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 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

May 5, 2018: New Article Explores Opportunities for Funding the Training of Future Health Services Researchers

In a new article, Dr. Vincent Mor, an NIH Collaboratory investigator, and Dr. Paul Wallace describe the history, current status, and opportunities for funding training in health services research (HSR). While the number of organizations seeking to solve problems with health services research has been expanding, direct government support for HSR is declining. The authors project 5 key challenges for the field and its professional development:

  • Formulating and prioritizing research topics
  • Whether to use team- or individual-based approaches
  • How new data sources, analytic methods, and the need for faster results affect supply and demand for HSR
  • Shifts from public to institutional funding and the associated effects on generalizability
  • Balancing proprietary concerns regarding data, predictive models, and study results with the need to improve public health and rapidly disseminate information

According to the authors, sustainable solution will involve active collaboration between those who use HSR as a part of decision-making (and will likely pay for it) and those who produce it.

“We believe that the key change needed to productively address the above challenges will be a closer collaboration between HSR users, especially health systems, and academic HSR training programs to work towards producing timely, internally relevant, and externally generalizable knowledge (Mor and Wallace 2018).”

Dr. Mor is a principal investigator for the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) trial, one of the NIH Collaboratory Demonstration Projects.

Mor V, Wallace P. 2018.  Funding the Training of Future Health Services Researchers. Health Services Research. doi:10.1111/1475-6773.12844.

April 9, 2018: PPACT Study Design Paper Published

Congratulations to Dr. Lynn DeBar and the investigators of the Collaborative Care for Chronic Pain in Primary Care pragmatic trial for recently publishing their study design paper. One of the NIH Collaboratory Demonstration Projects, the trial is designed to test whether a primary care–based behavioral intervention the Pain Program for Active Coping and Training (PPACT)—will provide a “more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment” than usual care for patients on chronic opioid treatment (Debar et al 2018). Learn more about this innovative trial in the article in Contemporary Clinical Trials. You can also download a trial snapshot.

Full Citation: DeBar L, Benes L, Bonifay A, et al. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial. Contemporary Clinical Trials. 2018;67:91-99. doi:10.1016/j.cct.2018.02.015

January 19, 2018: New Research Methods Resources Website on Group- or Cluster-Randomized Studies

The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.

December 7, 2017: Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video

In a new video in the Living Textbook, Dr. Greg Simon describes the differences between individual, cluster, and stepped-wedge randomization using props, including marbles, Play-Doh, and glassware.

“In the end, it’s all about randomly assigning who gets which treatment, or who gets which treatment when, so that we’re able to make some un-biased judgement about which treatment is really better.” —Greg Simon, MD

November 3, 2017: Dr. Miguel Vazquez Shares Lessons From the Improving Chronic Disease Management with Pieces (ICD-Pieces) Trial

In this interview, Dr. Miguel Vazquez gives an update on the first years of the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial. Dr. Vazquez discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

“Try to really learn from others who have done this—even if you are the first one doing your specific trial with your specific questions. It was helpful for us to learn from the other Collaboratory projects; they had already faced some problems, and we were able to anticipate and develop solutions proactively.” – Dr. Miguel Vazquez

Read more from Dr. Vazquez in the full interview (PDF).

October 27, 2017: Dr. Doug Zatzick Shares Lessons From the Trauma Survivors Outcomes and Support (TSOS) Trial

In this interview, Dr. Doug Zatzick gives an update on the first years of the Trauma Survivors Outcomes and Support (TSOS) trial. Dr. Zatzick discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

Dr. Zatzick’s advice: “Embed implementation teams within embedded trials. The bottom line is, go to the sites, do training at the sites and with the team, and take field notes in real time. ”

Read more from Dr. Zatzick in the full interview.

October 20, 2017: Dr. Vincent Mor Shares Lessons From the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) Trial

In this interview, Dr. Vincent Mor gives an update on the first years of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) project. Dr. Mor discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

Dr. Mor’s advice: “The health care system must agree that the outcome your intervention is seeking to achieve is consistent with their mission. Your outcome goal should be something they care about.”

Read more from Dr. Mor in the full interview.

October 18, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Biostatistics and Study Design Core

We recently asked Dr. Liz DeLong, Chair of the Biostatistics and Study Design Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says the biggest impact of the Core has been working with the individual Demonstration Projects to provide a sounding board to discuss statistical challenges. Further, Core members have contributed to new knowledge through manuscripts that address key methodological issues related to pragmatic clinical trials. She’s hoping the Core will continue to push the boundaries of statistical methods in the coming years.

“The statisticians on the individual trials have not only developed excellent statistical methods for their own studies, but also contributed substantively to the Core.” Dr. Liz DeLong

Download the interview (PDF).