As noted elsewhere in this textbook, recruitment targets of the embedded PCT may be individual patients, or clusters of patients, healthcare providers, community clinics, units in a hospital, and/or the healthcare system itself. Examples of targeted individuals could be patients living with heart disease or hypertension; adults in need of colorectal cancer screening; patients undergoing diagnostic spine imaging; nursing home residents involved in advance care planning; or patients and their physicians managing multiple chronic conditions. Examples of targeted clusters could be small medical practices in underserved communities testing disease-screening approaches; hospital units evaluating strategies to reduce infections; or healthcare systems studying how to increase guideline-concordant practices.
The plan for recruiting trial participants is integral to the design of the embedded PCT. The intervention, if effective, will be implemented with typical participants in routine clinical care settings. To maximize generalizability of the trial’s results, the recruitment eligibility criteria will tend to be as wide as possible, with little selection beyond the clinical indication of interest (Loudon et al. 2015).
In the design phase, it is recommended that study teams evaluate several characteristics and capabilities of their partner healthcare system that could contribute to, or have an impact on, their trial’s recruitment; for example:
- Presence of an electronic health record (EHR) system, its maturity in the healthcare system, extent of integration of its data systems, and research infrastructure to support using the EHR for the trial
- Presence of decision support tools
- Use of patient-reported outcome measures and extent those measures are digitized
- Presence of comprehensive disease registries
- For those that have previously participated in clinical research, typical strategies used to recruit participants routinely served in the healthcare setting
- Specific facilitators or barriers to recruitment
- How consent and opt out have been conducted in other studies in that setting
DISCLAIMER: The views expressed in this chapter are those of the contributors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.