Dissemination and implementation strategies for embedding pragmatic clinical trials in learning health systems This work is supported by the National Institutes of Health Leah Tuzzio, MPH (NIH) Common Fund, through cooperative agreement Eric B. Larson, MD, MPH U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. The views presented here are James Fraser solely the responsibility of the authors and do not necessarily Kaiser Permanente Washington represent the official views of the National Institutes of Health. Health Research Institute @Collaboratory1 │ @ TuzzioL │ #DIScience18
The NIH Collaboratory Story Launched through the National Institutes of Health (NIH) Common Fund in 2012. Goal: Strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners Vision: Support the design and execution of innovative pragmatic 15 multi-site pragmatic clinical trials embedded in clinical trial Demonstration Projects to establish best practices and proof hospitals, community health centers, integrated delivery of concept systems, nursing homes, and acute and specialty facilities @Collaboratory1 │ @ TuzzioL │ #DIScience18
Tools and resources http://rethinkingclinicaltrials.org/ Living Textbook Knowledge Repository Monthly Newsletter Comprehensive, searchable A convenient wrap up of NIH Archives for the Living information on design, Collaboratory news, featured Textbook, videos, stakeholder conduct, & dissemination of stories, and events — with interviews, guidance embedded PCTs links to recent and upcoming documents, & more Grand Rounds webinars @Collaboratory1 │ @ TuzzioL │ #DIScience18
What key strategies promote implementation within LHSs? Plan for dissemination & implementation Summer 2016: Interviews with project leaders from 9 NIH Collaboratory Build (or strengthen) relationships & nurture pragmatic clinical trials trusting partnerships “How did you design and 5 building roll out your trials in ways Collaborate & co-design that would lead to blocks successful implementation of the results, if the desired Pilot test, evaluate, & outcomes were achieved?” continuously improve Build sustainable infrastructure & resources @Collaboratory1 │ @ TuzzioL │ #DIScience18
Plan for dissemination & implementation @Collaboratory1 │ @ TuzzioL │ #DIScience18
Plan for dissemination and implementation “In addition to studying health outcomes, it is especially important in pragmatic trials to also Use a D&I framework, theory, or model study implementation outcomes since acceptability, feasibility Integrate D&I constructs in planning, delivery, evaluation, etc. and appropriateness predict adoption.” – Bev Green, MD, MPH Understand and document health system context Decide which outcomes to measure to support scale/spread @Collaboratory1 │ @ TuzzioL │ #DIScience18
Build (or strengthen) relationships & nurture trusting partnerships @Collaboratory1 │ @ TuzzioL │ #DIScience18
Build (or strengthen) relationships and nurture trusting partnerships “Build relationships with health systems early. It’s like dating, you need to date before you get Set expectations to work collaboratively engaged .” – Jerry Jarvik, MD, MPH Include multiple disciplines and areas of expertise “There can be incredible delay and waste if people Expect roadblocks and be flexible don’t trust each other. It’s inevitable there will be challenges even if you assume the best Maintain communication intentions.” – Doug Zatzick, MD @Collaboratory1 │ @ TuzzioL │ #DIScience18
Collaborate & co-design @Collaboratory1 │ @ TuzzioL │ #DIScience18
Collaborate and co-design “Our trial is guided by Van de Ven’s concept of ‘engaged scholarship’ where Ask how the pragmatic trial can add value to the health system knowledge co-created via continuous collaboration with customers and stakeholders.” Learn about each other’s goals, priorities, needs, and motivations – Greg Simon, MD, MPH Understand what a “win” looks like on both sides “Each system is going to implement the trial in a slightly different way that Anticipate potential pain points and competing priorities works best for them and their workflows.” – Miguel Vazquez, MD Co-design study materials, workflows and processes @Collaboratory1 │ @ TuzzioL │ #DIScience18
Pilot test, evaluate, & continuously improve @Collaboratory1 │ @ TuzzioL │ #DIScience18
Pilot test, evaluate, and continuously improve “A pilot study helps set the groundwork for conversations and understanding the Pilot test at the start and continuously to learn what’s possible context.” – Jerry Jarvik, MD, MPH Begin by testing feasibility of the design & assessing capacity “Different from a randomized controlled Identify barriers and facilitators and make adjustments trial, PCTs use an iterative process and include a lot of refinement.” Evaluate what’s working and what’s not – Lynn DeBar, PhD, MPH Document adaptations and lessons learned @Collaboratory1 │ @ TuzzioL │ #DIScience18
Build sustainable infrastructure & resources @Collaboratory1 │ @ TuzzioL │ #DIScience18
Build sustainable infrastructure and resources “The more complicated the intervention is to existing workflow, the more difficult it is to get compliance .” Collaboratively build infrastructure for continued use – Vincent Mor, PhD “Give the clinicians and Integrate with existing processes to optimize design and rollout staff the opportunity to of study protocol have a positive learning experience with research by giving them the tools Increase capacity to learn, grow, adapt, and sustain they need.” – Edward Septimus, MD @Collaboratory1 │ @ TuzzioL │ #DIScience18
In summary Plan for dissemination & implementation Build (or strengthen) Quality relationships & nurture trusting partnerships Collaborate & co-design Context Value Pilot test, evaluate, & continuously improve Build sustainable infrastructure & resources @Collaboratory1 │ @ TuzzioL │ #DIScience18
Thank you! ACP 15 NIH Collaboratory pragmatic clinical trial TSOS ABATE PEACE teams and their health system partners SPOT PPACT HiLo The NIH Common Fund The NIH Health Care Systems Research ICD- LIRE GGC4H EMBED Collaboratory Coordinating Center Pieces For more information, visit STOP TiME Nudge CRC http://rethinkingclinicaltrials.org/ To contact me, e-mail: PROVEN PRIM-ER Leah.Tuzzio@kp.org @Collaboratory1 │ @ TuzzioL │ #DIScience18
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