August 14, 2018: Interview With NIH Collaboratory Leadership Highlights New Demonstration Projects

In a recent video interview, NIH Collaboratory leaders Dr. Lesley Curtis, Dr. Adrian Hernandez, and Dr. Catherine Meyers share their enthusiasm for the Collaboratory’s 6 new Demonstration Projects. The projects include new areas of expertise, such as pediatrics, new digital technologies, and the Collaboratory’s first A vs B trial.

“The new demonstration projects coming into the Collaboratory provide the opportunity to generate more knowledge and new knowledge about what works best in these settings. That’s really exciting.”—Lesley Curtis, PhD

August 13, 2018: JAMA Commentary Highlights the Value of Data Enclaves and Distributed Data Networks

In a JAMA Viewpoint published online last week, NIH Collaboratory investigator Dr. Richard Platt and colleague Dr. Tracy Lieu discuss the value of “data enclaves” to facilitate information sharing in support of research, quality improvement, and public health reporting.

Creating data enclaves allows health systems to share useful information from their clinical data without releasing the actual data. Data enclaves can be linked with each other in distributed data networks to create powerful resources for researchers and other analysts. The authors note that efforts to realize this vision must address concerns about protecting patients’ personal information, the costs and work required to make the data usable for analysis, and incentives for health systems to participate.

Dr. Platt is a cochair of the NIH Collaboratory’s Distributed Research Network, which uses a common data model that enables investigators to collaborate with each other in the use of electronic health data while safeguarding protected health information and proprietary data.

August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool

The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, were published online this week in JAMA Internal Medicine. The analysis found that colorectal cancer screening rates were higher in community clinics that implemented a mailed fecal immunochemical test (FIT) outreach program than in clinics that practiced usual care. The improved screening rates occurred despite low and highly variable rates of implementation of the program among participating clinics.

Almost half of eligible adults in the United States are not up to date with recommended screening for colorectal cancer, the second leading cause of cancer-related deaths. Screening rates are especially low among racial/ethnic minority and low-income populations, including those served at federal qualified health center clinics.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federal qualified health centers. The intervention involved embedding a tool in the electronic health record to identify patients who were overdue for colorectal cancer screening, mailing a FIT kit and reminder letter to eligible patients, and implementing a practice improvement process at participating clinics. Of the 26 clinics in the study, 13 received the intervention and 13 practiced usual care.

Compared with clinics that practiced usual care, intervention clinics had a significantly higher proportion of participants who completed a FIT (3.4 percentage points) and any colorectal cancer screening (3.8 percentage points). The higher screening rates occurred despite another important finding of the study, that low rates of implementation of the intervention were common. Higher rates of implementation were correlated with higher rates of FIT completion.

The STOP CRC experience offers lessons on how to use electronic health records to improve guideline-based screening. In a recent NIH Collaboratory Grand Rounds, investigators Dr. Gloria Coronado and Dr. Beverly Green presented findings from the trial and lessons from the implementation of the intervention. Download a study snapshot about the STOP CRC trial.

Additional reading:

Read the press release from the Kaiser Permanente Center for Health Research: Community Health Centers Can Help Boost Rates of Colorectal Cancer Screening, Kaiser Permanente Study Shows

Read Dr. Beverly Green’s blog post on the Kaiser Permanente Washington Health Research Institute’s Healthy Findings blog: Community Health Centers Can Boost Colon Cancer Screening

August 9, 2018: New Interview with Dr. David Shurtleff about the NIH Collaboratory

In a recent video interview, Dr. David Shurtleff, acting director of the National Center for Complementary and Integrative Health (NCCIH), discusses the unique work of the Collaboratory in bringing together multiple NIH Institutes and Centers to develop best practices, methods, guidance, and tools for conducting rigorous pragmatic research.

“The Collaboratory has been transformative in how it’s developed a novel, supportive infrastructure to conduct pragmatic research in a way that allows it to be embedded within healthcare systems.” David Shurtleff, PhD

August 7, 2018: New Podcast: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

 

July 30, 2018: Learn More About the New NIH Collaboratory Demonstration Projects

Check out the new program materials from the Collaboratory:

Study information for the 6 new UG3 Demonstration Projects:

  • ACP PEACE: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
  • EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder
  • GGC4H: Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (Guiding Good Choices for Health)
  • Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
  • PRIM-ER: Primary Palliative Care for Emergency Medicine
  • HiLo: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis

In addition, the May 2018 Steering Committee Meeting materials are now available, including presentations from the UG3 and UH3 Demonstration Projects and the full-day intensive workshop “Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions.”

July 30, 2018: Registration Open for 3rd Seattle Symposium on Health Care Data Analytics

Registration is open for the 3rd Seattle Symposium on Health Care Data Analytics. The symposium will bring together biostatisticians, health informaticists, epidemiologists, and other data scientists to discuss health research and methods that involve large health care databases.

Experts involved in national research initiatives that use large health care databases will discuss methodological challenges encountered in this setting and share ideas for addressing them. Speakers will share their research on:

  • statistical approaches to learning from electronic health care data;
  • methods for precision medicine; and
  • health policy.

Space is limited, and registration is required.

The event is sponsored by the Biostatistics Unit at Kaiser Permanente Washington Health Research Institute and the Department of Biostatistics at the University of Washington.

July 25, 2018: NIH Collaboratory Launches 5 New Demonstration Projects

This post was updated on August 3, 2018.

The NIH Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects. The new research awards, which are supported by 6 NIH institutes, centers, and offices, total $4.15 million for an initial 1-year planning phase and an estimated $30.85 million for 4 years of study implementation.

NIH Collaboratory Demonstration Projects are multicenter, pragmatic trials that engage healthcare delivery systems in research partnerships to gather real-world evidence and answer clinical questions of major public health importance. Five Core Working Groups of experts, each focused on a specific topic related to the implementation of pragmatic clinical trials, support all of the Demonstration Projects. The Core Working Groups help the research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process.

In its first 5 years, the NIH Collaboratory successfully guided 10 complex Demonstration Projects through the planning phase, 9 of which proceeded to full study implementation.

The 5 new Demonstration Projects are supported by the National Center for Complementary and Integrative Health (NCCIH), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute on Drug Abuse (NIDA), the Office of Behavioral and Social Sciences Research (OBSSR), and the Office of Disease Prevention (ODP). They include:

Over the next 5 years, the new Demonstration Projects will extend the NIH Collaboratory’s mission to improve how clinical trials are conducted by creating a new infrastructure for implementing cost-effective, large-scale research studies that involve healthcare delivery organizations.

Update: A sixth new Demonstration Project, HiLo, was subsequently announced.

July 23, 2018: New Report Summarizes Patient-Reported Health Data and Metadata Standards in the ADAPTABLE Trial

A new report in the Living Textbook describes results of a literature review of data standards and metadata standards for variables of interest to the ADAPTABLE trial. Based on the review, the authors recommend standards for ADAPTABLE, also known as the Aspirin Study, which is the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network (PCORnet). The trial aims to identify the optimal dose of aspirin therapy for secondary prevention in atherosclerotic cardiovascular disease.

Because the ADAPTABLE trial relies on patients to report key information at baseline and throughout follow-up, it represents a unique opportunity to develop, pilot, and evaluate methods to validate and integrate patient-reported information with data obtained from electronic health records (EHRs). In 2016, the National Institutes of Health implemented a project with the goal of using the ADAPTABLE study to develop methods to (1) assess the quality of patient-reported data and (2) integrate the data with existing EHR data. It is hoped that this project will inform future efforts to synthesize potentially inconsistent data from patient-reported and EHR sources and identify opportunities to streamline data.

Download the report.