Resource Type

Special COVID Grand Rounds June 2020

Covid-19 Among Older Persons in Health Care Systems: Pragmatic Responses to the Crisis

Posted on by Sonya Sutton

June 2020 – In this Special Grand Rounds, Drs. Lipsitz, Rudolph, and White discuss their ongoing projects to meet the unique challenges COVID-19 presents managing care of older persons.

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Lewis Lipsitz, MD

Lewis Lipsitz, MD
Marcus Institute for Aging Research
Hebrew SeniorLife

James Rudolph, MD

James Rudolph, MD
Brown University

Elizabeth White, PhD, ARPN

Elizabeth White, PhD, ARPN
Brown University

Learning Objectives

  • Describe key ethical issues raised by pragmatic RCTs and which may be particularly salient to the ADRD context
  • Describe the challenges of identifying a sample of pragmatic RCTs from the literature
  • Describe the landscape of key ethical issues in published pragmatic RCTs in ADRD

Podcast

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Podcast Transcript: Download the transcript here.

Stakeholder Engagement in ePCTs for People Living with Dementia

Posted on by Sonya Sutton

May 2020 – In Grand Rounds 6, Ellen Tambor, MA from IMPACT's Engaging Partners Team presents on the special considerations for engaging stakeholders in ePCTs for AD/ADRD and provides an overview of plans for promoting meaningful stakeholder engagement in the IMPACT Collaboratory.

Speaker

Ellen Tambor, MA

Ellen Tambor, MA

Executive Committee, Engaging Partners Team

Research Director, Center for Medical Technology Policy

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Learning Objectives

  • Describe the rationale for stakeholder engagement in research and the importance of engaging stakeholders in ePCTs
  • Understand special considerations for engaging stakeholders in ePCTS for AD/ADRD.
  • Describe plans for promoting robust stakeholder engagement throughout the IMPACT Collaboratory.

Podcast

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Podcast Transcript: Download the transcript here.
COVID-19 Grand Rounds & Podcast May 2020

COVID-19 in Nursing Homes: Pragmatic Research Responses to the Crisis

Posted on by Sonya Sutton

May 2020 – In this Special Grand Rounds, Drs. Grabowski, Mitchell, and Mor, experts in dementia care and pragmatic clinical trials, provide an update on how COVID-19 is impacting nursing homes and to share preliminary data for research related to COVID-19.

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David Grabowski, PhD

David Grabowski, PhD

Professor of Health Care Policy

Department of Health Care Policy, Harvard Medical School

Vince Mor, PhD 

Vince Mor, PhD 

Principal Investigator, Administration Core (AC)
Member, Steering Committee

Professor of Health Services, Policy & Practice and the Florence Pirce Grant University Health, Brown University School of Public Health
Research Health Scientist, Providence Veterans Administration Medical Center

Susan Mitchell, MD, MPH

Susan Mitchell, MD, MPH

Principal Investigator, Administration & Management Core (AC)
Member, Steering Committee

Senior Scientist, Hebrew SeniorLife’s Hinda and Arthur Marcus Institute for Aging Research
Professor of Medicine, Harvard Medical School
Faculty, Division of Geriatrics, Beth Israel Deaconess Medical Center

 

Learning Objectives

  • Learn about impact of COVID-19 in U.S nursing homes
  • Gain knowledge about rapid pragmatic research approaches in response to the crisis in health care systems
    • Hebrew SeniorLife
    • Genesis Health Care
    • Bluestone

 

Podcast

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Podcast Transcript: Download the transcript here.

Health equity as foundational to the design of pragmatic trials

Posted on by Sonya Sutton

April 2020 – In Grand Rounds 5, Drs. Quiñones and Jackson discuss health equity issues have not yet been fully considered, assessed, or integrated into ePCT designs. Health disparities populations may not be well represented in ePCTs without special efforts to identify and successfully recruit sites of care that serve larger numbers of these populations.

 

Speakers

Ana Quiñones, PhD, MS

Ana Quiñones, PhD, MS

Team Leader, Health Equity Team (HET)

Associate Professor, Department of Family Medicine, OHSU-PSU School of Public Health, Oregon Health & Science University

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Jonathan Jackson, PhD

Jonathan Jackson, PhD
Executive Committee, Health Equity Team (HET)

Instructor in Neurology, Massachusetts General Hospital
Instructor, Harvard Medical School

Learning Objectives

  • Understand the role and objectives of the Health Equity Team in the IMPACT Collaboratory.
  • Describe the conceptualization of health equity as it relates to ePCTs design.
  • Understand and describe important health equity considerations in the design of ePCTs.

 

Podcast

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Podcast Transcript: Download the transcript here.

AcademyHealth report identifies health systems’ priority research questions on COVID-19

Posted on by Sonya Sutton

AcademyHealth has developed a report focused on information needs of the health care and community organizations engaged in the COVID-19 response. The report is intended to inform decision-making of federal and foundation funders of health services research to guide investments in responsive research.

Read the full report and background information on the AcademyHealth website.

Modifications and Waivers of Informed Consent in Pragmatic Clinical Trials

Posted on by Sonya Sutton

February 2020 – In Grand Rounds 4, Dr. Karlawish discusses waivers and alterations of written informed consent in pragmatic clinical trials (ePCTs). He provides two case studies of ePCTs to determine whether or not it is appropriate to permit a modification or a waiver of research informed consent.

Speaker

Jason Karlawish, MD

Jason Karlawish, MD
Core Leader, Ethics & Regulation Core

Professor of Medicine, Medical Ethics and Health Policy, and Neurology
Co-Director, Penn Memory Center, University of Pennsylvania

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Learning Objectives

  • Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
  • Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
  • Apply what we’ve covered to two case studies.

 

Podcast

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Podcast Transcript: Download the transcript here.

Additional Resources

  • 45 CFR 46 – Protection of Human Subjects
  • Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
  • January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at https://hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html

Using a Pilot to Test and Refine Your Measurement Strategy

Posted on by Mia

January 2020 – In Grand Rounds 3, Dr. McCreedy presents a case example to describe how a pilot can be used to test the adequacy of existing data for evaluating an ePCT outcome. Dr. McCreedy also describes a potentially efficient ePCT design that accommodates under-detection in existing data while maintaining large-scale implementation and evaluation.

Speaker

Ellen McCreedy, PhD, MPH

Executive Committee, Technical Data Core

Assistant Professor, Brown University School of Public Health

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Learning Objectives

  • Describe how a pilot study can be used to test the adequacy of existing data sources for the purposes of evaluating your ePCT.
  • Give three reasons why existing administrative data may suffer from under-detection of behaviors in persons with dementia.
  • Discuss an alternative ePCT design that addresses potential under-detection in existing administrative data sources.

 

Podcast


Podcast Transcript: Download the transcript here.

Related Articles and Resources

McCreedy EM, Yang X, Baier RR, Rudolph JL, Thomas KS, Mor V. Measuring effects of nondrug interventions on behaviors: music & memory pilot study. Journal of the American Geriatrics Society. 2019 Oct;67(10):2134-8.

Stepped Wedge Cluster Randomized Trials: What, How, And When?

Posted on by Jodi Snare

December 2019 – In Grand Rounds 2, Dr. Taljaard describes the use of stepped wedge design in cluster randomized trials (SW-CRT), a novel research design embraced by clinical researchers.

Speaker

Monica Taljaard, PhDMonica Taljaard, PhD

Executive Committee, Design & Statistics Core

Senior Scientist, Ottawa Hospital Research Institute
Associate Professor, University of Ottawa

Download Webinar Slides

 

Learning Objectives

  • Describe the key characteristics and main types of stepped wedge cluster randomized trials (SW-CRTs) with examples.
  • Explain the main approach to analysis and sample size calculation for SW-CRTs.
  • Discuss what is an appropriate justification for using a SW-CRTs.

 

Podcast

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Podcast Transcript: Download the transcript here.

Related Articles and Resources

  1. Kasza J1, Taljaard M2,3, Forbes AB1 Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present https://www.ncbi.nlm.nih.gov/pubmed/31321806
  2. Teerenstra S, Taljaard M, Haenen A, Huis A, Atsma F, Rodwell L, Hulscher M. Sample size calculation for stepped-wedge cluster-randomized trials with more than two levels of clustering. Clinical Trials. 2019; 16(3):225-236. doi: 10.1177/1740774519829053.
  3. R package ‘swCRTdesign’  http://faculty.washington.edu/jphughes/pubs.html
  4. R-Shiny (Hemming & Kasza) https://clusterrcts.shinyapps.io/rshinyapp/ 

Are you ready for a pragmatic trial? The RAPT model and implementation considerations

Posted on by dcridigital

November 2019 – Grand Rounds 1 focuses on using the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for an ePCT. RAPT includes 9 domains that reflect a range of considerations regarding the feasibility of successfully employing pragmatic methods and the prospect of an intervention’s widespread adoption, if proven effective.

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Laura Gitlin, PhD, FGSA, FAAN

Laura Gitlin, PhD, FGSA, FAAN

Core Leader, Implementation Core

Dean, Distinguished Professor, Drexel University
Adjunct Professor, Johns Hopkins University

Joe Gaugler, PhD

Joe Gaugler, PhD

Associate Core Leader, Implementation Core

Robert L. Kane Endowed Chair in Long-Term Care and Aging, Professor, University of Minnesota

Rosa Baier, MPH

Rosa Baier, MPH

Executive Committee, Implementation & Health Care Systems (HCS) Cores

Director, Center for Long-Term Care Quality & Innovation
Associate Professor, Health Services, Policy & Practice, Brown University School of Public Health

Eric Jutkowitz, PhD

Eric Jutkowitz, PhD

Executive Committee, Implementation Core

Assistant Professor, Brown University School of Public Health

Learning Objectives

  • Understand how RAPT complements and differs from PRECIS-2
  • Understand RAPT's domains and their relevance for conducting an ePCT
  • Learn how RAPT results can inform decisions about and preparation for proceeding to an ePCT
  • Be prepared to apply RAPT to interventions and use results to guide team discussion

Podcast

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Podcast Transcript: Download the transcript here.

IMPACT Members Contribute to Lessons Learned from National Research Summit

Posted on by dcridigital

The Experiences of Persons Living with Dementia Planning for a Dementia Research Meeting. Lessons Learned From the National Research Summit on Care, Services, and Supports for Persons With Dementia and Their Caregivers

October 28, 2019

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