Recruitment strategies for a pragmatic cluster randomized oral health trial in pediatric primary care settings

Shelley Curtan; Tashyana Copeland; Erin McNamee; Jelena Debelnogich; Taylor Kula; David Selvaraj; Jeffrey Albert; Andrew Hertz; Suchitra Nelson

doi:10.1016/j.conctc.2021.100748

Recruitment strategies for a pragmatic cluster randomized oral health trial in pediatric primary care settings

Contemp Clin Trials Commun. 2021 Feb 16:21:100748. doi: 10.1016/j.conctc.2021.100748. eCollection 2021 Mar.

Authors

Shelley Curtan¹, Tashyana Copeland¹, Erin McNamee¹, Jelena Debelnogich¹, Taylor Kula¹, David Selvaraj¹, Jeffrey Albert², Andrew Hertz³, Suchitra Nelson¹

Affiliations

¹ Case Western Reserve University, Community Dentistry, 10900 Euclid Ave, Cleveland, OH, 44106-4905, USA.
² Case Western Reserve University, School of Medicine, 10900 Euclid Ave, Cleveland, OH, 44106-7341, USA.
³ University Hospitals Rainbow Babies & Children's Hospital, 11100 Eucild Ave, Cleveland, OH, 44106, USA.

Abstract

Objectives: To describe multilevel recruitment strategies for an ongoing clinical trial in pediatric primary care settings, and assess adoption and reach of these strategies via the RE-AIM framework.

Methods: This study is part of a larger pragmatic cluster randomized clinical trial focused on the effectiveness of interventions on the practice, provider, and caregiver levels on dental utilization for Medicaid-enrolled 3-6 year old children. Pediatric practices were recruited according to the proportion of Medicaid-eligible children, geographic region, and County. In accordance with the RE-AIM framework, providers reached were those approached directly and consented, and those who participated in the intervention training adopted to deliver the intervention. Caregivers reached were those approached and consented at their child's well-child visit to participate in the trial.

Results: Recruitment goals were met over a 21 month period, with an overall enrollment of 18 practices, 62 providers, and 1024 caregivers-child dyads. The majority of practices enrolled were small, suburban, and located in an urban county. The participation rates among approached providers and caregivers was 93% and 84% respectively. Enablers for recruitment was the one-on-one interaction with the provider and caregivers. Barriers to recruitment for caregivers included no-shows and cancellations at well-child visits. Adoption of intervention among providers was high, and caregiver reached were representative of the eligible target population.

Conclusions: Active approaches to recruitment, such as utilizing opinion leaders, in-person recruitment, and building relationships with practice staff, can result in successful enrollment and imp lementation of a multi-level intervention in pediatric primary care settings.

Keywords: AAP, American Academy of Pediatrics; Adoption; CAB, Community Advisory Board; Clinical trial; EMR, Electronic Medical Record; MOC, Maintenance Of Certification; Oral health; Patient selection; Primary health care; RCC, Rainbow Care Connection; WCV, Well Child Visit.