Practices that emphasize communication and

continuity are associated with higher levels of trust in physicians

How is trust experienced in a clinical context?

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Challenging Concepts: Randomization Public’s and patients’ preferences for

descriptions of randomization compared with clinicians’ own practice

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Jenkins V, Leach L, Fallowfield L et al British Journal of Cancer 2002 87(8) 854-858


Explaining Concepts: Titering

Clinical Trial vs. Standard Treatment

Use of Placebo

Answering the “guinea pig” question

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Documents

strengthening provider patient communication skills in clinical trials