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Kidney Failure, ChronicNCT02922361

Spending and Outcomes for Complex Medicare Advantage Patients

An observational study of Kidney Failure, Chronic, run by University of Pennsylvania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Kidney Failure, Chronic
How many people
61,546 participants
Where
No sites listed yet
Study dates
Sep 2016to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Medical subject headings
Kidney Failure, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    The study team will evaluate mortality by using 30 day mortality after readmission.

    Measured: 12 months

Secondary outcomes (4)
  1. Hospital Readmissions

    The study team will evaluate re-admissions by measuring 30-day all-cause unplanned readmission.

    Measured: 12 months

  2. Cost

    The study team will evaluate cost by measuring total medical spending.

    Measured: 12 months

  3. Ambulatory sensitive condition admission

    The study team will evaluate admissions by measuring ambulatory sensitive conditions admissions.

    Measured: 12 months

  4. Utilization

    The study team will evaluate utilization be measuring the index of outpatient and inpatient utilization.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2018
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
61,546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922361
Sponsor's protocol ID
825923
Status last verified
Feb 2022
First submitted
28 Sep 2016
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Failure, Chronic, run by University of Pennsylvania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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