Obtaining Informed Consent for Research Participation from Older Adults

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Obtaining Informed Consent for Research
Participation from Older Adults

• Marianne Shaughnessy, PhD,CRNP
• Baltimore VA GRECC

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Informed Consent

• Informed Consent is a Process
• The form to be signed is the document!
• Obtaining informed consent from any potential
  study subject involves the same process, but
  there are special considerations for vulnerable
  populations, including the elderly.

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Informed

• Subjects must be informed regarding
• Purpose of the study
• Duration of involvement
• Risks and Benefits
• What participation will involve
• Costs
• Confidentiality

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Consent

• Subjects participation must be voluntary
• No coercion, duress
• Must have legal capacity to give consent
• Sufficient comprehension of study purpose and
  requirements

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Common Problems with consent process

• variable presentation of the content
• consent forms too complicated
• subjects hesitation to ask detailed questions
• difficulty verifying subjects comprehension

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Issues with older adults

• Many older adults experience decreases in
• Visual acuity
• Auditory acuity
• Cognitive status
• That may impair attention and/or comprehension of
  protocol

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Visual changes

• Presbyopia
• Cataracts
• Glaucoma
• Macular Degeneration
• Retinopathy

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Compensating for visual changes

• Use color contrast
• Control glare
• Increase light levels
• Use large print, pictures or graphics when
  possible
• Allow extra time

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Auditory Changes

• Conductive hearing loss
• sound waves not conducted to the inner ear
• All sounds seem muffled and faint
• Sensorineural hearing loss
• Sound waves reach inner ear, but not properly
  transmitted to the brain
• Presbycusis

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Compensating for auditory changes

• Talk face to face, dont shout
• Eliminate/reduce background noise
• Speak distinctly, enhance speech through visual
  aids
• Re-word messages as needed
• Use assistive listening devices
• Allow time to respond

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Cognitive Changes Impairment

• Multiple potential causes
• Minimal screening done in community
• If index of suspicion is high for target
  population consider cognitive screen
• GCP have a referral plan

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Cognitive screen instruments

• Folstein Mini Mental State Exam (MMSE) cutoff
  24/30
• Sens 50-87 PV 60-93
• Spec 90 PV- 77-95
• Short Portable Mental Status Questionnaire
  (SPMSQ) - cutoff 4/10
• Sens 50-82 PV 90
• Spec 90 PV- 70-80

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GRECC Metabolic Procedures

• Multiple studies with older adults participants
• Complex metabolic testing procedures designed to
  educate/remind patients about testing procedures
• Can also be used for informed consent

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GRECC Metabolic Procedures - OGTT

• Learning about your bodys ability to control
  blood sugar levels

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What is an OGTT?

• An OGTT is short for oral glucose tolerance test.
  It measures your blood sugar and insulin levels
  before and after you drink a very sweet drink.
  This test is often used to diagnose diabetes. In
  research studies it is used to determine how well
  your body uses glucose and how well your body
  makes and uses insulin.

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Before the Procedure

• Do not eat or drink anything except water for 12
  hours before the test.
• Bring all of you regular morning medications with
  you.
• The dietician will give you instructions about
  what you should eat the day before

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Before the Procedure

• When you arrive on the unit, you will be weighed,
  your blood pressure will be taken and you will
  sit in a comfortable chair.

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The OGTT Procedure
First, an IV line will be started in your arm
(near your elbow)
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This is a close up view of the blood drawing
apparatus used in this test
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Next, a few baseline blood samples will be drawn
from the IV line
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Following the initial blood draws you will be
asked to drink a bottle of a substance that
resembles orange soda
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The nurses will pour the orange beverage it into
a cup and request that you finish it within a
10-minute time period
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After finishing the orange drink, blood samples
will be taken every 30 min. for 3 hours.
Those samples will be stored on ice and later
analyzed for levels of glucose and insulin
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By keeping track of your blood sugar and insulin
levels for 3 hrs. we will be able to determine
how quickly and efficiently your body disposes of
the sugar you drank. This is a good test for
determining your diabetes risk, or if you already
have a mild form of the disease.
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After the OGTT

• When sampling is complete, the IV will be taken
  out and a band-aid placed over the site, which
  you may remove after one hour.
• Very rarely, there may be some irritation at the
  IV site. If this happens, and the site becomes
  tender and warm, put warm compresses on it and
  call us.

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After the OGTT

• You will be given a light breakfast after the
  test.
• You may feel dizzy and hungry after the test. If
  this happens, eat or drink something sweet (with
  real sugar in it) such as a small piece of candy
  or some fruit juice, then eat something starchy,
  such as a piece of bread. If you do not feel
  better shortly, call us.

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We hope you have a pleasant experience today in
the Metabolic Lab!
The Nursing Staff
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Take Home Messages

• Use a quiet, private place
• Be clear in communications
• Be on lookout for cognitive impairments
• Break information down into small components
• Use multimedia to standardize, simplify consent
  process
• Provide written materials
• Answer all questions thoroughly
• Be prepared to explain it again

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References

• Brady, JS Multimedia Delivery Can Enhance the
  Consent Process, Applied Clinical Trials,
  January 2003, 36-42.
• Fried, E. (2002). Clarifying the Ethics of
  Clinical Research A Path Toward Avoiding the
  Therapeutic Misconception, American Journal of
  Bioethics, 2 (2), 22-23.
• Pfeiffer, E. (1975). A short portable mental
  status questionnaire for the assessment of
  organic brain deficit in elderly patients. J Amer
  Geriatrics Society, 23, 433-441.
• Folstein, MF, Folstein, SE, McHugh, PR (1975).
  Mini Mental State a practical method for
  grading the cognitive state of patients for the
  clinician. J Psychiatr Res, 12, 189-98.
• Lavelle-Jones, C, Byrne, DJ, Rice, P et al.
  (1993). Factors affecting quality of informed
  consent. BMJ, 306, 885-90.
• Kirsch, I, Jungblut, A,Jenkins, L, et al. (1993).
  Adult literacy in America a first look at the
  results of the national adult literacy survey.
  Washington, DC National Center for Education, US
  Dept of Education.