building partnerships

October 29, 2020: Article Describes Perspectives for Engaging Front-line Clinicians in PCTs

Posted on by Gina Uhlenbrauck

Ellen Tambor, MA, and colleagues have recently published in Learning Health Systems a PCORI-funded study of clinician perspectives on participating in pragmatic clinical trials (PCTs). In One size does not fit all: Insights for engaging front-line clinicians in pragmatic clinical trials, the authors wanted to better understand how clinicians view their role in research in the context of health care delivery, and what might be the common barriers to engagement. The authors describe results from focus group discussions conducted with physicians, nurses, and other care providers as the first phase of their study. The second phase involved key informant interviews with PCT research teams and clinicians participating in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness), the first pragmatic trial to leverage PCORI’s National Patient-Centered Clinical Research Network (PCORnet).

Funding mechanisms that allow adequate time and flexibility for protocol development (eg, the UG3/UH3 model employed for the NIH Health Care Systems Research Collaboratory Trials) can allow for more meaningful use of clinician feedback. (Tambor et al. 2020)

This study partly arose from early work in the NIH Collaboratory’s Stakeholder Engagement Core, which was established to disseminate best practices and guidelines for conducting research studies in partnership with healthcare systems to a broad audience of stakeholders. Read more in the Living Textbook in Building Partnerships and Teams to Ensure a Successful Trial.

October 20, 2020: All of Us Research Program Issues Funding Opportunity for New Engagement Partners

Posted on by Damon Seils

The All of Us Research Program has issued a new funding opportunity seeking partnerships with national, state, and local engagement partners to recruit and engage participants in the landmark NIH program. Through these partnerships, All of Us aims to create bidirectional and co-equal relationships that engage communities that have historically been underrepresented in biomedical research.

Logo for the All of Us Research Program

All of Us, a historic effort to accelerate research and improve health, launched nationally in 2018 to create one of the most comprehensive and diverse biomedical data resources of its kind. More than 358,000 participants have enrolled in the program. This latest funding opportunity illustrates the program’s commitment to partnering with organizations that are influential in their respective communities, especially those organizations that work with diverse communities.

The program anticipates funding at least 6 awards in fiscal year 2021 through this latest funding opportunity, each with a total project period of 5 years. Applications are due on November 23, 2020.

All of Us encourages eligible applicants with experience working with and engaging underrepresented communities to apply for this funding. All of Us considers the following populations underrepresented in research: racial and ethnic minority groups; children and seniors; sexual and gender minorities; people living with disabilities; people with barriers in access to care; people who have low income or low educational attainment; and rural residents.

For full details regarding this opportunity, please see the funding announcement.

October 16, 2020: Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative (Danny Benjamin, MD, PhD; Kanecia Zimmerman, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Danny Benjamin, MD, PhD
Kiser-Arena Distinguished Professor of Pediatrics, Duke University
Chair, Pediatric Trials Network
Deputy Director, Duke Clinical Research Institute

Kanecia O. Zimmerman, MD, MPH
Associate Professor of Pediatrics
Co-chair, ABC Science Collaborative
Duke University School of Medicine

Topic

Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative

Keywords

COVID-19; ABC Science Collaborative; Public school administration; Health disparities; Infection mitigation; Risk-benefit ratio; Community engagement

Key Points

  • The ABC Science Collaborative is a program that pairs scientists and physicians with school and community leaders to help understand the most current and relevant information about COVID-19. The program uses a data-driven approach to help school leaders make informed decisions about returning to school, using data from their own communities, with the goal of keeping teachers, children, and their local communities healthy and safe.
  • School boards, superintendents, principals, staff, and families are essential stakeholders in the ABC Science Collaborative.
  • Science shows that bringing kids back to school can be a success—if done the right way, including adherence to mask-wearing, hand hygiene, and physical distancing. Leadership support and implementing a coordinated, detailed plan are crucial to a successful approach.

Discussion Themes

The real power of the ABC Science Collaborative is the partnership between the researchers and stakeholders and their commitment to study the outcomes—and learn—together.

With scarce school resources, it’s better to maximize what has been shown to work in an interior environment, such as boosting adherence to masking and hand hygiene.

It could be said that “an ounce of data on COVID-19 provides more than an ounce of prevention.”

For resources and information, visit the ABC Science Collaborative website.

Tags

#pctGR, @Collaboratory1

August 14, 2020: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (Jon Tilburt, MD; Andrea Cheville, MD)

Posted on by Gina Uhlenbrauck

Speakers

Jon Tilburt, MD
Professor of Medicine and Biomedical Ethics
Mayo Clinic

Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic

Topic

Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial

Keywords

PRISM; NIH Heal Initiative; NOHARM; Postoperative care; Nonpharmacologic pain care (NPPC); Stepped wedge; Cluster-randomized trial; Electronic health records (EHRs); Patient engagement; Clinical decision support

Key Points

  • The Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) NIH Collaboratory Trial is completing its pilot phase. This embedded, stepped-wedge PCT will test a sustainable strategy in perioperative, nonpharmacologic pain management that preserves patient function, honors patient values, and maintains the availability of opioids as a last resort.
  • NOHARM is a pragmatic, EHR-integrated intervention that bundles a portal-based conversation guide that captures patient preferences for postsurgical pain care and a clinician-directed decision support tool.
  • Nonpharmacologic pain care management options include walking, yoga, tai chi, acupressure, massage, meditation, and relaxation.

Discussion Themes

Opioids are insufficient in postsurgical care. Guidelines recommend nonpharmacologic pain care (NPPC), but there have not been studies showing how to make NPPC more viable.

The COVID-19 pandemic caused disruption in scheduled surgeries and also air travel, which precluded on-the-ground support at two study sites. However, the team was able to adjust recruitment methods during the pilot phase.

What was the team’s proactive process in working with the IRB in order to obtain a waiver of consent?

The NOHARM intervention has sustained high-level institutional support despite the impact of COVID-19.

Read more about the NOHARM NIH Collaboratory Trial.

Tags

#pctGR, @Collaboratory1

April 29, 2020: Materials from the Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 22 and 23, 2020, more than 90 participants joined the online Steering Committee meeting to hear about the evolution of the embedded PCT (ePCT) ecosystem, discuss how to strengthen partnerships across the ecosystem, and identify approaches and lessons that will help inform and broaden the ecosystem. All presentations are available for downloading.

April 7, 2020: Support for the PRISM Embedded PCTs From the Health Care Systems Interactions Core

Posted on by Gina Uhlenbrauck

In a recent video interview, Dr. Eric Larson, chair of the Collaboratory’s Health Care Systems Interactions Core, and Leah Tuzzio, research associate, describe ways the Core is supporting the PRISM Demonstration Projects. A priority for conducting embedded PCTs (ePCTs) is establishing strong, sustainable relationships between the study team and health system leadership, clinicians, and staff.

For researchers who are evaluating pain management interventions, the Core advises remaining flexible when integrating the intervention and being mindful of documenting any adaptations made throughout the trial. Other best practices include understanding the context of the health setting, anticipating road blocks, and incorporating the intervention with minimal burden to clinicians and staff.

“Pain is a complicated area. It’s not a specific disease, it’s a state, and it’s a state that everybody experiences.”

For additional suggestions from the Core, read the new chapter in the Living Textbook on how to monitor intervention fidelity and adaptations. Learn more about the Health Care Systems Interactions Core and view interviews with the PRISM Demonstration Projects:

March 27, 2020: Living Textbook Grand Rounds Series: Part 3-Tips for Putting Together a Successful PCT Grant Application (Wendy Weber, ND, PhD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

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

Topic

Tips for Putting Together a Successful PCT Grant Application

Keywords

Pragmatic clinical trials; Embedded PCTs; Healthcare systems; NIH; Scientific officers; Funding opportunity announcement; Request for application

Key Points

  • Investigators interested in developing a compelling grant application for a pragmatic clinical trial (PCT) should consider these tips:
    • First, confirm that a PCT is the best study design to answer your research question.
    • From the NIH’s 27 Institutes and Centers, find the one that matches your disease area, organ system, or stage of life—and talk with the program official.
    • Also find the right funding opportunity announcement (FOA) and tailor your application to address all the FOA-specific instructions and review criteria.
  • Do not assume that the study panel is going to understand what pragmatic means; they may have a completely different definition. It is important that you get on the same page early in the application.
  • In your application, make sure you justify the research, include pilot data, address potential overlaps, reduce complexity, ensure the aims will advance the field, choose expert personnel for a multidisciplinary team, link data collection and analysis to aims, and justify the use of multiple sites and sample size.

Discussion Themes

For some urgent clinical problems, a PCT may be the only study design that can answer the research question.

Phased awards can be helpful. Determine the key elements of your trial to test in the planning phase. It’s important to “fail quickly”—not in the implementation phase. Applicants should identify milestones in the planning phase that will help convince reviewers their study will be feasible.

Because PCTs take place in changing conditions and real-world healthcare settings, they are not necessarily easier to implement than a traditional efficacy trial.

For more information, visit the Living Textbook’s Developing a Compelling Grant Application.

Tags
#pctGR, @Collaboratory1

March 12, 2020: Transforming Our Understanding of How to Conduct Research in a Real-World Setting

Posted on by Gina Uhlenbrauck

In a recent video interview, Dr. Helene Langevin, director of the National Center for Complementary and Integrative Health at the NIH, discusses the important work of the NIH Collaboratory in sharing knowledge and lessons learned as well as in harnessing expertise across the 19 Demonstration Projects it supports. “It is very important that we understand how research can be successfully implemented and tested in real-world clinical practice.”

 

 

For more interviews about the HEAL and PRISM projects, check out the February 21 news story.

February 28, 2020: Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Posted on by Gina Uhlenbrauck

Speakers

Vincent Mor, PhD
Florence Pirce Grant University Professor
Department of Health Services Policy & Practice
Brown University School of Public Health

Leah Tuzzio, MPH
Research Associate
Kaiser Permanente Washington Health Research Institute

Jeffrey (Jerry) G. Jarvik MD MPH
Professor, Radiology, Neurological Surgery and Health Services
Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine
University of Washington

Topic

Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Keywords

Embedded research; Implementation; Healthcare systems; Nursing homes; Radiology reports; Electronic health records; Data collection; Pragmatic clinical trials

Key Points

  • Early engagement between study teams and health system leaders and staff can help ease the embedded intervention into the clinical workflow. Consider, for example, who will deliver the intervention and how difficult it will be to implement.
  • In the pilot phase, show that you can implement the intervention effectively. For example, demonstrate that you can collect the outcome data you will need within the pilot’s time frame. Ensure that your study questions are important to the partner healthcare system.

Discussion Themes

It is essential to anticipate, identify, and make a plan to address changes in the healthcare system as your trial is being conducted.

Among the NIH Collaboratory Trials, many have good measures of how much site-to-site variation there is, which helps to understand what the preconditions are for high levels of implementation.

Use the pilot study to maximize acceptability, maintain affordability, and consider the scalability of the intervention.

These topics and more are on the Living Textbook of Pragmatic Clinical Trials. Plan to hear the next topics in the Living Textbook Grand Rounds series.

Tags
#pctGR, @Collaboratory1

March 3, 2020: Healthcare System Leaders Give Advice to Pragmatic Trial Investigators

Posted on by Karen Staman

In a new section of the Living Textbook on Building Partnerships to Ensure a Successful Trial, Kenneth Sands, the chief epidemiologist and chief patient safety officer at HCA, and Jonathan Perlin, the chief medical officer and president of clinical services at HCA, offer advice to investigators who wish to conduct pragmatic clinical trials.

“Healthcare systems have constrained bandwidth, and participating in learning activities involves significant costs and challenges: there are direct costs but also intangible costs, which can be substantial, such as personnel time, IT time, distraction of clinical staff, and the potential for supply chain issues.” — Advice from Healthcare System Leadership

The authors establish principles of partnership that include establishing and maintaining a durable partnership, selecting topics of mutual interest, and giving precedence to operational imperatives.

For more, see the article “Real-World Advice for Generating Real-World Evidence” in NEJM Catalyst.