clinical trials

October 23, 2020: Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework (Patrick O’Connor, MD, MA, MPH; JoAnn Sperl-Hillen, MD)

Posted on by Gina Uhlenbrauck

Speakers

Patrick O’Connor, MD, MA, MPH
Senior Clinical Investigator
HealthPartners Institute

JoAnn Sperl-Hillen, MD
Senior Clinical Investigator
HealthPartners Institute

Topic

Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework

Keywords

Clinical decision support; Electronic health record (EHR); Automated tools; Web applications; Clinical informatics

Key Points

  • A well-designed clinical decision support (CDS) system should fire only when there is a potential large benefit, such as a cardiovascular benefit for patients with a reversible risk. The CDS trigger should be patient-centric, and the system should save clinician time and improve the quality of care.

  • The CDS in question was designed for use in cardiovascular (CV) disease to:

    • Identify and target individuals with the greatest potential for a CV benefit and prioritize CV risk factors based on potential benefit.

    • Display personalized treatment options (eg, medication intensification, behavioral/lifestyle change, safety alerts, referrals, and testing due).

    • Provide tools to both the patient and clinician to support patient engagement and shared decision-making.

Discussion Themes

How are the interventions prioritized in the CDS system? What about decision-making across other clinical domains?

What do you see as the drivers of uptake and adoption of CDS with triggers compared with telehealth?

What clinic challenges did you encounter after the onset of COVID-19?

Read more in Clinical Decision Support Directed to Primary Care Patients and Providers Reduces Cardiovascular Risk: A Randomized Trial (J Am Med Inform Assoc, 2018) and NCT01420016 (ClinicalTrials.gov).

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#pctGR, @Collaboratory1

October 6, 2020: Four PRISM NIH Collaboratory Trials Awarded Continuation From Planning to Implementation Phase

Posted on by Gina Uhlenbrauck

The NIH Collaboratory is pleased to announce that the four PRISM NIH Collaboratory Trials received approval to transition from the planning phase to the implementation phase of their studies. These embedded PCTs (ePCTs) are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments.

Congratulations to the PIs and study teams for their excellent work!

BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

Karen Sherman, PhD, MPH
Photo of Lynn DeBar, principal investigator of PPACT
Lynn DeBar, PhD, MPH

BackInAction is conducting a three-arm pragmatic trial of older adults who have chronic low back pain to evaluate acupuncture versus usual care. The study will compare a standard 12-week course of acupuncture, an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course), and usual care to assess back-related function at 26 weeks.

 

 

 

 

FM TIPS: Fibromyalgia TENS in Physical Therapy Study

Kathleen Sluka, PT, PhD
Leslie Crofford, MD

The aim of FM TIPS is to demonstrate the feasibility of adding transcutaneous electrical nerve stimulation (TENS) to the treatment of patients with fibromyalgia in a real-world physical therapy setting, and to determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy, and allows patients with fibromyalgia to reach their specific functional goals with less medication use.

 

 

 

NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management

Photo of Andrea Cheville, co–principal investigator of NOHARM
Andrea Cheville, MD
Jon Tilburt, MD

NOHARM is a stepped-wedge cluster-randomized trial that is testing a sustainable system-wide strategy for perioperative pain management using nonpharmacologic options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort.

 

 

 

 

OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting

Natalia Morone, MD

OPTIMUM aims to evaluate the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in a real-life clinical setting. Mindfulness is effective for the treatment of chronic low back pain, yet remains underutilized as it has not been regularly woven into the outpatient clinical setting.

 

 

 

 

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center and is supported by the National Center for Complementary and Integrative Health. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

September 25, 2020: Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program (Rick Bright, PhD; Rachael Fleurence, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Rick Bright, PhD
Senior Advisor to the NIH Director

Rachael Fleurence, PhD
Special Assistant to the NIH Director for COVID-19 Diagnostics

Topic

Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program

Keywords

National Institutes of Health; COVID-19; Rapid Acceleration of Diagnostics (RADx); COVID-19 testing protocols; Innovative technologies; Coronavirus testing

Key Points

  • The NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
  • RADx is creating programs to rapidly scale-up testing across the country and enhance access to those most in need. Newer technologies offer user-friendly designs with lower cost and increased accessibility at home and at the point of care.
  • Deploying the right tests at the right time to the right people will be critical to managing the pandemic until a vaccine is available and beyond. Testing will still be necessary after the vaccine becomes available.

Discussion Themes

The supply chain continues to be a challenge in COVID-19 testing procedures, for example the availability of plastic tips and swabs. However, barriers are driving innovations such as saliva technologies and extraction-less approaches.

Are there efforts underway to link testing data from disparate sources such as EHR clinical data, administrative claims data, antibody testing, symptom trackers/COVID-19 registries?

A new goal will be implementing the real-time matching of COVID-19 hot spots with available testing.

Read more about the NIH’s RADx program and in a special report in New England Journal of Medicine.

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#pctGR, @Collaboratory1

September 11, 2020: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (Gordon Bernard, MD; Sonia Thomas, DrPH)

Posted on by Gina Uhlenbrauck

Speakers

Gordon R. Bernard, MD
CONNECTS ACC Science Unit P
Professor of Medicine
Executive Vice President for Research
Senior Associate Dean for Clinical Science
Vanderbilt University Medical Center

Sonia Thomas, DrPH
CONNECTS ACC Principal Investigator
Senior Research Statistician
RTI International

Topic

Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies

Keywords

COVID-19; CONNECTS; NHLBI; Collaborative research; Data sharing; Adaptive trials; Data standardization; ACTIV; Therapeutic agent prioritization

Key Points

  • The Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) is a research partnership coordinated by the Research Triangle Institute, Vanderbilt University Medical Center, and the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
  • CONNECTS aims to build on existing clinical research networks to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery. Studies will enroll participants with health conditions that are known to increase their risk for severe complications from COVID-19.
  • The immediate goal is to design and implement master protocol-driven adaptive clinical trials, including outpatient, inpatient, and recovering master protocols.
  • CONNECTS is part of a larger ecosystem in the Department of Health and Human Services that includes the FDA, CDC, BARDA, Operation Warp Speed, and NIH. More than 34 trial networks and 1,000 sites are participating in CONNECTS.

Discussion Themes

Are the CONNECTS resources, such as the common data elements manual, draft protocols, and case report forms, publicly available?

In your effort to reach underrepresented communities, have you considered collaborating with Historically Black Colleges and Universities (HBCUs), particularly those that conduct health research?

While COVID-19 is providing you with plenty to focus on, do you see the potential for sustainability of CONNECTS beyond this pandemic?

Read more about CONNECTS.

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#pctGR, @Collaboratory1

August 28, 2020: Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting (Trevor Lentz, PT, PhD, MHA; Lesley Curtis, PhD; Frank Rockhold, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Trevor Lentz, PT, PhD, MHA
Assistant Professor in Orthopaedic Surgery
Duke Clinical Research Institute

Lesley Curtis, PhD
Chair and Professor, Department of Population Health Sciences
Duke University School of Medicine

Frank Rockhold, PhD, ScM, FASA, FSCT
Professor of Biostatistics and Bioinformatics
Duke Clinical Research Institute

Topic

Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting

Keywords

Pragmatic clinical trials; Think tank; Risk-based monitoring; Data quality; Real-world data; Electronic health records

Key Points

  • Pragmatism in study design is not a binary concept: some trial elements are purely explanatory (to establish efficacy in ideal settings) and some elements are purely practical (to establish effectiveness in the real world). The study design must serve the research question.
  • Findings from the think tank discussions on best practices and actionable steps included:
    • Ask precise research questions, and select the appropriate degree of pragmatism.
    • Optimize data quality through study design.
    • Focus on primary endpoints in data capture to maximize likelihood of success.
    • Innovate on mechanisms for data capture.
    • Promote adherence to the study protocol.
    • Evolve trial operations staff to focus on data science and informatics.
    • Share learning experiences openly and widely.

Discussion Themes

There is a misconception that PCTs, because they pursue pragmatism, are less rigorous and conducted without proper oversight or adherence to a protocol. Quality by design and good clinical practice principles apply equally to PCTs.

Risk-based monitoring is a potentially dynamic system that could improve study safety and quality, and make better use of study resources.

There is great interest from regulators, sponsors, and the academic research community to move PCT methods forward. To achieve this, we need to see more examples of successful PCTs in a context of regulatory decision-making.

Read the proceedings from the think tank meeting published in Therapeutic Innovation & Regulatory Science.

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#pctGR, @Collaboratory1

August 21, 2020: Adaptive Platform Trials: Scalable from Breast Cancer to COVID (Laura Esserman, MD, MBA)

Posted on by Gina Uhlenbrauck

Speaker

Laura Esserman, MD, MBA
Director, UCSF Carol Franc Buck Breast Care Center
Alfred A. de Lorimier Endowed Chair in General Surgery
Professor of Surgery and Radiology, UCSF

Topic

Adaptive Platform Trials: Scalable from Breast Cancer to COVID

Keywords

COVID-19; Adaptive platform trial; Study design; Learning healthcare system; Collaborative research

Key Points

  • Adaptive trial design is an innovative, collaborative approach with the potential to maximize learning about treatments so as to prioritize therapeutic agents and drive better patient outcomes.
  • Adaptive platform trials are designed to identify early endpoints that can be captured in the course of care. Multiple agents are evaluated simultaneously, and those with a potential for big impact are advanced quickly.
  • As a “learning engine,” adaptive platform trials could be used to accelerate high-impact treatments for COVID-19 and future pandemics.

Discussion Themes

Essential to an adaptive platform trial are checklists of data and nimble EHR tools that evolve as the disease evolves.

What is the process to monitor for and make the decision to modify the standard of care backbone?

Read more about adaptive platform trials at the I-SPY Trials website and a recent Grand Rounds presentation, Optimized Learning While Doing: The REMAP-CAP Adaptive Platform Trial.

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#pctGR, @Collaboratory1

August 19, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Puts Spotlight on Adaptive Platform Trials

Posted on by Damon Seils

Photo of Dr. Laura EssermanIn this week’s COVID-19 Grand Rounds session, Dr. Laura Esserman of the University of California, San Francisco will present “Adaptive Platform Trials: Scalable From Breast Cancer to COVID.” The Grand Rounds session will be held on Friday, August 21, 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.

Previous COVID-19 Grand Rounds:

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

August 11, 2020: Grand Rounds Webinar Discusses the Democratization of Medical Research

Posted on by Gina Uhlenbrauck

A recent Grand Rounds webinar presented by C. Michael Gibson, MS, MD, described how open access, patient empowerment, social media, and digital health are transforming clinical trials. Dr. Gibson is a professor of medicine at Harvard Medical School and president and CEO of Baim and PERFUSE Research Institutes.

Among the key points:

  • The COVID-19 pandemic has been a call to arms to physicians to combat not only the virus but the misinformation.
  • As the internet is replacing the printing press, “copyleft” is replacing copyright in this new open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information.
  • In this new world of clinical research, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.
  • Patient-empowered trials have the potential to provide more generalizable study results and to lead to patient-specific predictions through use of artificial intelligence.

Watch the complete webinar and download the slides.

Read more in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (Gibson, JAMA Cardiology, 2017) and learn about the Heartline Study as an example of a “giga trial.”

August 7, 2020: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research (C. Michael Gibson, MS, MD)

Posted on by Gina Uhlenbrauck

Speaker

C. Michael Gibson, MS, MD
Professor of Medicine
Harvard Medical School
President and CEO
Baim and PERFUSE Research Institutes

Topic

The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research

Keywords

Clinical research; Open access; Social media; Artificial intelligence; Heartline study; WikiDoc; WikiPatient

Key Points

  • As the internet is replacing the printing press, “copyleft” is replacing copyright in the open-access era. It is a participatory community with bidirectional flow of information through social media.
  • Health data does not equal health care. Patients are looking to physicians to curate health information from huge volumes of data.
  • Social media and open access during the COVID-19 pandemic has meant that physicians are citizen journalists, innovators, activists, and educators.
  • In this new world, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.

Discussion Themes

The COVID-19 pandemic has been a call to arms to clinicians to combat not only the virus but the misinformation. As educators we must set the path and not allow uninformed people to take control.

Enabling patient-empowered trials has the potential for more generalizable study results and can lead to patient-specific predictions through use of artificial intelligence.

How do we validate the quality of open-access data and reports that are not peer-reviewed?

How can we diminish the hazards of skewed research outcomes arising from trial participant conversations on social media?

Read more from C. Michael Gibson in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (JAMA Cardiology 2017).

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#pctGR, @Collaboratory1

July 24, 2020: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (Leslie J. Crofford, MD; Kathleen Sluka, PT, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center

Kathleen Sluka, PT, PhD
Kate Daum Research Professor
Department of Physical Therapy and Rehabilitation Science
University of Iowa

Topic

TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

Keywords

Fibromyalgia; Musculoskeletal pain; Neuropathic pain; Transcutaneous electrical nerve stimulation (TENS); Physical therapy; Nonpharmacologic pain treatment; PRISM; Patient-reported outcomes (PROs)

Key Points

  • Fibromyalgia (FM) is a condition of widespread pain that is worsened with physical activity. It involves chronic musculoskeletal and visceral pain and is often accompanied by fatigue, depression, or anxiety.
  • Transcutaneous electrical nerve stimulation (TENS) is a technique that uses a device to deliver an electric impulse through the skin. Treatment with TENS has been shown to improve resting and movement-evoked pain and fatigue.
  • While physical therapists generally are trained in the use of TENS, the technique remains underused in clinical practice.
  • The goal of the FM TIPS pragmatic trial is to determine, in a real-world clinical setting, whether physical therapy combined with TENS for patients with FM is more effective than physical therapy alone. The study is being piloted in 24 sites across 5 physical therapy health systems.

Discussion Themes

While COVID-19 has had an impact on piloting the FM TIPS study, some kind of physical therapy will be possible through telemedicine. Other challenges include that conducting embedded research in physical therapy clinics is new, and there are multiple different EHR systems in use across the partnering clinics.

The recently published results from Fibromyalgia Activity Study With TENS (FAST) showed that TENS can be safely used in addition to other treatments to improve pain and fatigue in women with fibromyalgia in the setting of a randomized controlled trial.

Read more about the Fibromyalgia TENS in Physical Therapy Study (FM TIPS) NIH Collaboratory Trial and watch a brief interview with the PIs of the study.

FM TIPS is one of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) studies.

Tags

#pctGR, @Collaboratory1