- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02922361
Spending and Outcomes for Complex Medicare Advantage Patients
February 6, 2022 updated by: Amol Navathe, University of Pennsylvania
Characterizing High-Cost, High-Need Patient Populations and Response to Care Management Programs at a NetworkModel Medicare Advantage Health Maintenance Organization
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
61546
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 12 months
|
The study team will evaluate mortality by using 30 day mortality after readmission.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Readmissions
Time Frame: 12 months
|
The study team will evaluate re-admissions by measuring 30-day all-cause unplanned readmission.
|
12 months
|
Cost
Time Frame: 12 months
|
The study team will evaluate cost by measuring total medical spending.
|
12 months
|
Ambulatory sensitive condition admission
Time Frame: 12 months
|
The study team will evaluate admissions by measuring ambulatory sensitive conditions admissions.
|
12 months
|
Utilization
Time Frame: 12 months
|
The study team will evaluate utilization be measuring the index of outpatient and inpatient utilization.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 6, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 825923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Failure, Chronic
-
Centre Hospitalier Universitaire DijonTerminatedEnd-stage Chronic Kidney FailureFrance
-
Baxter Healthcare CorporationRecruitingAcute Kidney Failure | Chronic Kidney FailureChina
-
Angiodynamics, Inc.TerminatedChronic Kidney Disease | Acute Kidney Injury | Acute Renal Failure | Renal Failure Chronic Contrast InducedUnited States
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
Hopital Jean MinjozUnknownCardiac Surgical Procedures | Preoperative KIDNEY FAILURE, CHRONIC | Postoperative KIDNEY FAILURE, ACUTEFrance
-
Nantes University HospitalNot yet recruiting
-
Ozge AKBABAAtatürk UniversityCompletedChronic Kidney FailureTurkey
-
Chinese PLA General HospitalCompletedKidney Failure,ChronicChina
-
Fatma Alzahraa Mohamed Ibrahim Hassan HaggagUnknown