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Pragmatic Trials for Real-World Change

      Pragmatic “real-world” trials offer the most promising pathway toward improving systems of long-term care for older adults — if they’re done right.
      At a National Institute on Aging (NIA)–funded consensus conference on pragmatic trials in long-term care, research experts and leaders of long-term care organizations and associations discussed how to get it right — with upfront collaboration between providers and researchers, for instance, and with trust, simplicity, and timeliness.
      “Pragmatic trials done right include the administrators, clinicians and other staff as full partners, and as such present an opportunity to advance policy and practice,” said lead convener Sheryl Zimmerman, PhD, a co-editor in chief of JAMDA, in an interview after the conference.
      The conference, held in March in conjunction with the 2021 Virtual Annual Conference of AMDA – The Society for Post-Acute and Long-Term Care Medicine and led by editors of the Journal of the American Geriatrics Society (JAGS) and Geriatric Nursing in addition to Dr. Zimmerman, aimed to identify priorities and best practices for pragmatic trials in long-term care, with a focus on people with dementia.
      Summaries of the conference presentations and consensus recommendations will be published in the coming months in JAMDA, JAGS, and Geriatric Nursing.
      Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life practice conditions, as opposed to the optimal and more tightly controlled settings of explanatory or efficacy trials. In recent years the NIA and other organizations have expressed increasing interest in funding studies that take a pragmatic approach and yield findings can be widely and routinely applied.
      “If we’re going to do research, we want to do research in a way that informs and changes care practices and policies,” Dr. Zimmerman told Caring. “The problem is, there are way too many instances where research [ends with] efficacy studies ... There’s quite a difference in going from ‘can it work?’ to ‘will it work?’”
      Advancements in implementation science will impact the future of pragmatic trials, she said. This field addresses the uptake of findings into practice and includes factors such as organizational readiness and alignment of values.
      Several panelists discussing implementation issues advised that pragmatic trials be designed collaboratively and conducted in tandem with quality improvement initiatives. “The more research can be tied to staff’s goals, if we at least have staff think of it as a quality improvement activity rather than a trial, the more viability it has and the more stickiness there will be,” said Robyn Stone, DrPH, senior vice president of research for LeadingAge.
      Juliet Holt Klinger, BSW, MA, senior director for dementia care at Brookdale Senior Living, said that when considering participation in a trial she looks for “synergy with the [quality improvement] priorities or projects I have going on.”
      Receiving timely and ongoing feedback on research projects, and starting studies soon after committing to them are also important for the success of pragmatic research, the experts said.
      “Much of the enthusiasm is there when we recruit facilities initially, but if researchers don’t find out for months [later] if their grants have been approved, you’ve lost some [of the energy],” said David Gifford, MD, MPH, senior vice president of quality and regulatory affairs for the American Health Care Association, referring to funders’ requirements for commitment letters from participating sites and providers when grant proposals are submitted.
      Consensus recommendations will address these issues, Dr. Zimmerman said. In addition, “if we really want to address care needs within the long-term care community, we need to be much more nimble [overall] ... we have to find ways to get studies designed quickly, and proposals written quickly, and research funded quickly,” perhaps through shorter-term research projects or phased projects.