Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial

OBJECTIVE: To determine effectiveness of text/telephone outreach messages, with and without coronavirus disease 2019 (COVID-19) vaccine information. STUDY DESIGN: We conducted an intent-to-treat, multiarm, randomized clinical trial with adolescents aged 12-17 years. Eligible patients did not have an adolescent well-care visit in the past year or scheduled in the next 45 days or an active electronic health record portal account. We randomized participants to the standard message, COVID-19 vaccine message, or no message (control) group and delivered 2 text messages or telephone calls (per family preference) to the message groups. The primary outcome was adolescent well-care visit completion within 8 weeks, and secondary outcomes were adolescent well-care visit scheduled within 2 weeks and receiving COVID-19 vaccine within 8 weeks. RESULTS: We randomized 1235 adolescents (mean age, 14 ± 1.5 years; 51.6% male; 76.7% Black; 4.1% Hispanic/Latinx; 88.3% publicly insured). The standard message group had higher odds of scheduling an adolescent well-care visit compared with the control group (OR, 2.07; 95% CI, 1.21-3.52) and COVID-19 vaccine message group (OR, 1.66; 95% CI, 1.00-2.74). The odds of completing an adolescent well-care visit did not differ significantly (standard message group vs control group; OR, 1.35; 95% CI, 0.88-2.06; COVID-19 vaccine message group vs control group, OR, 1.33; 95% CI, 0.87-2.03). In per-protocol analyses, adolescents in the standard message group were twice as likely as the control group to receive the COVID-19 vaccine (OR, 2.48; 95% CI, 1.05-5.86). CONCLUSIONS: Outreach messages were minimally effective. Efforts are needed to address widening disparities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04904744.