Advisory Council January 2018 Meeting Presentation: Care Summit Report

01/26/2018

ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES

Friday, January 26, 2018

Printer Friendly Version in PDF Format (15 PDF pages)

 

Care Summit Report

Laura Gitlin and Katie Maslow

"State of the Science for Pragmatic Trials of Non-Pharmacological Interventions to Improve Outcomes among Persons with Dementia & their Caregivers"

National Institute on Aging
7201 Wisconsin Avenue, Bethesda, MD 20814
Friday, December 1, 2017

MEETING RECOMMENDATIONS

Meeting Information

  • Organized by the Brown University School of Public Health and Hebrew SeniorLife
  • Supported by an administrative supplement to Brown's NIA grant # P01AG027296-09S1
  • A Post-summit Activity of the 2017 "Research Summit on Care and Services for Persons Living with Dementia and Caregivers," which was sponsored by the Advisory Council on Alzheimer's Research, Care, and Services of DHHS

Meeting Goals

  1. Review the state of the evidence regarding the effect of interventions to improve care and outcomes for people with dementia and caregivers;
  2. Establish criteria for determining which interventions are ready for launch as pragmatic trials; and
  3. Consider the infrastructure necessary to prepare to conduct, translate, and disseminate such a program of research.

Rationale for Pragmatic Clinical Trials (PCTS)

  • Need evidence to inform decisions that lead to improved, efficient, and affordable care
  • Historical disconnect between research and clinical care
  • Shortcoming of traditional RCTs
    • Stand-alone settings to ensure validity
    • Non-diverse populations
    • Underpowered
    • Expensive
    • Not applicable to "real-world"
  • Move toward "learning health system"
  • Embed clinical trials into healthcare system
    • "Big data," connectivity, team-based care, systems engineering
  • Rapid feedback of evidence into clinical care and clinical care informs evolution of evidence
  • "Continuous learning at a lower cost"

Definition of PCTs

"PCTs are designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens, and risks of a biomedical or behavioral health intervention at the individual or population level" (Califf and Sugarman 2015)." http://www.rethinkingclinicaltrials.org/pragmatic-clinical-trial/what-is-a-pragmatic-clinical-trial-2/#references

Key Attributes

  Explanatory Pragmatic
Question Efficacy--can the intervention work? Effectiveness--does the intervention work in practice?
Setting Well resourced, "ideal" setting Normal practice
Randomization Usually individual level Usually clustered at practice unit
Participants Highly selected; individual consent Little selection; may waive consent
Intervention Strict enforcement and adherence monitoring Applied flexibly as in normal practice
Comparator Placebo/Non-treatment Real-world alternatives
Outcomes Short-term surrogate measures Directly relevant to stakeholders
Data Collection By researchers outside of clinical care By clinicians/administrators at point of care
Stakeholder engagement Not much, "top-down" driven by investigators/sponsors Input from varied stakeholders at all stages
Zwarenstein M, et al BMJ. 2008

State of the Evidence

  • Evidence of numerous effective programs
    • Designed to improve care for people with dementia
    • Targeting people with dementia or their caregivers
    • In all community and institutional care settings
  • Many appear suitable for testing as pragmatic trials in healthcare systems
  • However:
    • Few have been replicated under real-world conditions
    • Even fewer have been translated from research into practice by healthcare providers

Suggested Key Criteria for Pragmatic Trials

  • Implementation Protocol: Well-defined, standardized, replicable
  • Evidence: Some level of demonstrated intervention efficacy required
  • Risk: Minimal risk of potential adverse events or unintended consequences
  • Alignment: Addresses priority area for all key stakeholders
  • Acceptability: Need upstream "buy-in" from providers and health care systems.
  • Feasibility: Can be implemented by providers & systems under real-world conditions
  • Business case: Cost savings or improvement in quality metrics
  • Measurement: Outcomes are important to all stakeholders and will inform clinical and policy decision-making

Recommended Infrastructure

  • A robust research infrastructure for pragmatic trials to improve dementia care would accelerate the testing & dissemination of effective programs
  • Ideally, a support center with expertise related to:
    • Research methods, design & statistics
    • Data linkage & integration
    • Measurement, including data outcomes & data acquisition
    • Ethics, regulatory compliance & IRB protocols
    • Pragmatic trial training
    • Provider network relations & stakeholders
  • Because few studies are likely to be 100% ready, should include preliminary studies & pilot studies

Meeting Co-Chairs

  • Vincent Mor, PhD Vincent_Mor@Brown.edu
  • Susan Mitchell, MD, MPH smitchell@hsl.harvard.edu
  • Rosa Baier, MPH Rosa_Baier@Brown.edu

 

Research Summit on Dementia Care: Building Evidence for Services and Supports

Summit Update

Laura N. Gitlin and Katie Maslow

Summits and the Work of the National Plan

Time Line. Arrow which states Annual National Plan Update. 2012-AD Summit(1); 2013-ADRD Summit(1); 2013-AD in Down Syndrome; 2015-AD Summit(2); 2016-ADRD Summit(2); 2017-Care Summit(1); 2018-AD Summit(3); 2019-ADRD Summit(3); 2020-Care Summit(2).

Research Recommendations

Source Number of
Research Recommendations
Specific Source
Stakeholder groups 150 Persons Living with Dementia. 6
Family Caregivers. 27
Service Providers. 74
States. 32
Workforce. 6
Payers. 5
Cross-cutting chairs 14 Technology. 5
Diversity, including Women's Issues. 9
Plenaries 43 Context for the Summit. 11
Demographics. 20
Nomenclature. 12
Session Speakers 323 Session I. 71
Session II. 77
Session III. 16
Session IV. 20
Session V. 44 + Moderated panel discussion in the middle of Session V. 18
Session VI. 39 + Moderated panel discussion at the end of Session VI. 28
Day 3 synthesis from Chairs 47
(Many of these are combinations of recommendations from the session speakers.)
Session I. 10
Session II. 9
Session III. 5
Session IV. 4
Session V. 9
Session VI. 10
Recommendations from Pre-summits 56
(Many of these were presented by session speakers)
National Institute on Aging Pre-summit. 15
UC Davis Pre-summit. 12
National Alliance for Caregiving/Alzheimer's Association Pre-summit. 11
National Task Group Pre-summit. 4
PCORI Pre-summit. 14
Public Comments on the ASPE Website ~100 At least 100; there were also about 25+ comments that were not research recommendations.
Notes from audience participation during Summit ~ 50 Moderated discussion after Session I. 8
Moderated discussion after Session II. 10
Moderated discussion after Session III. ~ 14
Moderated discussion after Session IV. 10
Moderated discussion after Session V. 8
TOTAL ~ 680 This estimate assumes that likely duplicates between stakeholder group and session speaker recommendations balance out likely omissions created by not including any recommendations from the Day 3 meeting or the pre-summits in the total.

Organization of Recommendations

  • 11 Themes
    • Focus areas
      • Research recommendations
        • Specific recommendations

Summit Themes

  • Heterogeneity
  • Clinical Approaches and the Lived Experience of Persons with Dementia
  • Caregiver Relationships, Roles, and Networks
  • Comprehensive Models of Care Across Trajectories and Care Settings
  • Strategies for Scaling and Disseminating Existing Evidence, Drawing Upon Implementation Science
  • Dementia-Related Terminology and Stigma: Words Matter
  • Financial Burden and Costs
  • Living Arrangements, Care Settings, and Persons with Dementia who Live Alone
  • Technology
  • Workforce
  • Research Methodology

Dissemination Plan

  • Initial publication ideas
    • Overview of Summit methodology and all in approach
    • Research recommendations
    • Stakeholder reports
    • Summary of evidence from each session (series of articles in a journal such as TG)
    • Other?
  • Presentations at conferences
  • Identification of funders for specific research recommendations
  • Other (?)

Questions?

 

 

HANDOUT: Summit Themes

Summit Themes

  1. Heterogeneity
  2. Clinical Approaches and the Lived Experience of Persons with Dementia
  3. Caregiver Relationships, Roles, and Networks
  4. Comprehensive Models of Care Across Trajectories and Care Settings
  5. Strategies for Scaling and Disseminating Existing Evidence, Drawing Upon Implementation Science
  6. Dementia-Related Terminology and Stigma: Words Matter
  7. Financial Burden and Costs
  8. Living Arrangements, Care Settings, and Persons with Dementia who Live Alone
  9. Technology
  10. Workforce
  11. Research Methodology

Example of Theme, Focus Areas, Recommendations, and Bullets

Theme: Dementia-Related Terminology and Stigma: Words Matter

There are currently three focus areas under this theme. There are 5 recommendations under Focus Area 1, including Recommendation 1, shown below. There are 3 recommendations under Focus Area 2, and 4 recommendations under Focus Area 3.

Focus Area I: Increase knowledge about the relationship between dementia-related terms, stigma, and desired outcomes for persons living with dementia and their families

Recommendation 1: Conduct research to increase knowledge about current awareness of and perspectives on frequently used terms for cognitive impairment and dementia among persons living with dementia, families, other caregivers, scientists, researchers, clinicians, community and residential care providers, public health organizations, and the general public.

  • Analyze available research findings about understanding of terms used for cognitive impairment and dementia and negative stereotypes and perceived stigma associated with particular terms.
  • Conduct additional descriptive research, as needed, to clarify and expand knowledge about understanding of frequently used terms for cognitive impairment and dementia and negative stereotypes and perceived stigma associated with particular terms.
  • Study differences in understanding of frequently used terms for cognitive impairment and dementia and negative stereotypes and perceived stigma associated with particular terms among individuals who differ In characteristics, such as race, ethnicity, culture, age, gender, primary language, and cause(s) and severity of dementia.

     

Focus Area II: Develop terminology that is can be understood and shared by various individuals and groups, positive, and to the greatest possible extent, free of negative stereotypes and associated stigma

Focus Area III: Disseminate New and Revised Terminology, Monitor Uptake, Evaluate Impact on Perceived Stigma, and Revise as Needed.

 

HANDOUT: Final Report Outline

Outline for Summit Final Report

National Research Summit on Care, Services, and Supports for Persons with Dementia and their Caregivers
Report to the National Advisory Council on Alzheimer's Research, Care, and Services
Co-Chairs: Laura N. Gitlin, PhD, and Katie Maslow, MSW
Federal Lead: Rohini Khillan, MPH

  • Abstract:
  • Introduction:
  • Advance Preparation:
    • Steering Committee:
    • Stakeholder Groups:
    • Pre-Summit Activities:
  • Organizing Participants and Sponsors
  • Summit Overview:
  • Session Highlights: brief overview of what occurred at each session
    • Plenary Sessions: Diversity, Nomenclature, and Thinking Outside the Box
    • Session I: Research On Care Needs And Supportive Approaches For Persons With Dementia (Session Co-Chairs: Richard H. Fortinsky, Phd And Ann Kolanowski, Phd, RN, FGSA, FAAN)
    • Session II: Research On Supportive Approaches For Family And Other Caregivers (Session Co-Chairs: Linda Teri, Phd And Lisa Fredman, Phd)
    • Session III: Involving Persons With Dementia And Caregivers As Members Of The Research Team (Session Co-Chairs: Mark Snowden, MD, MPH And Lee Jennings, MD, MSHS)
    • Session IV: Involving Persons With Dementia As Study Participants (Session Co-Chairs Darby Morhardt, Phd, LCSW And David M. Bass, Phd)
    • Session V: Research On Models Of Care For Persons Living With Dementia And Their Families Across The Disease Trajectory (Session Co-Chairs Vincent Mor, Phd And David B. Reuben, MD)
    • Session VI: Thinking Outside The Box (Session Co-Chairs: Christopher Callahan, MD And Alan B. Stevens, Phd)
    • Cross-cutting Themes: Heterogeneity, Technology, Differential Impact on Women
  • Recommendations: how many and process to consolidate and organize
  • Priority Recommendations: We consolidated to 11 themes and the following recommendations under each.
    • Heterogeneity
      • Focus Area 1
        • Rec 1
        • Rec 2
        • Rec 3
      • Focus Area 2
        • Rec 1
        • Rec 2
        • Rec 3
    • Clinical Approaches and the Lived Experience of Persons with Dementia
    • Caregiver Relationships, Roles, and Networks
    • Comprehensive Models of Care Across Trajectories and Care Settings
    • Strategies for Scaling and Disseminating Existing Evidence, Drawing Upon Implementation Science
    • Dementia-Related Terminology and Stigma: Words Matter
    • Financial Burden and Costs
    • Living Arrangements, Care Settings, and Persons with Dementia who Live Alone
    • Technology
    • Workforce
    • Research Methodology
  • Post-Summit Follow-Up:
    • Anticipated outcomes:
    • Post-Summits:
    • Publications:

Appendixes:

  • Steering Committee Members
  • Stakeholder Groups
  • Writing Committee (3rd Day participants)

January 26, 2018 -- Advisory Council Meeting #27

The meeting was held on Friday, January 26, 2018, in Washington, DC. The Research Subcommittee took charge of this meeting's theme, focusing on the process from targets to treatments. The Council heard speakers on the preclinical pipeline, the clinical trial pipeline, and the industry perspective. The meeting also included discussion of a driver diagram to guide the Council's future work, updates and a report from the October Care Summit, and federal workgroup updates. Material available from this meeting is listed below and at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services-meetings#Jan2018.

Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.


 

General Information

 

Handouts

 

Presentation Slides

 

Videos

  • Updates since October meeting -- [Video]

  • NAPA Driver Diagram -- [Video]

  • Federal Updates -- [Video]

  • Public Comments -- [Video]

  • Research Subcommittee Agenda -- [Video]

  • Care Summit Update -- [Video]


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