The NIA IMPACT Collaboratory is inviting applications from early- and mid-career researchers for its first annual training workshop and retreat, “Building Skills to Conduct Embedded Pragmatic Clinical Trials for People Living with Dementia (PLWD) and Their Care Partners.” Up to 25 participants will be accepted to attend the event on April 7 and 8, 2021.
This virtual 1.5-day workshop and retreat will provide a foundation in practical aspects of designing and conducting embedded pragmatic clinical trials in Alzheimer disease and related dementias through a combination of panel discussions, small group sessions, and networking opportunities with experts in the field. Workshop modules will focus on healthcare systems, implementation science, and study design.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
NIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.
So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:
Longtime NIH Collaboratory researcher Dr. Vincent Mor will lead a study to identify adverse health impacts among elderly nursing home residents following COVID-19 vaccination. The study is supported by a supplemental award from the National Institute on Aging to the NIA IMPACT Collaboratory. It will be used to design an adverse event monitoring system in collaboration with Genesis HealthCare, a post-acute care provider organization with more than 350 facilities in 25 states. Read more about the award.
Dr. Mor was a co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial. He also serves as a principal investigator of the IMPACT Collaboratory.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
The Patient-Centered Outcomes Research Institute (PCORI) will issue a funding announcement in January for pragmatic clinical studies to evaluate patient-centered outcomes. A total of $90 million will be available in the funding cycle to support individual awards of up to $10 million in direct costs with a maximum project duration of 5 years.
More from the preannouncement:
PCORI seeks to fund clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; or eliminating health or healthcare disparities. Randomized study designs are strongly encouraged but not required.
Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.
The PCORI funding announcement will open on Tuesday, January 5, 2021, with more information about the funding opportunity.
The NIH Collaboratory recently welcomed 2 new embedded pragmatic clinical trials on pain management and reducing opioid prescribing. The projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program as part of the NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠. The new projects join 4 PRISM projects that are just finishing their first year and 15 other NIH Collaboratory Trials that are in various phases of completion.
We heard from some of the “more seasoned” principal investigators of these trials to glean lessons learned and tips for the new trials.
What are your top 2 lessons learned to share with the investigators conducting their first embedded pragmatic clinical trial?
1. Keep the intervention as simple as possible; it is easy for it to spiral into something complex given that the setting is a healthcare system. Things change all the time and get more and more complex.
2. Understand the unique complexities of your partner healthcare systems. This requires a dedicated partnership with healthcare systems leaders. Have those partnerships in place from the start,
and understand that there will be a back-and-forth across time.
1. Our intervention was multifaceted and complex, involved numerous centers, and we took on a huge regulatory task that included many independent IRB reviews. My recommendation is to track your project in parallel across the Core Working Groups so they can help you.
2. Given how new embedded pragmatic clinical trials are, you might encounter unexpected barriers and challenges. Rely on the Living Textbook and the Cores. Bring all your issues to the Cores—whatever comes up. Be transparent. You can get through the issues with their help.
1. It is challenging to get pilot work done and have your study protocol drafted in the first year. You should start working on that now, on your outcome measures, and incorporating HEAL domains.
2. When you have a problem someone has encountered before, the Cores can easily help. When you encounter unique problems, then your problem can be used as a test case. Try to keep ahead in areas where you can. It is a huge amount of work.
1. Adaptability is crucial. There may be changes that are requested from HEAL, or there might be changes in your design because the Biostatistics Core may see ways to improve, or you may have to adapt your trial due to outside forces. For example, we had to adapt our intervention to virtual because of COVID-19. Our 3 healthcare systems are different from each other and many adaptations needed to be made.
2. Expect and accept change. If you expect change, then it will be less stressful.
1. I echo the themes of simplicity, flexibility, adaptability. Also be well organized. This is a Collaboratory, so it requires collaboration among multiple teams, individuals, and organizations. Be willing to bring others onto your team to make things possible. Go beyond a small group, and be deliberate.
2. Besides being organized and deliberate, you also need to be persistent. Healthcare systems are competing for priorities on all sides, and there can be methods changes, personnel changes, and guidelines changes. Because we can’t control workflows, we need be persistent to ask for help from healthcare system partners and frontline leaders.
1. In your planning year, keep track of the milestones. The first year is short; you have about 9 months to get your pilot work done, write it up, and start submitting for your UH3.
2. Keep the Collaboratory Coordinating Center and Cores up to date and get advice from them, especially in the first year.
Other advice and encouragement from the PRISM projects:
Dr. Morone: I was grateful that the other folks are seeing this process as very time intensive and they were also feeling the deer in the headlights feeling. The new PIs should feel free to contact us. There are some simple questions that can easily be answered by me and the other PIs. You will come out the other end. And you will come out fine.
Dr. Sherman: We just finished our first year, and we are here, and we are smiling. Feel free to reach out. You want to make sure that your team is happy, because they will have to work hard. There are lots of resources, and you will get through this. Keep going and you’ll survive.
What tips do you have for managing year 1?
How did your team engage the Cores?
Delegate specialists on your team who can attend Core meetings and summarize the information for you.
Really participate and share openly. Don’t be afraid to air your problems to the Core—you can benefit and learn from the wisdom of a highly experienced crowd.
Remember that one of the other PIs may have encountered a problem before, and the Cores can help. If you encounter something new, the Cores may ask you do document it so you can write a paper on it in order for your experience to be helpful to others in the future.
How do you balance delegating activities and staying in the loop?
We split our team across the Cores, which helped keep the coinvestigators invested in the project.
Divide and conquer. And proactively reach out and ask questions.
How did you manage deliverables & milestones?
Have good people on your team and an organized project manager.
Stay in regular communication with the site PIs.
Have established, untouchable times and dates where the PIs review everything that happens in a project.
How did you manage administrative requirements?
DSMB expertise is variable—and this can have a big impact on your trial.
Have bidirectional communication with the DSMB. With very close oversight, there is effort to provide detailed reports, and can make your study stronger.
The NIH Collaboratory serves as the resource coordinating center for the NIH Collaboratory Trials. The 2 newest projects are GRACE and BeatPain Utah.
On November 9, 2020, the NIH Collaboratory held a virtual onboarding meeting to welcome two new UG3 NIH Collaboratory Trials to its Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. More than 60 participants joined to welcome the new PRISM projects; provide introductions, an overview of the Collaboratory program and the NIH HEAL Initiative, hear from the new PRISM projects; and discuss lessons learned from other NIH Collaboratory Trials.
The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the NIH Collaboratory’s Living Textbook. They include CDEs for adult acute pain, adult chronic pain, and pediatric acute and chronic pain, and represent patient-reported outcomes that HEAL Initiative clinical trials are required to collect.
“Having common measures to capture the patient’s perspective regarding pain will enable researchers to compare meaningful data across pain conditions, in diverse populations, and in multiple research studies, including in pragmatic clinical research. This should greatly increase our understanding of pain and how best to treat it.”
The NIH Collaboratory serves as the resource coordinating center for 6 NIH Collaboratory Trials funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative:
Because the PRISM studies are pragmatic clinical trials embedded in healthcare systems, it may not be feasible for investigators to collect all the required CDEs, as the trials need to be incorporated into clinical workflow with as little burden as possible. The NIH Collaboratory’s Patient-Centered Outcomes Core Working Group will work with the NIH Collaboratory Trials to understand and document which patient-reported outcome measures are collected and the perceived burden associated with collecting them.
NIH Collaboratory investigators Drs. Greg Simon, Rachel Richesson, and Adrian Hernandez published an opinion piece in Healthcare arguing that clinical trials investigators should align their dissemination processes with industry-sponsored trials to favor speed, and that years-long delays in dissemination reduce the relevance of clinical research.
“Delays reduce the ability for researchers to apply trial findings to new research questions, impede clinicians from having the most up-to-date information, and perhaps most importantly, are a disservice to patients who could benefit from the information.”
The authors use experiences with pragmatic trials supported by the NIH Collaboratory to explore faster dissemination of results, and suggest the following solutions:
Real-time access to outcome data
Continuous data curation and cleaning
Immediate data analysis
Rapid reporting of trial results
Much change is needed to reach these goals. The authors suggest that by modeling processes after industry-sponsored trials, researchers may be able to improve the speed and quality of results reporting.
“Cultural incentives are aligned in industry sponsored trials to favor speed: readiness for generalizing topline results is considered valuable to shareholders, and the culture encourages a system where data are liquid, available, and continuously cleaned and curated, such that topline results can be reported within a timespan of two weeks rather than two years.”
As part of the NIH Collaboratory’s commitment to dissemination and sharing, all NIH Collaboratory Trials are expected to share data and resources, and topline results are reported in our weekly Grand Rounds Webinars.
In a qualitative analysis of the PRIM-ER pilot study, receiving the support of institutional leadership and leveraging existing institutional processes emerged as keys to successfully implementing the study intervention.
The results of the analysis were published last week in the Journal of General Internal Medicine.
PRIM-ER, an NIH Collaboratory Trial, is a stepped-wedge cluster randomized clinical trial that will test a multidisciplinary primary palliative care intervention consisting of education, clinical decision support, and other elements in a diverse mix of emergency departments in the United States. The intervention is intended to improve the delivery of goal-directed emergency care of older adults.
In the pilot study, the research team launched the intervention in 2 emergency departments. The purpose of the qualitative analysis was to measure and evaluate the reach and effectiveness of the intervention. Both sites in the pilot study achieved a high level of reach, or intervention completeness. The intervention’s effectiveness—in terms the success of its implementation—was enhanced by support from institutional leadership and use of the sites’ existing processes for quality improvement. The findings will guide the research team as they implement the intervention at additional study sites.
PRIM-ER is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging. Read more about PRIM-ER.
The NIA IMPACT Collaboratory is inviting applications from early- and mid-career researchers for its first annual training workshop and retreat, “Building Skills to Conduct Embedded Pragmatic Clinical Trials for People Living with Dementia (PLWD) and Their Care Partners.” Up to 25 participants will be accepted to attend the event on April 7 and 8, 2021.
NIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and 
The Patient-Centered Outcomes Research Institute (PCORI) 
The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the 
