NCT03407885

Brief Summary

Bundled payments (BP) are a key part of Medicare's shift away from the traditional fee-for-service (FFS) payment model. The investigators propose to study a nationwide randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was designed and implemented by CMS and launched in April 2016. Randomization was conducted at the Metropolitan Statistical Area (MSA) level with 67 MSAs and about 800 hospitals assigned to the treatment group. The investigators will examine the impact of bundled payments on Medicare spending, utilization, and quality. Study findings should be directly relevant for the design of payments for knee and hip replacements, two common and expensive medical procedures. Average impacts, as well as variation in impact across types of providers and markets may also shed light on economic mechanisms, which should be relevant for bundled payment initiatives under consideration for other medical services.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

April 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

October 13, 2017

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Share of LEJR admissions discharged to institutional Post-Acute Care (PAC)

    Share of lower extremity joint replacement (LEJR) index admissions discharged to institutional post-acute care facilities (i.e. skilled nursing facilities (SNF), long term care hospitals (LTCH) or inpatient rehabilitation facilities (IRF)). LEJR index admissions are eligible admissions at acute care hospitals (ACH) that result in a discharge in either DRG 469 or 470.

    At hospital discharge up to 3 days

Secondary Outcomes (6)

  • Share of LEJR admissions discharged to any Post Acute Care (PAC)

    At hospital discharge up to 3 days

  • Number of days in Institutional PAC during episode

    Begins with index admission and ends 90 days post-discharge from index admission

  • Total covered Medicare payments during episode

    Begins with index admission and ends 90 days post-discharge from index admission

  • Total covered Medicare payments for Institutional PAC during episode

    Begins with index admission and ends 90 days post-discharge from index admission

  • Total covered Medicare payments for any PAC during episode

    Begins with index admission and ends 90 days post-discharge from index admission

  • +1 more secondary outcomes

Other Outcomes (11)

  • Any THA/TKA complication

    Begins with index admission and ends 90 days post-discharge from index admission

  • Number of THA/TKA complications

    Begins with index admission and ends 90 days post-discharge from index admission

  • Share of LEJR admissions with an ER visit within 90-days of discharge from index admission

    Begins with index admission and ends 90 days post-discharge from index admission

  • +8 more other outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Bundled payments for knee and hip replacement

Other: Bundled payments for knee and hip replacement

Control

NO INTERVENTION

No intervention

Interventions

The bundled payment model holds acute care hospitals (ACHs) financially responsible for the spending and quality of an entire episode of care for two types of hospital admissions: MS-DRG 469 and 470. An episode begins with an ACH stay that results in a discharge in one of the two DRGs, and ends 90 days after discharge. Before each performance year begins, hospitals receive target prices from CMS, determined by historical hospital and regional episode expenditures. Hospitals are eligible for reconciliation payment from CMS if they spend less than the target prices for an episode, provided that they met an "acceptable" quality standard. Conversely, they are responsible for paying the difference if they spend more than the target prices.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Acute care hospital paid under the inpatient prospective payment system (IPPS)
  • Hospital admission for major joint replacement or reattachment of lower extremity with and without major complications or comorbidities (MS-DRG 469 and 470)

You may not qualify if:

  • MSAs with low volume of LEJR
  • MSAs with high take-up of BPCI
  • MSAs with large share of LEJR in Maryland hospitals
  • Hospitals participating in certain models of BPCI.
  • Patient not covered by both Medicare Parts A and B
  • Patient eligibility for Medicare is due to end stage renal disease (ESRD)
  • Patient is in a managed care plan
  • Patient is in a United Mine Workers of America Plan
  • Medicare is not the primary payer for the patient
  • Patient dies during the episode
  • Patient is re-admitted to an ACH for one of the two CJR DRGs during the episode
  • Patient initiates an LEJR episode under BPCI during the episode
  • Payments and services that occur in the episode that are excluded are:
  • hemophilia clotting factors
  • new technology add-on payments
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Finkelstein A, Ji Y, Mahoney N, Skinner J. Mandatory Medicare Bundled Payment Program for Lower Extremity Joint Replacement and Discharge to Institutional Postacute Care: Interim Analysis of the First Year of a 5-Year Randomized Trial. JAMA. 2018 Sep 4;320(9):892-900. doi: 10.1001/jama.2018.12346.

  • Einav L, Finkelstein A, Ji Y, Mahoney N. Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform. Proc Natl Acad Sci U S A. 2020 Aug 11;117(32):18939-18947. doi: 10.1073/pnas.2004759117. Epub 2020 Jul 27.

  • Einav L, Finkelstein A, Ji Y, Mahoney N. VOLUNTARY REGULATION: EVIDENCE FROM MEDICARE PAYMENT REFORM. Q J Econ. 2022 Feb;137(1):565-618. doi: 10.1093/qje/qjab035. Epub 2021 Sep 20.

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Amy N Finkelstein, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR
  • Yunan Ji

    Harvard University

    PRINCIPAL INVESTIGATOR
  • Neale Mahoney, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Jon Skinner, PhD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientific Director, J-PAL North America

Study Record Dates

First Submitted

October 13, 2017

First Posted

January 23, 2018

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 1, 2022

Last Updated

March 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share