Grand Rounds

January 19, 2022: PCT Grand Rounds Will Feature PRIM-ER Study of Primary Palliative Care in Emergency Medicine

Posted on by Damon Seils
Headshot of Dr. Corita Grudzen
Dr. Corita Grudzen, principal investigator of PRIM-ER

In this Friday’s PCT Grand Rounds, the principal investigator of PRIM-ER, an NIH Collaboratory Trial, will share an update on the implementation of this innovative pragmatic clinical trial.

Principal investigator Dr. Corita Grudzen of the NYU Grossman School of Medicine will present “Primary Palliative Care for Emergency Medicine.” The Grand Rounds session will be held on Friday, January 21, at 1:00 pm eastern.

PRIM-ER, or the Primary Palliative Care for Emergency Medicine study, is a cluster randomized pragmatic trial of a multidisciplinary primary palliative care intervention that consists of education, clinical decision support, and other elements in a diverse mix of emergency departments in the United States. The intervention is intended to improve the delivery of goal-directed emergency care of older adults.

Join the online meeting.

PRIM-ER is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging.

January 12, 2022: COVID-19 Grand Rounds to Address Stakeholder Perspectives in Outpatient Trials

Posted on by Damon Seils
Headshot of Dr. Christopher John Lindsell
Dr. Christopher John Lindsell

In this Friday’s COVID-19 Grand Rounds session, Christopher Lindsell of Vanderbilt University will present “Searching for A Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials.” Lindsell will discuss lessons about choosing endpoints in outpatient COVID-19 trials.

The Grand Rounds session will be held on Friday, January 14, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Grand Rounds January 28: EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Speakers:
Edward R Melnick, MD, MHS
Associate Professor of Emergency Medicine, Yale School of Medicine
Associate Professor of Biostatistics (Health Informatics), Yale School of Public Health
Program Director, Yale-VA Clinical Informatics Fellowship Program

Gail D’Onofrio, MD, MS
Albert E. Kent Professor of Emergency Medicine
Yale School of Medicine
Professor of Public Health, Chronic Disease & Epidemiology
Yale School of Public Health

Topic: EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Date: Friday, January 28, 2022, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

Click ‘Connect to Audio”
Choose ‘Computer Audio’ or ‘I will call in’.
If using the ‘call in option’, follow the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 2622 682 0537
Meeting Password: 12345

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 2622 682 0537

NOTE: For Toll-free users, the call-back (call me) services are also available.

December 17, 2021: Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None (Eric Perakslis, PhD)

Posted on by terren.green@duke.edu

Speaker

Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor
Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine

Topic

Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None

Keywords

Cybersecurity; Attack Surface; Cyber-Compliance; FISMA; InfoSec

Key Points

  • Over 40 million medical records are compromised each year.
  • Electronic Health Information is targeted due to its high value with respect to improper medical payments. Medicare estimates over $25 billion in improper payments each year.
  • The focus for cybersecurity should be on the most vulnerable groups. Women, BIPOC, and elderly populations experience cyberattack and identity theft more often than other populations.
  • Security objectives should focus on confidentiality, integrity, and availability.
  • The Cyber Risk Equation: Risk = Threat*Vulnerability*Impact*Likelihood
  • When starting a study, design with cybersecurity in mind, minimize attack surface, know your weakest link, add InfoSec expertise to the design team, and lean-in to innovation.

Discussion Themes

Researchers should take some responsibility for learning how to secure patient information. Training programs to make researchers more aware of cybersecurity concerns would increase researcher comfort in working with electronic health data.

A research network consisting on multiple sites may have differing needs and capacity to secure data. Treating each research site individually could allow greater representation in research, but those sites may be more vulnerable to cyberattack.

 

Read more about cybersecurity by Dr. Perakslis in A cybersecurity primer for translational research.

 

Tags

#pctGR, @Collaboratory1, @eperakslis

December 10, 2021: Decentralized Trials: Naughty or Nice? (Adrian F. Hernandez, MD, MHS)

Posted on by terren.green@duke.edu

Speaker

Adrian F. Hernandez, MD, MHS
Executive Director, Duke Clinical Research Institute
Vice Dean, Duke University School of Medicine

Topic

Decentralized Trials: Naughty or Nice?

Keywords

Decentralized trials; Study design; Implementation; Patient engagement; Patient-reported data

Key Points

  • Decentralized trials have been occurring since the start of the internet and mobile devices to reach people where they are and collect data in places we were not able to in the past.
  • One key problem decentralized trials can help solve is the gap between those who wish to participate in research and those who actually do participate. Clinical trial deserts and lack of broadband widen the gap between those who wish to participate and those who are able.
  • Decentralized trials attempt to capture data remotely instead of at a site and virtually(patient-reported) rather than recorded by study personnel.
  • COVID-19 flipped the model for clinical trial visits from that of site-based visits and care to home based, virtual visits and care.
  • Enrollment can be a challenge for decentralized trials and requires engagement campaigns at various timepoints in the study to achieve desired enrollment numbers.
  • Decentralized trials can help ensure inclusion of diverse communities in your study population.
  • The HeartLine study, CHIEF-HF study, HERO-Together study, and ACTIV-6 study are taking advantage of various technologies to decentralize study design.

Discussion Themes

Decentralized methods may improve recruitment, but may not improve retention. We may need a hybrid model to keep a patient engaged.

Decentralized methods may require decisions about what data we should collect and what we could collect, but don’t need.

 

Read more about decentralized study design in Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review and Digitizing Clinical Trials.

 

Tags

#pctGR, @Collaboratory1

December 15, 2021: This Friday in PCT Grand Rounds, Cybersecurity and Compliance in Clinical Research and Healthcare

Posted on by Damon Seils
Headshot of Dr. Eric Perakslis
Dr. Eric Perakslis

In this Friday’s PCT Grand Rounds, Dr. Eric Perakslis of Duke University will present “Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None.” The Grand Rounds session will be held on Friday, December 17, at 1:00 pm eastern.

Dr. Perakslis is the chief science and digital officer for the Duke Clinical Research Institute and the chief research technology strategist in the Duke University School of Medicine. Join the online meeting.

Grand Rounds January 14: Searching for a Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials

Speaker:
Christopher Lindsell, PhD
Professor of Biostatistics and Biomedical Informatics
Director, Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program
Codirector, Vanderbilt Health Data Science (HEADS) Center

Topic: Searching for A Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials

Date: Friday, January 14, 2022, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

Click ‘Connect to Audio”
Choose ‘Computer Audio’ or ‘I will call in’.
If using the ‘call in option’, follow the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 2622 682 0537
Meeting Password: 12345

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 2622 682 0537

NOTE: For Toll-free users, the call-back (call me) services are also available.

December 8, 2021: PCT Grand Rounds Asks, ‘Decentralized Trials: Naughty or Nice?’

Posted on by Damon Seils
Head shot of Dr. Adrian Hernandez
Dr. Adrian Hernandez

In this Friday’s PCT Grand Rounds session, Dr. Adrian Hernandez of Duke University will present “Decentralized Trials: Naughty or Nice?”

Dr. Hernandez is a professor of medicine at Duke University and a co–principal investigator of the NIH Collaboratory Coordinating Center.

The Grand Rounds session will be held on Friday, December 10, at 1:00 pm eastern. Join the online meeting.

December 3, 2021: Primary Care-Based Behavioral Treatment for Long Term Opioid Users with Chronic Pain: Primary Results and Lessons Learned from the PPACT Pragmatic Trial (Lynn DeBar, PhD MPH)

Posted on by terren.green@duke.edu

Speaker

Lynn DeBar, PhD MPH
Senior Scientist
Kaiser Permanente Washington Health Research Institute
Seattle, WA

Keywords

PPACT, Chronic pain, Opioid use, Patient reported outcome data, Patient-centered research, Cognitive behavioral therapy

Key Points

  • Chronic Pain is responsible for far more years lived with disability than a large number of other diseases and injuries, such as COPD, diabetes, dementia, stroke and others, combined.
  • PPACT was a cluster randomized study aimed at integrating interdisciplinary pain management methods into primary care to improve care for patients with chronic pain.
  • Participants had been prescribed long-term opioids for mixed chronic pain conditions.
  • Study intervention lasted 12 weeks and included cognitive behavioral therapy, yoga-based exercises, physical therapy, a medication review, and support from a primary care provider.
  • Participants in the treatment group of the PPACT study showed a modest reduction of pain that was sustained over a 12 month period.
  • The PPACT intervention was cost effective versus usual treatment methods.

Discussion Themes

An in-person enhanced enrollment session was conducted to give potential subjects a comprehensive overview of the study procedures. This enrollment session led to fewer people enrolling in the study, but of those that did, more completed the study.

The key to successful CBT is an interactive patient-centered approach.

 

Read more about the PPACT study.

 

Tags

#pctGR, @Collaboratory1

December 1, 2021: PCT Grand Rounds to Highlight Primary Results of PPACT Study

Posted on by Damon Seils
Head shot of Dr. Lynn DeBar
Dr. Lynn DeBar, principal investigator of PPACT

In this Friday’s PCT Grand Rounds, the principal investigator of the PPACT study, an NIH Collaboratory Trial, will announce the study’s primary results.

Principal investigator Dr. Lynn DeBar of the Kaiser Permanente Washington Health Research Institute, will present “Primary Care-Based Behavioral Treatment for Long Term Opioid Users With Chronic Pain: Primary Results and Lessons Learned From the PPACT Pragmatic Trial.” The Grand Rounds session will be held on Friday, December 3, at 1:00 pm eastern.

PPACT, or the Collaborative Care for Chronic Pain in Primary Care study, was a pragmatic, cluster randomized trial that enrolled 850 patients who were receiving long-term opioid therapy for chronic pain. Patients in the intervention group participated in weekly group sessions that taught a variety of pain self-management techniques. The strategy was compared with usual care.

Join the online meeting.

PPACT was supported within the NIH Collaboratory by the NIH Common Fund and by cooperative agreements from the National Institute of Neurological Disorders and Stroke.