COVID-19

May 7, 2021: Online Recruitment in the Era of COVID-19: Pitfalls and Progress (Megan L. Ranney, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Megan L. Ranney, MD, MPH, FACEP
Director, Brown-Lifespan Center for Digital Health
Warren Alpert Endowed Associate Professor of Emergency Medicine, Brown University
Associate Dean of Strategy and Innovation, School of Public Health, Brown University
Chief Research Officer, AFFIRM
Co-founder, GetUsPPE

Topic

Online Recruitment in the Era of COVID-19: Pitfalls and Progress

Keywords

COVID-19; Online trial recruitment; Clinical trials; Emergency medicine; Digital health technologies; Remote interventions; Electronic informed consent

Key Points

  • The Center for Digital Health at Brown University is a research and education hub that explores innovative solutions to urgent health challenges. The Center has supported studies involving the use of digital health technologies for recruiting participants and delivering behavioral health interventions.
  • Due to disruptions caused by the COVID-19 pandemic, many research studies pivoted from in-person contact toward the use of digital technologies such as smartphone apps and remote telehealth.
  • To advance clinical trials in a post-pandemic world, we will need to establish best practices for digital health technologies—and recognize when online recruitment is appropriate and when it is not. Hybrid recruitment models offer a solution.

Discussion Themes

It remains clear that the relationship between study staff and participants is essential to forming positive alliances and determines the likelihood of follow up.

For social media advertising, it’s possible that an IRB could approve a group of images, headlines, and content that study teams can combine in different ways to optimize the advertising over the course of a study.

The Pew Research Center provides recent data on which social media platforms are used most by Americans. Read more about digital health science at the Center for Digital Health.

Tags

#pctGR, @Collaboratory1

May 4, 2021: COVID-19 Grand Rounds Continues Friday With Dr. Megan Ranney on Online Recruitment in the Era of COVID-19

Posted on by Damon Seils

Dr. Megan RanneyIn this Friday’s COVID-19 Grand Rounds session, Dr. Megan Ranney of Brown University will present “Online Recruitment in the Era of COVID-19: Pitfalls and Progress.” The Grand Rounds session will be held on Friday, May 7, at 1:00 pm eastern. Join the online meeting.

Dr. Ranney is a practicing emergency physician, researcher, and advocate for innovative approaches to health. Her work focuses on the intersection between digital health, violence prevention, and population health. She also currently serves as a medical analyst for CNN.

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.

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

May 3, 2021: HERO Registry and HERO-TOGETHER Expand Beyond Healthcare Workers

Posted on by Damon Seils

Logo for the Healthcare Worker Exposure Response & Outcomes (HERO) project.The Healthcare Worker Exposure Response & Outcomes (HERO) Registry and the HERO-TOGETHER study are now open to anyone who lives, works, or interacts with healthcare workers in their households or anyone in the surrounding community. The HERO program enables participants to share their experiences after receiving a COVID-19 vaccine, contribute to the science, and help to build vaccine confidence over time.

HERO-TOGETHER is a nationwide paid study focused on the long-term impact of the COVID-19 vaccines. Healthcare workers around the country have already signed up. Now all healthcare workers and anyone who lives, works, or interacts with them are invited to join the study. Participants answer brief surveys about how they’re feeling and any health changes since receiving a COVID-19 vaccine. Participants receive information back and up to $200 compensation for their time. Sign up here.

View the NIH Collaboratory’s recent COVID-19 Grand Rounds session on HERO-TOGETHER.

 

Grand Rounds May 21: The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery

Speakers:

Chris Butler, MD
Nuffield Department of  Primary Care Health Sciences
University of Oxford

Ben Saville, PhD
Berry Consultants

Topic: The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery
Date: Friday, May 21, 2021, 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=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using 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: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

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

Grand Rounds May 7: Online Recruitment in the Era of COVID-19: Pitfalls and Progress

Speaker:

Megan L. Ranney, MD, MPH, FACEP
Director, Brown-Lifespan Center for Digital Health
Warren Alpert Endowed Associate Professor of Emergency Medicine, Brown University
Associate Dean of Strategy and Innovation, School of Public Health, Brown University
Chief Research Officer, AFFIRM
Co-founder, GetUsPPE

Topic: Online Recruitment in the Era of COVID-19: Pitfalls and Progress
Date: Friday, May 7, 2021, 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=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using 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: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

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

April 23, 2021: COVID Clinical Trials: The Intermountain Healthcare Experience (Samuel M. Brown, MD, MS)

Posted on by Gina Uhlenbrauck

Speaker

Samuel M. Brown, MD, MS
Associate Professor and Director of Pulmonary/Critical Care Research
Intermountain Healthcare
Associate Professor, University of Utah

Topic

COVID Clinical Trials: The Intermountain Healthcare Experience

Keywords

COVID-19; Public health; Integrated health system; COVID-19 treatment trials

Key Points

  • Intermountain Healthcare is a nonprofit, community-based healthcare system that maintains an academic referral center and several hospitals in Utah.
  • During the pandemic, the health system was able to integrate COVID-19 research with urgent clinical, operational, and public health needs. The health system currently supports 15 randomized clinical trials in COVID-19 research, investigating immunologic and virologic therapies.
  • Collaboration and communication across divisions were essential elements to the successes achieved.
  • Among the challenges of conducting the COVID-19 trials, there remains a wish for a comprehensive risk management solution and regulatory reform.

Discussion Themes

Could we establish a robust program that provides better training and pay for study coordinators? These staff have direct contact with participants for recruitment and retention and can make or break a trial.

What aspects of institutional culture contributed to the success of conducting these trials?

What is needed is a clinical research ecosystem that appropriately balances regulatory oversight with the agility to answer urgent health questions.

Read more about Intermountain Healthcare’s experiences with COVID-19 clinical trials in these recent publications:

Tags

#pctGR, @Collaboratory1

April 27, 2021: COVID-19 Grand Rounds Continues With the ACTIV-6 Direct-to-Participant Platform Trial

Posted on by Damon Seils

PhotoIn this week’s COVID-19 Grand Rounds session, Dr. Susanna Naggie of Duke University and Dr. Elizabeth Shenkman of the University of Florida will present “ACTIV-6: A Direct-to-Participant Platform Trial of Repurposed Drugs for COVID-19 in Non-hospitalized Patients.” The Grand Rounds session will be held on Friday, April 30, 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 April 30: ACTIV-6: A Direct-to-Participant Platform Trial of Repurposed Drugs for COVID-19 in Non-hospitalized Patients

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: A Direct-to-Participant Platform Trial of Repurposed Drugs for COVID-19 in Non-hospitalized Patients
Date: Friday, April 30, 2021, 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=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using 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: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

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

April 22, 2021: Materials From the NIH Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 14 and 15, 2021, more than 100 participants joined the online Steering Committee meeting to discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including adaptations made due to COVID-19, data sharing models and experiences, barriers encountered, and lessons learned. All presentations are available for download.