Emulated Study of Vitamin D Correction Vs Non-Correction
- Conditions
- Vitamin D Deficiency
- Registration Number
- NCT06366776
- Lead Sponsor
- The Cooper Health System
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 9000
- Any patient with at least one 25-OH vitamin D test result. Patients with one test result will remain in the limited dataset for potential future research.
- Any patient with a 25-OH vitamin D level(s) always lower than 40 ng/ml (low level) with subsequent level(s) in the 40 ng/ml to 100 ng/ml range. The 40 ng/ml to 100 ng/ml range is maintained for three years. This corrected group is labeled as the Treatment Group.
- Any patient with a 25-OH vitamin D level always lower than 40 ng/ml with maintenance of that lower than 40 ng/ml level for 3 years. This uncorrected group is labeled as Control Group A.
- Any patient who has an uninterrupted 25-OH vitamin D level greater than or equal 40 ng/ml and less than or equal to 100 ng/ml (sufficient level) for a continuous 3-year period. Prior to the 3-year period there were no levels lower than 40ng/ml or higher than 100 ng/ml. This vitamin D3 sufficient group is labeled as Control Group B.
- Any patient with only one 25-OH vitamin D3 test result or any patient who cannot be included in the Treatment Group, Control Group A, or Control Group B is excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A. 3 year observation period The ten healthcare costs parameters: total billed costs for any reason; costs for hospitalizations; costs for ICU admissions; costs for emergency room visits; costs for all other outpatient services; costs for urgent care visits; costs for primary care physician (PCP) services; costs for nurse practitioner (NP) services; costs for all other professional services; and costs for medical pharmacy services and products among Treatment Group and Control Group A..
Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A. 3 year observation period The ten healthcare utilization parameters: number of hospitalizations; number of ICU admissions; number of emergency room visits; all other outpatient services; number of urgent care visits; number of primary care physician services; number of nurse practitioner services; all other professional services; number of medical pharmacy services or products; and number of free-standing prescriptions among Treatment Group and Control Group A.
- Secondary Outcome Measures
Name Time Method Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B). 3 year observation period The secondary outcomes are the ten healthcare costs parameters listed in the primary outcomes above relating to patients with sufficient vitamin D levels who did not require a prior correction (Control Group B).
Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B). 3 year observation period The secondary outcomes are the ten healthcare utilization parameters listed in the primary outcomes above relating to patients with sufficient vitamin D levels who did not require a prior correction (Control Group B).
Trial Locations
- Locations (1)
Cooper Health System
🇺🇸Camden, New Jersey, United States