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Spending and Outcomes for Complex Medicare Advantage Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02922361
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : March 11, 2020
Blue Cross Blue Shield
Information provided by (Responsible Party):
Amol Navathe, University of Pennsylvania

Brief 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.

Condition or disease
Kidney Failure, Chronic

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characterizing High-Cost, High-Need Patient Populations and Response to Care Management Programs at a NetworkModel Medicare Advantage Health Maintenance Organization
Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mortality [ Time Frame: 12 months ]
    The study team will evaluate mortality by using 30 day mortality after readmission.

Secondary Outcome Measures :
  1. Hospital Readmissions [ Time Frame: 12 months ]
    The study team will evaluate re-admissions by measuring 30-day all-cause unplanned readmission.

  2. Cost [ Time Frame: 12 months ]
    The study team will evaluate cost by measuring total medical spending.

  3. Ambulatory sensitive condition admission [ Time Frame: 12 months ]
    The study team will evaluate admissions by measuring ambulatory sensitive conditions admissions.

  4. Utilization [ Time Frame: 12 months ]
    The study team will evaluate utilization be measuring the index of outpatient and inpatient utilization.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population will be all patients with at least one CareMore and CareMore ESRD patients - both enrolled in ESRD SNPs and traditional MA plan - and Medicare FFS ESRD patients in matched geographies.

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.

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Responsible Party: Amol Navathe, Principal Investigator, University of Pennsylvania Identifier: NCT02922361    
Other Study ID Numbers: 825923
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs