COVID-19 Impact on Community-Based Participatory Randomized Controlled Trials-Lessons From the Oral Health Disparities in Children Consortium.

The COVID-19 pandemic has had a major impact on nearly every sector of science and industry worldwide, including a significant disruption to clinical trials and dentistry. From the beginning of the pandemic, dental care was considered high risk for viral transmission due to frequent aerosol-generating procedures. This resulted in special challenges for dental providers, oral health care workers, patients, and oral health researchers. By describing the effect that the COVID-19 pandemic had on four community-based randomized clinical trials in the Oral Health Disparities in Children (OHDC) Consortium, we highlight major challenges so researchers can anticipate impacts from any future disruptions.

Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial.

BACKGROUND: Effective prevention-focused, value-based strategies are needed to improve oral health. Despite evidence that monetary incentives can motivate healthy behavior, well-powered studies have yet to examine incentives for improving children's oral hygiene. AIM: Describe the rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial, which tests lottery-based monetary incentives as a consumer-oriented, value-based care model for improving children's oral hygiene. DESIGN: Phase II, stratified, permuted block randomized, controlled, two-arm, parallel groups, prevention trial. SETTING: Study visits occur at three Los Angeles, CA health clinics. PARTICIPANTS: Two hundred and forty-four parent-child dyads with a child aged 6-48 months. INTERVENTIONS: Eligible dyads were randomized in equal allocation to one of two groups: lottery incentive group or waitlist (delayed incentive) control group. Weekly lottery incentives were offered for 6 months based on Bluetooth-recorded toothbrushing frequency. Both groups received weekly text message feedback on toothbrushing performance. OUTCOMES: The primary outcome was toothbrushing performance from baseline to 6 months, measured as the mean number of qualifying half-day Bluetooth-recorded episodes per week when the child's teeth were brushed. Secondary outcomes included toothbrushing performance sustainability through 12 months and dental caries status. CONCLUSIONS: BEECON offers a consumer-oriented approach to promoting value-based oral health care. We hypothesize that lottery-based incentives can improve oral hygiene in young children. Study results will inform programming efforts to enhance oral disease prevention in young children. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03576326.