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Clinical Trials/NCT06591182
NCT06591182
Enrolling By Invitation
Not Applicable

Impacts of Social Determinants of Health for Patients Seeking Intravenous Iron Treatments At a Large Community Hospital Adult Infusion Center

BayCare Health System1 site in 1 country130 target enrollmentNovember 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Determinants of Health (SDOH)
Sponsor
BayCare Health System
Enrollment
130
Locations
1
Primary Endpoint
Association between SDOH and patient compliance
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2024
End Date
January 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
BayCare Health System
Responsible Party
Principal Investigator
Principal Investigator

Les Louden

Pharmacy Manager

BayCare Health System

Eligibility Criteria

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

Outcomes

Primary Outcomes

Association between SDOH and patient compliance

Time Frame: 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 Outcomes

  • Patient Perceptions of IV Iron(Through study completion, an average of 1 year)

Study Sites (1)

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