Demonstration Project

January 15, 2020: NIH Collaboratory Announces Data and Resource Sharing Page

Posted on by Karen Staman

The NIH Collaboratory Coordinating Center has published a new Data and Resource Sharing Page on the Living Textbook, which is designed to share the data and resources generated by the NIH Collaboratory Trials.

“As part of the Collaboratory’s commitment to sharing, all NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code.”  —Data and Resource Sharing Page

The page holds links to datasets and data dictionaries, study tools, ethics and regulatory documentation, computable phenotypes and analytic code, data collection forms, study design papers, main outcomes papers, and other information that might be useful to others.

To assist clinical investigators in planning for sharing these resources, NIH Collaboratory Trials are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire during the onboarding process.

These documents contain:

  • Questions designed to help investigators think through the unique concerns when sharing data and resources from embedded pragmatic trials
  • Data sharing requirements for the NIH Collaboratory, NIH, and medical journals
  • Examples from NIH Collaboratory Trials.
  • Descriptions of data sharing mechanisms, such as archives and enclaves
  • Examples of data sharing platforms
  • Examples of data sharing statements

At closeout, NIH Collaboratory Trials are provided a Closeout Data and Resource Sharing Checklist, and investigators from the completed projects use this checklist to provide a final data share package.

For more on data sharing, see the Living Textbook Chapter, Data Sharing and Embedded Research.

January 9, 2020: NIH Collaboratory Investigators Respond to Draft NIH Policy on Data Sharing

Posted on by Karen Staman

NIH Collaboratory leadership and NIH Collaboratory Trial principal investigators, along with their colleagues, responded this week to the recently released Draft NIH Policy for Data Management and Sharing and supplemental draft guidance. The draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared.

“We applaud the NIH’s policy and commitment to making the results and outputs of the research it funds and conducts available to the public. We enthusiastically support data sharing and agree with the principles of this policy. However, we believe more detail is warranted about the different types of research (ie, embedded pragmatic research), the associated protections, and acceptable mechanisms for sharing data, such as public and private archives and enclaves.” —Response to Draft NIH Policy for Data Management and Sharing

The main topics covered in the response are:

  • Support for the goals of the draft data sharing policy
  • Assessing and mitigating re-identification risk
  • Protecting secondary subjects
  • Use of data enclaves
  • Crediting those who share data

Other signatories include participants in the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative of the Leadership Consortium for Value and Science-Driven Health Care, and leaders of the Health Care Systems Research Network.

The full letter is available for download and includes the list of signatories.

Comments are due no later than January 10, 2020, and may be submitted online.

For more on data sharing, see the Living Textbook chapter, Data Sharing and Embedded Research.

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

Posted on by Damon Seils

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ABATE Infection NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TiME NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

December 13, 2019: Reissuance of Funding Opportunity Announcement for HEAL Initiative/PRISM Coming January 2020

Posted on by Gina Uhlenbrauck

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, intends to reissue Funding Opportunity Announcement (FOA) HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain To Reduce Opioid Prescribing (PRISM) (UG3/UH3 Clinical Trial Optional).

This RFA solicits applications for phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications in the health care delivery setting. The re-issuance of the FOA will prioritize the following areas for pragmatic trials to integrate multimodal or multiple interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based guidelines:

  • Pain management in emergency departments, dental clinics, primary care, and hospitals
  • Chronic overlapping pain conditions
  • Pain management in individuals at risk of or with opioid use disorder
  • Pain management in those with co-occurring mental health disorders
  • Noncancer pain management in persons with medical comorbid conditions

The FOA is expected to be published in January 2020 with an expected application due date in March 2020.

The announcement is part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

 

November 1, 2019: Collaboratory PIs Give Advice to New Pragmatic Trials

Posted on by Karen Staman

The NIH Health Care Systems Research Collaboratory program is welcoming new embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing as part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). At the same time, many of the Collaboratory’s early NIH Collaboratory Trials are completed and now publishing results. At a recent Collaboratory Steering Committee meeting, we spoke with four of the principal investigators (PIs) of completed trials to glean advice for new trials.

What words of advice do you have for investigators conducting their first embedded PCT?

Dr. Laura Dember, PI of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial (NCT02019225).

Dr. Dember: “An important message is that progress in making big changes to how trials are conducted is going to be incremental. We need to be aspirational, but we also need to recognize that we’re not going to solve all of the problems with one try. We should not be discouraged by the things that don’t work, but rather keep moving forward by building on what we’ve learned.”

Dr. Lynn Debar, PI of the Collaborative Care for Chronic Pain in Primary Care (PPACT) trial (NCT02113592).

Dr. DeBar: “Regarding stakeholder engagement, recognize that these are really complex adaptive systems, and sometimes, more resources and harder pushing is not the way to accomplish your goal. You have to really think through how to communicate: where and how you push requires thinking about all the stakeholders involved.”

Dr. Beverly Green, Co-PI of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) trial (NCT01742065).

Dr. Green: “The collaboration part of bringing the investigators together to figure out the pieces of the puzzle has really been valuable to me. Really try to understand stakeholder engagement, the values of the people involved, and work to align them. This way, when you get it right, embedded pragmatic research can save money, improve health, and be a better experience for staff and patients. It’s a win-win.”

Dr. Susan Huang, PI of the Active Bathing to Eliminate (ABATE) Infection trial (NCT02063867).

Dr. Huang: “Communication is so important because if you have stakeholders at the table, not all of them will have the exact vantage point as you, and you will learn by communicating. And, if you’re learning different things and reaching different forks in the road that require decision-making and troubleshooting, it’s only by talking about them that you get everybody to really understand what the goal is. And in this way, you come up with better solutions than you could come up with yourself.”

What was the biggest lesson learned in conducting your trial?

Dr. Dember:  “It’s important to effectively engage with people on the ground. The extent to which this is possible depends on the setting, but, at least for some interventions, being able to engage with the people who are actually implementing the trial procedures is critical.”

Dr. Huang: “The biggest lesson is the critical nature of the partnership and the investment involved in maintaining it. The strength of our trial, and our ability to conduct it, was dependent on a strong partnership.”

Dr. Debar: “Vertical integration is important: you need high level buy-in, but you also need buy-in from people on the ground who are providing care.”

Dr. Green: “Someone in NIH did the math regarding how much an implementation study costs per participant, and he said, ‘That has to be cheaper.’ This prompted me to think about what things could be answered with embedded research. As a clinician, day to day, I am always making decisions that I don’t really know the answer because there isn’t enough evidence. There are so many questions that need to be answered, and embedded pragmatic research is a great starting point for getting more answers. We’ll never get there by doing this one trial at a time with traditional research.”

Congratulations to all four investigators for their groundbreaking work on their NIH Collaboratory Trials!

September 27, 2019: NIH Collaboratory to Serve as Coordinating Center for New Pragmatic Trials Addressing Opioid Crisis

Posted on by Gina Uhlenbrauck

The NIH Health Care Systems Research Collaboratory program is excited to announce that it has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing. As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center will provide technical support and pragmatic trial expertise for the research that this program funds. PRISM trials will determine the effectiveness of multiple non-opioid interventions for treating pain and assess the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids.

The PRISM Resource Coordinating Center funding and new research awards, described below, are part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). This federal research initiative, launched in early 2018 by NIH Director Francis S. Collins, aims to apply scientific solutions to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery for opioid addiction.

“The NIH Collaboratory Coordinating Center is excited to be supporting these novel pragmatic trials that address an urgent health crisis. We hope the patients, clinicians, researchers, and health systems will benefit from knowledge we’ve gained supporting complex trials embedded in health care systems over the past 7 years, which will help deliver improvements in pain management to the American public faster.” – Adrian Hernandez, MD, MHS, Vice Dean for Clinical Research, Duke University School of Medicine.

The PRISM awards total approximately $35.7 million and are supported by 8 participating NIH institutes, centers, and offices. With these awards, the NIH Collaboratory will add 4 new large-scale ePCTs to its portfolio of innovative NIH Collaboratory Trials. The trials will be conducted at Boston Medical Center, Massachusetts; Kaiser Foundation Research Institute, California; Mayo Clinic, Minnesota; and University of Iowa. They include:

  • Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial
  • Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial
  • Group-based mindfulness for patients with chronic low back pain in the primary care setting
  • Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

The NIH Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The Collaboratory has 5 Core Working Groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.

Related links:

NIH press release

Duke press release

NIH HEAL Initiative website

The Coordinating Center of the National Institutes of Health (NIH) Health Care Systems Research Collaboratory is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Read more about the NIH Collaboratory Trials and the Core Working Groups.

June 25, 2019: GGC4H Awarded Continuation From Planning to Implementation Phase

Posted on by Karen Staman

The investigators of Guiding Good Choices for Health (GGC4H), an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to the GGC4H study team for their excellent work!

At the May 2019 NIH Collaboratory Steering Committee meeting, we talked with Drs. Stacy Sterling, Margaret Kuklinski, and Richard Catalano to hear about progress and challenges during the UG3 planning phase. The goal of GGC4H is to test the feasibility and effectiveness of implementing Guiding Good Choices—a universal evidence-based anticipatory guidance curriculum for parents of early adolescents—in 3 large, integrated healthcare systems serving socioeconomically diverse families.

“Guiding Good Choices is a tested and proven intervention in community and school-based settings. We think primary care is an ideal implementation setting because pediatricians have parents’ trust, and the AAP recommends that they offer anticipatory guidance to parents. Community and school settings do not often have the same advantages.” — Rico Catalano, Co-PI of GGC4H

In the UG3 phase, the study team partnered with 5 pediatric primary care clinics in Kaiser Permanente Northern California, Kaiser Permanente Colorado, and Henry Ford Health System, finalized the trial protocol, obtained IRB approval, and presented UG3 and pilot study findings at 2 recent national meetings: the Society for Prevention Research and the National Academy of Medicine Collaborative for Healthy Parenting in Primary Care.

Were there any surprises during the study’s planning phase?

“I’ve been pleased and surprised to see the near universal excitement for Guiding Good Choices across the 3 healthcare systems and in multiple clinics. My previous work has been with adolescents who have already started to develop problems and are clearly at risk. Often when you are engaging those teens and their parents, they are coming from a place of crisis and have a lot of anxiety and worry. With Guiding Good Choices, we’re offering it to all families of young adolescents in the pediatric clinics, and we’re heartened to see pediatricians and parents welcoming this.

“The parents and kids were so enthusiastic and excited in our pilot. It’s been extremely heartening, and I think it bodes well for the reception we’re going to get.” — Stacy Sterling, Co-PI of GGC4H

What is an example of a challenge that you were able to overcome with the help of a Core Working Group?

Our study has two core questions: Will Guiding Good Choices improve adolescent behavioral health when offered in a health care setting? Will parents in a health care setting actually enroll in Guiding Good Choices and to what degree? Our initial study design attended more to the second question, and in doing that, raised problems for the valid assessment of effectiveness. These issues could have prevented us from transitioning to the implementation phase, so we needed a good design for assessing both effectiveness and implementation. Our original plan would have included all adolescents who had well visits, but at some clinics, 25% of teens don’t have them. Our new design, developed with the IRB chair and the Biostatistics and Study Design Core, includes everyone who receives care at the pediatric clinic. Although we may enroll some people who don’t engage with the intervention, this will make the study results more generalizable and valid for both effectiveness and implementation.

What words of advice do you have for investigators conducting their first embedded PCT?

“It’s a really fasted-paced year. I think we have complementary strengths across the leaders at our sites, and that is important. Pay attention to the qualities of your team and how they can help you hit the ground running and eventually help you get across the finish line to the UH3 phase.”  — Margaret Kuklinski, Co-PI of GGC4H

GGC4H is supported within the NIH Collaboratory by a cooperative agreement from the National Center for Complementary and Integrative Health and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about GGC4H in the Living Textbook, and learn more about the NIH Collaboratory Trials.

June 7, 2019: Meeting Materials from the 2019 NIH Collaboratory Steering Committee Meeting

Posted on by Gina Uhlenbrauck

The Collaboratory has made available all the presentations from their recent Steering Committee meeting held in Bethesda May 1-2, 2019.

Highlights of Day 1 included updates on the progress and sustainability of the NIH Collaboratory, perspectives on the landscape of embedded PCTs (ePCTs) and the need for real-world evidence, challenges and lessons learned from the UH3 NIH Collaboratory Trials, updates on progress and transition plans from the UG3 NIH Collaboratory Trials, and discussions on data sharing policy and planning. Day 2 featured an intensive workshop hosted by the NIH with the goal of starting discussions on statistical issues with ePCTs.

View or download the meeting materials on the website.

May 16, 2019: NIH Collaboratory Investigators Author Recommendations for Responding to Guideline or Policy Changes That Affect Ongoing Pragmatic Trials

Posted on by Karen Staman

A new perspective article by NIH Collaboratory investigators describes the unique, unexpected challenges researchers face when clinical practice guidelines and policies change during the conduct of a pragmatic clinical trial (PCT). The article was published online this week in Clinical Trials.

The NIH Collaboratory Trials are PCTs that test interventions to address urgent public health problems. They involve hundreds to thousands of participants and generally include usual care as a control arm. During the course of these years-long trials, clinical practice guidelines and policies changed due to new evidence from observational studies, small trials, and shifting expert opinion. Such changes can have profound effects on usual care and, therefore, threaten the ability of the PCTs to address the questions they were designed to answer. Investigators must strike a balance between the primary ethical obligation to protect patients by adhering to new best-practice guidelines and policy and the secondary, yet crucial, obligation to develop high-quality evidence to improve care.

“PCTs are an important means of producing high-quality evidence needed to better inform clinical practice. However, when guidelines or reimbursement policies change during the conduct of a PCT, the ethical obligation to gather information to develop evidence-based practices may conflict with the primary ethical obligation to participants.” — Curtis et al, Clinical Trials, 2019

Based on their aggregate experience with the NIH Collaboratory, the authors provide broad recommendations and strategies for overcoming these challenges, including protecting the well-being of patients; involving stakeholders, health system leaders, and the entity charged with data and safety monitoring; and actively monitoring changes and site-level responses to them. If changes to the standard of care are merited, investigators should provide equal opportunity and support for the recommended changes. Finally, during the design phase, investigators should communicate with the entities charged with creating guidelines to see what is needed and to anticipate possible future changes.

“The ability to appropriately address the tension between modifications to clinical guidelines and the need to generate quality evidence to support those guidelines is a crucial consideration for the fulfilment of a learning health system.” — Curtis et al, Clinical Trials, 2019

May 8, 2019: Dr. Greg Simon Receives National Suicide Prevention Award

Posted on by Karen Staman

At the Lifesavers Gala in New York last night, Dr. Greg Simon received the American Foundation for Suicide Prevention (AFSP’s) Research Award for his contributions to suicide prevention. Dr. Simon leads the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Trial that builds on previous work demonstrating that patients who answer “yes” to thoughts of self-harm on routinely administered PHQ-9 questionnaires at primary care visits are more likely to attempt suicide. For these high-risk patients, SPOT explores different modes of outreach (care management or online skills training versus usual care) to prevent suicide.

“There’s a conspiracy of silence around suicidal thoughts, because it’s awkward to discuss. So we’ve found that we have to incorporate talking about it into our standard care. Our suicide prevention work is a great example of how research and care keep influencing each other to improve our patients’ health. When research springs from clinicians’ and patients’ questions, ‘learning health systems’ can put results into practice much faster than the oft-cited 17-year lag.” — Dr. Greg Simon, from the Kaiser Permanente Washington Health Research Institute Press Release

Dr. Simon and his colleagues are also studying how machine-learning models can be used to predict risk of suicide. The models combine the PHQ-9 mental health questionnaire responses with information from electronic health records, including prior suicide attempts and mental health and substance use diagnoses. In a blog post regarding his research (and recent publication) on machine learning, Dr. Simon compares machine learning to warning lights on cars:

Our paper prompted many questions from clinicians and health system leaders about the practical utility of risk predictions:

“Are machine learning algorithms accurate enough to replace clinicians’ judgment?” our clinical partners asked.

“No,” I answered, “but they are accurate enough to direct clinicians’ attention.”

The AFSP also honored four others, including Anderson Cooper, a CNN and 60-minutes correspondent, and Kate Snow, an NBC news correspondent, for their work raising public awareness of suicide prevention.

Read more about what inspired Dr. Simon to study mental health.