Comparing models that integrate obstetric care and WIC on improved program enrollment during pregnancy: a protocol for a randomized controlled trial

Abstract

Abstract Background Low-income, rural pregnant women are at disproportionate risk for adverse pregnancy outcomes as well as future cardiovascular risk. Currently, less than half of eligible women enroll in the Women, Infants, and Children’s (WIC) Program. This study aims to evaluate whether integrating clinical care and social care may advance health equity and reduce health disparities by directly linking women receiving obstetric care to the Special Supplemental Nutrition Program for WIC and/or a Registered Dietitian/Nutritionist (RDN). Methods This pragmatic study is situated in real-world care and utilizes a randomized controlled trial design. A total of 240 low-income, rural, pregnant patients will be recruited from Geisinger (Pennsylvania, USA) obstetric clinics and randomized to receive one of four models: (1) Clinic; (2) Clinic-WIC; (3) Clinic-RDN, or (4) Clinic-WIC-RDN. Participants provide consent for electronic referrals that directly link their contact information from the electronic health record to WIC and/or RDN. Patients in the Clinic model receive standard prenatal care, which includes provision of basic information about WIC. The Clinic-WIC model includes a clinical decision alert to queue clinical staff to ask about WIC interest and place a referral to WIC using a social health access referral platform. In turn, WIC staff contact the pregnant woman about enrollment. The Clinic-RDN model includes a referral to an RDN for telehealth counseling to promote heart healthy eating and food resource management. The Clinic-WIC-RDN model includes referrals to both WIC and RDN. The primary outcome is difference in WIC enrollment between the Clinic and Clinic-RDN models versus the Clinic-WIC and Clinic-WIC-RDN arms at 6-months post-baseline. Secondary endpoints include WIC retention and adherence, change in participant behavior, skills, and food security, preterm delivery, birthweight, and maternal and child health outcomes. Implementation outcome measures include acceptability, appropriateness, and feasibility from the perspective of clinic and WIC staff. Discussion Study findings will inform system models that integrate clinic care and social care to improve health equity among a high-risk population. Specifically, these findings will advance implementation of strategies to increase enrollment in a widely available but underutilized food provision program during pregnancy. Trial registration ClinicalTrials.gov identifier (NCT06311799). Registered 3/13/2024.

Keywords

• Food security
• Poverty
• Pregnancy
• Quality of health care
• Food assistance