Grand Rounds

March 29, 2022: PCT Grand Rounds to Highlight Experiences From ICD-Pieces

Posted on by Damon Seils

Headshots of Dr. Miguel Vazquez and Dr. George (Holt) OliverIn this Friday’s PCT Grand Rounds, researchers from ICD-Pieces, an NIH Pragmatic Trials Collaboratory Trial, will present aggregate outcomes from the study and share experiences from trial implementation.

Dr. Miguel Vazquez of the University of Texas Southwestern Medical Center and Dr. George (Holt) Oliver of the Parkland Center for Clinical Innovation will present “ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems.” The Grand Rounds session will be held on Friday, April 1, at 1:00 pm eastern.

ICD-Pieces is a pragmatic trial of a collaborative primary care–nephrology care model for patients with chronic kidney disease in a predominantly minority population. The study is implementing a novel technology platform (Pieces) that enables the use of electronic health record data to improve chronic kidney disease care within primary care practices or medical homes in the community.

Join the online meeting.

ICD-Pieces is supported within the NIH Collaboratory by the NIH Common Fund and by a cooperative agreement from the National Institute of Diabetes and Digestive and Kidney Diseases.

March 25, 2022: A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons with Chronic Low Back Pain (Natalia Morone, MD, MS)

Posted on by terren.green@duke.edu

Speaker

Natalia E. Morone, MD, MS
Associate Professor of Medicine
Boston University/Boston Medical Center

Keywords

Chronic pain; Mindfulness; Stress Reduction; Low back pain; OPTIMUM; The Pain, Enjoyment of Life and General Activity (PEG) Scale; HEAL Initiative

Key Points

  • Chronic back pain is very common across all racial and ethnic groups. Doctors treat chronic back pain with non-pharmacologic methods before resorting to pharmacologic treatments.
  • Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) is a randomized study of mindfulness for low back pain operating in 3 health settings: Boston Medical Center; UPMC, Pittsburgh, PA; and University of North Carolina, Chapel Hill in partnership with Piedmont Health Services.
  • Participation in the OPTIMUM study requires 8 weekly 90 minute group-based sessions of mindfulness meditation training delivered in primary care through a telehealth medical visit with follow up assessments at 6 and 12 months.
  • Four methods of mindfulness meditation are taught: Walking meditation, body scan, breath focused meditation, and mindful stretching.
  • The OPTIMUM study uses the PEG scale as the main outcome measure at the 6 and 12 month follow up assessments.
  • Group tele-health visits provide a variety of benefits for patients including more time with a clinician, better medication adherence, and more patient satisfaction.

Discussion Themes

Primary care usually consists of 1 provider and 1 patient, but family medicine evolved to see patients in a group. This group setting model may have unexpected benefits.

OPTIMUM is part of the PRISM project and is collecting data on participant use of opioids along with all PRISM projects.

Recruiting minority participants has been a priority in the OPTIMUM trial. Targeting recruitment advertisements to zip codes where more minorities live makes a difference in recruiting a diverse population.

 

Read more about the OPTIMUM trial.

 

 Tags

#pctGR, @Collaboratory1

March 23, 2022: OPTIMUM Pragmatic Trial Will Be Featured in PCT Grand Rounds

Posted on by Damon Seils
Headshot of Dr. Natalia Morone
Dr. Natalia Morone, principal investigator of OPTIMUM

In this Friday’s PCT Grand Rounds, Dr. Natalia Morone of Boston University and Boston Medical Center will present “A Telehealth-Delivered Pragmatic Trial of Mindfulness for Persons With Chronic Low Back Pain.” The Grand Rounds session will be held on Friday, March 25, at 1:00 pm eastern.

Mindfulness-based stress reduction is now recommended by the American College of Physicians for initial treatment of chronic low back pain. The primary goal of OPTIMUM, an NIH Pragmatic Trials Collaboratory Trial, is to determine the impact of a group-based mindfulness intervention under usual care circumstances.

Join the online meeting.

OPTIMUM is supported by the NIH through the NIH HEAL Initiative under an award from the National Center for Complementary and Integrative Health.

March 18, 2022: Early Treatment of COVID-19: The TOGETHER Adaptive Platform Trial (Edward Mills, PhD, FRCP; Craig Rayner, PharmD)

Posted on by terren.green@duke.edu

Speakers

Edward Mills PhD, FRCP
Professor, McMaster University

Craig R Rayner FRCP Edin PharmD MBA
Certara Distinguished Scientist
Adjunct Associate Professor, Monash University

Keywords

COVID-19; Ivermectin; TOGETHER trial; Patient engagement; Adaptive platform trial

Key Points

  • The TOGETHER trial is a randomized adaptive platform trial investigating 11 different treatments for COVID-19 including Ivermectin.
  • Initial in vitro experiments of Ivermectin in April of 2020 showed promising results, but many of those original papers were later retracted.
  • The TOGETHER trial used PBPK modelling to determine trial dose regimen. The trial started with 1 dose and later moved to 3 doses.
  • The primary outcome of the TOGETHER trial was emergency room visits due to COVID-19 or hospitalization due to the progression of COVID-19.
  • No evidence was found of treatment effect for ivermectin compared to placebo, but a small treatment effect cannot be ruled out. It may have an effect for a subgroup of patients.

Discussion Themes

A low confidence interval could signal that the trial was stopped too early.

Building trust within the community is key to the success of a trial. Recruitment is difficult if the patients don’t trust the trial or researchers.

Read more about the TOGETHER trial.

 

 Tags

#pctGR, @Collaboratory1

March 11, 2022: Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8,000 Patient MIPACT Study and Implementation in a National Pragmatic Trial (Sachin Kheterpal, MD, MBA; Jessica Golbus, MD; Nicole Pescatore, MPH)

Posted on by terren.green@duke.edu

Speakers

Sachin Kheterpal, MD, MBA
Professor of Anesthesiology
Associate Dean for Research IT
PI for MIPACT and Co-PI for THRIVE University of Michigan

Jessica Golbus, MD
Clinical Instructor, Cardiovascular Medicine
Co-I for MIPACT
University of Michigan

Nicole Eyrich, MPH
MIPACT Clinical Research Project Manager University of Michigan

Keywords

MIPACT; Patient-reported outcomes; Virtual recruitment; Cohort Identification Toolkit; VALENTINE study; THRIVE study; Wearable data research; Propofol

Key Points

  • The MIPACT study combined patient reported outcome data with electronic health record data and data collected from wearable devices.
  • The MIPACT study followed over 7,000 participants for 3 years. Both in-person and virtual recruitment had similar success rates. Participant diversity was a priority during recruitment.
  • The VALENTINE Study was a prospective randomized controlled study using mobile wearable devices to enhance cardiac rehabilitation.
  • Older participants in the VALENTINE study were receptive and capable of using wearable technology to assist data collection for the study.
  • THRIVE is pragmatic clinical trial studying Propofol anesthesia in 22 states and 2 countries.

Discussion Themes

Economic barriers to participation may be present when using wearable device technology as an inclusion criteria for a study. There are various methods to reduce these barriers, such as providing participants with the wearable device and a minimal data plan.

There may be limits to the types of participant reported outcomes that can be collected remotely. Ideally, participants will decide what data researchers will have access to.

Read more about MIPACT, VALENTINE, and THRIVE study.  Read results from MIPACT and VALENTINE.

 

 Tags

#pctGR, @Collaboratory1

March 16, 2022: Ivermectin Results From the TOGETHER Trial Will Be Shared in COVID-19 Grand Rounds

Posted on by Damon Seils
Headshots of Dr. Edward Mills and Dr. Craig Rayner
Dr. Edward Mills and Dr. Craig Rayner

In this Friday’s COVID-19 Grand Rounds session, Dr. Edward Mills of McMaster University and Dr. Craig Rayner of Monash University will present “Better Data on Ivermectin Is Finally Here: Results from the TOGETHER Trial.”

The Grand Rounds session will be held on Friday, March 18, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials 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.

March 4, 2022: ACP COVID: A Trial to Evaluate an Advance Care Planning Video and Communication Skills Training Intervention for Older Adults During an Evolving Pandemic (Angelo E. Volandes, MD, MPH; James A. Tulsky, MD; Sophia N. Zupanc, BA)

Posted on by terren.green@duke.edu

Speaker

Angelo E. Volandes, MD, MPH
Associate Professor, Harvard Medical School and Massachusetts General Hospital

James A. Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School

Sophia N. Zupanc, BA
Dana-Farber Cancer Institute

Keywords

Advanced Care Planning; VitalTalk; ACP DECISIONS; Unstructured data; Patient engagement; Clinician engagement

Key Points

  • ACP COVID combines the VitalTalk program and ACP DECISIONS videos to help patients and families navigate difficult decisions around advanced care planning.
  • VitalTalk is a non-profit organization providing evidence-based communication training. VitalTalk trained health care providers to communicate advanced care planning options with patients.
  • The ACP COVID study compared advanced care planning documentation rates at three specific timepoints: 6 months prior to COVID-19(control period, Sep 2019-Mar 2020), during the first wave of COVID-19(control period, March 2020-Sep 2020), and during the time period when vaccines were first rolled out in New York state(intervention period, Dec 2020-June 2021).
  • Advanced care planning conversations best happen in the outpatient setting, not in the hospital right before intubation.
  • Almost 24% of patients in the intervention period had Advance Care Planning conversations which was significantly higher than the control periods.

Discussion Themes

The clinician training program gave clinicians the skills to cope with the implications of the pandemic and led to increased clinician engagement.

 

 

Read more about ACP-COVID.

 

 Tags

#pctGR, @Collaboratory1

March 9, 2022: PCT Grand Rounds to Feature MIPACT Study and THRIVE Pragmatic Trial

Posted on by Damon Seils
Headshots of Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore
Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore

In this Friday’s PCT Grand Rounds, Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore of the University of Michigan will present “Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8000 Patient MIPACT Study and Implementation in a National Pragmatic Trial.” The Grand Rounds session will be held on Friday, March 11, at 1:00 pm eastern.

The Michigan Predictive Activity and Clinical Trajectories (MIPACT) study is a prospective observational study exploring whether data collected on an Apple Watch, combined with home blood pressure measurements and other health information, can provide insights into health and disease. The Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia (THRIVE) trial is a pragmatic trial of of intravenous vs inhalational general anesthesia in patients undergoing elective noncardiac surgery.

Join the online meeting.

March 2, 2022: COVID-19 Grand Rounds to Share Findings of ACP COVID Study of Advance Care Planning

Posted on by Damon Seils
Headshots of Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc
Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc

In this Friday’s COVID-19 Grand Rounds session, Dr. Angelo Volandes of Massachusetts General Hospital and Dr. James Tulsky and Sophia Zupanc of Dana-Farber Cancer Institute will present “ACP COVID: A Trial to Evaluate an Advance Care Planning Video and Communication Skills Training Intervention for Older Adults During an Evolving Pandemic.” The study is supported by a supplemental grant award to the investigators of ACP PEACE, an NIH Pragmatic Trials Collaboratory Trial.

The Grand Rounds session will be held on Friday, March 4, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials 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.

February 18, 2022: Building a Resource: The Process of Developing a Trans-stakeholder Framework to Enable Pediatric Drug Development (Perdita Taylor-Zapata, MD)

Posted on by terren.green@duke.edu

Speaker

Perdita Taylor-Zapata, MD
Best Pharmaceuticals for Children Act (BPCA) Program Lead and NICHD Program Officer
Obstetric and Pediatric Pharmacology and Therapeutics Branch
National Institute of Child Health and Human Development

Keywords

NIH Best Pharmaceuticals for Children Act; Pediatric Trial Network; Trial design; Pediatric drug development

Key Points

  • The current model for pediatric drug development can be slow and neglect neonates and rare pediatric conditions.
  • The NIH Best Pharmaceuticals for Children Act (BPCA) allows the NIH to conduct clinical trials with off-patent drugs in children.
  • Goals of the BPCA program include developing novel trial designs and including diverse and understudied populations.
  • A new framework to enable pediatric drug development could identify resources to assist in drug development, identify areas in need of further research, provide a pathway for integrating approaches, and connect pediatric researchers.
  • The BPCA went through a rigorous systematic approach to develop a comprehensive resource listing for best practices for pediatric drug trials.

Discussion Themes

Most data collected through the opportunistic model presented is PK data to determine dosing so that a more traditional drug trial can be conducted in the future.

With the right infrastructure in place, such as the Pediatric Trials Network, can substantially improve time to conduct trials.

 

Read more about the BPCA and their commitment to diversity in pediatric drug trials.

 

Tags

#pctGR, @Collaboratory1