Tag Archives: Healthcare systems interactions

STOP CRC Trial: Analytic Challenges and Pragmatic Solutions

Cluster Randomized Trials, Comparative Effectiveness Research, Data analysis, Pragmatic clinical trials, , , , ,

Investigators from the STOP CRC pragmatic trial, an NIH Collaboratory Demonstration Project, 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.

New Lessons Learned Document Draws on Experiences of Demonstration Projects

Electronic health records, Institutional review boards, Pragmatic clinical trials, Regulatory issues, Research tools, , , , , , ,

The NIH Collaboratory’s Health Care Systems Interactions Core has published a document entitled Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects. The Principal Investigators of each of the Demonstration Projects shared their trial-specific experience with the Core to develop the document, which presents problems and solutions for initiation and implementation of pragmatic clinical trials (PCTs). Lessons learned are divided into the following categories: build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, consider institutional review board and regulatory issues, and assess potential issues with biostatistics and the analytic plan.

Other tools available from the Health Care Systems Interactions Core include a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures and an introduction to PCTs slide set.

New Guidance Document on Training Front-Line Staff & Clinicians in PCTs

Pragmatic clinical trials, Research tools,

Tools for ResearchThe NIH Collaboratory’s Health Care Systems Interactions Core has published a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures. The purpose of this guidance is to help pragmatic clinical trial (PCT) teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources.

Other tools available from the Health Care Systems Interactions Core include an introduction to PCTs slide set.

Minimizing the Burden of Practical Research: Case Studies from the NIH Collaboratory

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In a forthcoming article in Healthcare, Dr. Eric Larson and colleagues present practical advice based on case studies from the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Physician–scientists, health services researchers, and delivery system leaders provide insight from their experience launching a pragmatic clinical trial (PCT) as part of the Collaboratory.

The authors make 5 recommendations:

  • Establish a partnership from the get-go
  • Do a pilot project
  • Take advantage of existing hospital and health system infrastructure
  • Minimize the impact on clinical workflow
  • Remember that even high-priority research questions must be balanced with the systems’ greatest priority: providing good healthcare to patients.

The authors note that researchers need to be flexible and prepared to adjust the study design to the workflow and culture of the system.

Reference: Larson E, Tachibana C, Thompson E, et al. Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthcare. 2015; in press. doi:10.1016/j.hjdsi.2015.07.005

Watch Dr. Larson’s Grand Rounds Presentation from June 2013: Trials, Not Tribulations: Minimizing the Burden of Research on Health Care Systems

Closer Partnerships Needed Between Researchers and Healthcare Executives

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Larson-JohnsonIn a commentary published this week in Modern Healthcare, Eric Larson, MD, MPH, and Karin Johnson, PhD, of Group Health Research Institute, argue that greater collaboration is needed between clinical researchers and healthcare system executives to address a “a gap between research approaches and delivery system needs.” Perspectives gathered through a survey and Institute of Medicine workshop with healthcare executives indicated that research is not conducted fast enough or designed in a way that facilitates translation of evidence into clinical practice. The NIH Collaboratory and National Patient-Centered Clinical Research Network (PCORnet) are cited as examples of effective partnerships between researchers and healthcare leaders; these research programs are addressing high-priority clinical questions and generating actionable knowledge. According to Drs. Larson and Johnson, pragmatic clinical trials and big data offer opportunities to create a learning health system, but this will require combining the perspectives and expertise of researchers and stakeholders from healthcare delivery systems. Drs. Larson and Johnson are part of the NIH Collaboratory’s Health Care Systems Interactions Core, a working group that “aims to support and facilitate productive collaboration between researchers, clinicians, and health system leaders.”

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