Grand Rounds

March 8, 2019: Dietary Trials in Heart Failure: SODIUM-HF (Justin Ezekowitz, MBBCh, MSc)

Posted on by Gina Uhlenbrauck

Video not available

Speaker

Justin A. Ezekowitz, MBBCh, MSc
Professor, University of Alberta
Co-Director, Canadian VIGOUR Centre
Cardiologist, Mazankowski Alberta Heart Institute

Topic

Dietary Trials in Heart Failure: SODIUM-HF

Keywords

Multicenter clinical trial; Heart failure; Dietary sodium; Cardiovascular health; Clinical equipoise; Clinical guidelines; SODIUM-HF

Key Points

  • The SODIUM-HF trial is a multicenter, multinational dietary study evaluating the long-term effects of a low-sodium diet in patients with heart failure on a composite clinical outcome of all-cause mortality, cardiovascular (CV) hospitalizations, and CV emergency department visits.
  • The recommended amount of dietary sodium for patients with heart failure varies among the guidelines, ranging from no restriction to <2300mg per day.
  • Among the successes of the study are the important research question, a simple electronic case report form, engaged clinicians and staff, 100% remote monitoring, and a low administrative burden.

Discussion Themes

Sodium restriction is one of the most challenging things for patients to undertake as it affects their lifestyle significantly.

What is your perspective on the importance of a low-sodium diet for patients with heart failure, given that low sodium was shown to be harmful in some studies?

How do you balance wanting a pragmatic/practical intervention versus wanting a rigorous test of your hypothesis?

For more information on this study, visit the SODIUM-HF trial website and ClinicalTrials.gov.

Tags

#HeartFailure, #pctGR, @SodiumHF, @Collaboratory1, @JustinEzekowitz, @CVC_UAlberta

February 1, 2019: Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial (James Tulsky, MD, Angelo Volandes, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

James Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School
Chief, Division of Palliative Medicine
Brigham and Women’s Hospital

Angelo Volandes, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital
Harvard Medical School

Topic

Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial

Keywords

Pragmatic clinical trial; Advance care planning; ACP PEACE; Dana-Farber Cancer Institute; National Institute on Aging; Palliative care; Video declarations; Goal-concordant care; Patient preferences

Key Points

  • Many people with serious illness die without receiving goal-concordant care, and patients over the age of 65 with cancer experience this disproportionately. Helping patients engage in advance care planning (ACP) can empower them to express and record their goals so that their care can be aligned with their preferences.
  • The ACP PEACE NIH Collaboratory Trial is a pragmatic, stepped-wedge, randomized trial of a comprehensive ACP program in oncology clinics at 3 health systems. It will involve a combination of 2 evidence-based programs:
    • VitalTalk teaches clinicians important communication skills in having empathic conversations with seriously ill patients.
    • ACP Decisions uses videos to promote planning and decision-making by patients and families.
  • The ACP PEACE study will monitor long-term outcomes to evaluate whether patients received the care they planned for and wanted.

Discussion Themes

The last element of the ACP PEACE trial is a video declaration (ViDec), recorded by a subset of patients. In recording the ViDec, patients are prompted by questions assessing their confidence with their decision, satisfaction, decisional regret, and patient-provider experience.

The ACP PEACE study team has a scaling strategy in place if the intervention proves effective. Implementing the intervention as standard of care will involve a culture shift from what is currently expected in health systems.

Read more about the ACP PEACE NIH Collaboratory Trial in the Living Textbook.

Tags

#AdvanceCarePlanning, #pctGR, @Collaboratory1 @VitalTalk, @ACPDecisions

November 16, 2018: Primary Palliative Care for Emergency Medicine (PRIM-ER) (Corita Grudzen, MD, MSHS)

Posted on by Gina Uhlenbrauck

Speaker

Corita R. Grudzen, MD, MSHS, FACEP
Vice Chair for Research
Associate Professor of Emergency Medicine and Population Health
Ronald O. Perelman Department of Emergency Medicine
NYU School of Medicine

Topic

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Keywords

PRIM-ER; Emergency department; Palliative care; NIH Collaboratory Trial; Pragmatic trial; Stepped-wedge study design; Clinical decision support; Best practice alerts; Advance care planning

Key Point

  • The PRIM-ER trial is a pragmatic, cluster-randomized, stepped wedge NIH Collaboratory Trial that will implement primary palliative care in emergency medicine across a diverse group of 35 emergency departments (EDs).
  • PRIM-ER’s clinical decision support intervention is tailored to each ED site. The study aims to enable system, organizational, and provider change in the emergency department workflow.
  • The study team is identifying and preparing site champions by conducting communication skills training in serious illness for emergency physicians and staff using the EM Talk program.

Discussion Themes

It is important to consider sustainability of the intervention during the planning phase of the trial. Plan for staff turnover and how new staff will be educated and oriented to the intervention.

The volume and sophistication of best practice alerts (BPAs) received by physicians varies across U.S. emergency departments. Alert “fatigue” can be a concern.

For more information on the PRIM-ER NIH Collaboratory Trial, visit the PRIM-ER website on the Living Textbook.

Tags

@Collaboratory1, #pctGR, #EmergencyMedicine

Grand Rounds (4-25-2014): CTTI’s Central IRB Advancement Project

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 25 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives”) will be presented by Cynthia Hahn and Petra Kaufmann, MD, MSc, team leaders for the Clinical Trials Transformation Initiative’s Central IRB Advancement Project. Ms. Hahn is vice president of Clinical Research & Regulatory Affairs for the Feinstein Institute for Medical Research. Dr. Kaufmann is director of the Office of Clinical Research for the National Institute of Neurological Disorders and Stroke.

CTTI’s Central IRB Advancement Project is a follow-up to its previous Central IRB Project that conducted expert and stakeholder interviews to produce considerations and recommendations for central IRB adoption. The current project will take additional steps in encouraging the implementation of these recommendations and addressing remaining barriers to further advance the use of central IRBs for multicenter clinical trials. Expected deliverables include tools and best practices for researchers, sponsors, sites, and IRBs.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 25. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (4-18-2014): Data Quality and Transparency Standards

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 18 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“Building PCOR Value and Integrity With Data Quality and Transparency Standards: An Introduction and Request for Input”) will be presented by Michael G. Kahn, MD, PhD, professor of epidemiology in the Department of Pediatrics at the University of Colorado Denver. Dr. Kahn is co-director of the Colorado Clinical and Translational Sciences Institute (CCTSI), Translational Informatics Core director for the CCTSI, and director of clinical informatics in the Department of Quality & Patient Safety at The Children’s Hospital.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 18. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (4-11-2014): A PCORnet Update

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 11 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Today’s NIH Collaboratory and PCORnet Grand Rounds (“A PCORnet Update”) will be presented by Richard Platt, MD, MSc, professor and chair of the Department of Population Medicine at Harvard Pilgrim Health Care Institute. Dr. Platt is co-principal investigator of the Coordinating Center for the NIH Collaboratory, principal investigator of the Coordinating Center for PCORnet, and principal investigator of the FDA’s Mini-Sentinel program.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 11. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (4-4-2014): Defining Denominator Populations Within and Across Complex Health Systems

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides from the April 4 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

This Friday’s NIH Collaboratory Grand Rounds (“Defining Denominator Populations Within and Across Complex Health Systems”) will be presented by Greg Simon, MD, MPH, of the Group Health Research Institute. Dr. Simon is the principal investigator for the NIH Collaboratory Trial “Pragmatic Trial of Population-Based Programs to Prevent Suicide Attempt” (detailed description available here).

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 4. Archived video and slide sets from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (3-26-2014): Why Is the FDA Interested in the Collaboratory and PCORnet?

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides  from the March 26 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Photograph of FDA CDER Director Janet Woodcock, MD
CDER Director Janet Woodcock, MD. Photo credit: FDA

The guest speaker for this Friday’s Collaboratory/PCORnet Grand Rounds presentation will be the FDA’s Janet Woodcock, MD. Dr. Woodcock is the current director of the Center for Drug Evaluation and Research (CDER), the division of the FDA primarily responsible for evaluating the safety and effectiveness of both prescription and over-the-counter drugs and biologic therapies marketed in the United States.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, March 26. Archived video and slide sets from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

Grand Rounds (3-21-2014): The Use of Social Media in Clinical Research

Posted on by Gina Uhlenbrauck

Update:

Archived video and slides  from the March 21 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

On Friday, March 21, the NIH Collaboratory and PCORnet Grand Rounds featured a presentation on “The Use of Social Media in Clinical Research” by Stephanie Startz, Associate Director of Digital Strategy for the Michael J. Fox Foundation. The Fox Foundation is a patient-focused nonprofit organization dedicated to finding a cure for Parkinson disease.

In December 2013, the Fox Foundation hosted a Twitter chat (#FoxChat) about challenges in clinical trial recruitment. The foundation’s blog notes that the discussion involved more than 90 participants and more than 600 tweets, making it one of Twitter’s hottest topics during that time. The Twitter chat, a full transcript of which is available online, engaged a diverse audience that included researchers, nonprofit organizations, patients, and patient advocacy groups, demonstrating that the Twitter chat format has the potential to elicit dialogue among these groups.

Ms Startz described the Fox Foundation’s other social media efforts on Facebook, Instagram, YouTube, etc, which have been successful in engaging the patient community and encouraging participation in clinical research. For example, a 3-day campaign on Facebook led to more than 1800 visitors to the Fox Trial Finder website. Advice for engaging patients via social media included being social by sharing stories and videos (not just requests for action), avoiding jargon, and responding to users. The Fox Foundation shares firsthand patient experiences, gives updates on trials, and thanks participants using social media. The Grand Rounds discussion covered issues of privacy and the extent to which social media could potentially play a role in involving patients in research design, not just research participation.