Optimizing outpatient cervical ripening: A mixed-methods study identifying implementation drivers during a multisite, randomized trial.

INTRODUCTION

Data have demonstrated decreased time in the hospital and improved patient satisfaction when using outpatient cervical ripening with a Foley catheter as compared to routine in-hospital induction. An ongoing multisite trial (the COMFORT trial) is evaluating the impact of outpatient ripening on cesarean delivery, maternal and neonatal morbidity rates. Here, we aimed to characterize provider and organizational level determinants of implementation related to outpatient cervical ripening with a Foley catheter during the COMFORT trial.

METHODS

This sequential mixed-methods study (quan- > QUAL; December 2022 to January 2025) was embedded into an ongoing five-site randomized clinical trial comparing outpatient versus inpatient cervical ripening. Prior to trial initiation, surveys (quan) were distributed to obstetric clinicians at all sites. The survey collected demographics, Foley placement experience, perceived acceptability, and feasibility of outpatient Foley via validated measures [Likert; total 4-20]. One year into the trial, clinician focus groups (QUAL) assessed barriers, facilitators, and sustainability of outpatient Foley, guided by the Consolidated Framework for Implementation Research 2.0 and coded in an integrated approach.

RESULTS

A total of 396 clinicians (64% physicians, 22% nurses, 10% certified nurse midwives [CNMs], 4% nurse practitioners [NPs]/physician assistants [PAs]) completed the pre-trial survey; 29.2% had previously used outpatient ripening. Acceptability (19/20 interquartile range [IQR] [16-20]) and feasibility (16/20 IQR [15-20]) were high overall but varied by site (p = 0.003; p = 0.006, respectively). Factors independently associated with acceptability included site, clinician role (physicians/CNMs vs. nurses), and clinician gender. As a result, focus groups were divided by site and role to elicit site-specific barriers and facilitate open discussion among nurses without physicians/CNMs present. Twelve focus groups (n = 33) identified facilitators including belief in the evidence/safety and benefit, as well as leadership support. Barriers included concerns about timely hospital return, perceived patient discomfort, and operational constraints (e.g., space and staffing). In response, participants discussed systematic strategies to promote sustainability, several already enacted, such as standardized patient education and workflow solutions. No meaningful differences in identified barriers, facilitators, or suggested strategies were noted by site or clinician role.

CONCLUSION

This work identified key determinants influencing the implementation of outpatient cervical ripening with a Foley catheter. Findings (1) allowed for real-time adaptations to intervention workflow and utilization of new implementation strategies during the course of the multisite trial, and (2) can be utilized to drive success for current and future sites implementing outpatient Foley cervical ripening clinically.