Effects of Social Determinants of Health on IV Iron Treatments

NCT06591182 | Enrolling By Invitation

• 2 other identifiers: 2024.001-BSJHNIS-ISS-37 SDoH
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Determinants of Health (SDOH)

Keywords

Iron; social determinants of health; intravenous iron; patient compliance

Outcome Measures

Primary Outcomes (1)

• Association between SDOH and patient compliance

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Patient Perceptions of IV Iron

  Through study completion, an average of 1 year

Interventions

Survey using a questionnaire. OTHER

Observational study, participants are not assigned an intervention as part of the study (Survey using a questionnaire).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending an appointment for an IV iron infusion at the community hospital infusion clinic on the same day they are being asked to participate in the survey; 18 years of age or older; those who speak English or Spanish.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• BayCare Health System: lead
• University of South Florida: collaborator

Study Sites (1)

St. Josephs Hospital Adult Infusion Center

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Les Louden, PharmD, MS

  BayCare Health System

  PRINCIPAL INVESTIGATOR

• Janelle Applequist, PhD

  The University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Manager

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: November 5, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)