Demonstration Project

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

Posted on by Gina Uhlenbrauck

Check out the new program materials from the Collaboratory:

Study information for the 6 new UG3 NIH Collaboratory Trials:

  • 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: Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems
  • 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 NIH Collaboratory Trials and the full-day intensive workshop “Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions.”

July 25, 2018: NIH Collaboratory Launches 5 New NIH Collaboratory Trials

Posted on by Damon Seils

This post was updated on August 20, 2018.

The NIH Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative NIH Collaboratory Trials. 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 Trials 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 NIH Collaboratory Trials. 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 NIH Collaboratory Trials through the planning phase, 9 of which proceeded to full study implementation.

The 5 new NIH Collaboratory Trials 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 NIH Collaboratory Trials 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: The NIH Collaboratory subsequently announced a sixth new NIH Collaboratory Trial, HiLo. Watch a video interview about the new projects with NIH Collaboratory leaders.

April 9, 2018: PPACT Study Design Paper Published

Posted on by Karen Staman

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 Trials, 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

February 15, 2018: Timely Tips from NIH Collaboratory Trial Principal Investigators

Posted on by Gina Uhlenbrauck

The NIH Collaboratory will soon welcome a new group of NIH Collaboratory Trials and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)­—to share tips and advice for investigators who are new to ePCTs.

Download the PDF.

“Integrate really well with the key stakeholders from your sites.”
– Lynn DeBar, PhD

“Engage with senior mentors and people who have gone down this road before.” – Jerry Jarvik, MD, MPH

“Recognize that the perspectives of key stakeholders may be different than anticipated by investigators.” – Laura Dember, MD

 

February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators

Posted on by Karen Staman

In the spring of 2018, the NIH Collaboratory will be welcoming a new set of NIH Collaboratory Trials and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice to the newcomers and other investigators new to conducting pragmatic trials.

Advice to New Pragmatic Trial Investigators from NIH Research Collaboratory on Vimeo.

“My greatest advice is to gain partners who are operational and have insight into particular areas—whether they be hospitals, or clinics, or nursing homes—who know about how they really work, how to best incorporate the intervention into workflow, how to get the right approvals, and how to get the best information technology support available to them.”—Susan Huang, MD

“One of the key things that we’ve received from being part of the Collaboratory—compared to an R01 grant—is the opportunity to interact across all of the institutes at NIH as well as learn about other projects that are working in pretty diverse health systems, including hospital systems, nursing homes, and dialysis centers.” —Gloria Coronado, PhD

November 17, 2017: New Video in Living Textbook Explores Data Sharing and Embedded Research

Posted on by Karen Staman

As part of an article published in Annals of Internal Medicine, Dr. Greg Simon created a short video in which he describes concerns related to data sharing and embedded research, as well as potential solutions for those concerns. We recently added this video to the Living Textbook chapter on Data Sharing and Embedded Research. In the chapter, the authors expand on the ideas presented in the Annals article and fame them using lessons learned from the NIH Collaboratory Trials. Data collected as part of research embedded in a health system comes from a fundamentally different context than stand-alone explanatory trials. When they are taken out of context or used for comparisons, they have the potential to do harm—something that can potentially discourage health systems from volunteering to participate in embedded research. The authors suggest that data sharing plans for embedded research be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.

“Ultimately, it’s a practical question: if we want healthcare providers and healthcare systems to participate in research, we shouldn’t expect them to bear extra risk. In an ideal world, all information about the quality of health care and healthcare outcomes across the country would be completely open to everyone, but we don’t live in that world now. So if we are asking healthcare providers and healthcare systems to open up and be more transparent by participating in research, we certainly would not want to punish those who volunteer.” — Simon et al. in video for Ann Intern Med

 

Simon G, Coronado G, DeBar L, et al. Data Sharing and Embedded Research: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/data-share-top/data-sharing-and-embedded-research-introduction/. Updated November 13, 2017.

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

Posted on by Gina Uhlenbrauck

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

Posted on by Karen Staman

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

Posted on by Karen Staman

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.

STOP CRC Trial: Analytic Challenges and Pragmatic Solutions

Posted on by Gina Uhlenbrauck

Investigators from the STOP CRC pragmatic trial, an NIH Collaboratory Trial, have recently published an article in the journal eGEMs describing solutions to issues that arose in the trial’s implementation phase. STOP CRC tests a program to improve colorectal cancer screening rates in a collaborative network of Federally Qualified Health Centers by mailing fecal immunochemical testing (FIT) kits to screen-eligible patients at clinics in the intervention arm. Clinics in the control arm provided opportunistic colorectal-cancer screening to patients at clinic visits in Year 1 and implemented the intervention in Year 2. In this cluster-randomized trial, clinics are the unit of analysis, rather than individual patients, with the primary outcome being the proportion of screen-eligible patients at each clinic who complete a FIT.

The team dealt with various challenges that threatened the validity of their primary analysis, one of which related to potential contamination of the primary outcome due to the timing of the intervention rollout: for control participants, the Year 2 intervention actively overlapped with the Year 1 control measurements. The other challenge was due to a lack of synchronization between the measurement and accrual windows. To deal with these issues, the team had to slightly modify the study design in addition to developing a few sensitivity analyses to better estimate the true impact of the intervention.

“While the nature of the challenges we encountered are not unique to pragmatic trials, we believe they are likely to be more common in such trials due to both the types of designs commonly used in such studies and the challenges of implementing system-based interventions within freestanding health clinics.” (Vollmer et al. eGEMs 2015)

The Publish EDM Forum Community publishes eGEMs (generating evidence & methods to improve patient outcomes) and provides free and open access to this methods case study. Readers can access the article here.