Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366776
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-12
Brief Title:
Emulated Study of Vitamin D Correction vs Non-Correction
Sponsor:
The Cooper Health System
Organization:
The Cooper Health System
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ngml 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 ngml 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
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 ngml 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None