The PRISM Toolkit: A Strategy for Improving Consent Form Readability

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The PRISM Toolkit A Strategy for Improving
Consent Form Readability

• caBIG Data Sharing Intellectual Capital
  Meeting
• January 22-23, 2007 ? Philadelphia, PA
• Sarah M. Greene, MPH
• Group Health Center for Health Studies

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Presentation Overview

• Health Literacy and the Birth of the CHS PRISM
  Project
• About the PRISM Readability Toolkit
• Examples Applying PRISM to Informed Consent
  Materials
• Uptake and Insights about Remaining Work

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Health Literacy the Birth of PRISM

• PRISMs humble, grass-roots origins
• Initial idea experienced research assistant and
  editor tasked with identifying best study
  materials (consent forms, recruitment letters) in
  use at our Group Health Center for Health Studies
  (CHS) and opportunities for improving, creating
  templates
• Readability emerged almost immediately as the
  primary area of concern.
• Discovered that consent forms rarely met IRBs
  8th grade reading-level target
• Analysis of study materials from 32 studies
  fielded from 2000-2005
• Average reading level was 11.2
• Nearly one-third of consent forms were at 12th
  grade or higher
• Coincident with the IOMs report Health
  Literacy A Prescription to End Confusion
• Opportunity to leverage broader focus on HL
  within the context of our work

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PRISM Project to Review Improve Study
Materials

• The PRISM Readability Toolkit - Contents
• How this Toolkit Can Help You
• What You Should Know Before Using this Toolkit
• The Principles of Plain Language
• How to Determine Reading Level
• Quick Reference Guide for Improving Readability
• Editing Checklist for Participant Materials
• Resources for Informed Consent Documents
• Resources for HIPAA Authorization Documents
• Other project components
• Customized workshops and ongoing dissemination
• Plain language editing service to ensure
  readability

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Key PRISM principles

• Readability is more than just using simple
  wordscommunicating clearly in writing entails
  the use of
• A conversational writing style including active
  voice, 1st person
• Short simple sentences and paragraphs, steering
  clear of jargon and medical terms as much as
  possible
• Reader-friendly formatting (white space, bold,
  bullets, etc.)
• Keeping readers needs in mind as material is
  organized presented
• Most important info first, steps in a research
  study presented chronologically
• This last bullet can be tricky
• Especially with consent forms, IRBs, study
  sponsors, or risk management folks may stipulate
  how and in what order information is presented

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Strategies and Tactics Used in PRISM

• Reading materials aloud
• Having an unfamiliar (preferably non-research)
  person read materials
• Use Microsoft Words built-in readability
  calculator for
• Flesch-Kinkaid (reported as a grade level)
• Flesch Reading Ease (reported as a value 0-100)
• of passive-voice sentences
• Use visual aids as appropriate to explain complex
  concepts
• Use road signs to help reader navigate
  (bullets, headers, format)
• Dont fear the white space

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PRISM Toolkit Consent Form References

• Consent form templates
• University of South Florida
• Johns Hopkins
• Guidelines for developing consent forms
• University of Illinois at Chicago
• Association of American Medical Colleges
• Helpful HIPAA authorization templates
• University of California (system wide)
  stand-alone HIPAA template
• Seattle Childrens Hospital Research Institute
  stand-alone HIPAA template
• University of South Florida stand-alone HIPAA
  template, and HIPAA language within the consent
  templates
• Johns Hopkins University HIPAA language within
  the consent template

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PRISM Principles in Action Before After
Examples (1)
If you agree to participate, we will arrange a
screening interview with you at our research
clinic. During this interview, you will be asked
to do some tasks that measure your thinking and
problem-solving abilities and answer questions
about your medical history and occupational
history. If you are willing, a trained technician
will obtain a blood sample of approximately two
tablespoons. This visit should take approximately
two hours. If you are eligible to participate in
the study, every two years we will repeat the
initial assessment procedures at the Center for
Health Studies, and we will periodically review
your medical record to see if there is a change.
If you agree to be in the study, we will invite
you to an interview at our research clinic.
During this interview, we will ask you to do some
tasks that measure your thinking and
problem-solving abilities. We will also ask you
questions about your medical and work histories.
If you are willing, we will take a blood sample
of about two tablespoons. This visit should take
about two hours. If you are eligible for the
study, we will ask you to come in for a similar
interview and blood draw every two years. We will
also check your medical record from time to time
to see if there is a change.
Original 13.2 Revised 7.2
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PRISM Principles in Action Before After
Examples (2)

• By signing this form, you consent to (authorize)
  the use of health information from your Group
  Health medical records needed for this study,
  which would include your use of health care
  services such as number and types of medications,
  clinic visits, laboratory test results and
  hospitalizations. Some of the information
  collected will be about mental health medications
  and visits. We will collect this information for
  a period of one year before your first telephone
  survey date and one year after your first
  telephone survey date.

• If you sign this form, you are authorizing us to
  use health information from your Group Health
  medical records for this study. This means you
  are giving consent for us to collect some
  information from your medical records. We will
  not look at your entire medical record. Instead,
  we will use a computer to collect information
  about your use of health care services,
  including
• number and types of medications.
• clinic visits.
• lab test results.
• trips to the hospital.
• mental health medications and visits.
• We will collect this information for a period of
  about two years, starting one year before your
  first phone survey and ending one year after.

Original 14.8 Revised 6.5
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17-page patient-friendly word list Useful, if
labor intensive to create!
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Impact at Our Research Center Data from the
PRISM Editing Service

• Reviewed grade levels of consent forms, letters
  and other materials before and after the PRISM
  in-service edited between October 2005 - October
  2007

Among 51 unique materials Before editing 9.8 (range 6.6 - 14.1) After editing 7.7 (range 5.3 10.3)
Among 19 consent forms Before editing 10.6 (range 7.8 14.1) After editing 8.6 (range 6.9 10.0)
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Interfacing with our IRB

• Resounding endorsement from IRB administrator
  members
• Investigators/project teams (especially those
  external to our research center) are strongly
  encouraged to use PRISM editing service as a
  means of ensuring IRB approval
• Still, this has not completely precluded consent
  form editing by the IRB, occasionally with
  negative impact on readability

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Uptake

• PRISM dissemination to research and
  clinically-oriented personnel
• Local Regional Workshops, Toolkit Distribution
• Multiple in-house trainings for staff faculty
• Sparked wider interest Plain Language
  initiative in Group Health
• University of Washington
• Fred Hutchinson Cancer Research Center
• Puget Sound Health Alliance
• Seattle-King County Public Health Department
• Nationally featured resource at conferences,
  other web sites
• NHLBI
• Americas Health Insurance Plans
• NIH Roadmap/NECTAR contractors
• PRIMR Human Research Protections Conference

So what???
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Creating a culture of health literacy within the
research enterprise

• Providing evidence or a business case that
  resonates with researchers, leaders and
  end-users.
• Evidence could include proven improvement in
  study participant/patient comprehension,
  satisfaction, or medication adherence.
• The business case could include fewer calls to
  study coordinator (in research setting) customer
  service (in healthcare) or decreased costs
  related to medication or treatment errors.
• In our research setting, we hope to mount a study
  which demonstrates that PRISM-ified materials
  result in higher recruitment rates, retention and
  lower costs since recruitment is completed more
  effectively and efficiently
• Our success was driven in part by accessible,
  simple resources, an internal champion with
  leaderships support, data, and early wins

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Still Much Work to Be Done

• Even in our own shop, where PRISM took root and
  flourished, its inordinately difficult to change
  old habits researchers are accustomed to
  writing for their peers on study sections and
  journal editorial boards, and using materials
  that have worked on bygone studies
• To get to health literate consent forms, our
  strategy has included
• A product (the PRISM Toolkit)
• A person (the in-house editing team)
• A culture change (leadership, IRB,
  organizational buy-in)
• Weve created awareness, built skills among our
  staff, and have a centralized resource.
• Readability is on the radar screen, but not quite
  embedded in everyones DNA

Each of these is necessary, but probably not
sufficient
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Thank you!

• Contact us at prism_at_ghc.org