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Étude De Faisabilité Pour L'étude Longitudinale
Canadienne Sur Le Vieillissement (ELCV)
Exploration Des Attitudes Sur L Incapacité
Mentale Et Participation À Long Terme
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• Feasibility Study for the Canadian Longitudinal
  Study on Aging (CLSA)  
• Exploring Attitudes about Mental Incapacity and
  Long Term Participation
• Dr. Linda Furlini
•  

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OUTLINE

• Overview of the CLSA
• Introduction to Feasibility Study
• Emerging questions
• Background
• Main Objectives
• Proposed Methodology
• Anticipated Results

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Overview of the CLSA

• Examine aging as a dynamic process
• Successful aging
• Broad , multidisciplinary long term
  observational
• study
• Study involves no experimentation
• Variety of data collection methods
• Information collected on the changing
  biological, medical, psychological, social,
  and economic aspects of
  older Canadians.

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Overview of the CLSA

• REQUIRES THE LONG TERM PARTICIPATION OF
  PARTICIPANTS
• 50,000 Canadian women and men aged 40 to 84
  living in the community
• followed for a period of at least 20 years
• not cognitively impaired at baseline
• Repeated assessments
• Every 3 years, until age 80
• Yearly thereafter
• Linkage to databases

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Overview of the CLSA

• 50,000 individuals will be interviewed with
  questionnaires administered over the phone or in
  person
• Subgroup of 30,000 individuals selected to
  undergo in-depth assessment over the course of
  the study
• Remaining 20,000 participating primarily through
  telephone interviews

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Data Collection Sites

• NFLD
• Nova Scotia
• Québec
• Ontario
• Manitoba
• Alberta
• BC
• St. Johns
• Halifax
• Sherbrooke Montréal
• Ottawa Ham/GTA
• Winnipeg
• Calgary
• Vancouver Victoria

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Introduction

• CLSA researchers will face particular
  challenges
• Participants must provide ongoing informed
  consent for a period of not less than twenty
  years.
• Emerging questions
• Relevant and important to most long-term
  observational studies involving older adults

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Emerging questions

• If mental incapacity develops
• Can researchers use data for purposes that were
  unforeseen at the time participants provided
  Informed Consent (IC)?
• Can researchers continue to collect data from
  mentally incapacitated participants?
• Will they be permitted to continue using data
  that have already been collected?

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Objective

• THE MAIN OBJECTIVE OF THIS FEASIBLITY STUDY IS
  TO DETERMINE HOW POTENTIAL CLSA PARTICIPANTS
  PERCEIVE ONGOING INFORMED CONSENT IF MENTAL
  INCAPACITY DEVELOPS

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Background

• Mental Capacity to provide Informed Consent
• Aging significantly increases likelihood of
  suffering from diseases that affect mental
  capacity to provide informed consent,
  particularly dementia
• Current incidence considerably underestimated
  (Canadian Study on Health and Aging Working
  Group, 2000)
• Prevalence will be magnified by aging baby
  boomers
• Older persons may be affected by a variety of
  other conditions and diseases, such as mental
  illness
• Some conditions may be transient, such as
  recovering from a stroke

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Risks of Participation

• Participants will receive little or no personal
  benefit
• A tendency to focus on risks in studies, such as
  the CLSA, where participants receive little or no
  personal benefit
• Potential risk Threat to personal privacy
• (Data collection, data linkage, data storage,
  future uses of DNA samples)
• Researchers face unique challenges in monitoring
  potential risks and conveying such information to
  participants

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Risks of Participation

• Future advances in research may introduce risks
  that are unforeseeable at the inception of a
  study
• Unforeseeable risks take on greater importance
  when participants become mentally incapacitated
• Unable to contribute to decisions about personal
  privacy that may have far-reaching effects
• An appreciation of public attitudes about the
  risks of participation in LOR is needed

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Substitute Decision-Making

• Substitute Decision-Makers (proxies who will
  answer for the participant in the event of mental
  incapacity)
• Legislation varies from province to province
• In Québec, substitute decision-makers are
  required for experimental research and their
  legal status remains ambiguous for research
  involving minimal risk
• Current laws do not specifically address LOR
  involving minimal risk
• Little is known about the willingness of
  participants to appoint SDMs or what their
  appointment may entail.

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Substitute Decision-Making

• Usually family caregivers
• Possess health data that would be inaccessible
  were they not involved
• May contribute to the reliability of participant
  information
• Facilitates patient tracing
• Involving Substitute decision-makers reduces
  attrition

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Substitute Decision-Making

• Researchers must be attuned to their specific
  needs and how to meet them
• Attrition is reduced when caregiver-centered
  approaches are used
• Further exploration is required about caregivers
  specific needs as SDMs

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Caregivers and SDM

• Past research
• Diagnosis
• Gray Zone
• Ethical tensions

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Substitute Decision-Making

• Lack information about
• information gathered about them and developments
  of new technology
• substitute decision-making
• Resources
• Educational needs

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Substitute Decision-Making

• Means to appoint Substitute Decision-Makers
• Advance Directives (e.g. Mandat en cas
  dinaptitude, Procuration)
• Legal document allowing participant to appoint a
  substitute decision-maker for health purposes,
  including research
• Research Advance Directives (specifically for
  CLSA)
• Informed Consent Form allowing participant to
  appoint a substitute decision-maker at inception
  of the study for purposes of the research only
• Research Study Advocates
• Consent Form allowing participant to appoint
  professionals with some expertise in substitute
  decision-making

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CANADIAN LONGITUDINAL STUDY ON AGING (CLSA)
INFORMED CONSENT PROCESS
CLSA PARTICIPANT
PARTICIPANT BECOMES MENTALLY INCAPACITATED

• OVER TIME MENTAL INCAPACITY DEVELOPS
• possible age-related diseases affecting mental
  capacity to provide informed consent

EVALUATE RISK OF PARTICIPATION
MINIMAL RISKS
(non invasive)
PRIVACY CONFIDENTIALITY (DNA, data linkage,
etc.)
Incapable of providing informed consent

• ALZHEIMERS
• VASCULAR DEMENTIA
• MENTAL ILLNESS

OPTIONS
SUBSTITUE DECISION MAKER MECHANISM OF INFORMED
CONSENT
WITHDRAWS
REMAINS IN STUDY
RESEARCH ADVANCED DIRECTIVES
RESEARCH STUDY ADVOCATES
ADVANCED DIRECTIVES
NO FOLLOW-UP INFORMATION AVAILABLE
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Public Engagement

• Public Engagement
• The perspectives of potential participants and
  substitute decision-makers are needed
• to help identify problems
• to reduce confusion about the CLSA
• to ensure public trust

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Need for Feasibility Study

• Little is known about how Canadians view
  providing informed consent if mental incapacity
  develops during the course of a longitudinal
  observational study

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Main Objective Of Feasibility Study

• EXPLORE HOW POTENTIAL CLSA PARTICIPANTS PERCIEVE
  ONGOING INFORMED CONSENT IF MENTAL INCAPACITY
  DEVELOPS.

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• Questions under study include
• Would Canadians enrolled in the study be willing
  to participate if they became mentally
  incapacitated during the course of the study?
• Who will make decisions about this study on their
  behalf?
• If substitute decision-makers are used, how will
  they be appointed? What will be their roles and
  responsibilities?
• What are the risks of participation (e.g., due to
  developments in technology, data and/or stored
  biological samples that may be used for purposes
  that were unforeseen when the study began).
• What types of information do participants or
  their substitute decision-makers need to
  encourage ongoing participation?

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Proposed Methodology

• QUALITATIVE
• Focus groups and interviews
• Participant recruitment
• Potential Participants
• Potential Substitute decision-makers

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• Proposed Methodology
• Complementary Analytic Strategies
• (Maxwell Miller, 1996)
• Categorization (Constant Comparison)
• Contextualization

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• Categorization
• Common elements of experience and group them into
  conceptual themes
• Contextualization
• Uniqueness of experience and specific context

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• Anticipated results will help
• Appreciate attitudes regarding ethical issues
  involving mental incapacity, consent, substitute
  decision-making, risks of participation, threats
  to personal privacy, and the content and quality
  of relevant information provided to the study's
  participants
• Identify and address challenges to retaining
  participants in the CLSA, thus ensuring its
  success