Emulated Study of Vitamin D Correction vs Non-Correction

Vitamin D Deficiency Clinical Trial

Official title: Emulated Clinical Trial of the Influence of Corrected Low 25-OH Vitamin D Levels on Healthcare Costs and Healthcare Utilization

Status Not yet recruiting

Clinical Trial Summary

• This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database.

• The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels.

Clinical Trial Description

• The purpose of the study is to characterize healthcare costs and healthcare utilization in subjects with corrected low (<40 ng/ml) 25-OH vitamin D levels compared to subjects with uncorrected low 25-OH vitamin D levels during a three-year period.

• The primary objective of this study is to determine whether ten healthcare costs are lower and ten healthcare utilization parameters occur less frequently in patients with corrected low vitamin D levels compared to patients with uncorrected low vitamin D levels in Cooper outpatients and inpatients.

The costs are:

1. total billed costs for any reason;

2. total billed costs for hospitalizations;

3. total billed costs for ICU admissions;

4. total billed costs for emergency room visits;

5. total billed costs for all other outpatient services;

6. total billed costs for urgent care visits;

7. total billed costs for primary care physician (PCP) services;

8. total billed costs for nurse practitioner (NP) services;

9. total billed costs for all other professional services;

10. total billed costs for medical pharmacy services and products.

The parameters are:

1. number of hospitalizations for any reason;

2. number of ICU admissions for any reason;

3. number of emergency room visits for any reason;

4. all other outpatient services for any reason;

5. number of urgent care visits for any reason;

6. number of primary care physician visits for any reason;

7. number of nurse practitioner visits for any reason;

8. all other professional services for any reason;

9. number of medical pharmacy services for any reason;

10. number of free-standing prescriptions for any reason.

• The secondary objective is to determine the effect of sufficient vitamin D levels (≥ 40 ng/ml) in subjects not requiring a prior correction on the ten healthcare costs parameters and the ten healthcare utilization parameters listed in the primary objective above. ;

Related Conditions & MeSH terms

• Vitamin D Deficiency

• NCT number: NCT06366776
• Study type: Observational
• Source: The Cooper Health System
• Contact: Investigator
• Phone: 856-968-7331
• Email: cafaro-teresa@cooperhealth.edu
• Status: Not yet recruiting
• Start date: April 2024
• Completion date: December 2024