Spending and Outcomes for Complex Medicare Advantage Patients

Kidney Failure, Chronic Clinical Trial

Official title:

Characterizing High-Cost, High-Need Patient Populations and Response to Care Management Programs at a NetworkModel Medicare Advantage Health Maintenance Organization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922361
• Other study ID #: 825923
• Status: Completed
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61546
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants in this study will be patients of CareMore with at least one claim, ESRD CareMore patients enrolled in a SNP or a traditional MA plan, and Medicare FFS ESRD patients in matched geographies.

Exclusion Criteria:

• Participants without at least one claim with CareMore or not located in a matched Medicare FFS geographies.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Blue Cross Blue Shield

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The study team will evaluate mortality by using 30 day mortality after readmission.	12 months
Secondary	Hospital Readmissions	The study team will evaluate re-admissions by measuring 30-day all-cause unplanned readmission.	12 months
Secondary	Cost	The study team will evaluate cost by measuring total medical spending.	12 months
Secondary	Ambulatory sensitive condition admission	The study team will evaluate admissions by measuring ambulatory sensitive conditions admissions.	12 months
Secondary	Utilization	The study team will evaluate utilization be measuring the index of outpatient and inpatient utilization.	12 months