Imperial County Clinical Research Network for Health Equity (Administrative Supplement) - Project Summary ICCRN is building the infrastructure (personnel, equipment, and systems [policies and procedures]) for clinical research within a Federally Qualified Health Center – Innercare - that serves a rural, border community in Southern California, specifically Imperial and South Riverside Counties. The ICCRN research infrastructure is intended to support both observational (e.g., cohort studies; secondary analyses using electronic health record [EHR] data) and intervention research (from efficacy to pragmatic trials). In this administrative supplement application, we propose to augment research activities already approved under the prime contract, including primary data collection of various social determinants of health (SDOH) using PhenX measures among patients with uncontrolled diabetes and women receiving prenatal and postpartum care through Innercare. These data will form the basis of our Common Data Elements (CDEs), data that will be harmonized with other clinical network sites. Identifying CDEs, as well as protocols and processes for data sharing and harmonization with other clinical network sites, has the potential to increase data interoperability and contribute generalizable knowledge relevant to address health disparities. The Specific Aims of this Administrative Supplement include: AIM 1 – Promote MHHD research by augmenting research staff support, including within the clinical partner organization. AIM 2 – a. PP1: Identify SDOH relevant to diabetes management and control, and treatment adherence. PP1 sample size is increased from N=126 to N=198 to support additional moderation and mediation analyses. In addition, PP1 T2 (3 months post-baseline) data collection is expanded to include the collection of additional PhenX measures from cohort participants; b. Identify SDOH relevant to adverse pregnancy outcomes (APOs). PP2 is augmented to include primary data collection of PhenX and other measures from a systematic sample of postpartum patients (N=600). In addition, PP2 is expanded to include qualitative data collection from patients (N=10). AIM 3 – Support data harmonization with other CRNHE clinical sites for rapid identification of new project ideas and dissemination of local and network-harmonized data to patient, organizational, and community stakeholders. Completion of Administrative Supplement AIMS 1-3 will augment both local and national efforts to identify important modifiable determinants to inform future interventions (as in the case of PP2), and determinants of treatment effectiveness (as in the case of PP1). Harmonized data with other network sites will contribute significant evidence for SDOH relevant across diverse populations who share some characteristics (e.g., patients of a Federally Qualified Health Center, education level) but not others (e.g., race/ethnicity, immigration status).
