Promises and Pitfalls of Existing Data in Nursing Homes

June 2021 – In Grand Rounds 18, Drs. Teno and Saliba discuss the use of administrative data, including the Minimum Data Set (MDS) in pragmatic clinical trials and share examples of how they have used this data in their own pragmatic clinical trials.

 

Speakers

 

Joan Teno, MD, MS

Joan M. Teno, MD, MS
Professor of Medicine, Oregon Health & Science University
Adjunct Professor of Health Services, Policy, & Research, Brown University School of Public Health Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN

Debra Saliba, MD, MPH

Debra Saliba, MD, MPH
Anna & Harry Borun Endowed Chair, Geriatrics and Gerontology, UCLA
Director, UCLA/JH Borun Center for Gerontological Research
Physician Scientist, VA Los Angeles, GRECC and HSR&D COIN

Webinar Recording

 

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Learning Objectives

  • Pros and cons of administrative data for use in pragmatic trials
  • Address potential limitations of using administrative data to infer the quality of care
  • Discuss a controversial claim that pragmatic trials of decision-making for persons with dementia need to consider adding PCROs:
    - Addressing understanding, coercion
    - Addressing safety, “balance measures
  • Identify advantages & challenges of using MDS assessment items
  • Describe some of the MDS data elements and their performance implications for persons with cognitive impairment
  • Understand performance of resident self-report items
  • Identify pragmatic skills for direct interviews

Pilot and feasibility studies for pragmatic cluster randomised trials

May 2021 – In Grand Rounds 17, Claire Chan presents on the growing number of studies described as pilot or feasibility studies, and describes the challenges in defining and designing these studies.

Webinar Slides

Speaker

Claire Chan, MSc

Claire Chan, MSc

Statistician
Institute of Population Health Sciences (IPHS)

Queen Mary University of London

Webinar Recording

Learning Objectives

  • To understand what pilot and feasibility studies are and how to design them
  • To understand some of the special considerations for pilot and feasibility studies in advance of a pragmatic trial
  • To understand some of the special considerations for cluster randomised trials

Mor and team share results of IMPACT supplement award study evaluating impact of SARS-CoV-2 vaccine among nursing home residents

Vince Mor, PhD, one of IMPACT Collaboratory’s two Principal Investigators, and team recently shared results from their investigation into the impact of SARS-CoV-2 vaccine among nursing home residents from 280 nursing homes in 21 states.  Results were published in the Journal of the American Geriatrics Society on April 16th.

Researchers partnered with Genesis Healthcare, the largest long-term care provider in the country, for the study, which was a supplement award through the IMPACT Collaboratory.  They monitored the impact of the SARS-CoV-2 vaccine rollout among nursing home residents in 280 nursing homes within 21 states.  Both the Moderna and Pfizer-BioNTech vaccines were included in the study. Researchers created two groups of participating facilities based on the date of their initial vaccine clinic and conducted a matched pair analysis of outcomes.

One week after their initial vaccine clinics, nursing homes with earlier clinics had 2.5 fewer new SARS‐CoV‐2 infections per 100 at‐risk residents than expected based on the experiences of matched facilities with later clinics. Cumulatively over 7 weeks, earlier vaccinated facilities had 5.2 fewer infections per 100 at‐risk residents and 5 fewer hospitalizations and/or deaths per 100 infected residents than expected without vaccinations. These results indicate that the vaccine led to a reduction in incident infections, morbidity, and mortality in this large multi-state nursing home population.

The researchers also suggested the findings support efforts to begin resuming family visitation and lessen other restrictions in nursing homes.

Read the full article at this link.

Inclusion, diversity, and equity in pragmatic clinical trials

April 2020 – In Grand Rounds 16, Dr. Wilkins discusses the definitions of inclusion, diversity and equity in pragmatic clinical trials, and offers insight into how research can be more inclusive and diverse.

Webinar Slides

Speaker

Consuelo H. Wilkins, MD, MSCI

Consuelo H. Wilkins, MD, MSCI
Vice President for Health Equity, VUMC
Associate Dean for Health Equity, Vanderbilt SOM
Associate Director, Vanderbilt Institute for Clinical and Translational Science
Professor of Medicine, Division of Geriatric Medicine

Webinar Recording

Grand Rounds 14- March 2021

Update on Two IMPACT Funded Pilot Studies

March 2021 – In Grand Rounds 15, Drs. Forester and Hwang share experiences as Pilot Cycle 1 awardees and provide updates to their funded pilot studies.

Brent P. Forester, MD, MSc on his pilot: Implementation of the Care Ecosystem training model for individuals with dementia in a high risk, integrated care management program

Ula Hwang, MD, MPH on her pilot: Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department

Speakers

Brent P. Forester, MD, MSc

Brent P. Forester, MD, MSc
Chief, Center of Excellence in Geriatric Psychiatry, McLean Hospital Medical
Director, Behavioral Health Integration, Quality, and Patient Experience, Mass General Brigham

Ula Hwang, MD, MPH

Ula Hwang, MD, MPH
Professor, Vice Chair for Research, Department of Emergency Medicine
Yale School of Medicine

Learning Objectives

Dr. Forester:

  • To understand the rationale and design of our adaptation of the Care Ecosystem model to train nurse case managers to deliver telephone-based collaborative dementia care.
  • To appreciate the successes and challenges encountered in stakeholder engagement, adaptation of the Care Ecosystem training program and implementation of the model.
  • To describe updates on pilot progress to date and plans for a larger embedded pragmatic clinical trial.

Dr. Hwang:

  • To describe the Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department (PD4ED) pilot.
  • To share challenges and solutions of implementation with an embedded pragmatic trial (during a pandemic and institution move).
  • To provide updates on the status of the PD4ED pilot study implementation.

 

Podcast 14: Ethical challenges with pragmatic RCTs: General issues and special considerations in dementia

link to brody profileStuart Nicholls, PhD, from the Clinical Epidemiology Program at the Ottawa Hospital Research Institute, continues the discussion from his February 18 Grand Rounds presentation. This discussion with IMPACT Principal Investigator Susan Mitchell, MD, MPH answers questions from Dr. Nicholls's presentation on giving an overview of ethical issues raised by pragmatic randomized controlled trials (RCTs) and which derive from ongoing work to develop guidance for those designing and conducting pragmatic RCTs.

 

 

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Ethical challenges with pragmatic RCTs: General issues and special considerations in dementia

February 2021 – In Grand Rounds 14, Dr. Nicholls provides an overview of ethical issues raised by pragmatic randomized controlled trials (RCTs), outlines challenges in conducting empirical studies of the published literature, and provides preliminary data on the reporting of key ethical issues in published pragmatic RCTs in AD/ADRD.

Speaker

Stuart G. Nicholls, PhD

Stuart G. Nicholls, PhD
Ottawa Health Research Institute

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Webinar Slides

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

Implementation in ongoing ADRD ePCTS in different health care settings using real examples

January 2021 – Ground Rounds 13, features Drs. Brody, McCreedy, and Colburn providing examples of ongoing implementation of ePCTs within health care systems for people with AD/ADRD followed by a response from Dr. Mittman, a prominent scientist with expertise in implementation of complex interventions in health care systems.

Webinar Slides

Webinar Recording

Ab Brody, PhD, RN, FAAN

Ab Brody, PhD, RN, FAAN

Core Leader, Pilot Studies Core
Member, Steering Committee

Associate Professor of Nursing and Medicine, New York University Rory Meyers College of Nursing
Associate Director, Hartford Institute for Geriatric Nursing
Founder, Aliviado Health

Ellen McCreedy, PhD, MPH

Ellen McCreedy, PhD, MPH

Executive Committee, Technical Data Core

Assistant Professor, Brown University School of Public Health

Jessica Colburn, MD

Jessica Colburn, MD

Johns Hopkins University School of Medicine

Implementation Workgroup Lead

 

Learning Objectives

  • Understand the implementation strategies used in 3 pragmatic clinical trials among persons living with dementia
  • Gain knowledge about implementation barriers and facilitators of complex interventions in pragmatic trials
  • Apply a novel framework to promote complex health intervention implementation in health care systems

 

Grand Rounds 12- December 2020

Improving Serious Illness Care Through Large Pragmatic Trials

December 2020 – In Grand Rounds 12, Dr. Halpern discusses improving care through large pragmatic trials. Dr. Halpern reviews explanatory trials in serious illness care, informed consent, and many other approaches of pragmatic clinical trials to improve the palliative care for seriously ill, hospitalized patients.

Webinar Slides

Speaker

Scott Halpern, MD, PhD

Scott Halpern, MD, PhD

Member, Steering Committee

Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy,
University of Pennsylvania

Webinar Recording

Learning Objectives

  • Participants will understand the importance of improving serious illness care and how it can be done through large pragmatic trials
  • Participants will understand the use of explanatory trials in serious illness care
  • Participants will understand how pragmatic trials can improve palliative care for hospitalized patients