A RANDOMIZED TRIAL OF PRIMARY CARE (PC) TO PREVENT LIFE-THREATENING ILLNESS(LTI) IN HIGH RISK INFANTS. ▴ 1540

Although widely accepted as a model for pediatric care, PC has not been shown in proper trials to reduce major adverse outcomes. We have conducted a randomized trial among infants at high social and medical risk to determine whether PC reduces their incidence of LTI (death or illness treated by pediatric intensive care [PIC], assessed by serial blinded reviews of state vital statistics and Medicaid records as well as hospital charts). All infants have been born in an inner-city county hospital (Parkland) and either weighed< 1001 g or were ventilator-treated and 1001-1500 g. They have been randomized to either conventional care (CC) for these infants (with well baby care, care for chronic illnesses, and developmental assessment provided in our follow-up clinic) or to PC (including care for acute illnesses in this clinic 5 d/wk and phone access to the PC provider 24 h/d). The same nurse practitioners and physician supervisors provide PC and CC. Preplanned sample size =762 infants. With 709 infants randomized, 616 have completed study at 1 year adjusted age; 310 have received PC and 306 have received CC. PC and CC groups have been at similar high-risk (e.g., 96 vs 94% ventilator-treated; 86 vs 84% minority). PC has increased mean number of contacts with clinic staff(22.1 vs 7.5) and reduced ER visits (638 vs 871), total hospital days (1725 vs 2081), and loss to follow-up (FU) (9 vs 35%) before 1 year adjusted age (each p <.01). Known deaths do not differ for PC and CC (10 vs 12) although fewer PC infant have an unknown outcome after extensive searching (10 vs 42). Despite more complete information for PC than CC, PC has had fewer identified days of PIC (227 vs 358), PIC admissions (17 vs 40), and LTIs (27 vs 49, p<.025). Among infants who have not moved from Dallas and were able to receive the intervention, the differences were more marked: 100 vs 336 PIC days, 16 vs 38 PIC admissions, and 26 vs 47 LTIs (p <.025). PC increases access to preventative health care, reduces loss to FU, and substantially reduces LTI among high-risk infants whose needs are not well met by the current health care system. Supported by Agency for Health Care Policy and Research.