patient engagement

September 10, 2021: Effect of Salt Substitution on Cardiovascular Events and Death (Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS)

Posted on by terren.green@duke.edu

Speaker

Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS
Executive Director, George Institute Australia
Professor of Medicine, UNSW Sydney
Honorary Professor, Sydney Medical School, University of Sydney
Professor of Clinical Epidemiology, Imperial College London

Topic

Effect of Salt Substitution on Cardiovascular Events and Death

Keywords

Cluster randomized trial; Salt substitute; Stroke; Cardiovascular disease; SSaSS

Key Points

  • The SSaSS study is a pragmatic, cluster randomized trial on the effects of salt substitutes versus regular salt on stroke, major adverse cardiovascular events, and mortality.
  • The SSaSS study followed almost 21,000 people in 600 village clusters over 5 years. At the end of the 5 year study, 92% of the intervention group was still using salt substitute and 6% of control started using salt substitute.
  • Data from the study show evidence of lower blood pressure, lower risk of stroke, lower risk of major adverse cardiovascular events, and protection against premature death with no evidence of harm.
  • There was no evidence of any increased risk of hyperkalemia.

Discussion Themes

Successful recruitment approaches in this large, long-term trial required extensive engagement and networking with local health workers and community leaders.

Salt substitute as a method to lower stroke and cardiovascular risk is attractive because it looks and tastes the same as salt, and doesn’t ask people to change their behavior.

The use of salt substitutes to decrease the intake of discretionary sodium, the salt used in home cooking or sprinkled on food after cooking, may have more effect in developing countries.  Developed countries consume processed and packaged foods more often and have less discretionary sodium intake.  In developed countries, it may be necessary to encourage food manufacturers to decrease sodium and increase potassium in the processed and packaged foods they produce.

Many millions of lives could benefit from the effects of salt substitute if this could be implemented in developing countries around the world.

Read more about Dr. Neal’s work with the SSaSS study.

Tags

#pctGR, @Collaboratory1

August 17, 2021: Grand Rounds Podcast with Survivor Corps Now Available

Posted on by Gina Uhlenbrauck

Survivor Corp logoIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez interviews Diana Berrent, JD, founder of Survivor Corps, Nick Guthe, Survivor Corps member and advisor, and Natalie Lambert, PhD, of the Indiana University School of Medicine, around best practices for medical professionals treating patients experiencing the debilitating effects of long-term COVID-19.

The full July 23 Grand Rounds webinar is also available.

Podcast August 5, 2021: Survivor Corps: Long-Term COVID-19 Patient Engagement (Diana Berrent, JD; Natalie Lambert, PhD; Nick Guthe)

Posted on by Gina Uhlenbrauck

This podcast continues the discussion with Diana Berrent, JD, and Nick Guthe, both of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, as they describe best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.

Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud.

Read the transcript.

July 16, 2021: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials? (David Chambers, DPhil; Amanda Midboe, PhD; Anne Trontell, MD, MPH)

Posted on by terren.green@duke.edu

Speakers

Panel:
Amanda Midboe, PhD
Center for Innovation to Implementation
U.S. Department of Veterans Affairs
Chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory

Anne Trontell, MD, MPH
Associate Director
Clinical Effectiveness and Decision Science Program
Patient-Centered Outcomes Research Institute (PCORI)

Guest Moderator:
David Chambers, DPhil
Deputy Director for Implementation Science
Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Topic

Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?

Keywords

Dissemination research; Implementation research; Participant engagement; Participant diversity; Health equity; PCORI; Ci2i

Key Points

  • The study of methods to best implement and disseminate interventions in diverse groups is crucial to the ultimate goal of benefiting population health.

  • Patient-centered outcomes are important measures to determine the total effectiveness of any health intervention.

  • By engaging the community in which research takes place and treating patients as partners in the development of implementation strategies, we increase diverse participation and improve patient retention.

  • Targeted recruitment strategies that leverage administrative data increase diverse study participation.

  • Outreach materials and methods that are tailored and adapted to the local culture and colloquial language are effective in engaging diverse populations.

Discussion Themes

Are there any ethical issues raised when underserved populations receive monetary incentives to participate in research trials?

What are the challenges of identifying diverse potential participants from the medical record or administrative data?

Do efforts to increase diversity in the study team improve the engagement and retention of a diverse study population?

Read more about methods to increase diversity in implementation trials at the Patient-Centered Outcomes Research Institute (PCORI) and the Center for Innovation to Implementation (Ci2i).

Tags

#pctGR, @Collaboratory1

July 19, 2021: COVID-19 Grand Rounds Will Feature Survivor Corps and the Use of Real-World Evidence From Citizen-Scientists

Posted on by Damon Seils

Survivor Corp logo

In this Friday’s COVID-19 Grand Rounds session, Diana Berrent, Natalie Lambert, and Nick Guthe of Survivor Corps will present “Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care.” The Grand Rounds session will be held on Friday, July 23, at 1:00 pm eastern. Join the online meeting.

Survivor Corps is an online community of 170,000 patients affected by COVID-19 and their families and friends. The advocacy group is using its members’ collective experience to build a repository of data sets and research tools to support COVID-19 research, including studies of post-COVID conditions, or “long COVID.” The group seeks to fill the gap between real-world evidence and scientific research to advance understanding of the disease and patients’ healthcare options.

“We have been sort of the canary in the COVID coal mine from the beginning,” said Berrent, who founded Survivor Corps in March 2020 after becoming one of the first people in the United States to be diagnosed with COVID-19.

Berrent will be joined during Grand Rounds by Survivor Corps research director Dr. Natalie Lambert and by Nick Guthe, a Survivor Corps member and adviser.

Survivor Corps’s website, which has been selected by the US Library of Congress for inclusion in the nation’s Coronavirus Web Archive, serves as a hub to provide support, information, and education about COVID-19, connect patients to researchers, and facilitate the nation’s COVID-19 response.

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.

June 22, 2021: Diversity Workshop Continues With Meeting Participants Where They Are

Posted on by Damon Seils

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity”—Dr. Wendy Weber of the National Center for Complementary and Integrative Health will host a panel of investigators for a discussion about strategies for maximizing participant diversity in pragmatic clinical trials by improving outreach and building trust.

The panel will include:

  • Dr. Jonathan Jackson, executive director of the Community Access, Recruitment, and Engagement (CARE) Research Center at Massachusetts General Hospital and Harvard Medical School
  • Dr. Judith Schlaeger of the University of Illinois at Chicago, co–principal investigator of GRACE, an NIH Collaboratory Demonstration Project
  • Dr. Stacy Sterling of the Kaiser Permanente Division of Research, Northern California, co–principal investigator of GGC4H, an NIH Collaboratory Demonstration Project

The Grand Rounds session will be held on Friday, June 25, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

Headshots of Emily O'Brien, Jonathan Jackson, Judith Schlaeger, and Stacy Sterling
Left to right: Drs. Emily O’Brien, Jonathan Jackson, Judith Schlaeger, and Stacy Sterling

June 4, 2021: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity (Wendy Weber, ND, PhD, MPH; Julie Fritz, PhD, PT; David Wetter, PhD, MS; Gloria Coronado, PhD; Amanda Petrik, MS)

Posted on by Gina Uhlenbrauck

Speakers

Panelists:

BeatPain Utah  
Julie Fritz, PhD, PT
Associate Dean for Research, College of Health
Adjunct Professor, Orthopaedic Surgery
Distinguished Professor, Physical Therapy & Athletic Training
Adjunct Professor, Orthopaedic Surgery Operations
University of Utah  

David Wetter, PhD, MS
Professor, Population Health Sciences
Adjunct Professor, Psychology
University of Utah  

STOP CRC  
Gloria Coronado, PhD
Distinguished Investigator Mitch Greenlick Endowed Scientist for Health Disparities
Kaiser Permanente Center for Health Research  

Amanda Petrik, MS
Sr. Research Associate Center for Health Research
Kaiser Permanente Northwest

Guest Moderator:

Wendy Weber, ND, PhD, MPH
Chief, Clinical Research in Complementary and Integrative Health Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)

Topic

Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity

Keywords

Participant diversity; Stakeholder engagement strategies; STOP CRC; BeatPain Utah; Health equity; Community health centers; Plan-Do-Study-Act

Key Points

  • Disparities in pain prevalence and pain management are well established. In particular, odds of receiving opioids for pain management are greater, and odds of nonpharmacologic care lower, in rural, low income, and Latinx communities.
  • It is essential that communities and researchers come together to create long-term solutions to prevent cancer, chronic and infectious disease, and improve health among underserved populations. Research projects should be driven by the priorities of community partners.
  • Study advisory boards can include health center leaders, patient advocates, legislators, and community organization leaders. These boards provide local context and, in the case of STOP CRC, they identified policy changes that were needed around access to colorectal cancer screening.

Discussion Themes

Sharing information and resources with community partners—and responding to their needs and building their capacity—helps to build trust around medicine and research.

To what extent is it important to show evidence of interest in and respect for the community beyond the specific focus of your initiative? For example, participating in important community activities and developing a deeper understanding of the culture.

We must design and plan for sustainability at the outset, and we must make targeted, specific efforts to ensure the inclusion of diverse populations in clinical trials.

Another way to increase diversity is to prepare and train more scientists and investigators from diverse populations.

Read more about the BeatPain Utah and STOP CRC Demonstration Projects.

Tags

#pctGR, @Collaboratory1

May 19, 2021: ADAPTABLE Results: High- and Low-Dose Aspirin Have Similar Effectiveness and Safety

Posted on by Karen Staman

Recently published results of the ADAPTABLE study demonstrate no difference in rates of death, hospitalization for heart attack or stroke, or bleeding in those who were assigned to high- versus low-dose aspirin (325 mg versus 81 mg). Trial participants frequently switched their dose, which may have biased the results toward the null: 41.6% of patients who were assigned to take the 325 mg dose switched to 81 mg daily dose. The study, funded by PCORI,  is the first randomized controlled trial conducted using PCORnet®, the National Patient-Centered Clinical Research Network, which involves patient representatives during all phases of the trial. It enrolled 15,076 patients with cardiovascular disease at 40 health centers across the United States.

“As interest grows for real-world evidence, the trial provides a demonstration that randomized clinical trials can leverage electronic health record data, direct-to-patient methods, and patient-reported outcomes to address important, patient-centered questions.” —Jones, et al. 2021, New England Journal of Medicine

An accompanying editorial states that this trial represents a step forward for pragmatic clinical trials, demonstrating proof-of-concept for PCORnet. The study and used electronic health record data to identify patients; low-touch recruitment strategies; and a patient portal for consent, collection of patient-reported outcomes, and follow-up.

“ADAPTABLE is a major achievement […] because it has shown a method of conducting trials efficiently and at low cost in the United States, and the method can now be adapted and used more widely. This should allow many more clinical questions to be answered, with obvious benefits to health care consumers.” —Baigent 2021, New England Journal of Medicine.

Read the plain language summary of results and learn more about the ADAPTABLE study.

May 10, 2021: Dr. Clyde Yancy to Give Keynote Address This Friday to Launch Diversity Workshop Grand Rounds Series

Posted on by Damon Seils

Photographs of Dr. Clyde Yancy on the left and Dr. Kanecia Zimmerman on the right
Dr. Clyde Yancy (left) and Dr. Kanecia Zimmerman (right)

The NIH Collaboratory this Friday, May 14, will use its popular ePCT Grand Rounds platform to launch a special workshop series on diversity in pragmatic clinical trials.

Dr. Clyde Yancy of Northwestern University will begin the series with a keynote address, “Diverse Representation Among Clinical Trial Participants: Why It Is Important and How We Can Improve.” Dr. Kanecia Zimmerman of Duke University will facilitate the discussion. The Grand Rounds session will be held on Friday, May 14, at 1:00 pm eastern. Join the online meeting.

The webinar series—Inclusion of Diverse Participants in Pragmatic Clinical Trials—will focus on increasing engagement of diverse participants and building trust, recruiting diverse research sites, learning from implementation science to maximize diversity, and developing a pipeline of trainees from underrepresented groups to be leaders in pragmatic clinical research.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

April 30, 2021: ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications (Susanna Naggie, MD, MHS; Elizabeth Shenkman, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Susanna Naggie, MD, MHS
Associate Professor of Medicine
Duke Clinical Research Institute

Elizabeth Shenkman, PhD
Chair, Department of Health Outcomes and Biomedical Informatics
Co-Director, Clinical and Translational Science Institute (CTSI)
University of Florida

Topic

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Keywords

COVID-19; NIH ACTIV Initiative; Repurposed drugs; Vaccines; Therapeutic agents; Direct-to-participant trials; PCORnet

Key Points

  • Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. The ACTIV initiative is coordinated by the Foundation for the National Institutes of Health.

  • ACTIV-6 asks: Are there medications currently approved for other conditions that improve symptoms in nonhospitalized patients with mild-to-moderate COVID-19 symptoms? The study aims to find out how to help patients feel better faster and how to prevent hospitalizations or death in newly diagnosed patients with mild or moderate COVID-19.

  • All study visits are conducted remotely: Participants use an online system to complete study surveys and report adverse events or changes in clinical status. Participants are assigned randomly to receive either a placebo or one of the treatments, which will be sent to them by mail. If deemed necessary by a study investigator, in-person or remote study visits are possible.

Discussion Themes

Vaccine hesitancy is still an issue, especially in rural areas; there will continue to be cases of COVID-19.

To ensure diversity in enrollment, the ACTIV-6 study takes a multipronged approach, including making it easy to participate without in-person appointments; partnering with community groups for broad outreach and messaging; and monitoring enrollment numbers closely.

Sites provide participant education and recruitment. The process is straightforward and appeals to both clinicians and patients. Each study site has a primary care physician as a clinical champion.

Read more about ACTIV-6, the NIH’s ACTIV initiative, and the ACTIV master protocols including ACTIV-6.

Tags

#pctGR, @Collaboratory1