NCT02922361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61,546

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

September 28, 2016

Last Update Submit

February 6, 2022

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Mortality

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

    12 months

Secondary Outcomes (4)

  • Hospital Readmissions

    12 months

  • Cost

    12 months

  • Ambulatory sensitive condition admission

    12 months

  • Utilization

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2021

Last Updated

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share