Applying the pragmatic-explanatory continuum indicator summary to the implementation of a physical activity coaching...

Observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD). Despite practice guidelines recommending regular physical activity (PA), there are no large-scale experimental studies to confirm that patients at high risk for COPD exacerbations can increase their PA and consequently, have improved outcomes.

The purpose of this case study is to describe the use of a widely accepted pragmatic trials framework for the design and implementation of a pragmatic clinical trial (PCT) of PA coaching for COPD in a real-world setting.

The aim of the trial was to determine the effectiveness of a 12-month PA coaching intervention (Walk On!) compared to standard care for 2,707 patients at high risk for COPD exacerbations from a large integrated health care system. The descriptions of our implementation experiences are anchored within the pragmatic-explanatory continuum indicator summary (PRECIS-2) framework.

Facilitators of PCT implementation include early and ongoing engagement and support of multiple stakeholders including patients, health system leaders, administrators, physician champions, and frontline clinicians, an organizational/setting that prioritizes positive lifestyle behaviors, and a flexible intervention that allows for individualization. Pragmatic challenges include reliance on electronic data that are not complete or available in real-time for patient identification, timing of outreach may not synchronize with patients' readiness for change, and high turnover of clinical staff drawn from the existing workforce.

PRECIS-2 is a useful guide for organizing decisions about study designs and implementation approaches to help diverse stakeholders recognize the compromises between internal and external validity with those decisions.