Effects of Social Determinants of Health on IV Iron Treatments

• Conditions: Social Determinants of Health (SDOH)

• Registration Number: NCT06591182
• Lead Sponsor: BayCare Health System

Brief Summary

This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-07
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients receiving one of the following IV iron products: Ferric Carboxymaltose, Ferric Derisomaltose, Ferumoxytol, Iron Sucrose, or Iron Dextran
• Patients 18 years of age or older
• Patients who speak English or Spanish

Exclusion Criteria

• Patients receiving an alternative IV iron product: Sodium ferric gluconate
• Patients under 18 years of age
• Patients who do not speak English or Spanish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between SDOH and patient compliance	Through study completion, an average of 1 year	To associate the percentage of patients with self-reported social needs (e.g., social determinants of health) with compliance of IV iron treatments at a large community hospital adult infusion center.; Measurements (social determinants of health) to be explored include: food insecurity, housing instability, utility needs, financial resource strain, transportation challenges, and socio-demographic information. Slightly adapted questions for each measure are derived from the Health Leads Screening Tool, a clinically-validated mechanism for assessing social needs. Questionnaire is structured in a yes/no and Likert scale format.

Secondary Outcome Measures

Name	Time	Method
Patient Perceptions of IV Iron	Through study completion, an average of 1 year	To study patient perceptions of IV iron treatment dosing (doses received) and administration rates (infusion time).

Trial Locations

Locations (1)

St. Josephs Hospital Adult Infusion Center; 🇺🇸 Tampa, Florida, United States