Clinical Trials Logo

Clinical Trial Summary

This project will use data from a large network-model health maintenance organization that operates Medicare Advantage (MA) plans (CareMore) and fee-for-service Medicare data to (1) better understand the characteristics of high-need, high-cost MA enrollees patients and (2) evaluate the impact of a care management program focused on high-need high-cost MA enrollees with end-stage renal disease.


Clinical Trial Description

There will be two aims. Aim 1 will describe and categorize high-need, high-cost populations. The investigators will use CareMore inpatient, outpatient, and pharmacy claims from years 2010-2014. The investigators will construct mortality and readmission risk category and they will utilize traditional claims-based risk models developed on out of sample data to categorize patient risk level. For the high health expenditure category, they will examine inpatient, outpatient, and pharmacy data to identify groups of patients who drive disproportionate health spending. Finally, for utilization the investigators will use claims and outpatient visit data (to the extent any electronic health record (EHR) data becomes available) to identify patients with disproportionate visit intensity. The approach to describe patients within these groups will be to categorize patients into deciles and utilize multivariate regression models to identify demographic, clinical, socioeconomic, and geographic characteristics associated with presence in a top decile along each metric. For example, the investigators will describe individual and clusters of diagnoses that are associated with high spending. They will also examine patients who meet multiple criteria and describe associated characteristics. Aim 2 will examine the impact of CareMore's end stage renal disease (ESRD) care model. They will use CareMore inpatient, outpatient, skilled nursing facilities (SNF), inpatient rehabilitation facilities (IRF), other facilities, pharmacy, and post-acute care claims and Center for Medicare and Medicaid (CMS) Fee-For-Service (FFS) data from matched geographies. They will also attempt to obtain the healthcare effectiveness data information set (HEDIS) data from health plan at patient and physician level, CMS stars measure data, available electronic medical record (EMR) data, and physician characteristics data to the extent CareMore can provide. They will perform a retrospective analysis of claims data. The investigators will use a primary comparison group of ESRD patients in Medicare FFS, particularly in localities where no ESRD special need plans (SNP) is offered to mitigate some effects of selection. The team will also explore a second comparison group of CareMore traditional MA plan enrollees who develop ESRD. They will first examine patient, physician, and plan or site characteristics associated with variation in utilization of the specialized services including enhanced nutritional counseling, personalized care plans, dialysis treatment evaluation, and supplemental medical evaluations -- using logistic regression. Second, they will perform a descriptive analysis of the association between use of these services and cost and quality outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02922361
Study type Observational
Source University of Pennsylvania
Contact
Status Completed
Phase
Start date September 2016
Completion date December 2021

See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Completed NCT01930396 - Use of Tinzaparin for Anticoagulation in Hemodialysis Phase 4
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01922843 - A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis Phase 2
Not yet recruiting NCT01674660 - Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients N/A
Completed NCT01209403 - Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients Phase 4
Not yet recruiting NCT01157260 - The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease Phase 4
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Completed NCT00528788 - How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis Phase 4
Completed NCT00534144 - Comparison Between Effects of Two Iron Preparations on Protein in the Urine Phase 1
Completed NCT00382044 - Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients N/A
Completed NCT00226902 - Vascular Reactivity in Kidney Disease Patients N/A
Recruiting NCT00235287 - Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease Phase 4
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00071214 - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis Phase 3
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00006297 - Risk Factors for CV Disease in a Dialysis Cohort N/A
Completed NCT05718765 - The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients N/A