NCT06366776

Emulated Study of Vitamin D Correction Vs Non-Correction

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,000 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vitamin D Deficiency

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2024-04-16
• Last updated: 2025-01-22

Locations

1 site across 1 country: United States