Introduction Our aim is to describe the challenges and levers to recruitment for a shared decision- making (SDM) stepped wedge cluster randomized trial (SWcRT).

Methods Informed by the extension of the Consolidated Standards of Reporting Trials for SWcRT, we performed sites recruitment for a SWcRT aiming at scaling up SDM for prenatal screening of trisomy in Quebec. The intervention was a set of scaling up strategies. From Quebec government websites, we compiled a list of sites potentially offering prenatal services. For data collection, we gathered recruitment meeting minutes and feedbacks from contacted eligible sites. Guided by a conceptual framework including factors influencing the recruitment such us participants characteristics, awareness and acceptance or refusal factors, we conducted a thematic analysis of gathered textual data to identify challenges and levers to the recruitment.

Results Out of 477 identified potentially eligible sites, 336 were contacted by telephone calls and email messages: out of these, 74 did not respond and 50 were not eligible. In the remaining 212, although we identified spokespersons, 115 did not respond and 65 refused to participate leaving 32 participating sites: six (18.8%) university family medicine groups, eight (25%) hospitals, eight (25%) midwives’ clinics and 10 (31.2%) obstetrics and gynecology clinics. Main challenges to recruitment were delayed response, no response, heterogeneity of the sites’ culture, their fear of the potential burden from the SWcRT and local approval process. Identified levers were follow-up contacts, effective SWcRT communication, sharing the SDM positive outcomes and adaptation of the SWcRT to sites’ context.

Discussion Our findings explain why some SDM SWcRT may not meet their recruitment targets.

Conclusion Allocating enough time and resources to the recruitment process is imperative. Moreover, flexibility, adapting the SWcRT to sites’ context and creating a relationship of trust with sites are assets that facilitate their recruitment.