Collection of implementation-related data in pragmatic clinical trials: a cross-sectional study from the NIH...

Embedded pragmatic clinical trials (ePCTs) are conducted as part of routine care, which provides researchers and health systems multiple opportunities to study implementation processes and outcomes.

We conducted a cross-sectional survey of 32 ePCTs associated with the NIH Pragmatic Trials Collaboratory to assess the implementation-related outcomes that were measured or were planned to be measured, including reach (number and percent of eligible patients who participate in an intervention and the representativeness of those patients), patient engagement in or adherence to the intervention, adoption (number and percent of eligible organizations or clinicians that decide to take up or use an intervention), fidelity (clinician's delivery of an intervention as intended), adaptations (changes or modifications to an intervention), sustainability (potential for an intervention to be maintained or institutionalized after a trial concludes), sustainment (actual maintenance or institutionalization of an intervention after a trial concludes), and costs. The trials represented different phases of progress (planned, ongoing, or completed).

91% of study teams completed the survey, and most (86%) reported measuring reach. The total number of teams measuring other outcomes was 76% for adherence, 45% for clinician adoption, 93% for fidelity, 69% for adaptations, 24% for sustainability, 38% for sustainment, and 31% for costs.

There is an opportunity for growth in measuring clinician adoption of the intervention, sustainability, sustainment, and associated costs. Measurement of these constructs in future ePCTs could result in development of improved implementation strategies to increase the likelihood of effective implementation leading to equitable, sustainable, and scalable improvement in practice.