Barriers and Facilitators to Participation in Intervention for High-risk Infants Enrolled in a Clinical Trial During the COVID-19 Pandemic

ABSTRACT

Background and Objective(s) Preterm birth is associated with a significant health, emotional, and financial burden on families. Racial, ethnic, and social inequities in the United States during COVID-19 did not spare infants born preterm and their families. While the rates of preterm birth declined during the lockdown, the highest proportions of preterm births continued to be in the Black, Indigenous, and other People of Color (BIPOC) groups. Limited data exists on factors influencing access to rehabilitation services for high-risk infants during COVID-19. We aim to identify barriers and facilitators impacting access to intervention in parents of preterm infants as measured by enrollment and retention in an intervention arm of a multisite rehabilitation clinical trial. Study Design: RCT. Study Participants & Setting: Fifty-seven extremely to very preterm infants (<29 weeks gestation) participating in an ongoing Supporting Play, Exploration, and Early Development (SPEEDI) trial. Intervention was conducted in the neonatal intensive care unit (NICU), home, and/or via telehealth. Materials/Methods: All infants were recruited in the NICU and randomized into SPEEDI intervention or usual care group. The intervention group received 10 sessions of therapist-guided, parent-provided intervention, delivered in two phases (5 sessions per Phase) across 4 months. Both groups continued to receive early intervention services in the community. The intervention was adapted to telehealth in response to COVID-19 and an online platform with videos and activities was created for parents. Enrollment and retention were descriptively analyzed in two time periods;pre-COVID (Before 03/12/20), and COVID (03/13/20 -03/ 12/21) with emphasis on distinctions between in-person vs telehealth participation. Result(s) Enrollment during the COVID period was reduced by 41.18% compared to pre-COVID. Thirty-five preterm infants participated in the intervention during both periods, of which 54% were white and 46% belonged to BIPOC groups. The overall completion rate (i.e.10/10 intervention sessions completed) was 65%, 11% missed >=1 visit, and 26% either withdrew from intervention or were lost to follow-up. The completion rates did not differ for pre-COVID (99%) and COVID (98%) periods. For withdrawals, 55% occurred during COVID, 66% of participants who withdrew self-identified as Black, and 77% had a sibling at home. Of the 63 sessions scheduled during COVID, 31.7% were in-person and 68.2% via telehealth. There was a 68% decline in in-person sessions during COVID compared to pre-COVID. The completion rate for telehealth during COVID was 97% (42/43). Conclusions/Significance: Caregiver engagement in intervention, provision of intervention materials online, and quick adaptation of interventionists to telehealth via training sessions and standardized protocols were identified as facilitators to retention. Navigating siblings at home and the burden of COVID were the primary barriers to retention. The impact of race on retention and participation in intervention and research for high-risk infants should be monitored.